Study On The Stability Of Xieqin Antipyretic Granules

Objective:Study on the stability of parsley and antipyretic granule preparation, to provide a basis for determining the parsley and antipyretic granule preparation production, packaging, storage conditions and period of validity, to ensure the safety and clinical application of effective.Methods:According to the "Chinese Pharmacopoeia" incoterms2010version of an appendix IC granules inspection items, using the sample production conditions in the GMP of the three batch of parsley and antipyretic granule, to simulate the condition of commercial packing following experimental study.1. Experimental study on influencing factors:investigate the change of parsley and antipyretic granule preparation in high temperature, high humidity, strong light conditions.2. Accelerated stability test:In general drug stability test chamber, tests of40℃±2℃, RH75%±5%conditions in0,1,2,3,6month sampling detection during the experiment.3. Long term stability test:Long term stability test is in the actual storage stability test conditions are close to the drug, at25℃±2℃, RH60%±10%conditions, In0,3,6,9,12months sampling detection, can also be carried out under the condition of normal temperature.4. Qualitative identification:The TLC identification method of parsley and antipyretic granule preparation of Ageratum, Scutellaria baicalensis, forsythia3herbs for long-term stability test and accelerated stability test qualitative research.5.Determination of content:Determination of parsley and antipyretic granule preparation in long-term stability test and accelerated stability test of the content of baicalin by hplcy Using Diamonsil C18(2) chromatographic column (250x4.6mm,5μ m); Methanol-0.2%phosphoric acid (46:54) as the mobile phase; The detection wavelength:280nm; Flow rate:1mL/min; The column temperature:30℃.Results:1. Determination of parsley and antipyretic granule preparation in long-term stability test and accelerated stability test of the content of baicalin by HPLC, the measured baicalin of quantities of not less than13mg/g.2. Study on chromatography thin-layer:in the long-term stability test and accelerated stability test study, TLC identification of patchouli, baikal skullcap root, forsythia3herbs clear, spots better separation.3. No significant changes in the particle parsley antipyretic and strong light irradiation, high temperature, high humidity conditions.4. According to "Chinese Pharmacopoeia"2010edition of an appendix IC granules under water, general solubility, particle size, content,microbial limit test inspection, the results are in line with the requirements of granules.Conclusion:Through the long-term stability test,the parsley and antipyretic granule preparation factors on the accelerated stability test and impact, results show that the nature and the contents of main components in the preparation had no obvious change. To provide the experimental basis for the parsley and antipyretic granule stability of declaration of hospital preparations approval.