1. Crushing, sieving and mixing Chinese medicine practical training operation technology
1. Crush
Objects show different hardness and properties due to different cohesion between molecules. Therefore, crushing is the process of partially destroying the cohesive force between material molecules by mechanical force, and breaking up large solid materials into small particles or fine powder, that is, converting mechanical energy into surface energy.
2. Sieve analysis
Sieving into sieving, sieve analysis refers to the operation of separating coarse and fine powder by air or liquid (water) flow or rotating force. That is, as long as required, the medicinal powder with appropriate fineness can be separated.
3. Mixed
Mixing is the process of cross-dispersing multiple solid powders.
Second, the extraction and concentration of traditional Chinese medicine training operation technology
Leaching refers to the whole process in which the solvent enters the cell tissue and dissolves its active ingredients and becomes the leachate. As long as there are extraction methods: decoction method, dipping method, percolation method, reflux method, steam distillation method. Among them, the decoction method is the most common method of extraction.
Concentration is an operation that uses a suitable method to remove part of the solvent in the drug solution to obtain a concentrated solution with a higher concentration. Concentration is an important operation for the pre-treatment of raw materials in traditional Chinese medicine preparations. In addition, reverse osmosis and ultrafiltration can also be used to concentrate the pharmaceutical industry.
Third, the filter training operation technology
Filtration is one of the most commonly used separation methods. When the precipitate and the solution pass through the filter, the precipitate remains on the filter, the solution passes through the filter and enters the container, and the resulting solution is called a filtrate.
Commonly used filtration methods are normal pressure filtration (common filtration), reduced pressure filtration (suction filtration) and heat filtration.
Fourth, recrystallization training operation technology
The operation of separating the purified substances and impurities in the same solvent with significant differences and separating them is called recrystallization.
Recrystallization is a common method for purifying solid organic compounds. The solubility of most organics in solvents increases with increasing temperature and decreases with decreasing temperature. Recrystallization is the use of this principle to dissolve organic matter in a hot solvent to make a solution close to saturation. Filter while hot to remove insoluble impurities. Then cool the solution to allow the organic matter to recrystallize in a cold solvent. The impurities dissolved in the solvent phase separate. If the solid contains colored impurities, activated carbon can generally be used for decolorization. After one or more recrystallizations, the purity of organic matter can be greatly improved. The key to the recrystallization operation is to select the dissolving agent.
5. Practical training operation technology of vacuum distillation
Vacuum distillation, also known as vacuum distillation, refers to distillation operations carried out below standard atmospheric pressure. It is suitable for separating and purifying substances that have been decomposed, oxidized or polymerized before distillation under normal pressure.
The boiling point of a liquid refers to the temperature when its vapor pressure is equal to the outside atmospheric pressure. Therefore, lowering the external pressure can reduce the boiling point of the substance, so that the substance will boil at a lower temperature and be distilled out.
6. Extraction training operation technology
According to the partition ratio (or different solubility) of the substance in two incompatible or slightly soluble solvents, the method of transferring the substance from one solvent to another solvent for separation and purification is called extraction.
Extraction is usually divided into liquid-liquid extraction and liquid-solid extraction.
For liquid-liquid extraction, there are two types of extractants. A type of extractant is usually an organic solvent, and its extraction principle is to use the difference in the solubility (or partition coefficient) of the substance in two incompatible (slightly soluble) solvents to transfer the substance from one solvent to another. In the solvent, the purpose of extracting the substance is achieved. For example, the solubility of organic compounds in organic solvents is generally greater than the solubility in water. Therefore, organic solvents that are insoluble or slightly soluble in water can be used to extract organic compounds from aqueous solutions.
According to the distribution law, multiple extractions with a certain amount of solvent are more efficient than one extraction. Generally, three extractions can extract most of the material.
