论文部分内容阅读
近十余年来,中草药注射剂发展很快。现根据中国药典和各地方标准中收载的情况,结合工作中的体会,对中草药注射剂质量标准中制订的一些项目作一综述。规格中草药注射剂规格的表示可分下列五种情况:1.所含成份是化学结构明确的单一有效成份,则以该成份表示。如汉肌松注射液,每10ml 含汉肌松30mg;汉防己甲素注射液,每2ml含汉防己甲素盐酸盐30mg 等。2.所含成份是某类总成份,其中主要成份较明确,则常以该成份表示总成份的含量。如益母草注射液含总生物碱以盐酸水苏碱计算,每1ml 含总生物碱20mg;或以某代表性成份代表其总成份,如灯盏细辛注射液每1ml 含总黄酮作为无水芦丁计算应为2.25～2.75mg。3.所含有效成份的结构未明,但有效部位明确,则常以注射液中所含的有效部位表示。
Over the past decade, Chinese herbal medicines have developed rapidly. Based on the information contained in the Chinese Pharmacopoeia and various local standards, combined with the experience in the work, a review of some of the items formulated in the quality standards for Chinese herbal medicine injections is given. The specification of the specifications of Chinese herbal medicine injections can be divided into the following five cases: 1. The contained ingredients are the single active ingredients with a clear chemical structure, and they are expressed in that ingredient. For example, Hanmusong injection contains 30mg of Hanmusongsong per 10ml; Tetrandrine injection contains 30mg of tetrandrine hydrochloride every 2ml. 2. Contained ingredients are certain types of total ingredients, in which the main ingredients are more specific, and often the ingredients are used to express the content of the total ingredients. Such as Motherwort injection containing total alkaloids calculated as stachydrine hydrochloride, containing 20 mg of total alkaloids per 1 ml; or as a representative component of the total composition, such as Erigeron breviscapi injection containing 1 ml of total flavonoids as anhydrous rutin The calculation should be 2.25 to 2.75 mg. 3. The structure of the active ingredient contained is not known, but the effective part is clear and often expressed as an effective part contained in the injection solution.