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Tramadol hydrochloride slow release dripping pill and its preparing method

A technology for tramadol hydrochloride and sustained-release dropping pills, which is applied in the directions of pill delivery, pharmaceutical formulations, and medical preparations containing active ingredients, can solve the problems of uncontrolled drug release time, high equipment requirements, complicated processes, etc. Sufficient drug, high bioavailability, and the effect of overcoming crystallization

Inactive Publication Date: 2006-08-23
北京博智绿洲医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantages of this process are: complex process and high requirements for equipment
[0006] Although the slow-release dripping pill preparation prepared by the prior art has the advantages of sufficient drug release, high bioavailability, and low cost, it has been verified in practice that instability often occurs in long-term storage, and the analysis may be affected by the ambient temperature. Influenced by factors such as these, the internal structure of the drug changes from an amorphous form to a crystalline form, which reduces the dissolution rate of the drug, releases the drug out of control, and decreases the bioavailability, thus offsetting the unique advantages of the sustained-release dropping pills to a certain extent.

Method used

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  • Tramadol hydrochloride slow release dripping pill and its preparing method

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Embodiment Construction

[0029] A group of specific examples are provided below, and the preparation method of tramadol sustained-release dropping pills is further described:

[0030] Example 1 In terms of total weight 100g, PEG400040%, PEG600025%, stearic acid 11%, glyceryl monostearate 12%, Tween-802%, tramadol hydrochloride 10%, after the base is heated and melted in a water bath , add tramadol hydrochloride, stir well to make it evenly mixed, and under the condition of 80°C heat preservation, drop the material liquid into the condensation column filled with simethicone oil, the temperature of the upper part of the condensate is 40°C, and the temperature of the bottom is 0 ℃, take it out after forming, use absorbent paper to absorb the simethicone oil adhering to the surface, and dry it under natural conditions.

[0031] The obtained product has a 2-hour cumulative release percentage of 35-55%, a 6-hour cumulative release percentage of 62-82%, a 10-hour cumulative release percentage of 75-95%, and ...

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Abstract

The present invention relates to pain relieving medicine preparation, and is especially one orally taken slow released preparation with tramadol hydrochloride as main material. The present invention provides slow released tramadol hydrochloride dripping pill superior to available technology. The slow released tramadol hydrochloride dripping pill has the advantages of controllable releasing period, complete medicine release and high bioavailability.

Description

technical field [0001] The invention relates to a pharmaceutical preparation for analgesia, in particular to an oral sustained-release pharmaceutical preparation prepared from tramadol hydrochloride. Background technique [0002] Tramadol is a new type of opioid receptor weak agonist and non-narcotic central analgesic. It has the characteristics of strong analgesic effect, low drug dependence and low abuse potential, and has great promotion and application value. At present, it is mostly used clinically for renal colic, angina in acute myocardial infarction (AMI), diabetic neuralgia, musculoskeletal breakthrough pain caused by osteoarthritis, thalamic pain, intractable trigeminal neuralgia, and postherpetic sequelae. Neuralgia (PHN) etc. (Huang Junhe. The Clinical Application of Tramadol. Medical Herald, Volume 21 Supplement, Page 45, May 2002). [0003] Tramadol Hydrochloride Sustained-release Tablets is a sustained-release oral dosage form that is conducive to maintaining...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K9/20A61P25/04A61P29/00
Inventor 曲韵智
Owner 北京博智绿洲医药科技有限公司
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