醋酸戈舍瑞林缓释植入剂细菌内毒素检查方法学研究
Study on gelation method of bacterial endotoxin test in goserelin acetate sustained-release depot
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摘要: 目的对醋酸戈舍瑞林缓释植入剂细菌内毒素检查的方法学进行验证。方法:用乙腈溶解醋酸戈舍瑞林缓释植入剂后形成混悬液,用水稀释乙腈混悬液后制成溶液,对此溶液进行凝胶法检查干扰试验;同时对乙腈溶解缓释植入剂的步骤进行内毒素回收率试验。结果缓释植入剂乙腈混悬液稀释200倍后,对凝胶法内毒素检查无干扰。乙腈溶解液回收率在25%~35%之间,需要对乙腈溶解液的内毒素限值进行折算降低。结论醋酸戈舍瑞林缓释植入剂进行凝胶法内毒素检查是可行的。Abstract: Objective To confirm the feasibility of gelation method of bacterial edotoxins tests for goserelin acetate sustained-release depot. Methods Acetonitrile were added to dissolve the sustained-release depot,the goserelin acetate will been precipitated out.Then the suspension could been removed to pyrogen-free water,the goserelin acetate will been dissolved;the interference test of the dilute solution can be conducted,the endotoxin recovery tests of acetonitrile suspension was conducted also. Results 200-fold diluents of the acetonitrile suspension dose not interfere with the test for bacterial endotoxins.The endotoxin recovery of acetonitrile suspension was 25 percent to 35 percent.,thus should to decrease the endotoxin limit of the acetonitrile suspension. Conclusion Gelation clot test is suitable for the detection of Goserelin Acetate Sustained-Release Depot.
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Key words:
- goserelin acetate /
- sustained-release depot /
- bacterial endotoxin /
- endotoxin recovery
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