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Red yeast rice extract oil and the preparation and application of the soft capsule thereof

A soft capsule and red yeast rice technology, applied in the field of medicine, can solve the problems of increasing gastrointestinal absorption load, adverse reactions, low content of active substances, inconvenience to patients, etc., and achieve the effects of reducing gastrointestinal load and adverse reactions, increasing the content and increasing the content.

Active Publication Date: 2009-11-25
云南永安制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the low content of active substances, the dosage of the preparation is relatively large, which increases the gastrointestinal absorption load and adverse reactions, causing inconvenience to patients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Take 1000g of red yeast rice medicinal material whose active ingredient lovastatin content is 2%, add 10000ml concentration of 100% ethanol, heat and reflux for 3 hours, filter, add 5000ml concentration of filter residue as 100% ethanol, heat and reflux for 2 hours, filter After that, combine the filtrates, concentrate at 70-85°C to a clear paste, then add 2000ml of absolute ethanol, dissolve, filter, recover the ethanol to a thick paste, add 500ml of ethanol with a concentration of 95%, dissolve, heat up to 85-95°C, and recover Ethanol, after keeping warm for 2 hours, add 2000ml of absolute ethanol to dissolve, then add 2800ml of vegetable oil, recover the ethanol while stirring at 60°C until there is no alcohol smell, filter to obtain the red yeast extract oil.

Embodiment 2

[0020] Get active ingredient lovastatin content and be 1% red yeast rice medicinal material 1000g, add 8000ml concentration and be 90% ethanol, heat and reflux, 4 hours, filter, add 6000ml concentration to filter residue and be 90% ethanol, heat and reflux for 3 hours, filter Pass, combine filtrate, 70~85 ℃ concentrate to clear paste, then add 2000ml absolute ethanol, dissolve, filter, reclaim ethanol to thick paste, add 1000ml concentration and be 90% ethanol, heat up to 85~95 ℃, reclaim ethanol, After 3 hours of heat preservation, add 1000ml of absolute ethanol to dissolve, then add 1000ml of vegetable oil, and recycle the ethanol while stirring at 60°C until there is no alcohol smell, filter to obtain the red yeast extract oil.

Embodiment 3

[0022] The preparation of red yeast oil soft capsules: take the red yeast extract oil obtained in Example 1, adopt the pressing method, select pharmaceutically acceptable auxiliary materials, and just mold into capsules; through conventional processes; shaping, drying, sorting pills, polishing , packaging and other processes to obtain red yeast extract oil soft capsules, the active ingredient lovastatin content of each capsule is 0.5%.

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PUM

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Abstract

Disclosed is a red yeast rice extract oil and the preparation and application of the soft capsule thereof. The preparation method comprises: adding solvent into the red yeast rice medicinal material, heating for backflow for 2-5 hours; filtering, adding the filter residue into the solvent, heating for backflow for 1-4 hours; merging the filtrates; condensing at 50-90 degrees centigrade into extract with relative density of 1.1-1.4 at 25 degrees centigrade; adding ethanol by amount of 1-4 times (mass) of the red yeast rice medicinal material into the extract; dissolving, filtering, recovering ethanol to obtain stiff paste; adding ethanol by amount of 0.5-1 times (mass) of the red yeast rice medicinal material into the stiff paste; distilling to dryness at 60-95 degrees centigrade, insulating thermal for 1-5 hours; adding 0.5-4 times of ethanol into the extract; adding 0.5-5 times of vegetable oil, stirring uniformly at 50-70 degrees centigrade; recovering the ethanol to obtain the red yeast rice extract oil. The content of the active ingredient: lovastatin in the soft capsule prepared by the red yeast rice extract oil is 0.2-1.2wt%; the soft capsule is applied for preparing medicament for treating hyperlipemia; The invention can remove the large amount of unavailability components in the red yeast rice, and increases the content of lovastatin compounds in the extract of per weight unit effectively.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method and application of red yeast rice extract oil and soft capsules thereof. Background technique [0002] In 1979, Japanese scholars Endo et al. isolated the HMG-GOA reductase inhibitor Monacolink from Monascus. In 1980, American researchers Alberts et al. isolated the substance Mevinolin acid with the same structure from Aspergillus terreus. It was transformed into Lovastatin (Mevinolin) and marketed under the trade name "Mevavor", and it was widely used, which promoted the research and development of statin drugs. After that, a variety of statin drugs were launched. Based on this, the second-generation statin was launched: Simvastatin. At present, there are nearly 10 kinds of statin drugs on the market. The clinical application of nearly two decades shows that statin drugs have the characteristics of significant curative effect and good tolerance. Side effe...

Claims

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Application Information

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IPC IPC(8): A61K36/06A61K9/48A61P3/06A61K31/366A61K31/22
Inventor 李朝晖陈春珍杨冠军
Owner 云南永安制药有限公司
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