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The bear bile Niuhuang capsules bear bile powder, artificial bezoar, berberine, peppermint oil, ephedra, natural indigo liuwei Chinese medicine group party prepared from clinical exogenous wind-heat known as heat, and the exogenous cold (respiratory viral infections) have significant effects provide the clinical foundation for the development of new drugs. Systematic experimental study of the preparation of the preparation process and quality standards to ensure safe and effective preparations. Study on Preparation according to the characteristics of the nature of the prescription drugs and indications, dosage form capsules. The prescription in the extraction process studies, first of berberine hydrochloric acid leaching and extract yield index, study berberine, ephedra mixed with berberine separate extraction solvents and extraction times on the leaching effect, the result is: berberine alone extract than berberine, ephedra mixed extract a high level of leaching, and the need extracted three times, no significant influence of the solvent extraction of berberine. Determine berberine, ephedra need a single mention on the basis of the soaking time, the amount of water, refluxing time to examine factors, the Orthogonal Test berberine water extraction conditions, preferred results: soaking in the water extraction 0.5h, extract three times the amount of water were 12 times, 10 times, 10 times the amount of extraction time for 1.5h, 1.0h, 1.0h. At the same time, the amount of ephedrine leaching and extract yield index investigated the impact of water extraction times on the leaching effect, and then soaking time, the amount of water, refluxing time for examining the factors Orthogonal Test ephedra water extraction The process conditions, preferably results: extraction when soaked in water 0.5h, and extracted three times, the amount of water is 10 times, 8 times, 8 times the amount, the extraction time for 1.5h, 1.0h, 1.0h, respectively. Determine the optimum extraction of berberine, ephedra, berberine hydrochloride, ephedrine evaluation index, study berberine, of ephedra separate water extraction and concentration process conditions, the result is: berberine water extract: first concentrated to a relative density of 1.30 ~ 1.35 (60 ° C heat test), and then at 60 ° C for vacuum drying (-0.06 to-0.08Mpa). The ephedra extract water: concentrated to heat measured with a relative density of 1.30 to 1.35 (60 ° C), and then dried under vacuum at 50 ° C (-0.06 to-0.08Mpa). The prescription peppermint oil with a pungent odor, and the presence of volatile instability, the use of beta LT; WP = gt; - cyclodextrins peppermint oil made of beta-cyclodextrin inclusion complex. It is considered as the evaluation index peppermint oil inclusion rate (peppermint oil utilization), saturated aqueous solution method, grinding method preferably peppermint oil inclusion process by orthogonal test results the optimal conditions for inclusion: beta- cyclodextrin (beta-CD) and peppermint oil feed ratio of 8:1, the amount of water for 4 times, grinding 3H, 40 ° C vacuum drying. Investigated different excipients (lactose, starch, microcrystalline cellulose) impact on the nature of the extract powder on the basis of the present the prescription preparation process determined; comparative test preferably granulating process conditions investigated particle mobility and absorbency. The best results: In the lactose to reduce the hygroscopic effect of the extract powder, the optimum granulation conditions for the extract powder with lactose in proportion to 89:11 mix, 2% povidone (PVP) as a binder system softwood 2% PVP of an amount of 20% of the extract powder, the flowability of the particles, the critical relative humidity of about 84%, take No. 1 capsules and granules, the average loading amount of 0.3 g. Second, the quality standard using thin layer chromatography were identified for the preparation of artificial bezoar, berberine, peppermint oil, ephedra, indigo. High performance liquid chromatography (HPLC) assay, berberine hydrochloride and Methodology of the study, the average recovery was 98.78%, RSD = 1.18%, and this method is accurate, reliable, and can be used for the preparation of the content of determination.
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