详细信息
FDA溶出方法数据库
检索页面
https://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm
溶出方法数据库-检索页
溶出方法数据库全部数据
https://www.accessdata.fda.gov/scripts/cder/dissolution/dsp_getallData.cfm
Dissolution Methods
Dissolution Methods Database
The dissolution methods included in the database reflect methods used for quality control testing in approved applications that have been previously found acceptable by the FDA, USP methods, and methods recommended in FDA guidance(s) (e.g., Guidance for Industry, Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances). These dissolution methods are not required to be used by applicants; FDA will consider alternate methods instead of those listed in the database, the acceptability of which will be determined based on whether the method is supported by appropriate data. It is important to note that the database contains a large amount of material, and methods and acceptance criterion/criteria may change over time. Methods used in more recently approved submissions may differ from methods currently reflected in the database.
数据库中包含的溶出度方法反映了之前已被 FDA、USP 方法和 FDA 指南（例如，行业指南、溶出度测试和验收指南）中推荐的已批准应用程序中用于质量控制测试的方法含有高溶解度原料药的速释固体口服剂型药物产品的标准）。这些溶出方法不要求申请人使用； FDA 将考虑替代方法而不是数据库中列出的方法，其可接受性将根据该方法是否得到适当数据的支持来确定。重要的是要注意数据库包含大量材料，方法和验收标准/标准可能会随时间变化。
Dissolution Methods Database Frequently Asked Questions
溶出方法数据库常见问题解答
1. What is the purpose of the Dissolution Methods Database?
1. 溶出方法数据库的用途是什么？
For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on dissolution methods presently recommended by the Division of Biopharmaceutics, Office of Pharmaceutical Quality. We are providing the Dissolution Methods Database to aid industry personnel in developing generic drug products. Dissolution Database Disclaimer
对于美国药典 (USP) 中没有溶出度测试方法的药品，FDA 溶出度方法数据库提供了药品质量办公室生物制药部门目前推荐的溶出度方法的信息。我们提供溶出方法数据库来帮助行业人员开发仿制药产品。溶出度数据库免责声明
2. How can I search the Dissolution Methods Database?
2. 如何搜索溶出方法数据库？
You can search the Dissolution Methods Database by entering any part of the generic name of a drug. You must enter at least three characters.
您可以通过输入药物通用名称的任何部分来搜索溶出度方法数据库。您必须至少输入三个字符。
To find all products, click on the link "Printable List of all Drugs in the Database" on the Search Page.
要查找所有产品，请单击搜索页面上的链接“数据库中所有药物的可打印列表”。
When searching combination products, enter the component ingredients in alphabetical order, separated by a slash (/), but with no spaces before or after the slash. You can also search each ingredient individually if you are not sure of the correct way to type the search terms.
搜索组合产品时，按字母顺序输入成分成分，用斜杠（/）分隔，但斜杠前后不能有空格。如果您不确定输入搜索词的正确方法，您也可以单独搜索每种成分。
3. How are drug names listed in the search results?
3. 药品名称在搜索结果中如何列出？
All drug products are listed alphabetically by non-proprietary (generic) names. For combination products, the active drug components appear in alphabetical order of their chemical generic names (for example, "sulfamethoxazole/trimethoprim").
所有药品均按非专有（通用）名称的字母顺序列出。对于组合产品，活性药物成分按其化学通用名称的字母顺序排列（例如“磺胺甲恶唑/甲氧苄啶”）。
4. What is a "Dosage Form"?
4. 什么是“剂型”？
A "Dosage Form" is the form in which a drug is produced and dispensed, for example, tablet, capsule, or suspension.
“剂型”是生产和分配药物的形式，例如片剂、胶囊或悬浮液。
5. Where can I find a detailed description of each "USP Apparatus"?
5. 在哪里可以找到每个“USP 装置”的详细说明？
A description of each official apparatus appears in the United States Pharmacopeia (USP).
每个官方仪器的描述出现在美国药典 (USP) 中。
6. Where can I find a detailed description of each "Medium"?
6. 在哪里可以找到每个“媒介”的详细说明？
For most of the drugs in the database, the preparation of the recommended dissolution medium is described in the United States Pharmacopeia (USP). Under normal circumstances, the dissolution testing should be conducted at 37° C unless otherwise noted.
对于数据库中的大多数药物，推荐的溶出介质的制备在美国药典（USP）中有描述。一般情况下，除非另有说明，溶出度测试应在37℃下进行。
7. What do the numbers in the "Recommended Sampling Times" column mean?
7. “建议采样时间”栏中的数字是什么意思？
The "Recommended Sampling Times" field specifies the times recommended for taking dissolution samples for a particular drug product to generate a dissolution profile. The times are given in minutes, unless the word "hours" appears after a number. FDA generally recommends that by the last sampling time, at least 70-85% (Q) of the labeled content of the active drug should be dissolved, depending upon the specific drug product.
“推荐采样时间”字段指定了对特定药品采集溶出样品以生成溶出曲线的推荐时间。时间以分钟为单位，除非数字后面出现“小时”一词。 FDA 通常建议，在最后一次采样时，活性药物标签含量的至少 70-85% (Q) 应溶解，具体取决于具体的药品。
8. What is the meaning of the date in the last column?
8. 最后一栏的日期是什么意思？
The "Date Updated" field contains the date of the latest dissolution information used to recommend a test for a particular drug product.
“更新日期”字段包含用于推荐特定药品测试的最新溶出度信息的日期。
9. What should I do if I can't find a Dissolution Method for a particular drug?
9. 如果找不到特定药物的溶出度方法，该怎么办？
Mail questions about dissolution methods to:
将有关溶解方法的问题邮寄至：
Division of Biopharmaceutics (HFD-003)
生物制药学部 (HFD-003)
Office of New Drug Products
新药办公室
Office of Pharmaceutical Quality
药品质量办公室
10903 New Hampshire Ave
新罕布什尔大街10903号
Silver Spring, MD 20993
银泉，马里兰州 20993
10. How often do you update the Dissolution Methods Database?
10. 溶出方法数据库多久更新一次？
We update the database quarterly, by the fifth working day of April, July, October, and January. The date of the latest database update appears at the bottom of each page.
我们每季度更新一次数据库，截止日期为四月、七月、十月和一月的第五个工作日。最新数据库更新的日期显示在每个页面的底部。