Another type of extractant is a reactive reagent whose extraction principle is to use it to chemically react with the substance to be extracted. This extraction is commonly used to wash small amounts of impurities from compounds or to separate mixtures. Commonly used alkaline extractants such as 5% sodium hydroxide and 5% (or 10%) sodium carbonate (or sodium bicarbonate) solutions can separate organic acids or remove acidic impurities from the mixture; and acidic extractants such as sodium sulfate Dilute hydrochloric acid can separate organic base or remove basic impurities from the mixture, concentrated sulfuric acid can remove unsaturated hydrocarbons from saturated hydrocarbons, and remove alcohols and ethers from haloalkanes.
For liquid-solid extraction, the extraction principle is to use the difference in solubility of the extracted substances and impurities in the solid sample in the same liquid solvent to achieve the purpose of extraction and separation.
Seven, sterilization, aseptic training operation technology
Sterilization refers to the use of physical, chemical or other suitable methods to kill or remove all living microorganisms. Microorganisms include bacteria, fungi, viruses, etc. Different microorganisms have different resistance to sterilization and different sterilization effects; bacterial spores have strong heat resistance and are not easy to kill, so the sterilization effect is often based on killing spore standard. Aseptic operation refers to a technical operation in which the entire process is controlled under aseptic conditions. It is not a sterilization process and can only maintain the original sterility. All utensils, materials and environment used for aseptic operation must be sterilized by a suitable method. Commonly used methods are physical sterilization and chemical sterilization. Physical sterilization is a method that uses high temperature or other methods, such as filter sterilization, ultraviolet rays, etc. to kill microorganisms. Heating can solidify and denature the protein of microorganisms, causing the death of microorganisms. The chemical sterilization method refers to the sterilization method that uses certain chemical drugs to directly act on the microorganisms to kill them without compromising the quality of the sterilized materials. The chemicals used to kill microorganisms are called fungicides. Gas sterilizers are generally used for sterilization of aseptic operating rooms or solid raw materials.
Eight, thin layer chromatography training technology
The test solution and the appropriate control were spotted on the thin-layer plate, and the chromatograms were developed and inspected to calculate the ratio of test solution spot to reference solution spot transplantation. Then make a comparison, or used for drug identification or impurity inspection.
Nine, chromatography column packing training technology
Chromatography is a technique established by using differences in physical and chemical properties of different substances. The chromatography system consists of two phases: one is the stationary phase, which is a solid substance or a component fixed on the solid substance; the other is the mobile phase, such as water and various solvents. When the mixture to be separated passes the stationary phase with the mobile phase (solvent), there are differences due to the physical and chemical properties of the components. Different from the two phases in the ability to interact (adsorption, dissolution, binding, etc.), the distribution (content comparison) in the two phases is different, and as the mobile phase moves forward, the components are continuously distributed in the two phases. The weaker the component interacts with the stationary phase, the smaller the retardation effect when the mobile phase moves, and the faster the forward movement. Conversely, the stronger the component interacting with the stationary phase, the slower the forward movement speed, and the effluent is collected in sections to obtain the individual components contained in the sample, thereby achieving the purpose of separating the components.
10. Training on the net system of traditional Chinese medicine
The net preparation is also called net selection. The purpose is to remove impurities, separate different medicinal parts, remove non-medicinal parts, and facilitate the next processing operation. It is the first process of processing Chinese medicinal materials. Generally, Chinese herbal medicines can be divided into different sizes after being cleaned, which is convenient for cutting and processing, which can ensure the accuracy of clinical medication and reduce side effects. Therefore, it is an important link to ensure the quality of Chinese herbal medicines. The evaluation index of the net selection operation is clarity.
11. Cutting of Chinese herbal decoction pieces
After the medicinal materials are softened, they are cut into pieces, silk, segments, blocks and other suitable medicinal shapes with a knife. Hand-cutting is mainly used for some soft, too sticky and powdery and some special medicinal materials. The main purpose of the cut pieces is: to facilitate the decoction of the active ingredients, to facilitate the preparation, to facilitate the preparation and storage, to facilitate the identification and stand on the preparation. Common methods of drying are: sun drying, shade drying, and drying.
