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Berberine hydrochloride dispensing tablet and its preparing method

A technology of berberine hydrochloride and dispersible tablets, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, organic active ingredients, etc., can solve the problems of incomplete dissolution, low dissolution rate, slow disintegration and dissolution, etc., to ensure that Therapeutic effect, rapid disintegration and dissolution, and the effect of overcoming bitter taste

Inactive Publication Date: 2005-10-19
广东怡康制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current berberine hydrochloride tablets have problems such as low dissolution rate and incomplete dissolution. There are large dissolution differences in different units of prescriptions, or different batches of products with the same prescription.
In addition, similar products on the market are plain tablets or sugar-coated tablets. Berberine hydrochloride tastes extremely bitter, and the taste of plain tablets is poor, while sugar-coated tablets disintegrate and dissolve slowly, which cannot meet the medication requirements of patients with acute diseases.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0014] Experimental Example 1 Formula Screening Experiment

[0015] In the dispersible tablet process, the main indicators for evaluating tablet quality are: appearance, hardness, disintegration time limit, dissolution rate, etc. Among them, the disintegration time limit and the dissolution rate are the most critical indicators affecting the efficacy of the drug. Therefore, in the formula screening experiment, we choose it as the main evaluation index.

[0016] 1. Instrument

[0017] ZB-1C intelligent disintegration instrument (Tianjin University Precision Instrument Factory)

[0018] 752 UV spectrophotometer (Shanghai Analytical Instrument General Factory)

[0019] RCZ-8A Intelligent Drug Dissolution Apparatus (Tianjin University Precision Instrument Factory)

[0020] ZP35A rotary tablet press (Shanghai Tianxiang Jiantai Pharmaceutical Machinery Co., Ltd.)

[0021] 2. Sources of main ingredients and excipients

[0022] Berberine hydrochloride (Sichuan Yabao Guangtai Pha...

experiment example 2

[0038] Experimental Example 2 Film Coating Dosage Selection

[0039] 1. Coating material: Opadry, stomach-soluble type, specification 03B62877, produced by Shanghai Colorcon Company.

[0040] 2. Preparation of coating solution: under stirring, quickly and evenly add Opadry to 80% ethanol to make a 6% solution, and continue stirring for 45 minutes to completely dissolve and disperse Opadry.

[0041] 3. Equipment: BGB-75B high-efficiency coating pan.

[0042] 4. Coating conditions: Use the coating parameters provided by Colorcon Company: inlet air temperature 85°C, tablet bed temperature 40-45°C, coating pan speed 8-10RPM, feed flow rate 4-6g / min. After spraying the coating solution, blow the cold air to dry, and wait for the temperature of the tablet to drop to room temperature before releasing the tablet.

[0043] 5. Screening of the coating powder dosage: Weigh the coating powder according to 5% of the tablet core weight, add 80% ethanol to prepare a 6% solution, and invest...

Embodiment 1

[0046] Embodiment 1 The preparation of berberine hydrochloride dispersible tablet of the present invention

[0047] a) pass the berberine hydrochloride and each auxiliary material through a 100-mesh sieve respectively, and set aside;

[0048] b) Weigh 100g of berberine hydrochloride, 26g of microcrystalline cellulose, and 15g of sodium carboxymethyl starch according to the formula, mix well, add an appropriate amount of 95% ethanol to make a suitable soft material, and pass through a 30-mesh sieve to make wet granules , dried at 65°C, passed through a 20-mesh sieve for granulation, added 2.6g of silicon dioxide and 1.3g of magnesium stearate, mixed evenly, punched with a shallow arc of Φ7.5mm, and pressed into 1000 plain tablets, each containing a small amount of hydrochloric acid Berine 0.1g, film-coated, packaged, ready to use.

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PUM

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Abstract

The present invention discloses a kind of berberine hydrochloride dispersing tablet and its preparation process. The berberine hydrochloride dispersing tablet contains berberine hydrochloride in recipe amount, microcrystalline cellulose in 10-40 wt%, sodium carboxymethyl starch 6-35 wt%, silicon dioxide in 1-20 wt% and magnesium stearate in 0.5-20 wt%. The preparation process includes 100 mesh sieving berberine hydrochloride and supplementary material; mixing berberine hydrochloride, microcrystalline cellulose and sodium carboxymethyl starch while adding proper amount of 95 % concentration alcohol solution to form soft material; 30 mesh sieving, palletizing, drying at 65 deg.c, 20 mesh sieving, adding silicon dioxide and magnesium stearate; tabletting, coating and packing. The dispersing tablet has the advantages of fast disintegration and leaching, and high medicinal effect.

Description

technical field [0001] The invention relates to an antibacterial and antiviral drug, in particular to a berberine hydrochloride dispersible tablet, and also relates to a preparation method of the dispersible tablet. Background technique [0002] Berberine hydrochloride is the second part of the Chinese Pharmacopoeia 2000 edition. Berberine is an alkaloid extracted from Chinese medicines such as Coptidis Rhizoma and Cortex Phellodendri, and is a common drug. Berberine has inhibitory effect on influenza A, B and C strains. It has antibacterial effect on Shigella, Staphylococcus aureus, Hemolytic Streptococcus, Diplococcus pneumoniae, Meningococcus, Vibrio cholerae, Salmonella typhi, Mycobacterium tuberculosis and Pertussis bacillus. In addition, it also has an antibacterial effect on some molds (Candida albicans). Although berberine has a wide antibacterial spectrum, its oral absorption is poor, and intramuscular injection and intravenous administration will produce some si...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K31/4375A61P1/00A61P31/04A61P31/10A61P31/16
Inventor 陈小坚卢竹丽
Owner 广东怡康制药有限公司
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