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Thesis Advisor高 林、赵文军
Degree Grantor中国科学院研究生院
Place of Conferral北京
Degree Name硕士
Degree Discipline有机化学
Keyword苯乙烯马来酸酐共聚物 红霉素 肠溶材料 Ph 敏感性

本论文是在合成苯乙烯马来酸酐共聚物的基础上,对其进行接枝衍生化,制备了pH 敏感性能不同的苯乙烯马来酸酐共聚物的接枝产物,并将此材料应用于红霉素素片的包衣,按照中国药典2005 年版相关的要求进行检测其材料的pH 敏感性能。本论文对接枝苯乙烯马来酸酐共聚物不同接枝率、不同接枝产物进行了筛选,最后筛选出了符合包衣条件的4 种材料进行包衣试验。根据中国药典2005 年版的肠溶片剂的检测结果,得出了水解苯乙烯马来酸酐共聚物、水解无规共聚物、接枝聚乙二醇单甲醚的苯乙烯马来酸酐共聚物在pH=1 时的缓冲溶液中具有透湿性,这可能会破坏对pH 敏感的药物的稳定性,降低药效或产生毒副作用,接枝乙醇的苯乙烯马来酸酐共聚物具有很强的抗透湿性。在包衣试验中对包衣层厚度也进行了考查,发现包衣层厚度越大,包衣层的溶解越缓慢,红霉素肠溶片的溶出度越低。当使用接枝乙醇的产物进行包衣时,包衣层厚度为0.02890 mg/mm2(即增重2.1%)的肠溶片剂的溶出效果与市面出售的红霉素肠溶片相近。

Other Abstract

In this article we have graft ethanol, butyl-ethylene glycol, methyl-poly ethylene glycol on the base of styrene and maleic anhydride copolymer synthesized by our laboratory. The derivatives have very sensitive properties on exterior condition’s pH. The graft copolymer was used as coatings for erythromycin enteric tablets and its enteric solubility was detected according to the Pharmacopoeia of the people’s Republic of China 2005ed. In the SMA’s derivatives, different graft materials and different graft ratio will be effect the derivative’s pH sensitivity .we have selected 4 kinds of materials which meet the enteric material’s pH sensitive. According to the Pharmacopoeia of the people’s Republic of China 2005ed., it can be found that hydrolyzed styrene maleic anhydride copolymer, hydrolyzed random styrene maleic anhydride copolymer and SMA-g-MPEG(350)’s coatings have not good at water resistance in buffer solutions of pH 1.This property will destroy the drug which are instable in acidic aqueous. But SMA-g-ethanol’s coating has a strong water-resistant ability. In coating experiments, the test also conclude coating’s thickness .According to the results, the thicker coating is, the slower the coating dissolved in aqueous of pH6.8. At last SMA-g-ethanol has an excellent characteristic as an enteric coating. When the enteric coating’s thickness is 0.02890 mg/mm2, the prepared erythromycin enteric tablets release erythromycin exceed 95%.This result agree with as the commodity of erythromycin enteric tablets.

Document Type学位论文
Recommended Citation
GB/T 7714
曹贞虎. 苯乙烯马来酸酐共聚物的改性研究及其在药物制剂中的应用[D]. 北京. 中国科学院研究生院,2007.
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