Twelve: Practical training of Chinese medicine cleaning method
Stir-fried yellow medicines that are about to be cleaned are placed in a pre-heated wok and heated with a simmer or medium heat until the yellow or darker color of the medicine surface is deepened, or there is a slight burnt spot, or the foam is bulged, or burst Stir-fry into white patterns, and escape the inherent smell of drugs.
Stir-fried coke, which is about to be cleaned or cut, is placed in a stir-fry appliance and heated with medium or arsenal until the surface of the medicine is burnt yellow or brown, and the smell of burnt incense escapes.
Stir-fried carbon is about to be cleaned or cut into medicines, placed in the frying utensils, heated with fire or medium heat, the surface of the fried medicines is burnt black, and the inside is burnt yellow or burnt brown.
Thirteen, Chinese medicine plus solid auxiliary materials frying method
The difference between the method of adding solid auxiliary materials and the method of frying is that the auxiliary materials must be added before the medicine is added, so that the medicine and the auxiliary materials are mixed and fried to a certain extent. Commonly used are bran, rice, river sand, heart soil, clam powder, talc powder and so on.
Bran stir-fry and rice stir-fry are to preheat the casserole first, add a certain amount of auxiliary materials and stir-fry until it meets the requirements, put in the herbs to be fried, and stir-fry them to the prescribed level.
Sand stir-fry is a method of mixing stir-fried net or cut medicine with hot sand. The preheating pot can be supplemented, but the ingredients should be fried to the required level before the drug is added.
14. Practical training of Chinese medicine calcination
The operation of the calcination method is divided into three types: open calcination, buckling pot calcination and calcination method, which is suitable for traditional Chinese medicines with different textures.
Mingjian puts the medicine directly into the calciner and heats it with a fire. This method is applicable to soluble mineral medicines, shellfish, fossils containing crystal water and mineral medicines with small particle size or fragile after calcination and burst during calcination.
The quenching method is suitable for mineral medicines that are hard in texture and cannot be loosened at high temperatures, and drugs that require the quenching method due to special needs in the clinic.
The pot-reduction calcination method is suitable for loose texture, fried carbon easy to ash, and some Chinese medicines require comprehensive carbon preparation drugs in the preparation process.
15. Practical training of Chinese medicine cooking method
Evaporation is to rinse the medicine to be steamed clean, divide it into different sizes, put it in a steaming container, and take it out when it is heated to the required level through water. When the medicine is steamed by adding an auxiliary material, the auxiliary material can be used to moisten the medicine in advance or mixed with the auxiliary material and the medicine. Divided into indirect steaming method and direct steaming method.
When the direct steaming method is used to prepare the medicine: put the medicine after the binning into the cage and steam it directly to a certain degree.
When indirect steaming is used to prepare medicines: (1) Run the binned medicines with auxiliary materials (or water), or mix them with the auxiliary materials and place them in the steaming container (the medicines with high tannin content should be placed in non-ferrous containers) ) Heated in water; 2. Steam on high heat first. When the "round gas" is changed to a small fire (when the wine is steamed in a non-closed container. Use a mild fire) to keep enough steam in the pot; 3. After the medicine is steamed to the desired level, wait for the temperature and room temperature in the pot Open the pot when approaching; 4. Place the medicine in a clean container; 5. Wash the steamer and other containers.
Chinese medicine cooking method training
The method of cooking the cleaned medicine with fresh water is called the boiling method, which can be divided into two kinds of boiling with fresh water and boiling with auxiliary materials.
Apparatus and utensils: tiltable cooking pot, gas stove, steamer, brush, medicine holding utensil, balance.
Test drug: sulfur
Accessories: tofu
Duplicate training
The method of placing the net-selected medicinal materials in a specific container, adding one or several auxiliary materials, and repeatedly processing according to the prescribed operating procedures is called the replication method. After replication, the toxicity of medicinal materials is reduced or the efficacy is enhanced.
