Studies On The Preparation And Quality Standard Of Xinnaotong Capsule

Xinnaotong Capsule is a marine compound preparation of Chinese medicine based on the experienced prescription of Ye Juquan who is a famous doctor of traditional Chinese medicine, which is an effective recipe to prevent and cure the cardiocerebrovascular diseases. It is prepared from the extracts of Laminaria japonica Arescb.,Changium smyrtzioides Wolff., Achyranthes bidentata Bl. and Stichopus japonicus Selenka. It can soften and resolve hard mass, promote blood circulation and dredge channel, invigorate the liver and nourish the kidney, promote the production of body fluid by nourishing yin, and lower the blood pressure. It is used on ischemic stroke, hyperlipidemic symptom, hypertention and vascular dementia, etc. The research include the preparation and the quality standard by HPLC,TLC and colormetric methods, which is based on the analysis of the prescription and active constituents,according to "the method of the new drugs approval"and the claim of research of the third class of new Chinese drugs. The main contents and results include: 1. The preparation of Laminariajaponica Aresch is studied on its active constituent -alginic acid which is acid polysaccharide and its soluble constituents which are mannitol and iodine.The optimized extracting technique of alginic acid is stirring for one hour under 60 degrees centigrade with thirty times 1% sodium carbonate solution. The optimized extracting technique of soluble constituents is heating the twenty mesh's crude drugs only once for half-hour with forty times water. 2. The preparation of Changium smyrnioides Wolff is studied on the soluble constituent which is L-aspargine. The optimized extracting technique is heating the twenty mesh's crude drugs only once for one hour with ten times water. 3. The preparation of Achyranthes bidentata Bl is studied on the effective constituent which is oleanolic acid. The optimized extracting technique is the twenty mesh's crude drugs refluxed by ten times 70% alcohol only once for one hour. 4. The preparation of Stichopus japonicus Selenka is studied on the acid mucopolysaccharide . The optimized extracting technique is stirring for two hours under 45 degrees centigrade with forty times 5% potassium hydroxide solution. 5. We research the quality control method of Xinnaotong Capsule and draw up the claim of crude drugs and the quality standards of finished products. It is the first time to use the quality control technology on the multi-ingredient from the main medicine. The method is better than present pharmacopoeia and the identification of the constituents is exclusive,accurate and stable. It gives the reliable basis to the internal quality control of the preparation. 6. The packed capsule was studied for four months under room temperture. The result showed it kept stable during the time. Also with the method of humidity acceleration test and emergency light illumination, the influence of humidity and illumination on the capsule was studied. It showed that the capsule was good for keeping in drier surroundings below the relative humidity of sixty-five percent to prevent from moisture. While the capsule still kept stable after illumination, that is to say the influence of the emergency light illumination on the capsule's stability was little. The research gave not only a new thought of the preparation on develop the marine medicine with high grade but also a new method on the quality control of marine o...