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Compound ambroxol hydrochloride sustained-release tablet and preparation method thereof

A technology of ambroxol hydrochloride and sustained-release tablets, which can be used in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery and other directions, and can solve problems such as no literature reports on sustained-release preparations

Inactive Publication Date: 2007-12-12
SHANDONG INST OF PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the sustained-release preparations of ambroxol hydrochloride and the sustained-release preparations of roxithromycin are both on the market, and both are taken once a day, but there is no literature report on the sustained-release preparations of the two compounds.

Method used

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  • Compound ambroxol hydrochloride sustained-release tablet and preparation method thereof
  • Compound ambroxol hydrochloride sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1 Compound Ambroxol Hydrophilic Gel Matrix Tablet

[0041] prescription:

[0042] Ambroxol Hydrochloride 75g

[0043] Roxithromycin 250g

[0044] HPMC K4M 80g

[0045] CMC-Na 80g

[0046] Tartaric acid 90g

[0047] Lactose 70g

[0048] Starch 100g

[0049] 95% ethanol appropriate amount

[0050]Magnesium Stearate 7g

[0051] Talc powder 7g

[0052] Preparation process: get ambroxol hydrochloride crude drug, pulverize and pass through a 100 mesh sieve, roxithromycin adopts micronized crude drug, mixes with HPMC K4M, CMC-Na, starch, tartaric acid and lactose, moistens with 95% ethanol Granulate after wet, granulate after drying at 50°C, add magnesium stearate and talcum powder, mix evenly and press into tablets.

[0053] For the release test, the release rate of the sample was measured according to the first method of Appendix XC of the Chinese Pharmacopoeia in 2005, Part Two of the Chinese Pharmacopoeia Edition. Use 900ml of dilute hydrochloric acid (6...

Embodiment 2

[0055] Example 2 Compound Ambroxol Hydrochloride Waxy Matrix Tablets

[0056] prescription:

[0057] Ambroxol Hydrochloride 75g

[0058] Roxithromycin 250g

[0059] Octadecanol 100g

[0060] Citric acid 80g

[0061] 160g pregelatinized starch

[0062] Magnesium Stearate 6g

[0063] Preparation process: take ambroxol hydrochloride and roxithromycin raw materials, mix them with pregelatinized starch and citric acid, add molten stearyl alcohol, granulate after mixing, add magnesium stearate, mix well Tablet.

[0064] The release test is the same as in Example 1, and the results are as follows:

[0065] time (hours)

Embodiment 3

[0066] Embodiment 3 compound ambroxol hydrochloride non-erodible matrix tablet

[0067] prescription:

[0068] Ambroxol Hydrochloride 75g

[0069] Roxithromycin 250g

[0070] Ethylcellulose 110g

[0071] Tartaric acid 100g

[0072] Lactose 80g

[0073] Starch 80g

[0074] 95% ethanol appropriate amount

[0075] Magnesium Stearate 7g

[0076] Talc powder 7g

[0077] Preparation process: Take ambroxol hydrochloride and roxithromycin raw materials, mix them evenly with lactose, starch, tartaric acid, ethyl cellulose, add appropriate amount of 95% ethanol to granulate, add magnesium stearate and talcum powder after drying, mix Press evenly.

[0078] The release test is the same as in Example 1, and the results are as follows:

[0079] time (hours)

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Abstract

The invention provides a preparation method of compound ambroxol hydrochloride sustained release matrix tablet. The inventive ambroxol hydrochloride sustained release tablet specifically comprises (g / g) ambroxol hydrochloride 5-20%, roxithromycin 15-60%, skeletal material 5-40%, diluent 5-50%, pH regulator 0-20%, proper amount of binding agent, and proper amount of lubricant. The preparation method comprises mixing the materials and tabletting directly; or granulating part of the materials, mixing with the rest materials, mixing, and preparing into sustained release tablet; or mixing part of the raw materials with adjuvant, preparing into quick-release part, mixing the rest raw material, skeletal material, pH regulator and diluent as slow-released part, and preparing into double layer tablet with quick-release layer and sustained release layer. The method for preparing granulate comprises dry method, wet method, melting or fusion.

Description

Technical field: [0001] The invention belongs to the technical field of drug sustained-release preparations, and specifically relates to a sustained-release matrix tablet containing two active ingredients, ambroxol hydrochloride and roxithromycin, and a preparation method thereof. technical background: [0002] The chemical name of ambroxol hydrochloride is: trans-4-[(2-amino3.5-dibromobenzyl)amino]cyclohexanol hydrochloride, molecular formula: C 13 h 18 Br 2 N 2 O HCl, molecular weight: 414.57, structural formula as follows: [0003] [0004] Ambroxol hydrochloride is soluble in methanol, slightly soluble in water, and slightly soluble in ethanol. [0005] The chemical name of roxithromycin is: 9-{O-[(2-methoxyethoxy)-methyl]oxime} erythromycin, molecular formula: C 41 h 76 N 2 o 15 , molecular weight: 837.03, the structural formula is as follows: [0006] [0007] Roxithromycin is easily soluble in ethanol or acetone, soluble in methanol, slightly soluble in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7048A61K9/22A61P31/04A61P11/00A61K31/137
Inventor 陈修毅张岱洲石海英李振志
Owner SHANDONG INST OF PHARMA IND
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