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目的:进一步深化对克林霉素磷酸酯注射液的工艺和质量控制的研究,使之安全性好,工艺稳定。方法:优化处方组成和制备工艺,建立质量研究方法,并进行鉴别、有关物质检查等质量研究,采用高效液相色谱(HPLC)法测定克林霉素磷酸酯注射液的含量及有关物质检查、影响因素考察及稳定性。结果:克林霉素磷酸酯的含量用HPLC法测定,线性方程A=2.5×108C+2.5×103,r=0.9998,平均回收率为99.86%,RSD=0.41%(n=9),用HPLC法在规定的色谱条件下测定放置不同时间样品,平均峰面积为589711,RSD=0.03%,证明本品溶液在室温下放置12小时稳定。结论:该制剂处方合理,制备工艺可行,含量测定方法准确,稳定性良好。
Objective: To further deepen the clindamycin phosphate injection process and quality control of the study, so that safety, process stability. Methods: To optimize the prescription composition and preparation process, establish the quality research methods, and to identify the quality of the relevant substances and other studies, using high performance liquid chromatography (HPLC) Determination of clindamycin phosphate injection and related substances, Study on influencing factors and stability. Results: The content of clindamycin phosphate was determined by HPLC. The linear equation was A = 2.5 × 108C + 2.5 × 103, r = 0.9998. The average recovery was 99.86% and the RSD was 0.41% (n = 9) France under the conditions of the chromatographic determination of the sample placed at different times, the average peak area of 589711, RSD = 0.03%, that the solution was stable at room temperature for 12 hours. Conclusion: The preparation prescription is reasonable, the preparation process is feasible, the content determination method is accurate and the stability is good.