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目的:制备菌克软膏并建立质控标准。方法:采用HPLC法进行定性鉴别并同时测定处方中盐酸林可霉素和硝酸咪康唑的含量。结果:盐酸林可霉素的平均回收率为101.23％,RSD为0.93％;硝酸咪康唑的平均回收率为99.89％,RSD为0.57％。结论:该制剂处方合理,工艺简单,质量可控。
OBJECTIVE: To prepare mycoplasma ointment and establish quality control standards. Methods: HPLC method was used for the qualitative identification and simultaneous determination of lincomycin hydrochloride and miconazole nitrate in the prescription. Results: The average recovery of lincomycin hydrochloride was 101.23% with RSD of 0.93%. The average recovery of miconazole nitrate was 99.89% and the RSD was 0.57%. Conclusion: The preparation prescription is reasonable, the process is simple, the quality controllable.