Study On Preparation Technology And Quality Standard Of Hugan Xinxin Pill

Liver protection tablets are listed in China’s national list of essential drugs.They are used in the treatment of early cirrhosis and chronic hepatitis and have significant clinical effects.At present,the preparation technology of hugan tablet is relatively backward,and the quality standard control of the product is relatively low.At the present stage,the preparation and extraction process of hugan tablet has undergone many times of extraction,and the loss of effective components is large,especially volatile components and fat-soluble components.Most of the finished products are sugar-coated tablets,and the weight gained by adding excipients is high.Long-term use will have adverse effects on human body.At the same time,product quality stability in appearance,weight differences,disintegration time and other problems,resulting in poor efficacy,and easy to pollute the environment.In order to solve the above problems,based on a large number of references and investigation,the project developed a new product-liver protecting heart drop pill.It is easy to absorb in the body with less weight gain and shorter dissolution time.In addition,the active components(volatile and fat-soluble components)of liver protection in the drug can be better retained.It can also eliminate the potential problems of long-term use of tablets,and improve the stability of product quality and efficacy.This paper makes a systematic study on the production and preparation technology,product quality standard and product stability of the new product,which lays a solid foundation for the new vigor of traditional Chinese classic recipe.Research on preparation technology of hugan drop heart pill:this paper firstly explores the effective ingredients of various Chinese medicinal materials in gufang hugan tablet through literature review and practical production experience,designs a preparation plan to extract the active ingredients of the medicinal materials,and studies the extraction technology and preparation technology.This paper mainly studied the extraction of schisandra chinensis,the selection of matrix,the ratio screening of main drug and matrix,the selection of coolant,the selection of coolant temperature,the design of droplet head temperature and droplet distance,the types of adhesives,the amount of matrix prescription,the drying process parameters of droplet heart pill and so on.By means of orthogonal test,the preparation technology of the product was determined.For schisandra chinensis which played a major role in the prescription,the effective components were extracted by CQ2 supercritical extraction method.The extraction pressure of 25MPa,extraction temperature of 45℃ and extraction time of 2.5h were selected as the optimal process.The residue of radix butauri,radix isatidis,radix isatidis and schisandra chinensis were extracted by water extraction method with 10 times the amount of water for 2.0h and Fried for 3 times.Then,decompression and concentration were carried out under the condition of relative pressure of-0.06～0.08mpa and temperature of 70℃,and decompression and drying were carried out under the condition of relative pressure of-0.08mpa and temperature of 70℃.Pig bile powder and mung bean were ground into fine powder,and water extract was made into fine powder for further preparation production.Substrate preparation process to choose PEGI0000:ratio of 1:10 PEG6000 mixed matrix,the main medicine and substrate ratio of 1:2,cooling fluid temperature is 10℃ of dimethyl silicone oil,the temperature drops to 85℃,from drop to 5 cm,selection of adhesive for glycerin:95%ethanol=1:9,powder and mass ratio of 1:2,drops of heart pill drying temperature is 70℃,the drying time of 4.0 h.Protect liver drop heart pill quality standards research:establishing inspection,identification and content determination of testing system,using thin layer chromatography(TLC)method to identify fructus schisandrae,pig bile powder,using high performance liquid chromatography(HPLC)method to content determination of fructus schisandrae,detection of fructus schisandrae alcohol armour,scientific and accurate,high repeatability,which can effectively detect the efficacy and safety of the heart pill.After testing,it was determined that all inspection items of hugan tiexin pills were in accordance with the provisions of the 2015 edition of China pharmacopoeia.The long-term stability experiment and accelerated stability experiment were carried out.The results of the stability experiment show that the test indexes of the sample of hugan tixinwan conform to the provisions of pharmacopoeia,and the new product has stable production process and uniform product quality.Through the research of the subject,the results confirm that the product of hugan drop heart pill has stable preparation process,comprehensive quality standard and good stability,which provides strong support for the development and research of new drugs and the largescale production of preparation enterprises.