药剂学 Pharmaceutics 第五章 固体制剂-2 (胶囊剂、滴丸和膜剂) 长沙医学院药学系药剂教研室 黄明秋
第 五 章 固体制剂-2 （胶囊剂、滴丸和膜剂） 药 剂 学 Pharmaceutics 长沙医学院药学系药剂教研室 黄明秋
第一节胶囊剂 、概述 胶囊剂( capsules)——药物装于空心硬质胶 囊中或密封于弹性软质胶囊中而制成的固体 制剂
第一节 胶囊剂 胶囊剂(capsules)——药物装于空心硬质胶 囊中或密封于弹性软质胶囊中而制成的固体 制剂. 一、概述
The capsules are made in two parts by dipping metal rods in molten starch or cellulose solution. The capsules are supplied as closed units to the pharmaceutical manufacturer Before use, the two halves are separated, the capsule is filled with powder (either by placing a compressed slug of powder into one half of the capsule, or by filling one half of the capsule with loose powder)and the other half of the capsule is pressed on. James Murdock patented the two-part telescoping gelatin capsule in London in 1847
The capsules are made in two parts by dipping metal rods in molten starch or cellulose solution. The capsules are supplied as closed units to the pharmaceutical manufacturer. Before use, the two halves are separated, the capsule is filled with powder (either by placing a compressed slug of powder into one half of the capsule, or by filling one half of the capsule with loose powder) and the other half of the capsule is pressed on. James Murdock patented the two-part telescoping gelatin capsule in London in 1847
>In 1834, Mothes and dublanc were granted a patent for a method to produce a single-piece gelatin capsule that was sealed with a drop of gelatin solution. They used individual iron moulds for their process, filling the capsules individually with a medicine dropper. >All modern soft-gel encapsulation uses variations of a process developed by r. p Scherer in 1933. His innovation was to use a rotary die to produce the capsules, with the filling taking place by blow molding. This method reduced wastage, and was the first process to yield capsules with highly repeatable dosage
➢In 1834, Mothes and Dublanc were granted a patent for a method to produce a single-piece gelatin capsule that was sealed with a drop of gelatin solution. They used individual iron moulds for their process, filling the capsules individually with a medicine dropper. ➢All modern soft-gel encapsulation uses variations of a process developed by R.P. Scherer in 1933. His innovation was to use a rotary die to produce the capsules, with the filling taking place by blow molding. This method reduced wastage, and was the first process to yield capsules with highly repeatable dosage
胶囊剂的特点: (1)能掩盖药物不良嗅味、提高药物稳定性; (2)药物在体内起效快; (3)液体药物的固体剂型化; (4)可延缓药物释放和定位释药
（1）能掩盖药物不良嗅味、提高药物稳定性； （2）药物在体内起效快； （3）液体药物的固体剂型化； （4）可延缓药物释放和定位释药. 胶囊剂的特点：
(二)胶囊剂的分类 缓释胶囊剂 硬胶囊剂 控释胶囊剂 (hard capsules 肠溶胶囊剂 胶囊剂 软胶囊剂(亦称胶丸剂) (soft capsules)
（二）胶囊剂的分类 胶 囊 剂 硬胶囊剂 软胶囊剂(亦称胶丸剂) (hard capsules) (soft capsules） 缓释胶囊剂 控释胶囊剂 肠溶胶囊剂
(1)硬胶囊剂:将一定量药物及适当的辅料 (也可不加辅料)制成均匀的粉末或颗粒, 填装于空心硬胶囊中制成 硬胶囊呈圆筒形 C apsule size 由上下配套的两节紧密套合而成 C 其大小用号码表示,可根据药物 apsule Size o 剂量大小而选用. C apsule size Capsule size 2 C capsule sIze
(1)硬胶囊剂：将一定量药物及适当的辅料 （也可不加辅料）制成均匀的粉末或颗粒， 填装于空心硬胶囊中制成. 硬胶囊呈圆筒形 由上下配套的两节紧密套合而成 其大小用号码表示，可根据药物 剂量大小而选用
(2)软胶囊剂:系将一定量的药物(或药材提取物) 溶于适当液体辅料中,然后封闭于软胶囊中而成的 种圆形或椭圆形制剂 根据制备方法不同,软胶囊剂又可分两种: 有缝胶丸:用压制法制成,中间往往有压缝 无缝胶丸:用滴制法制成,呈圆球形而无缝
(2)软胶囊剂：系将一定量的药物（或药材提取物） 溶于适当液体辅料中，然后封闭于软胶囊中而成的 一种圆形或椭圆形制剂. 根据制备方法不同，软胶囊剂又可分两种： 有缝胶丸：用压制法制成，中间往往有压缝； 无缝胶丸：用滴制法制成，呈圆球形而无缝
二、胶囊剂的制备 (一)硬胶囊制备 制备空胶囊、填充物料 填充 封口
二、胶囊剂的制备 制备空胶囊、填充物料 填充 封口 (一)硬胶囊制备
1.空胶囊制备 明胶 (1)空胶囊组成 geat Inum 空胶囊的主要成囊材料 是由骨、皮水解而制得 骨明胶:脆、硬、透明度差 皮明胶:柔韧、透明 根据制备方法: A型明胶:由酸水解制得,等电点pH7~9 明胶 B型明胶:由碱水解制得,等电点pH4.7~5.2
根据制备方法： A型明胶：由酸水解制得，等电点pH7～9 明胶 B型明胶：由碱水解制得，等电点pH4.7～5.2 明胶 （gelatinum） 1.空胶囊制备 (1)空胶囊组成 空胶囊的主要成囊材料 是由骨、皮水解而制得 骨明胶：脆、硬、透明度差 皮明胶：柔韧、透明