有关《中国药典》的几点商榷

Some Suggestions on China Pharmacopoeia

目的:完善《中国药典》的有关标准,增加可操作性。方法:就《中国药典》的“制剂通则”、“细菌内毒素检查法”、葡萄糖注射液的含量测定等相关问题进行分析和探讨。结果与结论:收载剂型有限,有些制剂品种难以归类;鲎试剂与细菌内毒素形成的凝胶在多长时间内不脱落判为阳性,应给出具体的时间限;采用旋光度测定法测定葡萄糖注射液含量时,半成品需加氨试液促进达到平衡,而成品则不需加,应予以区别。

OBJECTIVE：To improve the related standards in China Pharmacopoeia and to enhance its operation.METHODS：Issues on“general rules on preparations”, “bacteria endotoxin test”, assaying of glucose injection in China Pharmacopoeia were analyzed and discussed.RESULTS ＆ CONCLUSION： The dosage forms recorded are limited and some varieties of preparations are hard to be classified ,How long exactly the gel formed by taehypleus ameboeyte lysate and bacteria endotoxins remained cemented should be regarded as positive, which should be clearly defined. In determining the optical rotation by polarimetry, ammonia test solution should be added to the semi - products to achieve balance but not in the finished products for differentiation.