Radix saposhnikoviae Tong Sheng capsules, preparation and quality control method thereof

A soft capsule, windproof technology, applied in capsule delivery, measuring device, pharmaceutical formulations, etc., can solve the problems of easy loss, affecting curative effect, low quality standard

Inactive Publication Date: 2010-06-30
津药达仁堂集团股份有限公司达仁堂制药厂
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The pills are made by directly crushing the medicinal materials. The technology is primitive and long-term storage. The volatile components in it are easy to lose and affect the curative effect.
Although granules and capsules are extracted preparations, they still do not solve the problem of loss of volatile components
In addition, the Fangfeng Tongsheng preparations recorded in the 2005 edition of the "Chinese Pharmacopoeia" and the "Ministerial Standards" only have thin-layer identification, but no content determination items, and the quality standard is low

Method used

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  • Radix saposhnikoviae Tong Sheng capsules, preparation and quality control method thereof
  • Radix saposhnikoviae Tong Sheng capsules, preparation and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0104] (1) Take 50 g of rhubarb and pulverize it, extract it with 60% ethanol under reflux, recover ethanol, concentrate, and dry to obtain dry extract, pulverize, sieve to obtain dry powder;

[0105] (2) Fangfeng 50g, Nepeta panicle 25g, Mint 50g, Ephedra 50g, Glauber's salt 50g, Gardenia 25g, Talc 300g, Campanulaceae 100g, Gypsum 100g, Chuanxiong 50g, Angelica 50g, Paeoniae Alba 50g, Scutellaria baicalensis 100g, Forsythia 50g, 200g of licorice, 25g of Atractylodes macrocephala and 6 times the amount of water are extracted once, and the volatile oil is extracted at the same time for later use. The water extract is filtered through alcohol precipitation, filtered, the filtrate is concentrated and dried to obtain a dry extract, crushed to obtain a dry powder;

[0106] (3) Mix the above two kinds of dry extract powders evenly (the weight of the dry powder in the capsule fluid accounts for about 37%), combine with the volatile oil, add 200g of corn oil, 27g of ethyl cellulose, an...

Embodiment 2

[0108] (1) Take 50 g of rhubarb and pulverize it, extract it by percolation with 70% ethanol, collect 8 times the amount of percolation liquid, recover ethanol, concentrate, and dry to obtain a dry extract, pulverize, and sieve to obtain a dry powder;

[0109] (2) The remaining sixteen medicinal materials (the weight is the same as in Example 2) are extracted twice with 8 times of water, and the volatile oil is extracted simultaneously for subsequent use. The decoction is filtered, combined, concentrated, alcohol precipitation, filtered, and the filtrate is concentrated and dried to obtain Dried extract, crushed to obtain dry powder;

[0110] (3) Mix the above two kinds of dry extract powders evenly (the weight of the dry powder in the capsule fluid accounts for about 47%), combine with the volatile oil, add 130g of salad oil, 11.6g of beeswax, 15.5g of soybean lecithin, and 31g of palm oil to make a mixture. Suspension, filling and sealing in soft capsule shells, made 1000 ca...

Embodiment 3

[0112] (1) Take 50 g of rhubarb and pulverize it, soak it in 10 times the amount of 80% ethanol for 24 hours; recover ethanol from the soaking solution, concentrate, and dry to obtain a dry extract, pulverize, and sieve to obtain a dry powder;

[0113] (2) The rest of the sixteen herbs (the same weight as in Example 2) were extracted twice with 10 times the amount of water, and the volatile oil was extracted simultaneously for subsequent use. The decoction was filtered, combined, concentrated, alcohol precipitated, filtered, the filtrate was concentrated and dried to obtain Dried extract, crushed to obtain dry powder;

[0114] (3) Mix the above two dry extract powders evenly (the weight of the dry powder in the capsule fluid accounts for about 53%), combine with the volatile oil, add 60g of corn oil, 100g of salad oil, 7.73g of beeswax, and 7.73g of soybean lecithin to make a suspension Liquid, filled into the soft capsule shell, to get final product. The total amount of emod...

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Abstract

A Chinese medicine 'Tongsheng softgel' is prepared from 17 Chinese-medicinal materials including ledebouriella root, mint, rhubarb, capejasmine fruit, etc, matrix, suspending aid, and lubricant. Its preparing process and its quality control method are also disclosed.

Description

technical field [0001] The invention belongs to a new dosage form made from a compound traditional Chinese medicine and a preparation method thereof, in particular to a Fangfengtongsheng soft capsule, a preparation method and a quality control method thereof. Background technique [0002] Fangfeng Tongsheng Recipe is a medicine that relieves exterior, clears heat, and conquers. The original prescription comes from "Xuanming Lunfang". It is a famous prescription created by Liu Hejian, a famous doctor in the Jin and Yuan Dynasties. Aversion to cold and strong fever, headache, dry throat, short red urine, constipation in stool, early onset of scrofula, rubella and eczema. Due to the long history of clinical application of Fangfeng Tongsheng Pills, it is safe and effective, and has now been included in the non-prescription drugs of Chinese patent medicines. The original dosage form of this prescription is boiled, decocted and taken. The 2005 edition of "Chinese Pharmacopoeia" ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/744A61K9/48A61P11/04A61P25/04A61P1/10A61P17/00G01N30/02G01N33/15A61K33/06A61K33/12
Inventor 徐晓阳
Owner 津药达仁堂集团股份有限公司达仁堂制药厂
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