Technical requirements for health food recording dosage form powder

1.粉剂概述

1. Overview of powder

用于保健食品备案的粉剂是以纳入保健食品原料目录的原料与辅料经粉碎、均匀混合制成的干燥粉末状成品。

The powder used for health food filing is a dry powder finished product made from the raw materials and auxiliary materials included in the health food raw materials catalog after being crushed and uniformly mixed.

2.粉剂产品说明书有关内容

2. Relevant contents of powder product manual

以下内容仅针对粉剂食品形态规定了需要满足的有关要求，不涉及使用的原料辅料在制成产品时另需要符合的其他规定。

The following contents only specify the relevant requirements that need to be met for the form of powder food, and do not involve other requirements that need to be met when the raw materials and excipients used are made into products.

产品说明书中有关内容要求如下：

Requirements for relevant contents in the product manual are as follows:

【适宜人群】该剂型应该适宜于所有人群

[Suitable for people] The dosage form should be suitable for all people

【不适宜人群】该剂型暂无特定的不适宜人群

[Unsuitable crowd] There is no specific unsuitable crowd for this dosage form

【食用量及食用方法】每日最大食用量为20g;增加提示“粉剂服用时一般溶于或分散于水或者其他液体中服用，也可直接用水送服”。对于食用方法为“直接口服”的，不适宜人群应包括“6岁以下人群”。

[Consumption and method] The maximum daily consumption is 20g; It is added that "when taking powder, it is generally dissolved or dispersed in water or other liquids, and can also be taken directly with water". For those whose consumption method is "direct oral", the unsuitable population should include "people under 6 years old".

【规格】对于大剂量包装的，限定每个包装的装量不超过500g(原则上不超过1个月的服用量)。大剂量包装应附分剂量的用具。

[Specification] For large dose packaging, the loading capacity of each package shall not exceed 500g (in principle, the dosage shall not exceed one month). Large dose packaging shall be attached with tools for different doses.

【保质期】不超过24个月

[Shelf life] No more than 24 months.

3.粉剂产品技术要求有关内容

3. Technical requirements for powder products

以下内容仅针对粉剂食品形态规定了需要满足的有关要求，不涉及使用的原料在制成产品时另需要符合的其他规定。

The following contents only specify the relevant requirements that need to be met for the form of powder food, and do not involve other requirements that need to be met when the raw materials used are made into products.

产品技术要求有关内容要求如下：

The product technical requirements are as follows:

　　【感官要求】

　　【理化指标】

　　【微生物指标】

【净含量及允许负偏差指标】

[Net content and allowable negative deviation index]

净含量及允许负偏差指标应符合JJF 1070规定

Net content and allowable negative deviation index shall conform to JJF 1070

4.产品名称

4. Product name

商标名+通用名+粉(原料名称已带“粉”的不再重复添加)

Trade name+common name+powder (the name of raw materials with "powder" will not be added repeatedly)