The Preparation Process And Quality Control Research Of Wu Zi Qing Long Granule

Objective:Wu Zi Qinglong particles is based on the Jiangmen People’s Hospital of traditional Chinese medicine experts in the clinical application of the basic experience "years of five sub Qinglong Decoction" on dosage form reform and. This from the traditional prescription "Xiaoqinglong Decoction" and Chinese medicine master Li Furen created "features five sub Dingchuan Decoction" in the treatment of asthma, complementary advantages and achieve. This paper, starting from the stability of effectiveness, simplicity, the angle of the particle preparation, clinical curative effect, the other agent preparation process, quality standards and other aspects of the scientific research system. In the extraction process of granule and quality control, innovation based on the determination of amygdalin, ephedrine hydrochloride, schisandrin B HPLC method was used as a concept, both to save experimental time and cost savings, improve efficiency, embodies the modernization of traditional Chinese medicine innovation and science. In study five Qinglong granule quality standard, uses the qualitative identification and quantitative approach of combining, specificity, good. The main chemical components in compound effect of amygdalin, ephedrine hydrochloride, schisandrin B as testing objects, TLC and HPLC analysis, and the method is stable and feasible study, develop the draft quality standards, provides the theory basis for quality control, ensure the clinical efficacy of drugs. The project will be the two prescriptions in accordance with the principle of composition monarch, the complementary advantages of the organic combination, selection of two party in the bitter almond10g, Jiang Banxia10g, white mustard seed, perilla10g, Tinglizi Schisandra lOg, ephedra8g, dried ginger8g, asarum5g, licorice6g,composed of five sub Qinglong mixture, and on the basis of granules of general preparation process to optimize the preparation process and the establishment of quality standard draft.MethodStudy on the preparation1.1alcohol extraction processThe single factor experiment with Box-Beknken response surface method, with ephedrine, amygdalin, schisandrin B as quantitative indexes experiment, the effects of extraction time, extraction times and solvent volume three factors extraction on alcohol, preferably five sub dragon particles optimum alcohol extraction process parameters. To optimize the extraction process of volatile oil in1.2By using the orthogonal method of steam distillation extraction Asarum ginger volatile oil of process conditions, the extraction of volatile oil as the index, the soaking time, the amount of water and extraction time as a major factor, L9(34) orthogonal experiment. Study1.3molding processIn order to extract, granular soft wood hand plastic and taste as index, the granulation process excipient, wetting agent, flavoring agent were investigated; and the rate of the dry extract was calculated daily dose and each package volume through the investigation.Study1.4five Qinglong granule quality standardDetermination of HPLC content in TLC identification and effective components of five sub Qinglong granule, and the content determination method.Result.1alcohol extraction process research results show that:the prescription take pieces the extraction container, add70%1H ethanol, refluxing and extracting for2times, extraction time60min. The extraction time:120min, solvent dosage:8.58times the drug amount, concentration of ethanol is78.6%.2study on Extraction Technology of volatile oil the results show that: adding the equivalent of adding4times amount of water, soaking for1.5hours, the distillation time is8hours.The3molding process research results show that:soluble starch17.03g per100g Chinese herbal medicine as the absorbent, paste in good condition; adding product particle size1%aspartame as a flavoring agent, the best taste; with75-80%ethanol as the dry extract granulating process of wetting granulation effect best; medicinal herbs by extracting granulation, granule the rate of dry extract was62.46%, therefore, the five sub dragon particles daily dose should be74*41.81%=30.94g, adult day take3times, every time dosage is about10g.4the TLC results showed that:in the thin layer chromatography of amygdalin, ephedrine hydrochloride,6-gingerol, alanine, four medicinal active ingredients reference standard, five sub Qinglong granule has the same control medicinal material and reference chromatograms location, the same color spots, the spots were clear, without interference of negative. Other ingredients have interference, not included in the standard.Results show that:5the content of Amygdalin in1.25-5μg, ephedrine in0.9-3.6μg, schisandrin B showed a good linear relationship with the peak area in1-4μg; the standard linear regression equation:amygdalin Y=2643.9X-158.28, r=0.9994; Y=830.82X-1.065r=0.999; ephedrine, schisandrin Y=1638.3X-37.954, for r=0.9992; the sample solution stability in three within24h were good. Repeatability of test results (n=6): the same batch of preparation of amygdalin, ephedrine hydrochloride, schisandrin B average absorption peak area (RSD) were14489(2.65%),3406(4.06%),2961(3.38%); recovery rate (RSD) were95.70μg (1.16%),100.20p. g (1.95%),97.02g (1.91%); the contents of six batches of samples (RSD) were4.70(1.35%),2.95(2.74%),2.75 Conclusion:Wu Zi Qinglong granule preparation process is reasonable and feasible, high stability.Quality standard2five sub dragon grain comprehensive, objective, advanced, with good reproducibility, can be used for the quality control of the preparation.