Pseudo-ginseng triol saponin enteric pellet and capsule and preparation method thereof

A technology of enteric-coated pellets and alcohol saponin saponin, which is applied in the field of medicine and can solve the problems of dry, brittle and cracked enteric-coated capsule shells

Active Publication Date: 2013-07-03
CHENGDU HUASUN GRP INC LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The purpose of the present invention is to solve the technical defects of the existing commercially available Sanqi Tongshu Capsules, and provide a kind of nonoginsanol saponin enteric-coated pellets, that is, to make the nonoginsanol saponin into the micropills first, and then enteric-coated
The enteric-coated pellets can be filled in ordinary gastric-coated capsules to make enteric-coated pellets-type Sanqitongshu capsules, which can not only ensure the intestinal drug release function of Sanqitriol saponins, but also overcome the difficulty of enteric-coated capsule shells. Quality problems such as dryness and brittleness

Method used

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  • Pseudo-ginseng triol saponin enteric pellet and capsule and preparation method thereof
  • Pseudo-ginseng triol saponin enteric pellet and capsule and preparation method thereof
  • Pseudo-ginseng triol saponin enteric pellet and capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 13 preparation example 1

[0087] Use a universal pulverizer (purchased from Shanghai Tianhe Pharmaceutical Machinery Factory, model GF-300) to pulverize 150 kg of dry rhizomes of Sanqi (place of origin: Wenshan, Yunnan Province), to the coarsest powder with a particle size range of 10 mesh to 24 mesh, and use 65wt% After the above-mentioned Panax notoginseng coarse powder is wetted with ethanol, it is airtightly placed for 8 hours, put into the percolation barrel, and the 65wt% ethanol which is 5 times the inner volume of the notoginseng medical material (hereinafter referred to as the bed volume) is packed into the percolator for percolation, The percolation flow rate is controlled to 0.22 times the bed volume per hour, and the percolation liquid is collected; ethanol in the percolation liquid is recovered under reduced pressure to obtain the total saponin alcoholic extract of Panax notoginseng. The above-mentioned Panax notoginseng saponin alcohol extract was prepared into a solution of 4 times the we...

Embodiment 2

[0089] Embodiment 2 Preparation example 2 of notoginseng triol saponin of the present invention

[0090] Use a universal pulverizer (purchased from Shanghai Tianhe Pharmaceutical Machinery Factory, model GF-300) to pulverize 100 kg of dry rhizomes of Sanqi (place of origin: Wenshan, Yunnan Province), to the coarsest powder of 10 mesh to 24 mesh in the particle size range, and use 70wt% After the above-mentioned Panax notoginseng coarse powder is wetted with ethanol, it is airtightly placed for 5 hours, put into the percolation barrel, and 60 wt% ethanol is packed into the inner volume of the percolator (hereinafter referred to as the bed volume) 6 times according to the coarsest powder of the Panax notoginseng medical material to carry out percolation. The percolation flow rate is controlled to 0.2 times the bed volume per hour, and the percolation liquid is collected; ethanol in the percolation liquid is recovered under reduced pressure to obtain the total saponin alcoholic ex...

Embodiment 3

[0092] Embodiment 3 The prescription of enteric-coated micropill drug ball core of the present invention

[0093] See Table 1 for each component, dosage and evaluation index measurement results in the enteric-coated micropill drug pill core prescription of the present invention.

[0094] Evaluation index in the research of the present invention's prescription process:

[0095] 1. Determination of the content of notoginseng triol saponins:

[0096] Refer to the content of "Assay" in the quality control method of enteric-coated pellets of the present invention.

[0097] 2. The total transfer rate of the main active ingredients of notoginseng triol saponins:

[0098] Total transfer rate=[(ginsenoside Rg1 amount+ginsenoside Re+noginsenoside R1 amount after the process) / (ginsenoside Rg1 amount+ginsenoside Re+noginsenoside R1 amount before the process)]×100%

[0099] 3. The physical indicators of pellets in the investigation of pellet formability:

[0100] Physical indicators in...

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Abstract

Disclosed are a panaxatriol saponins enteric pellet and a method for preparing same, and a capsule comprising the enteric pellet. The enteric pellet comprises a core having a diameter of 20-24 mesh consisting of panaxatriol saponins and pharmaceutical necessities, and an enteric coating layer over the core, wherein the panaxatriol saponins, the pharmaceutical necessities and the enteric coating layer are in a weight ratio of 100:(165-208):(45-65). Preferred pharmaceutical necessities consist of microcrystalline cellulose, starch and polyvidone K30 in a weight ratio of (80-100):(80-100):(5-6), or consist of microcrystalline cellulose, micronized silica gel and polyvidone K30 in a weight ratio of 100:100:8. Preferred enteric pellet has the following components and weight ratio thereof of panaxatriol saponins : microcrystalline cellulose : starch : polyvidone K30 : enteric coating layer = 100:93:93:5.7:58.3, or panaxatriol saponins : microcrystalline cellulose : micronized silica gel : polyvidone K30 : enteric coating layer = 100:100:100:8:62. The enteric pellet is prepared by fluid-bed method or extrusion-spheronization method.

Description

technical field [0001] The present invention relates to the field of medicine, in particular, the present invention relates to a kind of notoginsengtriol saponin enteric-coated pellets mainly used for treating cardiovascular and cerebrovascular embolism diseases, capsules containing the enteric-coated pellets, and the enteric-coated pellets. Preparation method of pellets. Background technique [0002] Sanqi Tongshu Capsules is an original national Class II new traditional Chinese medicine that has been marketed. It is an enteric-coated preparation of the active part of Sanqi, and is mainly used for the treatment of vascular embolism diseases (such as stroke). The raw material drug of Sanqi Tongshu Capsules (nonoginsanol saponin) is separated and purified by macroporous adsorption resin technology, and the substance group is controlled by fingerprint technology. Its process technology and quality control technology are advanced, the material basis is clear, and the efficacy ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/704A61K9/16A61K9/48A61P9/10A61P7/02A61J3/06
CPCA61K31/704A61K9/5021A61K36/258A61P7/02A61P9/00A61P9/10A61K2300/00
Inventor 万方杨华蓉林大胜曹科冷静唐磳
Owner CHENGDU HUASUN GRP INC LTD
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