兰州大学机构库 >药学院
泻痢固肠丸的质量标准提高研究
Alternative TitleStudy on Improving the Quality Standard of Xieliguchang Pills
杨丹
Subtype硕士
Thesis Advisor赵建邦
2017-03-31
Degree Grantor兰州大学
Place of Conferral兰州
Degree Name硕士
Keyword泻痢固肠丸 质量标准 薄层色谱 高效液相 罂粟壳 含量测定
Abstract

目的:泻痢固肠丸现行的质量标准比较简单,为了能够科学地评价并有效地控制该制剂的质量,本课题在原标准的基础上从质量标准的完善、药品的安全性和质量评价三个方面进行提高研究,以保证该制剂质量的有效、安全和可控。

方法:质量标准的完善方面:采用TLC法对方中白芍、诃子、罂粟壳等7味药材进行了定性研究;采用HPLC法对方中罂粟壳的代表性成分吗啡等3种生物碱以及白芍的指标成分芍药苷进行了定量研究。药品的安全性方面:采用GC-MS法检测该制剂中可能存在的28种农药的残留量;采用ICP-MS法检测该制剂中铅、砷、汞、铜、镉等18种重金属元素的含量;建立该制剂中黄曲霉毒素残留量和SO2残留量的检测方法。质量评价方面:建立泻痢固肠丸HPLC指纹图谱;建立HPLC法同时测定泻痢固肠丸中没食子酸、芍药苷、甘草苷和橙皮苷四种成分的含量;采用高效液相色谱法对泻痢固肠丸中芍药苷的溶出度进行研究。

结果:新增了方中人参、甘草、陈皮、白芍、诃子5味药材的TLC法,改良了原标准中的白术和罂粟壳2味药材的TLC法,厂家A和厂家B的全部样品均能检出相应成分。确立方中吗啡、可待因、罂粟碱及芍药苷含量测定的HPLC条件,厂家B有两批样品芍药苷的含量不合格。确立的农药残留量、重金属元素含量、SO2残留量及黄曲霉毒素残留量检测方法简便可行,全部样品均未检出28类农药残留和黄曲霉毒素且五种重金属含量均符合规定,厂家B有一批样品SO2残留量较高。建立了泻痢固肠丸HPLC指纹图谱,厂家B样品与对照制剂的相似度较差。建立了HPLC法同时测定多组分的含量,厂家A样品的主成分含量较高。建立了HPLC法测定方中芍药苷的溶出度,厂家B有两批样品与对照制剂的溶出过程不相似。结论:通过以上研究拟定了该制剂的质量标准并对其质量进行了分析和评价。

Other Abstract

Objective: The current quality standard of Xieliguchang Pills is very simple. In order to evaluate scientifically and effectively control the quality of the preparation, the subject was improved from three aspects: the improvement of quality standards, the safety and quality evaluation.To ensure the quality of the preparation is effective, safe and controllable.

Methods: Improvement of quality standards: Using the TLC method has a qualitative research on 7 herbs such as Radices paeoniae alba, Myrobalan, Atractylodes,Poppy capsule and so on. Using the HPLC method has a quantitative study on Morphine, Codeine, Papaverine and Paeoniflorin. Drug safety: Using the GC-MS method to detect the residues of 28 pesticides.The contents of 18 heavy metal elements such as lead, arsenic, mercury, copper and cadmium were determined by ICP-MS method. Establishing methods to detect contents of Aflatoxin and Sulfur dioxide. Quality evaluation: To establish the HPLC fingerprint of Xiliguchang pills. To establish an HPLC method for the determination of gallic acid, paeoniflorin, liquiritin and hesperidin in the preparation. Establishing an HPLC method to determine the dissolution rate of paeoniflorin in the preparation.

Results: The establishment of TLC identifacation method on Ginseng, Licorice, Pericarpium citri reticulatae, Radices paeoniae, alba and Myrobalan. The TLC method of Atractylodes and Poppy capsule was improved in the original standard. All samples of Manufacturers A and B can detect the corresponding components. The establishment of HPLC conditions on morphine, codeine, papaverine and paeoniflorin. The paeoniflorin content of 2 samples was not qualified in Manufacturer B.The methods are simple and feasible that determine the residues of pesticide residues, heavy metal elements, sulfur dioxide and aflatoxin.The 28 kinds of pesticide residues and aflatoxin were not detected in all the samples. The contents of 5 heavy metals were all in accordance with the regulations. There is 1 sample of high sulfur dioxide residue in Manufacturer B. The HPLC fingerprint of Xieliguchang pills was established. The similarity between simples of Manufacturer B and control preparations was poor.A HPLC method was established for the determination of multi-components.The content of main components in Manufacturer A samples was higher. HPLC method was established for the determination of the dissolution of paeoniflorin. There were 2 samples from the manufacturer B which were not similar to those in the control preparation.

Conclusion: The quality standard of the preparation was developed by the above studies. Its quality was analyzed and evaluated.

URL查看原文
Language中文
Document Type学位论文
Identifierhttps://ir.lzu.edu.cn/handle/262010/233815
Collection药学院
Recommended Citation
GB/T 7714
杨丹. 泻痢固肠丸的质量标准提高研究[D]. 兰州. 兰州大学,2017.
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