| Chromic prostatitis is a common disease in urinary surgery. The reason of it is complicated and it is hard to cure. Huoshitonglin capsule is formed by Barrenwort, Astragalus, Plantian, etc. It is the Chinese medicine oral prescription in treating the chromic prostatitis. This issue is mainly about the preparation process, quality standards, stability of Huoshitonglin capsule. It lay a foundation for applying the new drug.Testing the content of total flavone of extract solution of medicinal materials as index, doing single factor experiment to confirm the optimum extract procedure; testing the molding of granule as index, choosing the appropriate wetting agent to confirm the optimum preparation prescription and procedure; using TLC for differentiating Astragalus, Plantian; the moisture, the gross deviation, disintegration, heavy metals, arsenic salt and the microorganism limit were determinated; using HPLC to examine the method and measure the content of effective constituent of Barrenwort; in the study of stability, investigating the acceleration test and the long-range test, examining the prescription's identification, check, content determination, etc.The best preparation extract process as follows:Add fifteenth times of the prescription medicines, boiled twice, each time 2 hours,1.5 hours; 70% ethanol as the wetting agent, using the extrusion to make granule, load capsule; The spots on the chromatograms are the same as the contrast, the results are in line with the Chinese Pharmacopoeia; a method for the determination recoveries were 99.4%, RSD is 2.98%. Three samples'stabilities are in line with Chinese Pharmacopoeia.Huoshitonglin capsule is reasonable in preparation, feasible in technics, controllable in quality and good in stability. |
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