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Masked berberine hydrochloride micro pill and its prepn

A technology of berberine hydrochloride and taste-masking pellets, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, organic active ingredients, etc. Berberine has a bitter taste and other problems, and achieves the effect of improving compliance, convenient taking, and easy swallowing.

Inactive Publication Date: 2007-03-21
SUNSTONE TANGSHAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In order to overcome the bitter taste of berberine hydrochloride, the defects that existing berberine hydrochloride preparations are not suitable for children and patients with dysphagia, the present invention provides a kind of berberine hydrochloride taste-masking pellets and preparations thereof. Meanwhile, the present invention Also provide the preparation method of this berberine hydrochloride taste-masking pellet and its preparation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1, the preparation of berberine hydrochloride pellets

[0032] The berberine hydrochloride pellets are made of berberine hydrochloride and pharmaceutical excipients; the pharmaceutical excipients used are selected from any one or more of microcrystalline cellulose, starch, sucrose, and dextrin; by weight percentage, The amount of auxiliary materials in the pellets is 15-90%.

[0033] The preparation of the berberine hydrochloride pellets can adopt any method in the extrusion centrifugal granulation method, centrifugal layering method or sugar-coated pan spheronization method.

Embodiment 2

[0034] Embodiment 2, preparation of berberine hydrochloride pellets by centrifugal layering

[0035] According to the method of embodiment 1: but the preparation of berberine hydrochloride pellets adopts centrifugal layering method:

[0036] Mix berberine hydrochloride and auxiliary materials evenly; take an appropriate amount of mixed powder and put it on a centrifugal granulator, spray an appropriate amount of binder to make pellets, screen the pellets with a particle size of 100-600 μm, and set aside.

Embodiment 3

[0037] Embodiment 3, the preparation of berberine hydrochloride taste-masking pellets

[0038] The berberine hydrochloride taste-masking pellets are made by coating the berberine hydrochloride pellets. The coating material includes: film-forming material, plasticizer, and anti-caking agent.

[0039] The film-forming material here is selected from one or more of Eudragit E100 (domestic acrylic acid IV resin), Eudragit EPO, Eudragit L100, hydroxypropyl methylcellulose; The dosage is 1-8%;

[0040] The plasticizer here is selected from castor oil, polyethylene glycol 6000, polyethylene glycol 1500, polyethylene glycol 400, any one or more in dibutyl sebacate, triethyl citrate; In terms of weight percentage, the amount of plasticizer in the coating material is 5-8% of the film-forming material;

[0041] The anti-adhesive agent here is selected from any one or more of magnesium stearate, talcum powder, and micropowdered silica gel; by weight percentage, the amount of the anti-ad...

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Abstract

The masked berberine hydrochloride micro pill is coated berberine hydrochloride micro pill, and the berberine hydrochloride micro pill is prepared with berberine hydrochloride and supplementary material through an extruding and centrifugal pelletizing process, a centrifugal laminating process or a rolling process in a sugar coating pot. The supplementary material is selected from microcrystalline cellulose, starch, cane sugar and dextrin, and accounts for 15-90 % of the micro pill. The coating material includes filming material, plasticizer and antiagglomerant. The masked berberine hydrochloride micro pill may be further prepared into granule, dispersed tablet, dry suspension, bolus or other preparation forms. The present invention has the bitter of berberine hydrochloride masked and thus raised patient's compliance, and is especially suitable for infant and old persons with dysphagia.

Description

technical field [0001] The invention relates to traditional Chinese medicine pellets and preparations thereof, in particular to berberine hydrochloride taste-masking pellets and preparations thereof. Background technique [0002] Berberine hydrochloride is a broad-spectrum antibacterial agent. It was mainly extracted in the early days, but now it is fully synthesized and supplied to the market. Berberine hydrochloride has a long history of clinical application. It is safe to use and has reliable curative effect. In recent years, berberine hydrochloride has many other applications, such as the treatment of hypertension and diabetes. Among the antibacterial agents that children can use, berberine hydrochloride plays an irreplaceable role. However, the taste of berberine hydrochloride is extremely bitter, and methods such as preparing sugar-coated tablets or putting medicine into capsules are traditionally used to mask the bitter taste; but the berberine hydrochloride preparat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/32A61K47/38A61K31/4375A61P31/04
Inventor 韩志强
Owner SUNSTONE TANGSHAN PHARM CO LTD
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