新的羟丙甲纤维素胶囊壳（HPMC或素食胶囊）USP各论

GMP News
02/11/2016

New USP monograph for Hypromellose Capsule shells (HPMC or veggie capsules)

新的羟丙甲纤维素胶囊壳（HPMC或素食胶囊）USP各论

A new USP monograph for Hypromellose Capsule shells (HPMC or veggie capsules) has been proposed in Pharmacopeial Forum (PF) 42(4), comment deadline was September 30, 2016, but the USP is still seeking for comments.

一个新的羟丙甲纤维素胶囊壳（HPMC或素食胶囊）USP各论发布在药典论坛（PF）42（4）中，征求意见截止日期为2016年9月30日，但USP还在征求意见中。

The Draft contains the following (amongst others):

草稿包括以下内容（还有其它）：

DEFINITION  定义
Hypromellose Capsule Shell consists of two overlapping pieces (cap and body). One end of each piece is rounded and closed while the other end is open. The cap overlaps the body and maintains a tight closure. Hypromellose Capsule Shells are composed of USP Hypromellose and water, and may also contain additives such as plasticizers, surfactants, gelling agents, dispersing agents, flavoring agents, antimicrobial agents, and sweeteners. They may contain opacifiers, colorants, and/or processing aids. They may be externally coated. They may be imprinted.

羟丙甲纤维素胶囊壳由2个重叠的壳瓣组成（胶囊帽和胶囊体）。每片的尾端都是圆的封闭的，另一端则是武器的。胶囊帽与胶囊体会重复，保持密闭。羟丙甲纤维素胶囊壳由USP羟丙甲纤维素和水制成，有时也含有添加剂，如塑化剂、表面活性剂、胶化剂、分散剂、矫味剂、防腐剂和甜味剂。它们可能含有乳浊剂、着色剂和/或加工助剂。他们可能外面包膜了，也可能有印字。

IDENTIFICATION TESTS (A+B)
  鉴别（A+B）
SPECIFIC TESTS  特定测试

• Loss on Drying  干燥失重 <731>
  

Acceptance criteria:  可接受标准1.0%–13.0%

• Disintegration 崩解度  <701>
  

For capsules larger than 18 mm:  Use the apparatus described in Disintegration and Dissolution <2040>.

大于18mm的胶囊：使用崩解度和溶出度<2040>中所述的仪器。

Acceptance criteria: 可接受标准 30 min

• Microbial Enumeration Tests <61>:  The total aerobic bacteria count does not exceed 103 cfu/g, and the total combined yeasts and molds count does not exceed 102 cfu/g.
• 微生物计数测试<61>：总厌氧菌计数不得过1000CFU/g，总酵母菌和霉菌计数不得过100CFU/g。
  

ADDITIONAL REQUIREMENTS 附加要求

• Packaging and Storage:  Store in tight, light-resistant containers at 15°–25° and at a relative humidity of 40%–65%, unless moisture impermeable containers are used.
• 包装和存贮：密闭、遮光，15-25度，相对温度40-65%RH，使用防水汽穿透容器者除外。
  

For more information please access the Pharmacopoeial Forum free of charge.

更多信息参见免费药典论坛。

来源：Julia

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