Preparation process of compound traditional Chinese medicine formula granule placebo

A technology for formula granules and compound traditional Chinese medicine, which is applied in pharmaceutical formulas, preparations for in vivo experiments, compound screening/testing, etc., can solve the problems of no compound traditional Chinese medicine formula granule placebo, and few reports on the production of traditional Chinese medicine formula granule placebo. , to achieve the effect of improving reliability and achieving a high degree of consistency

Active Publication Date: 2017-01-04
SICHUAN NEO GREEN PHARMA TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In clinical trials in my country, there are few reports on the preparation of placebos for traditional Chinese medicine formula granules, and there are no reports of placebos for compound Chinese medicine formula granules.

Method used

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  • Preparation process of compound traditional Chinese medicine formula granule placebo
  • Preparation process of compound traditional Chinese medicine formula granule placebo
  • Preparation process of compound traditional Chinese medicine formula granule placebo

Examples

Experimental program
Comparison scheme
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preparation example Construction

[0054] (6) Preparation of Compound Formula Granules Placebo

[0055] Mix the coloring agent granules prepared in step (4) and step (5) with the granules of the original prescription formula, and carry out granulation processing, and divide into small packages into polyethylene plastic bags according to the prescription dosage.

[0056] All the above %, unless otherwise specified, are expressed in terms of the mass of the final placebo, and are expressed as a percentage by mass.

Embodiment 1

[0057] Embodiment 1 compound recipe-placebo preparation

[0058] 1.1 According to the original prescription formula granule mixing and parameter recording

[0059] The formula granule species and dosage calculated by the original TCM clinical prescription: American ginseng 1.20g, Ophiopogon japonicus 2.14g, Nansha ginseng 1.09g, Trichosanthes mellifera 1.50g, Fritillaria 0.82g, Pulsatilla 0.57g, Radix Paeoniae Rubra 1.09g, Purple Peony Suzi 0.45g, tangerine peel 0.82g.

[0060] The above-mentioned granules are weighed by mass, and after mixing evenly, the granules have various colors, and after brewing, they are brownish yellow and have a slight bitter taste.

[0061] 1.2 Selection of accessories

[0062] 1.2.1 Investigated different excipients (soluble starch, maltodextrin), and selected the appropriate excipient type for compound formula granules as maltodextrin. Determine the amount added to be 90.4%.

[0063] 1.2.2 Colorant selection

[0064] According to the color of...

Embodiment 2

[0090] Preparation of embodiment 2 compound two placebos

[0091] 2.1 According to the original prescription formula granule mixing and parameter recording

[0092] The dosage of the original traditional Chinese medicine clinical prescription formula granule is: 0.91g of safflower, 0.53g of Pinellia chinensis, 1.36g of salvia miltiorrhiza, 0.88g of poria cocos, 0.48g of raw cattail, 1.43g of purified hawthorn, and 0.48g of fried radish seed.

[0093] After the above-mentioned granules are weighed and mixed in proportion, the observed granule colors are various. After brewing, the color is brownish-yellow-green, and the smell is obvious.

[0094] 2.2 Selection of accessories

[0095] 2.2.1 Investigated different excipients (soluble starch, maltodextrin, lactose, flour), and selected the appropriate excipient type of compound formula granules as maltodextrin. The addition amount is 90%.

[0096] 2.2.2 Colorant selection

[0097] According to the color of the granules and the...

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Abstract

The invention relates to the technical field of medicine preparation, in particular to a preparation process of a compound traditional Chinese medicine formula granule placebo. The process comprises the following steps: 1) mixing formula granules of an original prescription; 2) recording related parameters of the prescription mixed granules; 3) investigating adjuvant materials; 4) producing coloring agent granules; 5) weighing the mixed formula granules of the original prescription; and 6) preparing the compound formula granule placebo. According to the process in which the traditional Chinese medicine formula granule placebo is prepared in accordance with the traditional Chinese medicine principle of the compatibility of various medicines in the clinical field, a color difference between a single-formula granule placebo and a traditional Chinese medicinal decoction of the original prescription after the placebo is blended is avoided from color; meanwhile, a visual effect that the colors of a plurality of formula granules are presented in the placebo is achieved by virtue of the process, so that researchers and tested objects can assess differences between therapeutic drugs and the placebo under test conditions more directly, and bias caused by such factors as color, taste and the like can be avoided, so that test reliability is enhanced.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a preparation process of compound traditional Chinese medicine formula granule placebo. Background technique [0002] Placebo (Placebo) is composed of neutral substances with no medicinal effect and no adverse reactions. Its appearance is similar to therapeutic drugs, and it is mostly composed of inert substances without pharmacological effects such as starch, lactose, glucose, and sodium chloride. With the development of evidence-based medicine in the field of traditional Chinese medicine and the continuous in-depth study and application of Good Clinical Practice (GCP) in clinical research of traditional Chinese medicine, the design of clinical trials of traditional Chinese medicine mostly follows the random, controlled, blinded, repeated Four principles, placebo-controlled trials can overcome the bias caused by researchers and subjects due to many factors, can dire...

Claims

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Application Information

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Patent Type & AuthorityApplications(China)
IPC IPC(8): A61K49/00
CPCA61K49/0004
Inventor周厚成胡昌江黄宇冯健李文兵
OwnerSICHUAN NEO GREEN PHARMA TECH DEV