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Toad essence capsule and its preparation method

A technology of soft capsules and cinobufacini, which is applied in the directions of capsule delivery, pharmaceutical formulations, and medical preparations containing active ingredients, can solve the problems of difficulty in ensuring stability, low safety, and low practicability, and achieves bioavailability. The effect of improving the degree of production, product quality assurance, and good stability

Inactive Publication Date: 2006-07-19
安徽威尔曼振星药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Cinobufacini Injection (WS3-B-3045-98) is directly injected into blood vessels and muscles, which has low safety and is likely to cause side effects such as allergic reactions, local irritation symptoms, and phlebitis, and its stability is difficult to guarantee. It brings a lot of inconvenience to carrying, transportation, storage, use, etc.; due to the bitter taste of the medicine, it has a fishy smell. Difficult to be accepted by patients when taken
[0004] Patent (Application No. 98103562.0) "Manufacturing Method of Cinobufacin Capsules" is a hard capsule, and its defects also lie in its stability and bad smell; ", this process is not refined, too many invalid impurities are brought in, and the practicability is not strong; the patent (application number 200410083994.4) "a kind of cinobufacin freeze-dried powder injection and its preparation method" solves the problem of "cinobufacin injection Liquid (WS3-B-3045-98)" has problems in stability, storage, and transportation, but it is still inconvenient for patients to use, and there are also problems in safety
[0005] No reports about cinobufacin soft capsules were found in the data search

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Take 2000g of dried toad skin, wash it, add water to decoct twice, add 12 times the amount of water for the first 45 minutes, add 10 times the amount of water for the second 30 minutes, combine the decoction, filter, and concentrate the filtrate to a relative The density is 1.1~1.2 (80°C), cooled to 40°C, add ethanol to make the alcohol content reach 60%, stir well, let it stand for 24 hours, take the supernatant to recover the ethanol until it has no alcohol smell, then add ethanol to make the alcohol content reach 60%. The amount reaches 85%, stir well, stand still for 48 hours, filter, recover ethanol until there is no alcohol smell, and concentrate to extract, add appropriate amount of starch, mix well, make granules, dry, crush into fine powder, add soybean oil , ground evenly, and compressed into soft capsules.

Embodiment 2

[0021] Take 3000g of dried toad skin, wash it, add 15 times the amount of water to decoct for 90 minutes, filter, concentrate the filtrate to a relative density of 1.0-1.3 (80°C-90°C), cool to 50°C, add ethanol to reduce the alcohol content up to 90%, stir well, stand for 48 hours, filter, recover ethanol until it has no alcohol smell, and concentrate to extract, add appropriate amount of dextrin, mix well, make granules, dry, grind into fine powder, add peanut oil and 2% beeswax, ground uniformly, and compressed into soft capsules.

Embodiment 3

[0023] Take 1000g of dried toad skin, wash it, add water to decoct twice, add 12 times the amount of water for the first 45 minutes, add 5 times the amount of water for the second 30 minutes, combine the decoction, filter, and concentrate the filtrate under reduced pressure until the relative density is 0.5-1.0 (50°C-60°C), cool to 45°C, add ethanol to make the alcohol content reach 50%, stir well, let stand for 12 hours, take the supernatant to recover the ethanol until there is no alcohol smell, and then Add ethanol to make the alcohol content reach 80%, stir well, let it stand for 24 hours, filter, recover ethanol until it has no alcohol smell, and concentrate to extract, add appropriate amount of sodium carboxymethyl cellulose, mix well, and make granules, Dried, crushed into fine powder, added corn oil-glycerin (3:1) mixture and 0.5% molecularly distilled monoglyceride, ground evenly, compressed into soft capsules, and obtained.

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PUM

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Abstract

The invention discloses a cinobufotoxin soft capsule and making method, which comprises the following steps: adapting the toad fur as raw material; utilizing the alcohol-extracting of water sediment method to condense the fur into concrete; adding fitful auxiliary even mixing material; making the particle; drying and disintegrating the toad fur extraction into fine powder; adding fitful auxiliary material to blend evenly; making the content of cinobufotoxin soft capsule. The invention improves the biological availability with good stability, which guarantees the production quality.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine pharmacy, and relates to a preparation method of a Chinese patent medicine for anticancer and treatment of hepatitis B diseases, in particular to cinobufacin soft capsules and a preparation method thereof. Background technique [0002] Cinobufacin is a preparation made from dried toad skin (also known as: toad skin) after extraction and processing. It has the effects of detoxification, swelling, and pain relief. It is used for middle and late stage tumors, chronic hepatitis B and other diseases. Dried toad skin is the skin of Bufo bufogargarizans Cantor or B.melanostictus Schneider, etc., which mainly contain bufadiene lactones, cinobufatoxins, steroids, indole alkaloids, Amino acid and other water-soluble active ingredients. Among them, indole alkaloids include serotonin, cinobufatryptamine, etc. At present, cinobufacin preparations made from dried toad skin include cinobuf...

Claims

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Application Information

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IPC IPC(8): A61K35/56A61K9/48A61P35/00A61P1/16A61P31/20A61K35/65
Inventor 颜礼双刘勇许忠跃
Owner 安徽威尔曼振星药业有限公司
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