2 English reference injection
Traditional Chinese medicine injection refers to the suspension extracted from traditional Chinese medicine and made into sterile solution, which is injected into the body, including muscle, acupoint, intravenous injection and intravenous drip, or made into liquid sterile powder before use.
3 Advantages of traditional Chinese medicine injections The advantages of traditional Chinese medicine injections are:
(1) The efficacy is quick and reliable.
(2) It is suitable for drugs that are not suitable for oral administration.
(3) It is suitable for patients who can't take drugs orally, such as patients who can't swallow or are in a coma.
(4) Local positioning can be generated. Such as compound Herba Artemisiae Scopariae injection, compound Folium Isatidis injection, Bupleuri Radix injection and Shenfu injection.
4 development of traditional Chinese medicine injections There is no injection in traditional Chinese medicine. Because injection has many unique advantages, people began to develop traditional Chinese medicine injections decades ago. As early as 1930s, "Bupleurum Injection" was successfully developed to treat diseases such as cold and fever, and achieved good results. After the founding of the People's Republic of China, traditional Chinese medicine injections developed in the mid-1950s. By the early 1960s, more than 20 varieties such as Protest 60 1 Injection, Yinzhihuang Injection and 20 12 (Radix Isatidis) Injection had been developed. Most of them are used in clinic, some of them have been put into production and are still widely used. Due to the continuous improvement of quality and stable curative effect, it has opened up a road for the development of traditional Chinese medicine injections. Traditional Chinese medicine injection was a period of great development in the 1970s. Not only scientific research, teaching and production units have developed it, but also many urban and rural medical units have carried out trial production. According to statistics, traditional Chinese medicine injections have been clinically tried during this period. More than 700 species have been reported, and 23 species are recorded in People's Republic of China (PRC) Pharmacopoeia (1977 edition). Among them, there are dozens of good quality and reliable curative effects. For example, unilateral injections include Ding Gongteng, Aesculus schefflera, Ginseng, Radix et Rhizoma Rhei, Radix Sophorae Tonkinensis total alkaloids, Trichosanthis Radix, Radix Salviae Miltiorrhizae, Ilex pubescens, Radix Stephaniae Tetrandrae total alkaloids, Herba Euphorbiae Humifusae, Radix Angelicae Sinensis, Luying, Herba Houttuyniae, Herba Andrographis, Rhizoma Corydalis, Cornu Cervi Pantotrichum, etc. Compound injection contains Shengmai, Radix Angelicae Sinensis Carthami, Radix Bupleuri, Radix Isatidis, Xiaozhiling, Qingkailing, etc. Good clinical results have been achieved. Some of them have remarkable curative effects, have been mass-produced and have stable quality, which meet the clinical requirements of traditional Chinese medicine and are especially suitable for emergency treatment. The quality control of traditional Chinese medicine injection is a key issue, because the injection is administered by injection and directly enters the body without being absorbed by the digestive tract, so the quality control must be strict. Traditional Chinese medicine injections are mostly extracted and refined from medicinal materials or decoction pieces. Objectively, there are many problems such as impurities, large differences in effective substances, and easy pyrogen. In recent years, a lot of in-depth research work has been done at home and abroad, and specific varieties have been tackled one by one. For example, the prescribed content determination standards of Trichosanthes root purified protein crystallization, Shengmai injection and Qingkailing injection are strictly pyrogen-tested; The stability experiments of rhubarb, Pulsatilla chinensis and baicalin injection were carried out. In addition, according to the characteristics of traditional Chinese medicine injections, a series of routine quality inspection items and standards have been stipulated, so that some traditional Chinese medicine injections can pass the quality test. It shows that traditional Chinese medicine injection, as a dosage form of traditional Chinese medicine, has been basically finalized and shows its unique advantages, which is a promising dosage form of traditional Chinese medicine. Especially in the development of Chinese medicine, it will be an indispensable main dosage form to solve the first aid of Chinese medicine. Not only will the variety of "small needles" be increased, but also the infusion will gradually pass the customs and then be put into production to meet the requirements of clinical medication of traditional Chinese medicine.
