| Objective:1, To study and make a sort of the form of emulsified patch for traditional Chinese medicine, which looks like the plaster.2, To study and make both patch preparations for Relieving Infantile Dyspneic Cough Patch (Xiaoer Kechuan Patch) and Compound Yuanhu Anodyne Patch (Fufang Yuanhu Zhitong Patch) with the form of the patch.3, To probe into academically the study on the percutaneous absorption preparation for traditional Chinese medicine according to the relevant both documents and theories.Method:1,The compound ratio of bases of the form of the patch was optimized by orthogonal text and the manufacturing technology of both Xiaoer Kechuan Patch and Fufang Yuanhu Zhitong Patch was researched, in which some basic materials of the ointment such as stearic acid, glyceryl monostearate, paraffin wax, vaseline, wool fat, glycerin, triethanolamine, and SDS were used as the basic materials of the form of the patch and some indicators such as glutinousness, degree of softness, meltability and uniformity were selected to give an overall mark about the patches made.2, According to the guidance principles on the study of new Chinese drugs, What we studied for Xiaoer Kechuan Patch were as follows. ①The content of total ephedrine in the monarch Herba Ephedrae, which was regarded as one of indicators of chemical compositions extracted, was determined by the acid dye colorimetric analysis method and that of baicalin in the assistant Radix Scutellariae, which was regarded as another, was determined by HPLC. The content data determined were used to optimize the extraction process of medicine by orthogonal design experiment. In the experiment four influence factors such as ethanol density, amount of ethanol, time for extraction, number of times for extraction were considered and the L9 (34) table was used. ②The manufacturing technology for Xiaoer Kechuan Patch was optimized by L9 (34) orthogonal text. ③Three medicinal materials in the patch preparation were distinguished by TLC. ④The content of ephedrine chloride in the patch preparation was determined by HPLC. The chromatographic analysis conditions were that the column of Inertsil-ODS-3 (4.6x250mm,5μm) was used, that mobile phase was composed of methanol-0.1% of phosphoric acid (5: 95) , that flow rate was 1ml·min-1, with UV detection at 207nm and that the column temperature was 30℃. ⑤The test of accelerated preliminary stable property for the patch preparation was gone on. ?The content of ephedrine chloride of both released and percutaneous absorbed from the patch preparation during distinct time stages was determined by... |
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