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Efavirenz, lamivudine and tenofovir disoproxil fumarate triplex compound tablet in tablet and preparation method thereof

A technology of tenofovir disoproxil fumarate and lamivudine, which is applied in the field of pharmaceutical preparations, can solve the problems of broken pellets, difficult to achieve degradation, uncontrollable degree and ratio of broken pellets, etc., to prevent degradation problems, Good dissolution, moderately sized effects

Active Publication Date: 2017-06-13
NORTHEAST PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation process of pellet tableting will inevitably cause some pellets to break during the compression process. The degree and proportion of pellet breakage are very uncontrollable, and it is difficult to achieve contact between tenofovir and the other two main drugs without degradation.
Therefore, developing a new pharmaceutical preparation and its preparation method to solve the degradation caused by the physical contact of the drug is a new topic to be solved urgently.

Method used

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  • Efavirenz, lamivudine and tenofovir disoproxil fumarate triplex compound tablet in tablet and preparation method thereof
  • Efavirenz, lamivudine and tenofovir disoproxil fumarate triplex compound tablet in tablet and preparation method thereof
  • Efavirenz, lamivudine and tenofovir disoproxil fumarate triplex compound tablet in tablet and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Preparation of the core part:

[0042] The tenofovir disoproxil fumarate bulk drug was processed through a 40-60 mesh sieve. Tenofovir disoproxil fumarate 150g (50%), anhydrous dibasic calcium phosphate 127.5g (42.5%), add 3g (1%) of pregelatinized starch to a clean container; put the weighed materials Put it into the wet mixing granulator, turn on the stirring and mixing for 3-10 minutes; add an appropriate amount of purified water to the wet mixing granulator, turn on the stirring and shearing granulation, the granulation time is 1.5-3 minutes, until it is made Appropriate soft and hard soft material; 18-24 mesh nylon screen is installed on the swing granulator, the soft material prepared in the previous step is slowly added to the swing granulator, the wet granules are prepared and the wet granules are dried in a drying oven at a temperature of 60°C. The 18-24 mesh screen is installed on the swing granulator, and the dried granules are sized through the 18-24 mesh swin...

Embodiment 2

[0046] The raw and auxiliary materials are mixed according to the proportion of the prescription, and ordinary tablets are compressed and then coated. Under the same conditions, the contents of the samples in the tablets of the present invention at 0 o'clock and long-term 3 months are compared under the same conditions. The results showed that there was little difference in the content of ordinary tablets and tablets at time 0, but after 3 months of long-term, the content of tenofovir disoproxil fumarate in ordinary tablets decreased significantly, while the content of tenofovir disoproxil fumarate in tablets decreased significantly. The content of fovir dipivoxil remained almost unchanged, and the results are shown in Table 1.

[0047] Table 1 Comparison of tenofovir disoproxil fumarate content at 0 o'clock and long-term 3 months

[0048] 0 o'clock Long-term 3 months Sanlian Compound Ordinary Tablet98.9％90.1％ Sanlian compound film in film100.3％99.5％

[0049] Note: Because th...

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Abstract

The invention relates to the field of medicine preparations, and provides a tenofovir disoproxil fumarate, efavirenz and lamivudine triplex compound tablet in tablet and a preparation method thereof. The tablet in tablet comprises a tenofovir disoproxil fumarate coating tablet core, and the tablet core is coated by the efavirenz, the lamivudine and auxiliary materials. The preparation method of the tablet in tablet has the advantages that the problem of degrading and slow dissolving caused by contact with the tenofovir disoproxil fumarate and other two crude drugs is solved; the degrading of the tenofovir disoproxil fumarate caused by contact of the tenofovir disoproxil fumarate with the efavirenz and the lamivudine is effectively avoided, and the good product stability is obtained.

Description

Technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and specifically relates to a middle tablet of efavirenz, lamivudine and tenofovir fumarate and a preparation method thereof. Background technique [0002] Clinical workers and related data have confirmed that efavirenz, tenofovir disoproxil fumarate, and lamiv customized preparations have been combined clinically, and the combined use of HIV is more effective than a single preparation One of these, but in the process of combined use, there will be problems of dysphagia and poor patient compliance. [0003] CN103908456A discloses the triple compound pellets of tenofovir, lamivudine and efavirenz. The patent describes that contact of tenofovir with other two main drugs will cause the degradation of tenofovir. The process prepares the three main drugs into coated pellets, and then presses them into tablets to avoid degradation problems caused by contact between tenofovir and the other...

Claims

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Application Information

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IPC IPC(8): A61K31/675A61K31/536A61K31/513A61K9/36A61P31/18
Inventor 宋林邢丹周联波鲍辉李霄曹沛潼陈雅琴王龙李岩那馨竹王金晶
Owner NORTHEAST PHARMA GRP
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