The production and storage of traditional Chinese medicine injections shall comply with the following regulations: 1. Solvents for injection include aqueous solvents, vegetable oils and other non-aqueous solvents. The most commonly used aqueous solvent is water for injection, and sodium chloride injection or other suitable aqueous solution can also be used. Common oily solvents are sesame oil and tea oil. , which shall meet the requirements under each oil item and be refined to meet the following requirements. (1) should be odorless and rancid; Unless otherwise specified, the color shall not be darker than the yellow No.6 standard colorimetric solution, and shall be clarified at 65438 00℃. (2) The iodine value is 79 ~128; The saponification value is185 ~ 200; The acid value does not exceed 0.56. Other solvents must be safe and harmless, and the dosage must not affect the curative effect. Two, the preparation of injections, according to the nature of the drug to add appropriate additives. If the additive has antibacterial effect, its dosage should be able to inhibit the growth of microorganisms in the injection. Commonly used bacteriostats and their dosage (g/ml) are 0.5% phenol, 0.3% cresol and 0.5% trichlorotert-butanol. Injections containing bacteriostatic agents should still be sterilized by appropriate methods. When the injection amount is more than 5ml, the bacteriostatic agent added must be carefully selected. Injection used for intravenous injection (unless otherwise specified) or intraspinal injection shall not be added with bacteriostatic agent. Three, unless otherwise specified, the container shall comply with the provisions of national standards on medical glass containers. Rubber stoppers of containers shall comply with relevant regulations. Four, the preparation of injection, the infusion of liquid medicine must be clear, the container should be clean and dry before use. When preparing the oil solution for injection, the refined oil should be sterilized in dry heat at 65438 050℃ for 65438 0 ~ 2 hours, and then cooled to an appropriate temperature. Unless otherwise specified, the fineness of drugs in suspension for injection should be controlled below 15μm, and the fineness of drugs in suspension for injection should not exceed 15 ~ 20μ m (occasionally 20 ~ 50μ m). The raw materials directly packaged into sterile powder for injection should be sterile. If freeze-drying method is used, the liquid medicine should be sterile, and the difference of filling quantity should be controlled within 4%. Five, injection in the preparation process, should strictly prevent deterioration and microbial, pyrogen and other pollution. The prepared liquid medicine should be filled and sterilized within the same day. If it can't be finished that day, the liquid medicine must be preserved under the condition of no deterioration and no microbial reproduction. Intravenous injection and spinal injection should be strictly controlled. Six, perishable drugs in contact with air, in the filling process, the container should be excluded from air, filled with carbon dioxide or nitrogen and other gases after melting and sealing. Seven, after melting or sealing, according to the nature of the drug to choose the appropriate sterilization method, must ensure that the finished product is sterile. Eight, molten injection after sterilization or sterilization, decompression method or other appropriate methods should be used for container leakage detection. Nine, the injection should be stored under the prescribed conditions.
6 Loading capacity of traditional Chinese medicine injections When filling injections, the loading capacity should be appropriately increased according to the following table to ensure that the injection dose is not lower than the marked amount. Unless otherwise specified, the injection quantity of multi-dose injections shall not exceed 10 per container, and the increased quantity shall ensure the dosage of each injection.
? Number of tags? Increase the amount? Easy-flowing liquid, viscous liquid? 0.5ml？ 0. 10ml？ 0. 12ml？ 1.0ml？ 0. 10ml？ 0. 15ml？ 2.0ml？ 0. 15ml？ 0.25ml？ 5.0ml？ 0.30ml？ 0.50ml？ 10.0ml？ 0.50ml？ 0.70ml？ 20.0ml？ 0.60ml？ 0.90ml？ 50.0ml？ 1.0ml？ Take 5 samples from the injection for inspection with the labeled amount of 1.5ml below 2ml, 3 samples from the injection above 2ml to 10ml, and 2 samples from the injection above 10ml; When opening, pay attention to avoid loss, use a dry syringe with corresponding volume (pre-standardized) to extract the contents, and check at room temperature; When measuring the volume of oil solution or suspension, it should be heated and shaken evenly, then pumped out with a dry syringe and cooled to room temperature for inspection. The number of injections per injection shall not be less than the number indicated. Unless otherwise specified, the loading tolerance of sterile powder for injection shall conform to the following table. ? Average load? What is the load difference limit? Under 0.05g or 0.0g? 15% ? Above 0.05g to 0. 15g? 10% ? 0. 15g to 0.5g? 7% inspection method: take 5 bottles (sticks) to be inspected, remove the label and aluminum cover, clean the outer wall of the container with ethanol, and air dry. When opening, pay attention to avoid foreign bodies such as glass fragments falling into the container, weigh quickly and accurately, and pour out the contents. You can clean the containers with water and ethanol, and after drying under suitable conditions, accurately weigh each container and calculate the load and average load of each bottle (rod). Compared with the average loading quantity, the loading quantity of each bottle (branch) shall conform to the provisions in the above table. 1 bottle (branch) does not meet the requirements, and then take 10 bottle (branch) for a second interview, all of which meet the requirements. The clarity of traditional Chinese medicine injections should be checked according to the Ministry of Health's "Regulations on the Inspection of the Clarity of Injections" and conform to the regulations.
The sterility requirements of traditional Chinese medicine should be inspected according to the method under the Sterility Inspection Law, which should comply with the regulations.
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