Preparation method of traditional Chinese medicine formula granule placebo

A technology of traditional Chinese medicine formula granules and placebo, which is applied in the field of medicine and can solve problems such as confusion in the preparation method of placebo

Pending Publication Date: 2022-01-04
CHINA RESOURCES SANJIU MEDICAL & PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is very common to use traditional Chinese medicine formula granules to add and subtract classic famous prescriptions in clinical practice. During the clinical research on classic famous prescription granules, it is often necessary to provide placebo granules as a blank control. Lack of research Due to the unified appearance standard as a reference, the preparation method of the formula granules and the placebo of the formula is confusing

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  • Preparation method of traditional Chinese medicine formula granule placebo
  • Preparation method of traditional Chinese medicine formula granule placebo
  • Preparation method of traditional Chinese medicine formula granule placebo

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] The present embodiment provides a kind of preparation method of placebo granules, comprising:

[0047] Take the traditional Chinese medicine formula granules of each herbal flavor, and in this example, choose to collect the traditional Chinese medicine formula granules prepared according to the quality control requirements in the "Notice on the Unified Standards for the Pilot Program of Traditional Chinese Medicine Formula Granules" issued by the State Pharmacopoeia Commission at the end of 2019. The appearance of each herbal flavor granule The properties meet the requirements, record the appearance and color parameters of the granules respectively, and then dissolve the granules according to the solubility requirements of the granules in the "Chinese Pharmacopoeia" (2020), and record the color parameters of the obtained solution; in this example, Pantone international color card is selected Compare the color samples in the sample with the traditional Chinese medicine fo...

Embodiment 2

[0056] 【Prescription Name】Shaoyao Gancao Decoction

[0057] [Prescription Composition]: Radix Paeoniae Alba 12g, Radix Glycyrrhizae 12g;

[0058] 【Amount of Formula Granules】: Radix Paeoniae Alba 2.7g, Radix Glycyrrhizae 5.2g;

[0059] [Preparation method of compound formula granule placebo]:

[0060] S1. Take the formula granules of each herbal flavor in the selected traditional Chinese medicine prescription, record the appearance and color characteristics of each herbal formula granule, and then dissolve the granules according to the solubility requirements of the granules in the "Chinese Pharmacopoeia" (2020), and record the obtained The smell and mouthfeel of each medicinal liquid, according to the appearance character, color feature and the mouthfeel of each medicine flavor recorded, select matching or similar placebo granules; in the present embodiment, select placebo granules from embodiment 1, wherein Radix Paeoniae Alba selects Matching or similar placebo granules t...

Embodiment 3

[0068] 【Prescription Name】Danggui Buxue Decoction Compound

[0069] [Prescription Composition]: Astragalus 30g, Angelica 6g

[0070] 【Amount of Formula Granules】: Astragalus 12g, Angelica 4g

[0071] [placebo granule]: according to the placebo granule in embodiment 1

[0072] Astragalus formula granules match the granule type II, specific formula: egg yolk 0.6g, caramel 1.2g, base maltodextrin 1000g;

[0073] Angelica formula granules match the granule type II, the specific formula: egg yolk 0.6g, caramel color 5g, matrix maltodextrin 1000g;

[0074] In [preparation method of formula granules placebo], choose to add the compound formula granules of Danggui Buxue Decoction with a mass percentage equivalent to the total granules of placebo granules;

[0075] [Preparation method of compound formula granules placebo]: the same as in Example 2.

[0076] The Chinese medicine formula granule placebo prepared in the above-mentioned method and the Chinese medicine formula granule a...

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Abstract

The invention provides a method for preparing placebo granules, which comprises the following steps of: preparing placebo granules, mixing the placebo granules according to a prescription proportion, properly adjusting the proportion of placebo granules with different color numbers, and mixing the placebo granules into a mixture of formula granules, so that the placebo granules are consistent with a real medicine in appearance, and the appearance, the smell and the taste of the solution in the brewing process are highly similar to those of compound formula granules.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a method for preparing a traditional Chinese medicine formula granule placebo. Background technique [0002] At the end of 2019, the National Pharmacopoeia Commission issued a document to announce the "Publicity on the Unified Standards for Pilot Types of Traditional Chinese Medicine Formula Granules". The publicity draft formulated a total of 160 commonly used traditional Chinese medicine formula granules quality standards, including the production volume, content and preparation process of each variety of granules Wait. Different from the pilot stage, the appearance and shape of the TCM formula granules prepared by each pilot unit are quite different, which has caused more doubts in clinical use. The traditional Chinese medicine formula granules prepared in accordance with the requirements of national standards have relatively stable odor, taste and appearance. [0003] Placebos refer...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K47/36A61K47/26
CPCA61K9/1605A61K9/1682A61K9/1652A61K9/1623
Inventor阮世发廖嘉宝王勇谭沛马鹏岗
OwnerCHINA RESOURCES SANJIU MEDICAL & PHARMA