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Abacavir, lamivudine and efavirenz compound tablet and preparation method thereof

A technology of efavirenz and lamivudine, applied to non-active ingredient medical preparations, pharmaceutical formulas, medical preparations containing active ingredients, etc., can solve poor patient compliance, poor tablet uniformity, etc. problems, to achieve the effect of good uniformity of tablets, less amount of excipients, and excellent uniformity

Active Publication Date: 2022-04-29
ANHUI BIOCHEM BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In view of this, the present invention aims to propose a compound tablet of abacavir, lamivudine, and efavirenz and a preparation method thereof, so as to solve the poor uniformity of the tablet and the compliance of the patient when taking it in the prior art bad question

Method used

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  • Abacavir, lamivudine and efavirenz compound tablet and preparation method thereof
  • Abacavir, lamivudine and efavirenz compound tablet and preparation method thereof
  • Abacavir, lamivudine and efavirenz compound tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] A compound tablet of abacavir, lamivudine and efavirenz, which comprises the following components:

[0030]

[0031] Preparation process: S1, preparation of the first particle

[0032] 1.1. Dissolve 60g of povidone with 30% ethanol at a ratio of 1:15 (W / V), add 200g of efavirenz and 15g of magnesium stearate to a constant temperature bath, control the temperature at 50°C, and stir at 120rpm for 10min for bonding agent, spare;

[0033] 1.2. Feed 351g of abacavir and 35g of colloidal silicon dioxide with D90≤25μm into the granulation chamber, pass in dry hot air at 62°C, and adjust the frequency of the air conditioner to 40HZ to keep the boiling height at about 77cm;

[0034] 1.3. Adjust the pressure of the compressed air entering the spray gun to 0.37MPa and the temperature to 57°C; turn on the liquid spray, transport the binder in step S1.1 to the granulation chamber for boiling granulation, and control the flow rate of the binder to 4.5L / h;

[0035] 1.4. After l...

Embodiment 2

[0041] A compound tablet of abacavir, lamivudine and efavirenz, which comprises the following components:

[0042]

[0043] Preparation Process:

[0044] S1. Preparation of the first particles

[0045] 1.1. Dissolve 72g of sodium alginate with 15% ethanol at a ratio of 1:10 (W / V), add 240g of efavirenz and 22g of calcium stearate to a constant temperature tank, control the temperature at 55°C, and stir at 100rpm for 15min as a bonding agent agent, spare;

[0046] 1.2. Add 351g of abacavir into 1500ml of 55% ethanol solution (V / V) and stir vigorously to dissolve it, add 25g of colloidal silicon dioxide with D90≤25μm, stir at 30rpm for 20min, dry under reduced pressure, pulverize, pass through 80 Prepare solid dispersion after mesh sieve, standby;

[0047] 1.3. Put the above solid dispersion into the granulation chamber evenly, pass in dry hot air with a temperature of 65°C, adjust the frequency of the fan to 38HZ to maintain a boiling height of 75cm; adjust the pressure o...

Embodiment 3

[0054] A compound tablet of abacavir, lamivudine and efavirenz, which comprises the following components:

[0055]

[0056] Prepared by the following process:

[0057] S1. Preparation of the first particles

[0058] 1.1. Dissolve 60g of ethyl cellulose with 18% ethanol at a ratio of 1:13 (W / V), add 210g of efavirenz and 15g of talcum powder and transport it to a constant temperature tank, control the temperature at 58°C, and stir at 110rpm for 12min as a binder ,spare;

[0059] 1.2. Add 351g of abacavir into 1250ml of 60% ethanol solution (V / V) and stir vigorously to dissolve it, add 20g of colloidal silicon dioxide with D90≤25μm, stir at 40rpm for 15min, dry under reduced pressure and pulverize for 80 Prepare solid dispersion after mesh sieve, standby;

[0060] 1.3. Put the above solid dispersion into the granulation chamber evenly, pass in dry hot air with a temperature of 64°C, adjust the frequency of the fan to 37HZ to maintain a boiling height of 73cm; adjust the pr...

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PUM

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Abstract

The invention provides abacavir, lamivudine and efavirenz compound tablets and a preparation method, the compound tablets are formed by mixing and tabletting 11-15 parts of first particles, 9-12 parts of second particles and 0.8-2 parts of a flow aid, and the weight ratio of the first particles to the second particles is (1-1.5): 1. According to the compound tablet, abacavir is coated with efavirenz to prepare first particles, efavirenz and lamivudine are mixed to prepare second particles, efavirenz is contained on the surfaces of the particles, only the flow aid is added for mixing, the dosage of auxiliary materials is small, and the uniformity of the tablet is good.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a compound tablet of abacavir, lamivudine and efavirenz and a preparation method thereof. Background technique [0002] Since the first anti-HIV-1 drug zidovudine came out in 1987, human beings have continued to explore the field of anti-HIV-1 research, and finally turned AIDS from a terminal illness to a manageable lifelong chronic disease. However, the current anti-HIV-1 drugs cannot completely eliminate HIV-1 in patients, and the side effects and drug resistance problems caused by long-term use are becoming more and more prominent. [0003] To address the rapid evolution of HIV and HIV drug resistance, oral combined antiretroviral therapy (cART) or highly active antiretroviral therapy (HAART) has emerged. At present, more than ten kinds of related compound preparations have been approved for marketing. Oral combined drugs can target multiple HIV proteins o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/26A61K31/536A61K47/04A61K47/10A61K47/26A61K47/32A61K47/38A61P31/18A61K31/513A61K31/52
CPCA61K31/52A61K31/513A61K31/536A61K9/2081A61K9/2054A61K47/10A61K47/32A61K47/26A61K47/02A61P31/18A61K2300/00Y02A50/30
Inventor 陈小峰王哲王志邦朱礼根柏俊廖结海郭立新刘安友何麓璐刘斌
Owner ANHUI BIOCHEM BIO PHARMA
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