Fermentation training
Fermentation method, also known as brewing method, refers to the method of purifying or treating the medicine, under certain temperature and humidity conditions, due to the catalytic decomposition of mold and enzymes, the method of making the medicine foam and raw clothes.
Chinese medicine germination method training
The germination method refers to a method of promoting the germination of fresh ripe fruits or seeds after net selection at a certain temperature or humidity. The operation is generally to select fresh, large-grained, full, and pest-free seeds or fruits, soak them with appropriate amount of water until they swell up (generally soak in spring and autumn 4-6h, winter 8h, summer 4h). After fishing, put it in a container that is breathable and leaky, or on the ground where the bamboo mat is cushioned. Cover with a wet object. Keep the temperature at 18-25 ° C. Spray clean water 2-3 times a day to keep it moist. . Young shoots germinate after 2-3 days. When the buds grow to 0.2-1cm, take out and dry.
Frost training
The proper method of heating and squeezing the oil to make loose powder is called frosting. It can be divided into degreasing frosting method, dialysis frosting method, sublimation frosting method and decoction frosting method.
Baking method training
The method of directly or indirectly heating the cleaned or cut medicines with a simmer to make them fully dry is called baking method. It is mostly used in the preparation of animal medicinal materials.
Simmering training
The medicine is wrapped with a wet surface or wet paper and placed in heated talc powder, or the medicine is directly placed in the heated bran, or the medicine is spread on the oil-absorbing paper and heated by layers of paper to remove part of the oil paper, These processing methods are collectively called the simmering method.
Training on the method of purification
The purification method, also known as the extraction method, is a method of recrystallizing certain mineral medicines, especially some soluble inorganic salt medicines, after dissolving, filtering, and removing impurities, often used in mineral medicines.
Water fly training
The water fly method refers to a method in which certain mineral medicines that are insoluble in water use different thicknesses of powders to suspend in water, and the minerals and shellfishes that are insoluble in water are repeatedly ground into very fine powders.
Training content and steps:
Crush the cinnabar properly, put it in a mortar or other suitable container, add an appropriate amount of water, grind it into a paste, and then add a lot of water to stir, the coarse powder will sink, and after a while, pour out the suspension, the coarse The powder is ground again, and the operation is repeated until the fines are ground, and finally the impurities that cannot be suspended are removed. The decanted suspensions before and after are combined and allowed to stand. After the precipitation, the above clear water is decanted, and the dried precipitate is ground into a very fine powder.
Main stream training
The dry distillation method is to place the medicine in a suitable container and roast it at high temperature. How to make it juice. Its main purpose is to prepare drugs suitable for clinical needs.
Preparation of various Chinese medicine preparations
Preparation of Chinese medicine powder
Powders refer to medicinal materials or extracts of medicinal materials that are crushed and mixed to make powdered preparations, which are divided into internal powders and external powders. The preparation process of powder is: crushing → sieving → mixing → divided doses → quality inspection → packaging
Mixing is an important procedure for preparing compound powders. When the proportions of the components in the powder differ greatly, the "equal increment method" or the blending method should be used to mix evenly. If the density of each component differs greatly, the component with the lower density should be added to the mortar first, and the component with the higher density should be added for mixing. â€For mixing, generally add the component with deep color to the mortar and then mix with the component with light color. If it contains low eutectic components, make them eutectic or avoid eutectic as needed; When medicines or powders with small doses are used, they should be mixed and sieved by the blending method.
Preparation and training of Chinese medicine pills
1. Water pill
Water pills refer to pills made of medicinal powder with water (or rice wine, vinegar, dilute juice, sugar liquid) as a binder.
Water pills are generally prepared by the pan method. The pan method is also suitable for the preparation of water honey pills, paste pills, and concentrated pills.
The preparation process flow is as follows: raw material processing → molding → forming → covering → pill selection → coating → quality inspection → packing.
