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Huperzine A solid composition and preparation method thereof

A solid composition, huperzine A technology, applied in the direction of drug combination, pharmaceutical formula, medical preparations of non-active ingredients, etc., can solve the problems of affecting the therapeutic effect, adverse reactions, content reduction, etc., and achieve simple preparation process , easy to industrialized large-scale production, the effect of stable quality

Active Publication Date: 2010-06-09
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the degradation of the main drug in the oral solid preparation of huperzine A, its content will decrease, and at the same time, the increase of related substances may affect the therapeutic effect and even produce adverse reactions

Method used

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  • Huperzine A solid composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Dissolve 0.5g of citric acid in 60ml of water, take about 50ml and add 0.05g of huperzine A to dissolve, then add it to the granulator, rinse the container where the main drug is dissolved with the remaining 10ml of citric acid aqueous solution, and add the rinse solution to the granulator . Then drop 119g of microcrystalline cellulose into it for mixing, and stir evenly at a medium speed. Then, under high-speed stirring, the cutter is turned on for wet granulation. After the granulation is completed, fluidized bed drying is carried out, the inlet air temperature is 85°C, and the outlet air temperature is 60°C. Finally, the dried granules were mixed with 0.7g magnesium stearate for 30min, and 1000 No. 4 capsules were filled, and the weight of the capsules was measured to be about 120mg / grain, and the content of huperzine A was about 50 μg / grain.

Embodiment 2

[0018] Dissolve 1.2g of phosphoric acid in 60ml of water, take about 50ml to dissolve 0.05g of huperzine A, and then add it to the granulator. The remaining 10ml is the container for dissolving the main drug, and add the rinse solution to the granulator. Add 112g of lactose and 125g of microcrystalline cellulose into it again and mix, and stir evenly at a medium speed. Then, under high-speed stirring, the cutter is turned on for wet granulation. After the granulation is completed, fluidized bed drying is carried out, the inlet air temperature is 85°C, and the outlet air temperature is 60°C. Finally, the dried granules were mixed with 10 g of micropowder silica gel for 30 minutes, and 1000 No. 4 capsules were filled. The weight of the capsules was measured to be about 240 mg / capsule, and the content of huperzine A was about 50 μg / capsule.

Embodiment 3

[0020] Dissolve 1.24g of citric acid in 60ml of water, take about 50ml to dissolve 0.075g of huperzine A, and then add it to the granulator. The remaining 10ml of citric acid aqueous solution rinses the container for dissolving the main ingredient, and the rinse solution is added to the granulator. Put 180g of pregelatinized starch into it and mix, and stir evenly at a medium speed. Then, under high-speed stirring, the cutter is turned on for wet granulation. After the granulation is completed, fluidized bed drying is carried out, the inlet air temperature is 85°C, and the outlet air temperature is 60°C. Finally, the dried granules were mixed with 0.8 g of magnesium stearate and 7 g of talcum powder for 30 minutes, and 1,000 No. 4 capsules were filled. The weight of the capsules was about 185 mg / grain, and the content of huperzine A was about 75 μg / grain.

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Abstract

The invention provides a huperzine A solid composition, which comprises huperzine A, filler, a pH regulator and a lubricant. The invention also provides a method for preparing the composition, which comprises the following steps: dissolving the pH regulator in water; adding the huperzine A into the pH regulator solution; mixing and stirring the solution and the filler after the huperzine A is dissolved; pelletizing, drying and granulating the mixture; mixing the grains and the lubricant; and filling the grains into capsules or tabletting the grains.

Description

technical field [0001] The invention relates to an oral solid composition of huperzine A and a preparation method thereof. Background technique [0002] Huperzine A is an alkaloid active substance extracted from the natural plant Melaleuca, which has obvious anticholinesterase effect and is a reversible, potent and low-toxic acetylcholinesterase (AchE) inhibitor. It inhibits The hydrolysis of acetylcholine by acetylcholinesterase increases the concentration of acetylcholine in the synapse and activates the function of the cholinergic transmitter system in the brain. Neuropathological studies have confirmed that the loss of learning and memory is directly related to the decline of acetylcholinergic nerve function. Huperzine A has the effect of treating memory impairment and dementia. Ability to recall images, re-recognize meaningless figures, and recall portraits. It can also improve memory impairment caused by dementia patients and brain organic diseases. The chemical nam...

Claims

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Application Information

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IPC IPC(8): A61K31/4748A61P25/28A61K47/12A61K47/04
Inventor 张旭
Owner YAOPHARMA CO LTD
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