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目的研究盐酸克林霉素注射液的处方及制剂工艺。研究方法通过对溶媒、活性炭的用量、pH值范围、灭菌方法及灭菌温度的选择,确定出盐酸克林霉素注射液的最优处方及最优制备工艺。研究成果以注射用水为溶剂和0.07%的活性炭用量,用氢氧化钠调节PH至4.5-5.5,100℃流通蒸汽灭菌30分钟制得盐酸克林霉素注射液。结论按研究的方法制得的盐酸克林霉素注射液符合规定。
Objective To study the formulation and preparation of clindamycin hydrochloride injection. Research Methods The optimal formulation and optimum preparation process of clindamycin hydrochloride injection were determined through the selection of solvent, activated carbon, pH range, sterilization method and sterilization temperature. Research results with water for injection and 0.07% of the amount of activated carbon, with sodium hydroxide to adjust the PH to 4.5-5.5, 100 ℃ circulating steam sterilization for 30 minutes to obtain clindamycin hydrochloride injection. Conclusions The clindamycin hydrochloride injection prepared according to the research method meets the regulations.