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Ambroxol hydrochloride drop pills and its preparation method

A technology of ambroxol hydrochloride dripping pills and ambroxol hydrochloride, which is applied in pill delivery, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve the problems of low dissolution rate and bioavailability, inconvenient medication, and patient pain Large and other problems, to achieve the effect of high dissolution rate and bioavailability, convenient carrying and taking, and improved curative effect

Inactive Publication Date: 2005-07-06
ZHEJIANG WANBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its injections have disadvantages such as inconvenient medication and greater pain for patients, while other oral dosage forms disintegrate slowly, have low dissolution rate and bioavailability, and are inconvenient to take for children, bedridden patients or patients with dysphagia, and poor compliance

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0018] 1. Prescription:

[0019] Ambroxol Hydrochloride 5.0g

[0020] Macrogol 4000 25.0g

[0021] Sodium lauryl sulfate 0.005g

[0022] Makes 1000 capsules

[0023] 2. Preparation method: Take ambroxol hydrochloride fine powder (containing 0.005g sodium lauryl sulfate) that has passed through a 300-mesh sieve through superfine grinding, add it to the molten matrix, stir well, use simethicone as the coolant, drop The preparation method is to make pills, wipe off the coolant on the surface of the dripping pills, and dry them to obtain.

[0024] 3, Ambroxol hydrochloride tablet and the comparison of dissolution time limit, dissolution rate of this example drop pill.

[0025] (1), detection index and method (each example of the present invention all adopts)

[0026] 1. Dissolution time limit

[0027] Check according to the disintegration time limit inspection method ("Chinese Pharmacopoeia" 2000 edition two appendix XA).

[0028] 2. Dissolution

[0029] (1) Preparation o...

example 2

[0044] 1. Prescription:

[0045] Ambroxol Hydrochloride 5.0g

[0046] Macrogol 4000 20.0g

[0047] Macrogol 4000 4.0g

[0048] Stearic acid 1.0g

[0049] Tween-80 0.01g

[0050] Makes 1000 capsules

[0051] 2. Preparation method: add ambroxol hydrochloride fine powder (containing 0.01% (w / w) glyceryl monostearate) through superfine grinding through a 300-mesh sieve into the molten matrix, stir evenly, and mix with simethicone As a cooling agent, the legal pellets are dripped, the cooling agent is removed, and dried, that is to say.

[0052] 3. Test results

[0053] (1), disintegration time: 6 minutes

[0054] (2), dissolution rate

[0055] Time (minutes) 5 10 20 30 45

[0056] Dissolution (%) 60.2 80.9 97.3 99.2 99.8

example 3

[0058] 1. Prescription:

[0059] Ambroxol Hydrochloride 5.0g

[0060] Macrogol 4000 14.0g

[0061] Polyethylene glycol 6000 6.0g

[0062] Makes 1000 capsules

[0063] 2, preparation method: get the ambroxol hydrochloride fine powder (the polyoxyethylene (15) oleyl alcohol ether that contains 0.03% (w / w)) that crosses 300 mesh sieves through superfine grinding and join in the molten matrix, stir evenly, with Simethicone oil is used as a cooling agent, and the pellets are prepared by dropping the method, removing the cooling agent, and drying to obtain the product.

[0064] 3. Sample test results

[0065] (1), disintegration time: 7 minutes

[0066] (2), dissolution rate

[0067]Time (minutes) 5 10 20 30 45

[0068] Dissolution (%) 46.8 85.2 96.4 99.5 99.9

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PUM

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Abstract

The invention disclses an Ambroxol hydrochloride drop pills and its preparation method, wherein the medicament is prepared from ultramicro disintegrated ambroxol hydrochloride fines and molten base material through the steps of mixing uniformly, dropping into cooling agent to obtain pills, removing the cooling agent and drying. The drop pill by the invention has the advantages of short disintegration time, high dissolution and biological availability, stabilized quality, small pill volume, administration by swallowing or mouth keeping, convenience in carrying and administration, quick effect, good compliance, and high curative effect. The medicament is especially suitable to be administrated by children, bedridden patients and dysphagia patients.

Description

technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to ambroxol hydrochloride dripping pills and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride is a new type of expectorant, its main function is to dissolve sputum, promote the secretion of pulmonary surfactant, activate the purification function of mucus cilia, reduce the adhesion between sputum and cilia, and make sputum easy to cough out. Clinically, it can be used for: ①Acute and chronic bronchitis, bronchial asthma, bronchiectasis, tuberculosis with thick sputum and difficulty in coughing with abnormal sputum secretion and poor expectoration function; ②Prevention of respiratory tract infection; ③Infants Respiratory distress syndrome; ④ pulmonary complications before and after surgery; ⑥ otitis media and sinusitis, etc. [0003] Ambroxol hydrochloride is currently available in dosage forms such as injections, tablets, capsules, an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/137A61P11/10
Inventor 王宗贵耿燕孙宏张
Owner ZHEJIANG WANBANG PHARMA
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