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1995年版《中国药典》共收载胶囊剂81个品种,其中软胶囊剂9个,硬胶囊剂72个,除了一部中5个品种和二部中17个品种有性状检查外,其余均没有规定。外观性状是对药品的色泽和外表的感观规定,不能没有法定的检验办法。我们在长期药品检验中发现药品外观性状与其质量有一定联系,可对产品的质量作出初步的评价。 增加胶囊剂性状检查,有利于改革生产工艺,控制药品质量。中国药典规定硬胶囊剂系指将一定量的药物加辅料制成均匀的粉末或颗粒,充填于空心胶囊中制成。由此可知,胶囊剂首先是将一定量的药物加辅料制成均匀的粉末或颗粒,然后才是分装,而某些生产厂家往往不考虑药物的稳定性和均匀性,为了降低成本、省事,常常采用原料直接分装,手工分装,这或多或少会影响到胶囊剂的质量。一般说来,硬胶囊剂中的固体粉末除主药外,均应根据需要加入
The 1995 edition of “Chinese Pharmacopoeia” contained a total of 81 varieties of capsules, including 9 soft capsules and 72 hard capsules. Except one of 5 varieties and 17 of the 2 varieties, there were no traits Provisions. Appearance traits of the color and appearance of the drug’s perception of the provisions can not be without statutory test methods. We found in the long-term drug testing the appearance of drugs and their quality have some connection, the quality of the product can make a preliminary assessment. Increasing capsule traits inspection, is conducive to reforming the production process, control the quality of medicines. Chinese Pharmacopoeia hard capsule means that a certain amount of drugs plus accessories made of uniform powder or granules, filled in hollow capsules made. This shows that the first capsule is a certain amount of drugs plus accessories made of uniform powder or granules, and then it is sub-packaging, and some manufacturers often do not consider the stability and uniformity of drugs, in order to reduce costs, save trouble , Often using raw materials directly packaging, manual packaging, which more or less will affect the quality of capsules. In general, the hard powder in the solid powder in addition to the main drug, should be added as needed