Particles Ttgb Pharmaceutical Part Of The Study

Post Menopausal Osteoporosis (PMOP) is a severe threat to the life quality and lifesafety of older women. Thus preparing a new traditional Chinese patent medicine having definite therapeutic effects as well as clinical safety against PMOP will gain great social effects and economic returns. In this study TTGB Granules which is a new classⅥdrug, was taken as model medicine, the pre-clinical pharmaceutical research of which was carried out under the guidance of traditional Chinese medicine theories together with the modern pharmaceutical technology applied.Base on the clinical demand and the properties of herbs in the prescription, the dosage form was chosen as capsule. According to the actions and indications as well as the physico-chemical properties of the ingredients included in the herbs, by means of the multiple guidelines grading method and the orthogonal test, the optimum extraction technology was determined as follows: Extract Fructus Psoraleae and Radix Salviae Miltiorrhizae with 70% ethanol under reflux for 3 times, using 8-fold volume of ethanol for 1 hour each time, combine the ethanol extract for use, and filter. Grind Rhizoma Cyperi and soak it in 6-fold volume of water for 30 minutes, then distill for 6 hours to extract volatile oil, collect the water solution after distillation in another container. Decoct the residue of Fructus Psoraleae, Radix Salviae Miltiorrhizae and Rhizoma Cyperi, together with the 6 herbs including Fructus Psoraleae, Radix Salviae Miltiorrhizae, Rhizoma Cyperi and so on, for twice, using 8-fold volume of water for 1.5 h each time; combine the decoctions, filter, then combine the filtrate and the above-mentioned water solution. Recover the ethanol under reduced pressure and then concentrate to a thin extract with a relative density of 1.25(60℃),chill, add a proper volume of ethanol to reach the ethanol concentration of 70%, stand, then combine the supernate and the above-mentioned ethanol extract, stand, filter. Recover the ethanol in filtrate under reduced pressure and concentrate to a thick extract with a relative density of 1.30(60℃), then arescent and pulverize it to powder, add dextrin, mannitol and aspartame, mix to even. Granulate with 80% ethanol, arescent, sieve, and spray the above-mentioned volatile oil into granules, mix to even, and then prepare it to 1000g.According to the guiding principles of Chinese medicine new drug research, the quality standard research was carried out. TLC was used to identify the 9 ingredients in prescription respectively, among which Fructus Psoraleae, Rhizoma Drynariae, Rhizoma Cyperi, and Radix Achyranthis Bidentatae had comparatively better results, thus the methods were included into the normal test of quality standard. The contents of psoralen and isopsoralen in Fructus Psoraleae, and naringin in Rhizoma Drynariae were determined using HPLC as indicators of internal quality control, and the systematic methodology were accomplished. All results complied with the specified standards concerned, thus the method was included into the normal test of quality standard. According to the experimental results of multi-batch samples, the content limits were established as follows: Referred to the total amount of psoralen (C₂₇H₃₂O₁₄) and isopsoralen (C₁₁H₆O₃),the content of Fructus Psoraleae per package is no less than 3.4mg; referred to the naringin (C₂₇H₃₂O₁₄), the content of Rhizoma Drynariae per package is no less than 2.4mg. Also in the stability research, a 12-month stay at room temperature sample inspection.The results of above tests indicate that the preparation technology is reasonable and practical, the standard is controllable, and the quality of the sample is stable on the whole as well.