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Gemfibrozil pharmaceutical composition and preparation method thereof

A technology of gemfibrozil and its composition, which is applied in the field of gemfibrozil pharmaceutical composition and its preparation, can solve the problems of increasing the difficulty of preparation, large proportion of disintegrating agent, large usage amount, etc., and achieve high preparation success rate, The effect of less side effects and cost saving

Inactive Publication Date: 2016-06-22
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN200910231057.1 discloses a gemfibrozil capsule and a preparation method thereof. The gemfibrozil capsule contains gemfibrozil, a disintegrating agent, a lubricant, and a binder. Disintegrant 19.0-29.5%, lubricant 0.5-1.0%, 5-8% starch slurry [containing polysorbate 80 (0.1-1.0%)] appropriate amount, large amount of main raw materials used, high cost, large proportion of disintegrant , which increases the difficulty of preparation, and the side effects of the drug need to be considered

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Prescription: (by weight percentage)

[0035] Gemfibrozil 65%, mannitol 19%, 14% cross-linked polyvinylpyrrolidone 5%, pregelatinized starch 8%, magnesium stearate 1%, talc 1%, silicon dioxide 1%.

[0036] Preparation:

[0037] 1) Raw and auxiliary materials (except lubricants) are sieved for later use;

[0038] 2) Dry mix the raw and auxiliary materials (except lubricant) evenly (stir for 5 minutes), add 10% alcohol of the prescribed amount of raw and auxiliary materials and stir to make soft materials;

[0039] 3) The soft material is granulated through a 16-mesh sieve, dried, and granulated with an 18-mesh sieve to obtain dry granules;

[0040] 4) Add the prescribed amount of lubricant and dry granules in step 3), mix evenly (mixing time is 40 minutes), compress into tablets, and pack.

Embodiment 2

[0042] Prescription: (by weight percentage)

[0043] Gemfibrozil 60%, microcrystalline cellulose 24%, sodium carboxymethyl cellulose 5%, pregelatinized starch 8%, micropowder silica gel 3%.

[0044] Preparation:

[0045] 1) Raw and auxiliary materials (except lubricants) are sieved for later use;

[0046] 2) Dry mix the raw and auxiliary materials (except lubricant) evenly (stir for 5 minutes), add 10% alcohol of the prescribed amount of raw and auxiliary materials and stir to make soft materials;

[0047] 3) The soft material is granulated through a 16-mesh sieve, dried, and granulated with an 18-mesh sieve to obtain dry granules;

[0048] 4) Add the prescribed amount of lubricant and dry granules in step 3), mix evenly (mixing time is 35 minutes), and pack in separate bags.

Embodiment 3

[0050] Prescription: (by weight percentage)

[0051] Gemfibrozil 57%, starch 25%, sodium carboxymethylcellulose 3%, hydroxypropyl cellulose 2%, pregelatinized starch 8%, talc 1.5%, magnesium stearate 1.5%, silicon dioxide 2% .

[0052] Preparation:

[0053] 1) Raw and auxiliary materials (except lubricants) are sieved for later use;

[0054] 2) Dry mix the raw and auxiliary materials (except lubricant) evenly (stir for 5 minutes), add 10% alcohol of the prescribed amount of raw and auxiliary materials and stir to make soft materials;

[0055] 3) The soft material is granulated through a 16-mesh sieve, dried, and granulated with an 18-mesh sieve to obtain dry granules;

[0056] 4) Add the prescribed amount of lubricant and dry granules in step 3), mix well (mixing time is 30 minutes), fill capsules, and pack.

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PUM

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Abstract

The invention provides a gemfibrozil pharmaceutical composition and a preparation method thereof. The pharmaceutical composition is characterized in that the prescription of the pharmaceutical composition consists of the following components in percentage by weight: 8-69% of gemfibrozil and 31-92% of pharmaceutical adjuvants. The preparation (gemfibrozil pharmaceutical composition) is obtained through the prescription of reasonable compatibility by mixing raw materials and adjuvant materials so as to obtain a soft material, drying, straightening granules and totally blending. The preparation method is simple and easy to operate; production demands can be satisfied by conventional equipment; the obtained gemfibrozil pharmaceutical composition is good in dissolving and release; and the gemfibrozil pharmaceutical composition has a market prospect.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a gemfibrozil pharmaceutical composition and a preparation method thereof. Background technique [0002] Gemfibrozil is a new blood lipid-lowering drug launched in the United States in 1982. It is suitable for patients with severe type Ⅳ or Ⅴ hyperlipoproteinemia, high risk of coronary heart disease and ineffective diet control, weight loss, etc. Patients with high risk of lipoproteinemia and coronary heart disease who are ineffective in diet control, weight loss, and other blood lipid regulation drugs. It overcomes the severe toxic and side effects of clofibrate on the liver in the past, retains its effective effect, helps to reduce the incidence of myocardial infarction, and can be taken for a long time. Because the drug is safe and reliable, it has been compiled into the United States Pharmacopoeia and has become a statutory drug. CN200910231057.1 discl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/192A61K9/22A61K9/48A61K9/16A61P3/06
Inventor 曾培安刘娟吴健民
Owner KAMP PHARMA
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