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目的通过原料勾兑来控制前列舒乐胶囊质量均一性。方法采用药材勾兑计算器V2对原料药进行均一化勾兑,比较原料勾兑前后前列舒乐胶囊中朝藿定C、淫羊藿苷质量分数的差异。结果原料勾兑前、后前列舒乐胶囊中朝藿定C质量分数的RSD分别为82.5%和11.2%,淫羊藿苷质量分数的RSD分别为35.3%和8.7%,指标成分质量分数差异减小,表明其质量均一性明显提高。结论原料勾兑在控制中成药质量均一性中效果明显,适用于实际生产中。
Purpose Through the blending of raw materials to control the forefront of Shu Lok capsule uniformity of quality. Methods The medicinal material blending calculator V2 was used to homogenize the bulk drugs. The differences of the contents of Epimedin C and Icariin in Qianlie Shule capsules before and after the blending of raw materials were compared. Results The RSD of epimedin C mass fraction in Qianlie Shule capsule before and after pre-blending were 82.5% and 11.2%, respectively. The RSD of icariin mass fraction was 35.3% and 8.7%, respectively. The difference of mass fraction of indicator components was decreased , Indicating that the quality of their uniformity was significantly improved. Conclusion The blending of raw materials has obvious effect in controlling the quality uniformity of proprietary Chinese medicines and is suitable for actual production.