Chinese medicine powder injection introduction

Traditional Chinese medicine powder injection is the abbreviation of sterile powder for injection of traditional Chinese medicine. It is dissolved by sterile water for injection or suitable sterilization solvent before use. Any drug that is unstable to heat or easily decomposes in water may be made into a powder injection because it cannot be made into an aqueous solution or is not suitable for heat sterilization.
Traditional Chinese medicine powder injection is developed on the basis of traditional Chinese medicine injection. It is applied to the production of traditional Chinese medicine injection by freeze-drying technology, spray drying technology and aseptic processing technology, which improves the instability of heat or the failure of decomposition in water. The stability of the injection improves the quality of the product, but the requirements for the production conditions, equipment and personnel of the traditional Chinese medicine powder injection are high, and the medicine which is generally stable in the aqueous solution does not need to be made into a powder injection.
According to the different production processes, the powder injections are generally divided into two categories: one is the freeze-dried product for injection, and the other is the medical education network for aseptic packaging products. The preparation method of the former is to prepare the traditional Chinese medicine extract into a sterile aqueous solution, and immediately into the corresponding container under aseptic conditions, freeze-drying, removing the moisture of the liquid medicine in the container, and sealing is obtained. The powder injection prepared by the method can prevent the active ingredient from being damaged and decomposed by heat, the product texture is loose, and the solution is quickly dissolved after adding water, but the production cost is high. The latter is prepared by spray-drying or freeze-drying a sterile aqueous solution prepared from a traditional Chinese medicine extract under a sterilizing condition, and dispensing in a highly clean sterilization chamber according to an aseptic method, and sealing is obtained.
At present, China's national standard powder injections include Shuanghuanglian for injection (freeze-dried), thrombus for injection (freeze-dried), Xuesaitong for injection (freeze-dried), Naoxinkang for injection (freeze-dried), injection Use bee venom (freeze-dried), breviscapine for injection, salvia miltiorrhiza injection and Qingkailing for injection.
Traditional Chinese medicine powder injections, like other injections, are constantly developing along with the development of science and technology in China. New technologies and new equipment are continuously applied in the production of traditional Chinese medicine powder injections, and the quality requirements are continuously improved. For example, the Harbin Pharmaceutical Group's Chinese Medicine No. 2 Plant, which produces Shuanghuanglian powder injection, has invested nearly 200 million yuan in the state and enterprises, and has carried out the transformation of the whole process automatic control production line of Chinese medicine extraction and separation production. The powder injection production process adopts a fully automatic control system, which improves the Product quality stability.
In 2001, the former State Drug Administration commissioned the National Pharmacopoeia Commission to carry out research on fingerprints of listed Chinese medicine injections. Through the research on fingerprints, the quality control of raw materials, intermediates and finished products was strengthened. Many companies have controlled fingerprints. As an internal control indicator of the enterprise, it is gradually improving and applying for the national fingerprint standard. In order to ensure the quality of traditional Chinese medicine injections, the Chinese Pharmacopoeia 2005 edition puts higher requirements on the quality and safety of traditional Chinese medicine injections, and increases related substance inspection (protein, tannin, resin, oxalate, potassium ion, etc.). Bacterial endotoxin or heat source inspection, revised the clarity inspection to visible foreign object inspection, the requirements are more stringent, revised the insoluble particles, and increased the application guidelines for the safety inspection method of traditional Chinese medicine injections (abnormal toxicity test, antihypertensive substance test, allergy) Reaction examination, hemolysis and coagulation examination, heat source examination, bacterial endotoxin test).
Traditional Chinese medicine powder injection is the same as other injections of traditional Chinese medicine. It is a two-way sword with quick onset and exact curative effect, but the incidence of adverse reactions is higher than other routes of administration. Special attention should be paid during clinical application.

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