论文总字数：21447字

摘 要

低血钾症是一种电解质的紊乱的病症，其基本的治疗方式是补钾，临床上多采用口服补钾或者是静脉补钾。但是静脉补钾的方式受到譬如给药速度等种种因素的限制，不适宜在院外非医务人员的监督下使用。而氯化钾的常释的口服剂型通常伴随有刺激胃肠道的症状的发生。因此，氯化钾缓控释剂型因为其安全有效，方便使用等优点使得患者的顺应性大大的提高。但是如果直接包衣的缓释片的包衣存在缺陷，则会造成药物的突然释放，降低药物的用药安全。因此本课题主要研究了氯化钾胶囊的体外分析方法。

本文在调研了大量的文献以后建立了用于氯化钾缓释胶囊的体外溶出度研究的高效液相色谱法。研究说明了体外分析实验中空白辅料无干扰，且通过方法学方面的检验，其存在良好的线性关系，回收比较高，方法精准可靠。

关键词 氯化钾 缓释胶囊 体外溶出方法

ABSTRACT

Hypokalemia is a common clinical disorder of electrolyte disorder， usually accompanied by other diseases co-appears， the level of serum potassium may be affected by the body's hormonal disorders and metabolic imbalance， as well as the impact of the role of drugs， many Endocrine diseases have shown the symptoms of hypokalemia. Potassium is the underlying treatment of hypokalemia disease， the clinical use of oral potassium or intravenous potassium way. However， the method of intravenous potassium is limited by various factors such as the speed of administration and the concentration of administration， therefore it is unsuitable for use under the supervision of non-medical personnel outside the hospital. While the oral release form of potassium chloride is usually accompanied by stimulation symptoms of gastrointestinal tract. Therefore， potassium chloride reduces the dosage of release form potassium chloride because of its drug safety， and reduce the number of medication， easy to use， etc.， improve greatly the patient's compliance in the medication. However， due to the release of sustained-release tablets into a single unit of the system， if the direct coating of sustained-release film coating defects， it will cause the drug burst， resulting in safety of medication reduced. Therefore， we have given the preparation of sustained-release pellets on the basis of the preparation process， the development of potassium chloride sustained-release capsules， the use of advanced technology of dry granulation of direct granulation of potassium chloride， Particles， filled with capsules.

The main research aspects of this subject is the establishment of in vitro analysis of potassium chloride capsules:

In this paper， based on the investigation of a large number of papers， the establishment of potassium chloride sustained-release capsules for the content analysis methods and in vitro dissolution of high performance liquid chromatography. The study shows that the blank auxiliary materials do not determinate interference， and demonstrate a good linearity of methodological verification， high recovery rate. Consequently， the method is precise and reliable.

Key Words: Potassium Chloride；Sustained-release capsule；Dissolution method in vitro

目 录

摘要 i

ABSTRACT i

第一章 文献综述 1

1.1低血钾症状概述 1

1.1.1内分泌系统相关疾病 1

1.1.2 肾脏相关疾病 2

1.1.3 摄入不足 2

1.1.4 药源性低钾血症 2

1.1.5 其他 3

1.2低钾血症的临床治疗现状及常用药物 3

1.2.1 口服补钾 4

1.2.2 保留灌肠补钾 4

1.2.3 静脉输入补钾 5

1.3氯化钾缓释胶囊概述 5

1.3.1临床研究 6

1.3.4适应症、用法和用量概述 7

1.4本论文的立题依据及主要研究内容 8

第二章 氯化钾缓释胶囊体外分析方法的建立 11

2.1 试验部分 11

2.1.1 试验材料 11

2.1.2 试验仪器 11

2.1.3释放度测定方法的建立 12

2.2 结果与讨论 16

2.2.1建立溶出度的测定方法 16

2.3 小结 18

第三章 总结与展望 20

3.1概述 20

3.2总结和展望 20

参考文献 22

第一章 文献综述

1.1低血钾症状概述

钾大多数情况下离子的形式存在于机体内，对机体起着重要的作用，例如可以帮助心肌细胞能够正常工作等。细胞内的钾占总钾含量约为98%，浓度约为150到155毫摩尔每升;细胞外的钾的比例占百分之2，血浆中钾仅占百分之0.3[1]。非常多的要素都可以影响钾的体内过程，从而导致血钾浓度的降低，当血液中钾离子的浓度低于3.5毫摩尔每升时引发的一系列症状和体征情况称之为低血钾症。

轻度低血钾(血清钾浓度为3~3.5毫摩尔每升)时，并没有太多的表现，但伴随着血钾浓度的持续下降，可能会呈现全身没力气，便秘等病症状况;当血中钾小于2.0毫摩尔每升时最终可能导致呼吸衰退，其症状表现与血液中钾的降低速率有一定的关联[2]。对于患有心脏方面病症的病患，即便是轻度到中度的低血钾也会放大心率反常的机率。

1.1.1内分泌系统相关疾病

1. 醛固酮增多症

原发性醛固酮增多症

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