The Pharmaceutical Research Of Chang Kang-ing Dual Unit Drug Release Capsule

Chang Kangn-ing is a compound prescription, composed of Astragalus and Coptis chinensis, and proposed by laboratory. To be mainly used in treating ulcerative colitis.Testing program:Astragalus, invigorating qi for relieving desertion, is made into Gastric soluble micro pill to treat the root cause. Coptis chinensis, clearing away heat and drying dampness, restraining and sterilizing bacteria, is made into colon targeting preparation to treat the symptoms. So Chang Kang-ning can treat both the symptoms and the root cause. In this study on technics of Chang Kang-ning, main contents include six aspects.1. The technology of extraction and purification of Coptis chinensisTo optimize the technology of extraction of Coptis chinensis by utilizing central composite design-response surface methodology, QAMS, and overall desirability. To screen two kinds of macroporous resin AB-8and D-101by investigating the indicators of static adsorption, dynamic adsorption and adsorption curve.2. The preparation technology of test samples of Coptis chinensisAccording to the pharmacopoeia of content determination on the active ingredient of Coptis chinensis, testing the ultrasound time and the amount of methyl alcohol. At last, to achieve the optimized preparation technology of the test samples which contain extracting solution and dry extract of Coptis chinensis.3. The technology of extraction and purification of AstragalusTo extract astragaloside and astragalus polysaccharide in one step by using microwave extraction, which increases the utilization rate of Astragalus. To.purify astragaloside and astragalus polysaccharide extractive in one step by using high-speed refrigerated centrifuge technology.4. The research on quality standard of the Astragalus extractive To determine astragaloside, astragalus polysaccharide and the total alkali of Coptidis chinensis by making use of thin-layer chromatography (TLC) and high performance liquid chromatography (HPLC) on two aspects of the nature and the quantity.5. The forming technology of Chang Kang-ning dual unit drug release capsulePreparing Astragalus pellet and Coptis chinensis pellet by using the technology of fluidization and, researching the technology of filling capsule. Coating Astragalus pellet by Eudragit100which has gastric solubility and moisture proof property, Coptis chinensis pellet by using the materials with good ability of colon targeting,including isolated layer material, enzyme-controlled material and PH sensitivity material.6. The study on quality standard of Chang Kang-ning dual unit drug release capsuleTo establish the qualitative discrimination method of Astragalus pellet and Coptis chinensis pellet, the quantitative assay method of astragaloside, astragalus polysaccharide and the total alkali of Coptidis chinensis. Referencing the appendix of Chinese Pharmacopoeia of2010, to establish the quality standard of Chang Kang-ning capsule.