Preparation points: The powder for pill making should be fine powder or very fine powder; the powder for molding, covering, and coating should be selected according to the nature of the prescription drug. There are many types of excipients for pills, and the proper wetting agent and adhesive are selected to make it not only beneficial to molding, but also help to control the dissolution time limit and improve the efficacy. In the process of manual panning, mass, turn, and bump should be used alternately to ensure that the pellets have appropriate hardness and are round and smooth.
2. Honey pill
Honey pill refers to a pill made of medicinal powder with honey as a binder.
Honey pill is generally prepared by plastic method. The plastic method is also suitable for preparing concentrated pills, paste pills, wax pills, etc. The preparation process is as follows: material preparation → pelletizing block → rubbing bar → granulating, rubbing round → drying, sterilization → quality inspection → packaging.
Pill making is the key to the operation of preparing honey pills. Generally, the color is consistent, soft and hard, not sticking hands, not sticking to the wall, which is convenient for making pills and rounding, and it is not easy to deform during storage.
Preparation and training of Chinese medicine granules
Practical training principle: granules refer to medicinal extracts and appropriate excipients or medicinal fine powders to make granular preparations with a certain particle size. Divided into soluble particles, suspended particles and effervescent particles.
The preparation process of soluble granules is: extraction → purification → granulation → drying → whole granulation, classification → mixing → quality inspection → packaging
Suspended granules are obtained by extracting a part of the medicinal materials in the prescription into a thick paste, and crushing another part of the medicinal materials into a very fine powder and adding them to the thick paste to make granules.
Effervescent granules are to divide the extracts and auxiliary materials into two equal parts according to the method of water-soluble granules in the prescription. One part is made of acidic particles by adding organic acid; Mix the two and you'll get it.
Tablet preparation training
Training principles:
Tablet refers to the preparation of medicinal material extract, medicinal herb extract plus medicinal material fine powder or medicinal material fine powder mixed with suitable auxiliary materials and compressed or made into disc-shaped or shaped tablets by other methods. Tablets are one of the most widely used dosage forms in the clinic. The preparation methods of tablets mainly include wet granulation and dry granulation (including direct granulation of powder, granulation of dry granulation and direct compression of crystalline materials).
Granulation in wet granulation is an important step in tabletting. First, wetting agent or adhesive must be selected according to the nature of the main drug. When the soft material is made by wet granulation, the amount of wetting agent or adhesive should be controlled to make the soft material reach the standard of "holding into a lump and light pressure to loosen".
The prepared wet granules should be dried at a suitable temperature (60-80 ℃) according to the nature of the main drug and auxiliary materials. For drugs that are stable in heat and humidity, the drying temperature can be increased appropriately. When drying, it should be noted that the particle thickness should not exceed 2.5cm. And the drying process should be turned frequently. The dried granules must be sieved and sized. During the granulation, the screen aperture should be the same as or slightly smaller than the screen aperture for granulation. Add lubricants, disintegrants and other auxiliary materials after mixing, mix well and tablet.
Capsule preparation training
Training principles:
Capsule refers to a preparation prepared by filling medicinal materials with suitable methods and filling appropriate hollow materials in hollow capsules or sealed in soft capsule materials, which can be divided into hard capsules, soft capsules and enteric capsules.
The preparation process of hard capsules is as follows: drug treatment and selection of hollow capsules → filling → capsule sealing → polishing → quality inspection → packaging
Ointment preparation training
Training principles:
Ointment refers to a semi-solid external preparation made by uniformly mixing medicinal material extract, medicinal material fine powder and suitable base. Commonly used bases are divided into oily, water-soluble and emulsion-based bases, and ointments made with emulsion-based bases are also called creams. The quality inspection items of ointment usually have appearance, microbial limit, difference in loading, main drug content, irritation, viscosity, stability, etc.
