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Chinese medicine soft capsules for clearing wind heat and clearing nasal passage, as well as preparation method and quality control method

A soft capsule and soft capsule technology are applied in the field of traditional Chinese medicine and can solve the problems of affecting the stability of pharmaceutical preparations, low bioavailability, unsuitable for microwave extraction and nano-grinding treatment, etc.

Active Publication Date: 2009-05-27
BEIJING ASIA EAST BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Today, traditional Chinese medicine has accumulated rich experience in the treatment of this disease, and has developed some safe and effective traditional Chinese medicine preparations. Huodan Biyan Capsule is one of them. Page "Huodan Biyan Capsule", standard number: WS3-B-2822-97, discloses that the hard capsule is made by adding starch auxiliary materials and then granulated and packed into capsules. However, because the preparation contains more volatile oil and fat-soluble ingredients , easily cause the loss of active ingredient, affect the absorption of medicine and the stability of preparation; CN1368349A discloses a kind of method that the raw material drug in the prescription is extracted by microwave and then nano-pulverized, and then made into a conventional dosage form. The characteristics of volatile components and extracts used as medicine are not suitable for microwave extraction and nano-grinding treatment, and the current patent has not yet been approved; CN1803155A discloses a scheme for preparing soft capsules with polyethylene glycol as an auxiliary material for this prescription. The active ingredient in the prescription is a fat-soluble substance, and polyethylene glycol is a water-soluble dispersion medium. The incompatibility of the two leads to instability and low bioavailability of the preparation made by this method. The patent has not yet been approved.

Method used

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  • Chinese medicine soft capsules for clearing wind heat and clearing nasal passage, as well as preparation method and quality control method
  • Chinese medicine soft capsules for clearing wind heat and clearing nasal passage, as well as preparation method and quality control method
  • Chinese medicine soft capsules for clearing wind heat and clearing nasal passage, as well as preparation method and quality control method

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0038] Experimental Example 1 Extraction Process Screening of Refined Pig Gallbladder Extract

[0039] We use the orthogonal test to investigate the concentration of solvent, the amount of solvent used, the time and frequency of reflux.

[0040] Experimental method: take 100g of pig bile powder and put it in a round bottom flask, add ethanol of specified concentration and quantity, reflux extraction according to the specified extraction time and times, filter while hot, combine the filtrates respectively, put them in an oven to dry under reduced pressure, press Huo bile Determine the total free bile acid content according to Biyan Capsule Standard, and calculate the yield of dry extract. Orthogonal experimental design is shown in Table 1-3.

[0041] Table 1 Ethanol extraction process of pig gall powder

[0042]

[0043] Table 2 Orthogonal test arrangement and results

[0044]

[0045] Table 3 variance analysis table

[0046]

[0047] The results show that there ar...

experiment example 2

[0055] Experimental Example 2 Preparation and Solubility Investigation of Soft Capsule Contents

[0056] In the extraction process of the contents of Huodanbiyan Soft Capsules, the refined porcini powder and cocklebur seed extracts are all extracted with ethanol, and patchouli oil is a volatile oil substance, which is difficult to dissolve in polyethylene glycol 400, so we use vegetable oil As a dispersant to improve the solubility of the extract. Through preliminary experiments, we preliminarily determined the preparation process of Huodan Biyan Soft Capsules.

[0057] Preparation of the contents of the soft capsule: weigh each drug according to the prescription, and prepare dry extract powder according to the extraction process; take 18g of beeswax, add 264.3g of vegetable oil, heat at 60°C to melt the beeswax, mix evenly, and add refined pig gallbladder powder in batches , stirred to dissolve and disperse evenly, then successively add Xanthium seed extract and patchouli oi...

experiment example 3

[0065] Experimental Example 3 Preparation of Soft Capsule Shell

[0066] Based on the qualified rate of the soft capsules and the blood concentration of the qualified products obtained in each test 2 hours after human consumption, the orthogonal test was used to study the ratio of the capsule to the shell, the suspending agent, the ratio of the drug to the dispersion medium, and the specific method as follows:

[0067] Get 9 parts of the former medical material of medicine of the present invention, extract medicine, pulverize according to above-mentioned preferred test method, the preferred vegetable oil of dispersion medium, arrange test according to orthogonal table L9 (34), prepare soft capsule, investigate the qualification rate and human body taking of soft capsule that make The blood drug concentration of the latter 2h (using the blood drug concentration measured in the soft capsule obtained in the A1B1C1 test at 2h as a reference value, calculate the ratio of each group...

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Abstract

The invention discloses a Huo-dan rhinitis soft capsule which has the effects of dispelling wind and heat and clearing the nasal passage. Main medicinal raw materials of the soft capsule include refined pig gall dry extract powder, Siberian cocklebur fruit extract and patchouli oil, and the soft capsule is characterized in that the soft capsule preparation further comprises accessories, i.e. soybean oil and beeswax; and a shell of the soft capsule is the mixture of glutin, glycerol and water. The invention also discloses a method for preparing the soft capsule and a method for controlling the quality of the soft capsule. Compared with Huo-dan rhinitis capsules, the Huo-dan rhinitis soft capsule has remarkably improved bioavailability.

Description

technical field [0001] The invention relates to a traditional Chinese medicine soft capsule which has the functions of clearing wind and heat and clearing nasal orifices, and is used for treating symptoms such as chronic rhinitis, chronic paranasal sinusitis and allergic rhinitis, and belongs to the technical field of traditional Chinese medicines. Background technique [0002] According to the news from the World Health Organization (WHO), rhinitis is listed as the first place in the high incidence of earth residents, and the incidence rate in 2003 was as high as 43%. Nasal cancer cases caused by rhinitis frequently occur in the world. The inflammation of nasal mucosa or submucosal lasts for more than several months, or the inflammation recurs repeatedly and does not return to normal during the intermission, and there is no clear pathogenic microorganism infection, which is called chronic rhinitis. Clinically, chronic rhinitis is divided into chronic simple rhinitis and chr...

Claims

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Application Information

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IPC IPC(8): A61K36/53A61K9/48A61K47/44G01N30/02G01N30/90A61P11/02A61K35/413
Inventor 付立家付建家
Owner BEIJING ASIA EAST BIO PHARMA CO LTD
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