Study on the Mixing Uniformity of TaoRen TongBi Pill by HPLC
OBJECTIVE To study on the mixing uniformity of the intermediate powder and soft material of TaoRen TongBi Pill by HPLC and determine the mixing endpoint.METHODS Samples with different sampling lo-cations at different mixing times were collected,and the main component in the sample of hydroxy saffron yellow pig-ment A was determined by HPLC,and the change trend of the content in the mixing process was analyzed,and the parameters of the mixing process were determined.RESULTS After statistical analysis and verification,the RSD change of Taoren Tongbi Pill powder and soft material was＜5％after 10-30 min mixing,which met the require-ments of mixing uniformity of oral solid preparations,and the optimal mixing process parameters were determined on mixing time of 10-20 min and mixing revolution of 24 r·min-1.CONCLUSION In this paper,the mixing uni-formity of the mixing process in the production process of TaoRen TongBi Pill was studied by HPLC,which was sim-ple and stable,and could be used to determine the mixing endpoint.At the same time,this method can provide a sci-entific analysis idea for the research and verification of the mixing process of oral solid preparations,which has good guiding significance.
HPLCContent DeterminationMixingUniformityHydroxy Saffron Yellow Pigment A
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NSTL
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