Different types of ointment bases have different effects on drug release and absorption, of which the emulsion-based base is the fastest. Different types of ointment can be divided into the preparation by the research method, fusion method and emulsification method according to the nature of the drug and matrix, the amount of preparation and the equipment conditions. If the ointment base is relatively soft, it can be evenly mixed with the drug by grinding at normal temperature, which can be researched; if the melting point of the ointment base is different, it cannot be mixed evenly with the drug at normal temperature, or the drug can be dissolved in the base, or the medicinal material must be heated by the base The effective ingredients are extracted by melting method; emulsification method is a special method for preparing cream.
Ointment preparation process: ingredients → adjustment (matrix treatment, drug treatment, configuration) → filling → quality inspection → packaging.
Preparation training of leaching agent
Training principles:
Leaching agents include wine, tincture, and syrup.
Alcohol, tincture and leaching cream are alcohol-containing leaching preparations, and the finished product should be checked for ethanol content.
Liquor refers to the extraction of medicinal materials with distilled wine to make clear liquid dosage forms. There is no uniform regulation on the amount of medicinal materials. Usually, wine is used as the leaching solvent. It is prepared by cold impregnation method, hot impregnation method, percolation method, and reflux method. Appropriate amount of sugar refining or honey refining can be added to correct the taste.
Liquor refers to a clear liquid preparation made by extracting or dissolving the drug with a specified concentration of ethanol, and can also be made by diluting with flow extract. Unless otherwise specified, the tincture of toxic drugs equals 10g of the original medicinal materials per 100ml; other tinctures equal to 20g of the original medicinal materials per 100ml. Different ethanol is usually used as the solvent, and it is prepared by the dissolution method, dilution method, dipping method and percolation method.
Flow extract refers to a preparation made by extracting and evaporating part of the solvent with an appropriate solvent and adjusting the concentration to the prescribed standard. Unless otherwise specified, each 1ml is equivalent to 1g of the original medicinal material. Generally, ethanol with different concentrations is used as the solvent, which is usually prepared by the percolation method, and can also be prepared by the dipping method or the decoction method. The finished product of flow extract contains at least 20% ethanol. If the flow extract uses water as a solvent, the finished product also needs to add 20% -25% ethanol as a preservative to facilitate storage.
The process flow of the percolation method is as follows: crushing of medicinal materials → wetting → packing → impregnation → percolation → collecting percolation liquid. When using the leaching method to prepare the flow extract, operate according to the leaching method. When collecting the leaching liquid, first collect 85% of the initial liquid of the medicinal material, save it in another device, continue to bleed, and collect about 3-4 times Continue the liquid. Recover the ethanol from the continuous liquid, concentrate it to a thick paste at low temperature, combine it with the initial liquid, mix well, adjust to the specified standard, let stand for more than 24h, and filter, that is.
Oral liquid preparation training
Training principles:
Oral liquid refers to a single-dose packaged preparation, that is, after extraction of medicinal materials with water or other solvents by an appropriate method, it is concentrated to make a single-dose oral liquid preparation. It is a new dosage form developed on the basis of decoction and traditional Chinese medicine injection. Absorbing the technical characteristics of traditional Chinese medicine injection, the soup is further refined, concentrated, potted and sterilized. The oral liquid has a small dosage, fast absorption, stable quality, easy to carry and take, and is easy to store, and is particularly suitable for industrial production. Therefore, the oral liquid has become one of the faster-developing dosage forms in traditional Chinese medicine preparations.
The preparation process of Chinese medicine mixture (oral solution) is: extraction → purification → concentration → liquid preparation → sub-packaging → mold etc.
Preparation principle of injection
Training principles:
The traditional Chinese medicine injection is an injection prepared by extracting and purifying the effective components or effective parts in which the pharmacological effect is clear. Commonly used methods include hydroalcoholic method, alcoholic water method, distillation method, double extraction method, dialysis method, ultrafiltration method, acid-base precipitation method, ion exchange method, etc. Preparation should be based on the characteristics of active ingredients, select appropriate extraction methods and preparations, as far as possible to remove impurities and retain active ingredients, to ensure the quality of injections.
