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Study on the Quality Effect of Traditional Chinese Medicine Preparation by Using the Medicament Assists Material Polyacrylic Resin II

Author: TanLing
Tutor: XiaHouLin
School: Chengdu University of Traditional Chinese Medicine
Course: Medicinal Chemistry
Keywords: Polyacrylic acid resin II Accessories A clear film Three pornographic films Compound Danshen Tablets Quality Research Stability
CLC: R283
Type: Master's thesis
Year: 2008
Downloads: 191
Quote: 1
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Abstract


Pharmaceutical excipients in pharmaceutical preparations occupies a very important position, with the development of polymer materials and the improvement of the drugs, preparations dosage form, process continuous improvement, the extremely rapid development of the world pharmaceutical excipients, accessories attention increasing. Traditional materials can not meet the needs of the modern traditional Chinese medicine preparation, the application of new materials brings a complex and diverse ingredients of traditional Chinese medicine, the application of new materials to be interested in the nature and efficacy of traditional Chinese medicine preparation have been affected. To investigate this question, we selected a class of widely used film coating materials, a systematic in-depth study on the quality and stability of the preparation before and after accessories, the main drug quality and stability. In this paper, a clear film, three pornographic films and compound Salvia tablets three preparations as the carrier, systematic study of the accessories polyacrylic acid resin Ⅱ before and after the preparation of the indicators. First evaluated the quality of the materials polyacrylic acid resin II, investigated Appearance, acid value, loss on drying, arsenic salts of heavy metals check; identification of infrared spectrophotometry; residual monomer contained limited to high-performance liquid chromatography of raw materials Inspection, initially to determine the total content limit; methacrylic acid unit content of the feedstock was measured by titration. Then after the preparation of polyacrylic acid resin quality, emphasis on the three preparation materials identification, examination and determination of monomer residue limits. The initial establishment of the quality of research methods to simulate the coated samples as controls and the preparation of three batches of samples by the method of quality evaluation. Accessories polyacrylic acid resin Ⅱ quality research in traditional Chinese medicine preparation can be concluded that the quality of the materials before and after preparation little difference. Examine the quality of the materials at the same time, the quality of the main drug formulations related research, polyacrylic acid resin in order to examine the quality of the main drug preparations. The results show that the content of the main drug Appearance in the the three preparation of the polyacrylic acid resin coating II, identification and determination, the use of the materials does not affect its overall appearance, improve stability there; coating before and after preparation TLC identification, a clear film coating after three batches, three pornographic films, compound Danshen tablets were able to identify the characteristic components; Using HPLC the three preparation content before and after the coating measurement results show that a clear film skullcap glycosides, three yellow emodin Chrysophanol, content, and Salvia miltiorrhiza Tanshinone Ⅱ _A index content was determined to meet the requirements. Accessories does not affect the main drug testing, and quality is stable before and after the preparation. This article also in respect of three batches of the drug product samples and its uncoated samples within the specified time accessories polypropylene resin II and preparations in the main drug accelerated stability test. The results show that uncoated preparations identification, inspection, disintegration time, assay meets the requirements, but the moisture content increases; three batches of the drug product samples in the three months accelerated stability test, polyacrylic acid resin II traits, infrared identification, single the body residue limits, determination of the indicators did not change significantly, the traits of the main drug formulations, TLC, moisture content, disintegration time and determination to meet the requirements, suggesting that the quality of materials and the main drug preparation were in stable condition, excipients polyacrylic resin Ⅱ use increases the stability of the formulation. This paper attempts to provide a scientific basis for the quality inspection of materials to the study of the quality of the preparation, evaluation criteria that improve the quality of traditional Chinese medicine preparation; lay the foundation for the application and promotion of pharmaceutical excipients.

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CLC: > Medicine, health > Chinese Medicine > Of Pharmacy > Chinese medicine processing,preparation
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