USP-1092-溶出度试验的开发和验证(中英文对照版).docx

(1092)溶出度试验的开发和验证【中英文对照版】

INTRoDUCTloN

.、八、-

刖言

PurPOSe

目的

The Dissoluti On Procedure: Developme ntand Validati On <1092> PrOVideS a COmPrehe nsive approach COVeri ng items to con SiderfOr develop ing and VaIidat ing dissoluti on PrOCedUreS and the accompa nyingan alytical procedures. It addresses the USe of automati on throughout the testa nd PrOVideS guida nce and Criteria for VaIidatiO n. It also addresses thetreatme nt of the data gen erated and the in terpretati on of accepta nce CriteriafOr immediate- and modified-release solid oral dosage forms.

溶出实验：开发和验证（1092）指导原则提供了在溶出度方法开发和验证过程中以及采用相应分析方法时需要考虑的因素。本指导原则贯穿溶出度实验的全部过程，并对方法提供了指导和验证标准。同时它还涉及对普通制剂和缓释制剂所生成的数据和接受标准进行说明。

Scope

范围

ChaPter <1092> addresses the developme nt an dvalidati on of dissoluti on procedures, With a focus on solid oral dosage forms.Ma ny of the con CePtS PreSe nted, however, may be applicable to other dosageforms and routes of adminiStration. General recomme ndati ons are give n With the Un dersta nding that modificati ons of the apparatus and PrOCedUreS as give n irUSPge neral ChaPterS n eed to be justified.

<1092>章节讨论了溶出度实验的开发和验证，重点是口服固体制剂。所提出的许多概念也可能适用于其他剂型和给药途径。关于设备和方法的修改部分在USP通则中给出了合理的说明。

The orga ni Zati on of <1092> follows the SeqUe nce of acti ons ofte n PerfOrmed in the developme nt and VaIidati on of a dissolutio n test. The SeCt ions appear in the follow ing SeqUe nce.

在进行溶解度实验的开发和验证时，常遵循指导原则<1092>,具体内容如下：

1. PRELIMINARY ASSESSMENT （FoR EARLY STAGES OF PRoDUCTDEVELoPMENT/DISSOLUTION METHOD DEVELOPMENT）

1. 前期评估（对产品开发以及溶出度方法开发的前期研究评估）

1.1 PerfOrming FiIter COmPatibiIity

1.1滤膜相容性研究

1.2 Determining Solubility and StabiIity of DrUgSUbStance in VariOUS Media 1.2原料药在不同溶出介质中溶解度测定和稳定性研究

1.3 Choos ing a Medium and Volume

1.3溶出介质和体积选择

1.4 Choos ing an APParatUS

1.4溶出设备选择（桨法和篮法以及其他方法）

2. METHoD DEVELoPMENT

2. 方法开发

2.1 Deaerati On

2.1脱气

2.2 Si nkers

2.2沉降篮

2.3 AgitatiO n

2.3转速

2.4 StUdy DeSign

2.4研究设计

2.4.1 TimePOi nts

2.4.1取样时间点

2.4.2 ObSerVatiO ns

2.4.2观察

2.4.3 SamPIi ng

2.4.3取样

2.4.4 Clea ning

2.4.4清洗

2.5 Data Ha ndli ng

2.5数据处理

2.6 Dissoluti On PrOCedUre ASSeSSme nt

2.6溶出方法评估

3. ANALYTICAL FINISH

3. 完成分析

3.1 SamPIe PrOCeSS ing

3.1样品处理

3.2 FiIterS

3.2过滤

3.3 Ce ntrifugati On

3.4 An alytical PrOCedUre

3.4分析方法

3.5 SPeCtrOphotometric An alysis

3.5光谱分析

3.6 HPLC

3.6HPLC 法

4. AUToMATloN

4自动化

4.1 Medium PreParati On

4.1介质的配制

4.2 SamPIe In troduct ion and Timi ng

4.2定时进样

4.3 SamPIing and FiItration

4.3取样和过滤

4.4 Clea ning

4.4清洗

4.5 OPerati ng SOftWare and COmPUtatiO n of ReSUItS

4.5操作软件和计算的结果

5. VALIDATION

5验证

5.1 SPeCifiCity/Placebo In terfere nce

5.1专属性/安慰剂（辅料）干扰

5.2 Lin earity and Range

5.2线性和范围

5.3 ACCUraCy/Recovery

5.3准确度/回收率

5.4 PreCiSi on

5.4精密度

5.4.1 REPEATABILITY OF ANALYSIS

5.4.1重复性

5.4.2 INTERMEDIATE PRECISION/RUGGEDNESS

5.4.2中间精密度/耐用性

5.4.3 REPRODUCIBILITY

5.4.3重现性

5.5 RObUSt ness