利福平注射液的制备与质量控制
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文章编号：(2005)05–0261–04,利福平注射液的制备与质量控制
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高 红1，王东凯1，仲静洁1，曾垂宇2，詹 君3
(1.沈阳药科大学 药学院，辽宁 沈阳 110016；2.上海医药科技发展有限公司，上海 201203；3.沈阳双鼎制药有限公司，辽宁 沈阳 110016)
摘要： 目的 制备质量可控、安全稳定的利福平注射剂。方法 选用适当的溶剂及抗氧剂，将利福平制成注射液，确定了以HPLC法测定本品含量的方法，进一步考察了注射液的稳定性。结果 利福平的平均回收率为100.0%，RSD为1.03%。经加速试验6个月、长期试验9个月考察，含量未见明显变化。结论 该方法制备的注射液性质稳定，质量控制方法准确可靠。
关键词： 药剂学；利福平注射液；药物稳定性
中图分类号：R 944 文献标识码：A
Preparation and quality control of rifampicin injection
GAO Hong1，WANG Dong-kai1，ZHONG Jing-jie1，ZENG Chui-yu2，ZHAN Jun3
(1.School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016,China; 2.Shanghai Pharmapro Co.Ltd. Shanghai 201203,China; 3.Shenyang Shuangding Pharmaceutical Co.Ltd,. Shenyang 110016,China)
Abstract: Objective To prepare rifampicin injection. Methods Rifampicin injection was prepared by using suitable solvent and antioxidant. According to the quality standard of rifampicin for injection in USP26, content of rifampicin injection was determined by HPLC and stability of the preparation was studied also. Results The recovery of rifampicin was 99.95% and RSD was 1.03%. Conclusions Stability of the injection made by this technique is good; Methods for content analysis and quality control is feasible and reliable.
Key words: pharmaceutics; rifampicin injection; drug stability
高 红1，王东凯1，仲静洁1，曾垂宇2，詹 君3
(1.沈阳药科大学 药学院，辽宁 沈阳 110016；2.上海医药科技发展有限公司，上海 201203；3.沈阳双鼎制药有限公司，辽宁 沈阳 110016)
摘要： 目的 制备质量可控、安全稳定的利福平注射剂。方法 选用适当的溶剂及抗氧剂，将利福平制成注射液，确定了以HPLC法测定本品含量的方法，进一步考察了注射液的稳定性。结果 利福平的平均回收率为100.0%，RSD为1.03%。经加速试验6个月、长期试验9个月考察，含量未见明显变化。结论 该方法制备的注射液性质稳定，质量控制方法准确可靠。
关键词： 药剂学；利福平注射液；药物稳定性
中图分类号：R 944 文献标识码：A
Preparation and quality control of rifampicin injection
GAO Hong1，WANG Dong-kai1，ZHONG Jing-jie1，ZENG Chui-yu2，ZHAN Jun3
(1.School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016,China; 2.Shanghai Pharmapro Co.Ltd. Shanghai 201203,China; 3.Shenyang Shuangding Pharmaceutical Co.Ltd,. Shenyang 110016,China)
Abstract: Objective To prepare rifampicin injection. Methods Rifampicin injection was prepared by using suitable solvent and antioxidant. According to the quality standard of rifampicin for injection in USP26, content of rifampicin injection was determined by HPLC and stability of the preparation was studied also. Results The recovery of rifampicin was 99.95% and RSD was 1.03%. Conclusions Stability of the injection made by this technique is good; Methods for content analysis and quality control is feasible and reliable.
Key words: pharmaceutics; rifampicin injection; drug stability
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