低分子肝素软膏剂的制备与质量控制

Preparation and quality control of the low molecular weight heparin oinment

本研究制备了低分子肝素(LMWH)软膏剂并建立了制剂质量控制方法。按照不同处方和制备工艺制得软膏剂基质,通过软膏剂综合评分法对所制得基质进行评价。将LMWH原料药溶解,合并入基质水相组分,按照所确定的软膏剂最佳处方和最优工艺,制备LMWH软膏剂。用羊血浆法分别测定原料药和制剂中LMWH的效价。结果表明,按照处方1制备工艺3所制得的软膏剂基质综合评价得分最高。测得的软膏剂中LMWH含量为147.03 U/g,为标示量的91.89%。因此,本研究中LMWH软膏剂的制备方法可行,制剂质量控制方法简单快速,适合少量制备LMWH外用剂型。

In this study,the low molecular weight heparin(LMWH)ointment is prepared and the quality control method of the preparation is established.According to different formulations,the ointment matrixes are prepared using different preparation processes.The prepared matrixes are then evaluated using the ointment comprehensive score method.LMWH raw material is solved,the solution is then added to the aqueous phase of the matrix,and the LMWH ointment is prepared according to the best formulation and optimized preparation process determined by evaluation.The potencies of LMWH in raw material and in the oinment are determined using the sheep plasma assay,respectively.The results showed the ointment matrix prepared according to formulation 1 and preparation process 3 got the highest score and that the content of LMWH in the ointment is 147.03 U/g,accounting for 91.89%of the labeled amount.Therefore,the preparing method of LMWH ointment in this study is feasible,and the quality control method is convenient and fast,which is suitable for preparing small amount of tropical application of LMWH.