Study On The Preparation Technology And Quality Standard Of Wendan KeliPreparation

Wendan tang was generally used in clinical medicine and prescription,and the herbal medicines in this prescription are prettyless,but it’s disease treatment is very extensive.Especially it’s of good treatment for phlegm syndrome and weird disease.Wendan tang had been commonly applied in the nervous system,alimentary System and other types of maladie,including significant disease curative effect to treat mental nerve symptoms.Since the birth of Wendan decoction,there are many changes.The most commonly used in clinical of Wendan tang "from sanyinji of disease and syndrome theory",in this recipe,Pinellia expectorant,dampness antiemetic Jiangni;orange peel regulates the flow of vital energy for tonifying spleen;Immature Bitter Oranger egulates qi-flowing for eliminating phlegm and harmonizes stomach for descending adverse qi;Poria cocos tonifys spleen and calm the nerve;licorice tonifys qi and eliminates phlegm;ginger to warm antiemetic,and can resist Pinellia toxicity;jujube tonifys qi and nourishes the blood and tranquilization,all parties to play clearing gallbladder and stomach and tranquilizing,treating bile stomach,phlegm heat,deficiency or trouble sleeping,vomiting,hiccup,palpitation restless,epilepsy.It is commonly used in clinical prescription,and through clinical practice of ancient physicians and modern pharmacological studies have verified,formed a series of Wendan tang.This paper summarized the comprehensive system for clinical application,Wendan tang and modern pharmacological research,and the use of modern extraction technology.Prepared Wendan tang into granules,in accordance with the related request ofnational traditional Chinese medicine development technology.Study on preparation process: through access to the 2015 edition of "China Pharmacopoeia" and related literature collected preparation of granules,reference to modern pharmacological active components of medicinal materials in the prescription and the physical and chemical properties,and clinical application,at the same time compared traditional and modern extraction technology by extraction ratio and content of active ingredients.The process route of reflux extraction with water as solvent was developed.Study on the forming process,the materials for study,optimize the proportion of suitable materials.Quality specification: to ensure the stable quality specification of Wendan granule,this paper developed quality specification of Wendan granule by thin layer chromatography to identify the main active components,naringin,hesperidin,glycyrrhizic acid and using HPLC to determin the content of hesperidin and glycyrrhizic acid.And the method was studied.Experimental results maked clear that the method had high precision and good repetition.The quality control system of Wendan granule was established.In the preparation of first step stability experiments,according to the requirements of "drug registration management measures" in technology,rudimentary constancy tests of Wendan granule were studied.The results showed that at 0-3 months on a regular index testing of property and identification,and the content,its physicochemical and other aspects,the study proved the indicators were basically stable and accorded with the quality standards and the relevant rules of "Chinese Pharmacopoeia" 2015 edition of a granule,with well stable.Carried out systematic research on this topic of Wendan granule preparation technique and quality standards,and developed the initial quality standard draft of Wendan granule,which provided the basis for product development and industrial production of Wendan granule.