The hydroalcohol method is one of the commonly used methods for extracting and refining traditional Chinese medicine injections. According to the nature that the active ingredients are both soluble in water and ethanol, water extraction and ethanol precipitation are used to remove impurities and retain the effective ingredients.
At present, the main problem of Chinese herbal medicine injection is the problem of clarity, that is, turbidity or precipitation occurs after sterilization or storage, the main reason is that the impurities are not removed, and the pH is not appropriate. The solution is generally to adopt gelatin precipitation method, alcohol solution pH adjustment method and polyamide adsorption method to further remove impurities; adjust the chemical solution to a suitable pH; heat treatment and refrigeration 'reasonable use of solubilizers, etc.
Preparation and training of microcapsules
Training principles:
Microcapsule is the abbreviation of microcapsule. It is a closed microcapsule made of solid or liquid medicine (capsular substance) by using natural or synthetic polymer materials as capsule material. The technique of preparing microcapsules is called microencapsulation, or microencapsulation for short.
The methods for preparing microcapsules include physical chemical method, chemical method and physical mechanical method. During the preparation, it can be selected according to the nature of the drug and the capsule and the preparation conditions. Among them, the single coacervation method and the double coacervation method are widely used, and it is a commonly used method for preparing microcapsules of water-insoluble solid or liquid drugs.
Preparation and quality inspection of pharmaceutical water
First, the training principle:
Pharmaceutical water is used as a solvent, diluent and cleaning and cleaning water for pharmaceutical preparation, extraction or preparation of medicinal materials during the production and use of prescription and single-flavor preparations. The 2005 edition of "Chinese Pharmacopoeia" pharmaceutical water includes drinking water, purified water, water for injection and sterilized water for injection. Generally, appropriate pharmaceutical water should be selected according to each production process or use purpose and requirements, and natural water should not be used as pharmaceutical water.
1. Drinking water
Drinking water is the water obtained from the purification of natural water, and its quality should meet the national standard GB-5749-2006 "Sanitary Standards for Drinking Water" of the People's Republic of China.
Drinking water can be used as rough washing water for rinsing pharmaceutical equipment during the preparation of medicinal materials. Unless otherwise specified, it can also be used as an extraction solvent for medicinal materials used in oral and general preparations for external use.
Drinking water shall not be used for the extraction of medicinal materials for sterilized preparations such as traditional Chinese medicine injections and eye drops.
2. Purified water
Purified water is pharmaceutical water prepared from drinking water by distillation, ion exchange, reverse osmosis or other suitable methods. Its quality should meet the relevant regulations.
Purified water does not contain any additives. It can be used as an extraction solvent for medicinal materials used in sterilized preparations such as traditional Chinese medicine injections, eye drops, etc .; a solvent or diluent for the preparation of oral and external preparations; and water for fine washing of appliances for non-sterile preparations. When necessary, it is also used as an extraction solvent for medicinal materials for sterilization preparations. Purified water should not be used for the preparation and dilution of injections.
Prevent microbial contamination during the preparation of purified water. Used as a solvent, thinner or water for fine washing, generally should be prepared before use.
3. Water for injection
Water for injection is pharmaceutical water obtained by distillation of purified water, and its quality should meet the relevant regulations.
Water for injection can be used as a solvent or diluent for the preparation of injections, the aqueous phase of the fat emulsion for intravenous use and the fine washing of injection containers.
In order to ensure the quality of water for injection, it is necessary to monitor the production process of water for injection prepared by distillation at any time, and regularly clean and disinfect the equipment for manufacturing and delivery of water for injection. The water for injection that has passed the inspection can be collected, and should generally be stored under sterile conditions and used within 12 hours of preparation.
4. Sterile water for injection
The sterilized water for injection is prepared from the water for injection according to the injection production process, and is sterilized pharmaceutical water. It is mainly used as a solvent for sterilized powder for injection or as a diluent for injection. Therefore, the filling specifications of sterilized water for injection should be adapted to the clinical needs to avoid pollution caused by large size and repeated use.
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