论文总字数：19800字

摘 要

目的：盐酸普萘洛尔片属于口服给药的速释片剂，通过进行它的体外溶出实验，包括测定它在四种不同溶出介质中的溶出曲线，由此来评价其自制片与原研片的质量一致性。

方法：根据Ch.P.2015和JP17，选择溶出度测定法的第二法（桨法），转速设置为每分钟50转，溶出介质选择pH1.2盐酸溶液，pH4.0乙酸盐溶液，pH6.8磷酸盐缓冲介质和水，体积选择900ml。采用紫外分光光度法测定不同时间点的溶出量，测定波长选择在290nm处，采用相似因子f₂对同介质的溶出曲线进行比较。

结果：经实验，在上述选择的四种溶出介质中，空白辅料对盐酸普萘洛尔的测定无干扰，用紫外分光光度法测定的结果精密度好，准确度高。通过对两种片剂溶出曲线的比较，发现在介质pH1.2盐酸溶液中，f₂gt;50；在pH4.0乙酸盐缓冲介质，pH6.8磷酸盐缓冲介质和水中，15min时溶出量均大于85%。

结论：三批自制片与原研片的溶出曲线相似。

关键词：盐酸普萘洛尔 溶出 紫外分光光度法 一致性评价

Consistency Evaluation of dissolubility of Propranolol

Hydrochloride Tablets

Abstract

Objective: Propranolol hydrochloride tablets are tablets which are administered orally. By studying on the dissolution in vitro of it, including measuring the dissolution profile of the dissolution medium in different dissolution media, so as to evaluate the quality consistency of its generic and original preparation.

Methods: Reference to the Ch.P.2015 and JP17, according to the dissolution of the second method (paddle method), the speed is 50 revolutions per minute. At the same time, the dissolution medium is hydrochloric acid solution with pH1.2, acetate solution with pH4.0, phosphate buffer with pH6.8 and water, whose volume is 900 ml. The dissolution rate of the same medium is determined by UV spectrophotometry at different time points and the wavelength is 290 nm. The similarity factor f₂ is used to compare the dissolution curves of the same medium.

Results: In the four dissolution medium above, the blank excipients doesn’t interfere the determination of propranolol hydrochloride. The results measured by UV spectrophotometry are of good precision, high accuracy. In the medium of hydrochloric acid solution with pH1.2 , the f₂ of the generic and the original dissolution curve is more than 50.While in three other medium , the dissolution rate is more than 85% in 15 minutes.

Conclusion: The three batches of generic drug have similar dissolution profile to the original drug.

Key words: propranolol hydrochloride; dissolution; ultraviolet spectrophotometry; consistency evaluation

目 录

摘 要 I

Abstract II

目 录 III

第一章 引言 1

1.1论文课题背景 1

1.1.1关于仿制药一致性评价 1

1.1.2关于溶出度 2

1.2药物基本信息 3

1.3临床新用途 3

1.4盐酸普萘洛尔药理药效 4

1.4.1交感神经β受体阻断作用 4

1.4.2.降压作用 4

1.4.3.膜稳定作用 4

1.5药代动力学 4

1.5.1血药浓度 4

1.5.2代谢 4

1.5.3排泄 5

1.6不良反应 5

第二章 实验仪器和试剂 6

2.1仪器 6

2.2试剂与药品 6

2.1.1试剂 6

2.1.2试药 7

第三章 实验内容与结果 8

3.1方法学验证 8

3.1.1测定波长确定 8

3.1.2专属性 8

3.1.3线性与范围 11

3.1.4溶液稳定性 14

3.1.5溶出度测定回收率实验 15

3.1.6耐用性（不同溶出仪之间） 17

3.1.7不同测定方法比较 18

3.2溶出实验方法 20

3.2.1介质： pH1.2盐酸溶液 20

3.2.2介质： pH4.0乙酸盐溶液 20

3.2.3 介质：pH6.8磷酸盐缓冲介质 21

3.2.4介质：水 21

3.3实验结果 21

3.3.1原研片溶出曲线 21

3.3.2自制片溶出曲线 23

3.3.3自制片和原研片溶出曲线比较 24

第四章 结果与讨论 27

参考文献 28

致谢 30

第一章 引言

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