The Pharmaceutical Research Of Compound Qingyan Granules

In recent years, with the continuous advance of the policy of reform and opening up, China’s economy has developed rapidly, the construction of a large number of factories, capped building, resulting in air quality plummeted. Sewage, vehicle exhaust, waste of life undoubtedly accelerated the pace of deterioration of the ecological environment. In addition, the majority of people abuse drugs, do not pay attention to diet, develop many bad habits, leading to throat disease, became the modern society in a high incidence.Based on years of clinical experience prescription, Radix Sophorae tonkinensis,Paris polyphylla, Scutellaria baicalensis extract, adding borneol and excipient into granules, has the effects of clearing away heat and toxic material, reducing phlegm and relieving sore throat effect.The purpose of this study is the preparation technology and quality standard of Qingyan granules. These include extraction, process, quality standard and stability.The experimental method of extraction process is mainly in accordance with the physical and chemical properties of the prescription and the effective components,select the appropriate extraction method, at the same time using orthogonal test method, optimize the best extraction process.Qingyan granules preparation mainly according to the nature of the extract, users,clinical requirements, choose single factor investigation method, selecting suitable materials and amount of excipients. By the wet granulation, according to the ‘hand into a group, gently press powder’ that is the principle of granulation.The content of matrine was used as the index of detection, Qingyan granules were determined by HPLC, Radix Sophorae tonkinensis and Paris polyphylla were identified by TLC.To establish the quality standard of Qingyan granules: the content of matrine was used as the index of detection, system suitability test, preparation content determination, specificity experiment, stability study, intermediate precision investigation, recovery rate, linear relation, etc.Through the stability test, the results show that the Qingyan granules have good stability.Experimental results:(1) To determine the extraction process of Radix Sophorae tonkinensis, Paris polyphylla and Scutellaria baicalensis(4:4:3), 12 times the amount of 80% ethanol, reflux extraction 2 times, each time 1 hour, filtrate drying, get dry paste;(2) The single factor experiment was used to select the auxiliary material and its dosage, Borneol 3g/100 g, sugar 195g/100 g, microcrystalline cellulose 5g/100g;(3)Prescription dosage: The alcohol extract of Radix Sophorae tonkinensis(600g), Paris polyphylla(600g) and Scutellaria baicalensis(450g), adding borneol(100g) and accessories made granules(1000g);(4) To establish the quality standard of Qingyan granules, The methodology includes specificity, precision, stability and recovery rate.The result is stable and reliable, the method is simple, convenient, accurate and stable.The quality control is very effective on Qingyan granules quality standard, Provide a guarantee for the production of Qingyan granule preparation in the future.