Study On Sustained Release Tablet Of Tripterygium Hypoglaucum Hutch

The traditional Chinese medicine Tripterygium hypoglaucum Hutch has the effect of clearing away heat and toxic material,rheumatism removing, dehumidifying, activate collaterals. In clinical practice, Kunming Shanhaitang tablet, often used in systemic lupus erythematosus,arthritis deformans and so on. However, this drug has the problem of short circulating half-life and frequent dosing. Besides, the clinical and experimental research report that Kunming Shanhaitang tablet will lead to some serious adverse reactions. The most common adverse reactions are hematological diseases, renal dysfunction and reproductive dysfunction. In order to reduce the side effects of drugs, satisfy the needs of clinical therapy, and enhance the bioavailability of drugs. This study intends to change the agent to sustained-release tablet make it a stable and controllable modern form and study the preparation technique set up the method of control quality. This study mainly includes the following four parts: 1.Study on quality control of Tripterygium hypoglaucum Hutch.For the 2015 edition of "Chinese pharmacopoeia" included Kunming Shanhaitang tablet while the Tripteiygium hypoglaucum Hutch not recorded. And "Standard of Chinese medicinal materials in Guangdong province" is not perfect, it only included name, source, usage, dosage and toxicity. So this article added TLC qualitative differentiation, moisture, total ashs of Tripterygium hypoglaucum Hutch. And determine the contents of triptolide, wilforgine, wilforine by HPLC.Besides, Method UPLC-MS was used to determine the contents of wilforgine, wilforine, triptolide, Demethylzeylasteral, triptolidenol, wilforlide A in its root, branch and leaf. Through determination of multi-target ingredients control the quality of Tripterygium hypoglaucum Hutch. The branch and leaf have the same chemical composition with root, but the content was lower than that in root.2.Screening of immunosuppression Active Site of Tripterygium hypoglaucum Hutch and analysis its chemical components.The effective ingredient is selected by the systemic impregnant means and the index of pharmacodynamic tests. And through the acute toxicity test, received the safe and effective ingredient.A total of twenty alkaloids were indentified by UPLC-MS from the effective ingredient. 3.Study on the prescription screening and pharmaceutics technology of Kunming Shanhaitang sustained-release tablet.Using the content of total alkaloids and andrographolide as target, the extraction technology was studied by orthogonal test design. The effective ingredient was purified through the pharmacodynamics and toxicology test to obtain the best medicinal parts. And optimizing the best parameter of condense and dry.Method of determination of the accumulative release and total alkaloids was established. By using the single-factor test on the formulation and processing study, prescription and preparation technology was optimized. The releasing characteristic parameter was explored by different mathematical model to explain the mechanism of drugs release and compared with tablets in sale. 4. Study on the quality standard and preliminary stability of Kunming Shanhaitang sustained-release tablet.Quality standard was established of Kunming Shanhaitang sustained-release tablet. Main contents include characters, TLC, release rate, weight variation and determination. Inspected the preliminary stability of sustained-release tablet.