Study On Extraction And Quality Standards Of Yanhou Granule

Yanhou granule is developed on the basis of Yanhou tablet. The study is a qualitative change in technology research, it is the eight categories of new drugs in Provisions for Drug Registration.Yanhou tablet is the Traditional Chinese Medicine on the basis of Clinical Experience, the ingredients of yanhou tablet is Radix Sophorae Tonkinensis, Herba Selaginellae Doederleinii, Radix Rubus Parvifolius, Herba Scutellariae Barbatae, Herba Hedyotis Diffusae, Radix Scrophulariae, Radix Codonopsis, Poria, Radix Trichosanthis and Radix Ophiopogonis. It can Clear away heat, eliminate toxic materials, soften masses,invigorate vital energy, nourish yin. Indicated for wind-heat stagnated in the chest, accumulation of phlegm-fire, heat-toxic attacked upwards and consumption of fluid manifested as dry throat, pharyngodynia, burning sensation over the throat, hoarse, headache, nasal obstruction, puric or bloody nasal discharge. Also applied for acute and chronic laryngopharyngitis, stomatitis, nasopharyngitis, and for the supplementary treatment of nasopharyngeal carcinoma after radiotherapy and chemotherapy.Since the Limitations of study of Yanhou tablet, use a large amount (0.4 g per unit, each serving 5), not easy to the nasopharyngeal carcinoma after radiotherapy and chemotherapy. To solve these problems, using of modern medicine extraction and separation technology, optimized extraction process to reduce use of, and facilitate the use and enhance the technology, At the same time, we add the Strong specificity Identificationts and the content so that we can control the quality of Yanhou granule.According to the research of the Effective Chemical Composition of ingredients of Yanhou tablet, which have good water-soluble, so choose the water as Solvent. Matrine of Radix Sophorae Tonkinensis is the main effective chemical composition, The extraction procession was studied by orthogonal design with Matrine as the detective marker, the Yield of Dry Extract as the Reference Indicators. According to the experience, With the actual situation of production, it should be set at twice the number of extraction. The other influential effect on the extraction are "how much Solvent " and "how long time." The study is to find two factors on the extraction effect of each factor for the level of the three orthogonal test. Orthogonal test results show that the extraction conditions: 10 times of prescription medicines water, extracted two times, each time for two hours.According to the research of the ingredients of Yanhou tablet, it is much starch in the extraction of Radix Trichosanthis and much chlorophyll in Herba Scutellariae Barbatae and Herba Hedyotis Diffusae, it is need to be sublimed so that it can remove the impurity which have no effect. The basis general experience, Under the general experience, the concentration of alcohol is the main factor of the effect of alcohol-Isolation. When the concentration of alcohol is about 60%-70% or above 70%, the non-therapeutic effects would be removed except hydroxybenzene compound and colophony. At the process of alcohol-Isolation, the most important two factors, concentration of the liquor and density of the liquid set to 3 levels to be a orthogonal test, matrine as the detective marker. The result of the test is show that the good concentration alcohol-depositing is: the liquor is 60%, the density of the liquid is 1.21 (75-80℃) .Thought the research of inspissation,desiccation and the process of Particles, the lipuor can be made to Products at the large-scale production process conditions . on the basis of this process, we study about the quality standards of Yanhou granule, and Formulate the quality standards. We choose Radix Sophorae Tonkinensis and Herba Scutellariae Barbatae as the Identificationts, the test show that: the identifications is Strong specificity, high sensitivity, simple operation, so can easy to checkout the Herbs in the granule. Radix Sophorae Tonkinensis is the Main herb, we choose its main active ingredient, Matrine as the content, the method of mensurate Matrine's content is Strong specificity, high sensitivity, simple operation too, it can Control the quality availability.The Pharmacodynamics and toxicology study results show that: Yanhou granule can Anti-inflammatory, anti-virus, enhance immunity. its pharmacological effects Superior or Close to Yanhou tablets. It is not found any delayed toxic effects in extract of Yanhou granule. So it further indicates that the extraction process is feasible.In accordance with the Methods, we have been finished 3 batches product in the adoption of the GMP certification workshop, the whole production running good, the equipments of Various processes are all in the normal and reliable operation. good controllability of production show that it can be volume-produced the required quality of granules.Summing up the above, compared with Yanhou tablets, In the same effect circumstances, the Dosage of Yanhou granule reduce Significantly, and more suitable for nasopharyngeal carcinoma after radiotherapy and chemotherapy. It is more stable and controllable.