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目的通过正交试验法优选确定乳没接骨丸的制备工艺路线。方法在预实验的基础上,对混合药材进行串粉,对生药细粉(半成品)灭菌方法进行优选;对乳没接骨丸的泛丸、成型工艺条件进行优选,对丸粒的光泽,圆整度进行了观察对比,对溶散时限、水分、丸重差异、微生物、含量进行测定。结果确定最有效且简便的生药细粉(半成品)灭菌方法为乙醇灭菌(75%乙醇喷洒,拌和,密闭闷润4~5 h,冷风吹干,低温干燥),可以达到卫生学标准,得细粉率达到85%以上;泛丸工艺为生药细粉粉碎至100目,中等泛丸速度,丸粒直径约4.8 mm,45℃干燥时间为12 h,成型丸剂符合规定。结论乳没接骨丸制备工艺切实可行,各项检测指标符合乳没接骨丸质量标准(草案)规定,适合批量化生产。
OBJECTIVE To determine the preparation route of milk-less bone-setting pills by orthogonal test. Methods On the basis of pre-experiment, mixed powder was mixed with powder to optimize the sterilization method of crude drug powder (semi-finished product). The optimum conditions for the preparation of pellets and forming process of milk- The degree of contrast was observed, the time of dissolution, water, pills weight difference, microbiological, content determination. The results confirmed that the most effective and simple method for sterilizing crude drug powder (semi-finished product) was to sterilize ethanol (75% alcohol spraying, mixing, closed and stuffy for 4 ~ 5 h, cold air drying and low temperature drying) Fine powder rate of more than 85%; Pan-pill process for the crude drug crushed to 100 mesh, medium Pan-pill speed, pellet diameter of about 4.8 mm, 45 ℃ drying time of 12 h, shaped pills meet the requirements. Conclusion The preparation method of Rujiaojiegu pill is feasible and feasible. The detection indexes accord with the quality standard (Draft) of Rujiaojiegu pill and are suitable for batch production.