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Fuxuekang granules and preparation process thereof

A technology of Fuxuekang and granules, which is applied in the field of Fuxuekang granules and its preparation, can solve the problems of non-compliance with the microbial limit inspection of granules, aggravate the loss of volatile active ingredients, and reduce stability, and achieve good appearance and shape. Good bioavailability, viscosity improvement effect

Active Publication Date: 2018-07-13
GUANGDONG YILI GROUP PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The granules are extracted by water extraction process, decocting at high temperature will easily lead to the decomposition of active ingredients protocatechuic acid and chlorogenic acid, and increase the loss of volatile active ingredients
In addition, since the extracts of Ainaxiang Diangui are mainly water-soluble substances, the granules made of soluble starch as fillers have relatively high hygroscopicity, which makes the granules easy to absorb moisture and breed bacteria during long-term storage. The microbiological limit inspection of granules does not meet the requirements and the stability is reduced

Method used

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  • Fuxuekang granules and preparation process thereof
  • Fuxuekang granules and preparation process thereof
  • Fuxuekang granules and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1 Preparation of Yunnan Osmanthus Ainaxiang Thick Paste

[0036] (1) Take 1000g of Diangui Ainaxiang, wash it, dry it, crush it into a coarse powder, and then feed it with a density of 1.29kg / m 3 The air is pressurized to 8MP at room temperature, puffed for 5 minutes, the pressure is released instantly, and then the gas is replaced with a density of 1.98kg / m 3 carbon dioxide, pressurized to 10MP under normal temperature conditions, puffed for 5 minutes, released the pressure instantly, and obtained material A;

[0037] (2) Add the above-mentioned material A to the mixed solvent at a solid-liquid ratio of 1:25g / mL, and mix well. The mixed solvent is composed of purified water and acetic acid at a volume ratio of 1:0.1, and then add an appropriate amount of zinc sulfate , the added amount of zinc sulfate is 0.4% (w / w) of the weight of the material A, and then exposed to a high-voltage pulsed electromagnetic field at normal temperature for 10 minutes to obtain the...

Embodiment 2

[0056] Example 2 Detection of active ingredients in Diangui Ainaxiang thick ointment

[0057] The Diangui Ainaxiang thick paste obtained in Example 1 and Comparative Examples 1-4 was dried to obtain a dry powder, and high performance liquid chromatography was used to analyze protocatechuic acid (C 7 h 6 o 4 ) and chlorogenic acid (C 16 h 18 o 9 ) for content detection, the results are shown in Table 1.

[0058] Table 1 Detection results of protocatechuic acid and chlorogenic acid content

[0059]

[0060]

[0061] The Pharmacopoeia stipulates that the extract obtained after decocting and extracting Ainaxiang laurel with water contains protocatechuic acid (C 7 h 6 o 4 ) is not less than 0.12 mg, the results show that the extraction process of the present invention can effectively improve the content of active ingredients protocatechuic acid and chlorogenic acid in Diangui Ainaxiang thick paste, wherein the extract contains 0.43 protocatechuic acid per gram mg, mu...

Embodiment 3

[0062] The composition of embodiment 3 different fillers affects granules

[0063] The effects of the composition of different fillers on the granules were investigated respectively, as shown in Table 2 and Table 3 below.

[0064] Table 2 Composition of granule formulations containing different fillers

[0065] group

Diangui Ainaxiang

filler

flavoring agent

1

1000 copies

150 parts of soluble starch

Appropriate amount of sucrose

2

1000 copies

Mannitol 150 parts

Appropriate amount of sucrose

3

1000 copies

Microcrystalline cellulose 150 parts

Appropriate amount of sucrose

4

1000 copies

Dextrin 150 parts

Appropriate amount of sucrose

5

1000 copies

150 parts of α-lactose

Appropriate amount of sucrose

6

1000 copies

Soluble starch and mannitol (1:1) 150 parts

Appropriate amount of sucrose

7

1000 copies

Soluble starch and microcrystalline cellul...

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PUM

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Abstract

The invention discloses Fuxuekang granules and a preparation process thereof. The Fuxuekang granules comprise the following preparation raw materials in parts by weight: 500 to 2000 parts of Blumea riparia DC, 75 to 300 parts of a filling agent and a proper amount of a flavoring agent. Preferably, the filling agent comprises alpha-lactose and microcrystalline cellulose according to the weight ratio of 1:(3.5-4.5), more preferably, the filling agent comprises alpha-lactose and microcrystalline cellulose according to the weight ratio of 1:4.25. Further, the flavoring agent is cane sugar, xylitol, sorbitol, maltitol or mannitol. By adoption of a special formula and a preparation process, the obtained Fuxuekang granules have high effective component content, excellent bioavailability and storage stability.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a Fuxuekang granule and a preparation process thereof. Background technique [0002] Fuxuekang Granules is a gynecological medicine developed from the Zhuang folk herbal medicine Diangui Ainaxiang, which has been included in the National Standards Compilation of Chinese Patent Medicines of the State Drug Administration (landmarks upgraded to national standards). The granule is a single-taste preparation of Yunnan Gui Ai Naxiang. Diangui Ainaxiang is the dried whole herb of Diangui Ainaxiang, which is mainly produced in Guangxi and Yunnan. It has the functions of promoting blood circulation, removing blood stasis, hemostasis and regulating menstruation. Postpartum lochia embolism. Clinical studies have shown that the unique functional components of this drug can promote uterine smooth muscle contraction, close blood vessels, and accelerate endomet...

Claims

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Application Information

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IPC IPC(8): A61K36/28A61K9/16A61K47/38A61K47/26A61P15/00
CPCA61K9/1623A61K9/1652A61K36/28A61K2236/10A61K2236/333
Inventor 曾胜曾佐达梁烽焱张浩陈尚杰
Owner GUANGDONG YILI GROUP PHARMA
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