Dissertation > Excellent graduate degree dissertation topics show

Study on the Quality Standards of a Combination Tablet Product of Pioglitazone Hydrochloride and Glimepiride

Author: ZhangHongZhen
Tutor: WangWeiHong
School: Shandong University
Course: Pharmaceutical Engineering
Keywords: Compound hydrochloride pioglitazone glimepiride tablets Hydrochloride pioglitazone Glimepiride Quality Research Stability studies Quality standards
CLC: R927
Type: Master's thesis
Year: 2011
Downloads: 77
Quote: 0
Read: Download Dissertation

Abstract


The compound hydrochloric pioglitazone glimepiride tablets developed by Japan's Takeda Pharmaceutical, following GSK (GlaxoSmithKline) developed maleate rosiglitazone glimepiride compound preparation, and the second by the U.S. FDA approved for compound formed by thiazolidinedione treatment of type 2 diabetes, TZDs and sulfonylureas. Hydrochloride topiramate grid columns one and glibenclamide US urea of ??hypoglycemic role of mechanisms, one kind of insulin increased sensitization agent pioglitazone, glimepiride is a sulfonylurea, increase insulin secretion, therefore pioglitazone and grid columns US urea drugs moving school there complementary role. Clinical studies have shown that the product can effectively control blood glucose levels of patients with type Ⅱ diabetes, efficacy, drug safety, to adapt to a wide range of development of this product has good market prospects. The compound pioglitazone hydrochloride pioglitazone glimepiride tablets current domestic and foreign the Pharmacopoeia were not received contained. The FDC overall quality and stability research, according to the research results developed draft quality standards for the quality control and quality assessment of the goods. This study to establish the simultaneous determination of hydrochloric topiramate grid column one and glimepiride urea content and related substances of high performance liquid chromatography method, establish the determination of hydrochloric acid were used to topiramate grid columns one and grid columns US urea dissolution degree of dissolution conditions and determination method, and in accordance with the Pharmacopoeia pharmaceutical research guidelines require detailed studies and method validation. The experimental results show that the established analytical method is specific, high sensitivity, good reproducibility, and the results are accurate, reliable, and suitable for the quality control of the compound hydrochloride pioglitazone glimepiride tablets. By impact factor test, accelerated testing and long-term test, the FDC stability oriented goods production, packaging, storage and transport conditions designed to provide a scientific basis, and initially identified based on the experimental results medicines expiration date . Formulate quality standards to reflect changes in quality of pharmaceutical products, provides effective analysis criteria for the quality control of the compound hydrochloride pioglitazone glimepiride tablets. The subject as part of the quality of the registration of new domestic research, important information necessary to apply for pharmaceutical production approval number, quality standards and to develop effective control of product quality.

Related Dissertations

  1. Studies on the Quality Standard of Brassica Rapa L.,R284.1
  2. Forsythia concocted and forsythiaside A Study on Separation and Purification,TQ461
  3. Studies on Quality Standards of Marsdeniae Tenacissimae Caulis, Polygoni Cuspidati Rhizoma Et Radix and Xiaoliu Capsule,R286
  4. The Evodia medicine quality, pharmacokinetics and tissue distribution studies,R284
  5. The Morinda chemical composition and processing technology,R283
  6. Coptis , the citrus aurantium drugs on the compatibility,R289.1
  7. Study on the Preparation and Quality Standards of Yao Tongkang Capsules,TQ461
  8. Study on Quality and Stability of Landiolol Hydrochloride,R927.2
  9. PAC-1 hydrochloride quality standard APIs,R927
  10. Studies on the Preparation of Hydrocolloid Dressings,TQ461
  11. Micron Crushed Ginseng Preparation and Preliminary Evaluation,TQ461
  12. Study on the Anti-influenza Drug Ganluxiaodu Capsule,R286
  13. The Quality of the Compound Simvastatin Niacin Slow-Released Tablet,R927
  14. Medicine in a single indicator component and multi-index constituents HPLC method for the determination of,R286
  15. Jiaoai Tang decoction agent Preparation and Quality Standards,R283
  16. Studies on Quality Evaluation of Bidens in Shandong Province,R284
  17. Study on Preparation, Quality Standards and Pharmacokinetics GBE50-HP-β-cyclodextrin Inclusion Complex,R96
  18. The Study on the Frost Process and Mechanism of Momordica,R283
  19. Compound anti - sense piece of Pharmaceutical Research,R285
  20. Compound muskrat pills molding process and quality standard,R286

CLC: > Medicine, health > Pharmacy > Pharmacopoeia Codex ( formulary ),drug identification > Drug identification
© 2012 www.DissertationTopic.Net  Mobile