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Process for producing placebo of traditional Chinese medicine formula granule

A traditional Chinese medicine formula granule and a technology for formula granules are applied in the directions of pharmaceutical formulas, preparations for in vivo tests, medical preparations containing active ingredients, etc., to achieve the effects of easy availability of raw materials, simple production and low cost

Inactive Publication Date: 2013-02-06
培力(南宁)药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the clinical trials in our country, there is no report on the production of placebos for traditional Chinese medicine formula granules. Therefore, the invention of this production process will be of great significance to the clinical research of traditional Chinese medicine formula granules, and has broad clinical application prospects.

Method used

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  • Process for producing placebo of traditional Chinese medicine formula granule
  • Process for producing placebo of traditional Chinese medicine formula granule
  • Process for producing placebo of traditional Chinese medicine formula granule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Preparation of placebo of Scutellaria baicalensis formula granules: choose dextrin as base, double edible caramel pigment, edible gardenia yellow pigment (500) and edible gardenia yellow pigment (60) as color correction agent, because its appearance and color mainly The influencing factor is the color correcting agent. Now, 1000g of placebo of Scutellaria baicalensis formula granules is used to carry out the orthogonal test of the raw material ratio of the color correcting agent. L can be selected. 9 (3 4 ) Orthogonal header design and arrangement of experiments, the experimental design and results are shown in Tables 1-3.

[0024] Table 1 for the placebo factor level of Huangqin Formula Granules

[0025]

[0026] Orthogonal Test of Huangqin Formula Granules Placebo Table 2

[0027]

[0028]

[0029] Index analysis of variance table 3

[0030]

[0031] According to the range intuitive analysis method and the variance analysis method, the optimal raw mater...

Embodiment 2

[0033]Preparation of placebo for ephedra formula granules: choose dextrin as base, double edible caramel pigment, edible gardenia yellow pigment (500) and sunset yellow pigment (85) as color correcting agents, due to the main influencing factors of its appearance and color It is a color correcting agent. At the same time, its taste is bitter and astringent, and citric acid monohydrate is used as a flavoring agent. Now with the production of ephedra formula granules placebo 1000g, carry out the orthogonal test of the raw material ratio of the color correction agent, you can choose L 9 (3 4 ) Orthogonal header design and arrangement of experiments, the experimental design and results are shown in Tables 4-6.

[0034] Mahuang formula granule placebo factor level table 4

[0035]

[0036] Mahuang Formula Granules Placebo Orthogonal Test Table 5

[0037]

[0038] Index analysis of variance table 6

[0039]

[0040] According to the range intuitive analysis method and t...

Embodiment 3

[0042] Preparation of ginger formula granule placebo: choose dextrin as base, double edible caramel pigment, edible gardenia yellow pigment (500) and sunset yellow pigment (85) as color correcting agents, because the main influencing factors of its appearance and color As a color correcting agent, now make ginger formula granule placebo 1000g, carry out the orthogonal test of the raw material ratio of color correcting agent, can choose L 9 (3 4 ) Orthogonal header design and arrangement of experiments, the experimental design and results are shown in Tables 7-9.

[0043] Ginger Formula Granules Placebo Factor Level Table 7

[0044]

[0045] Ginger formula granule placebo orthogonal test Table 8

[0046]

[0047] Index analysis of variance table 9

[0048]

[0049] According to the range intuitive analysis method and the variance analysis method, the optimal raw material ratio is determined as: A 2 B 1 C 1 , according to the calculation of 1000g placebo of ginger...

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Abstract

The invention discloses a process for producing a placebo of a traditional Chinese medicine formula granule. The process comprises the steps of: selecting a matrix, a toner, a flavoring agent and a solvent according to the mixture ration, mixing, drying, crushing, screening, granulating and sorting whole granules to achieve color matching with the traditional Chinese medicine formula granule. According to the process, the mixture ratio of the matrix, the toner and the solvent can be adjusted according to the property of each traditional Chinese medicine formula granule, and is optimized using an orthogonal design and synthetic colligation score method. The process has the advantages that different placebos for different formula granules are produced according to the property of each traditional Chinese medicine through screening different mixture ratios by using specific toners and flavoring agents, the production is simple, the raw materials are easily obtained, the cost is low, and the placebos have similar appearance, color and odor to the corresponding formula granules; and the process can be used for producing placebo controls for clinical tests and research of a traditional Chinese medicine formula granule.

Description

technical field [0001] The invention relates to a process for preparing a traditional Chinese medicine formula granule placebo. Background technique [0002] Traditional Chinese medicine formula granules are made using modern production technology, using traditional Chinese medicine decoction pieces as raw materials, and made according to a certain production process. They are only granules for clinical dispensing. At present, my country has not yet started the approval number management and is still in the scientific research stage. Since its development is based on the traditional clinical use of decoction, its clinical safety and effectiveness need to be confirmed by more clinical trials. In the process of clinical trials, the design of the control group usually includes five types, namely, placebo control, blank control, dosage control, positive drug control and external control, while the control drug is divided into negative control drug (placebo) and positive control d...

Claims

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Application Information

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IPC IPC(8): A61K49/00A61K49/18A61K36/539A61P43/00
Inventor 邱莉林琳粟华生温庆伟许银姬吴蕾
Owner 培力(南宁)药业有限公司
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