Kangfulingshuan medicine production technique

A preparation process and technology for medicines, applied in the directions of anti-infective drugs, suppository delivery, drug combination, etc., can solve problems such as drug effect influence, non-conformity, failure to reach frying temperature, etc., and achieve process environmental protection, convenient use, and drug efficacy. reliable results

Active Publication Date: 2009-06-17
TONGHUA BAIXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

"Frying rhubarb in fragrant oil has four disadvantages: one is that it does not meet the requirements of GMP, and the sesame oil is seriously volatilized when frying rhubarb in a pan in the production clean area, which is not allowed by GMP regulations; For rhubarb, the fume is discharged outside through the pipe. Although it meets the requirements of GMP, the temperature can reach up to 100°C, which cannot reach the frying temperature, and does not meet the requirements of "deep-fried" rhubarb specified in the standard; the third is to meet the requirements of "

Method used

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  • Kangfulingshuan medicine production technique

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0009] Example 1

[0010] Production process of Kangfuling suppository: pulverize 19.2g of borneol and 27.4g of catechu into fine powder for later use; 674g coarse powder of rhubarb, add 95% ethanol for reflux extraction twice, 1.5 hours each time, recover ethanol, concentrate in vacuum, and vacuum Dry and crush for later use; take 274g of comfrey, soak in 657.5ml of sesame oil for 72 hours, filter out comfrey. When the remaining sesame oil is less than 493.2ml, use heated sesame oil to make up to 493.2ml, add 330g paraffin wax and 110g beeswax, add semi-synthetic fatty acid fat , Heat to 45°C, stir, add borneol, catechin powder and rhubarb dry paste powder, stir and mix, potting, 2.5g each to make 1000 suppositories.

Example Embodiment

[0011] Example 2

[0012] The preparation process of Kangfuling suppository: 384g of borneol and 548g of catechu powder as fine powder, and 13480g coarse powder of rhubarb, add 95% ethanol for reflux extraction twice, 1.5 hours each time, recover the ethanol, vacuum concentration, vacuum drying, Shattered. Take 5480g of comfrey, soak in 13150ml sesame oil for 72 hours, filter out comfrey, if the remaining sesame oil is less than 9864ml, use heated sesame oil to make up 9864ml, add 6600g paraffin wax, 2200g beeswax, add semi-synthetic fatty acid ester, heat to 45℃ , Stir, add cold slices, catechu powder and rhubarb dry paste powder, stir and mix, potting, 2.5g each to make 20,000 suppositories.

Example Embodiment

[0013] Experimental example

[0014] In order to verify whether the process is reasonable and feasible after the process change, the present invention conducted a pharmacodynamic test on the Kangfu Ling suppository before and after the process change through Changchun University of Traditional Chinese Medicine.

[0015] Methods and results

[0016] 1. Comparison of antibacterial and insecticidal effects of two Kangfuling suppositories

[0017] 1. Tube dish method:

[0018] Two kinds of Kangfu Ling suppository were sterilized in water at 80℃ for 2h, and the strains were inoculated into appropriate medium (broth blood medium, chocolate blood medium, broth agar medium, blood agar medium, Sabouraud culture) Base, liver-peptone-sugar medium), respectively diluted to a bacterial content of 900,000 cells / ml, and Candida albicans to 50,000 cells / ml, and add 0.25g of Kangfu Ling to the tube dish of each strain Suppositories were cultured at 37°C for 18 hours, and the inhibition zone was me...

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Abstract

The invention relates to a preparation method of a Chinese traditional medical preparation, namely a preparation technique for producing Kangfuling suppositories, comprising the following steps of crushing 19.2g of borneol and 27.4g of catechu for later use; adding 95% of ethanol to extract 674g of crude powder of rhubarb under reflux for two times, 1.5 hours each time, recycling the ethanol, concentrating under vacuum, drying under vacuum, and crushing for later use; soaking 274g of redroot gromwell with 657.5ml of balm for 72 hours, filtering out the redroot gromwell, adding balm to 493.2ml when the balm is less than 493.2ml after being heated, adding 330g of paraffin and 110g of beeswax, stirring to synthesize into sorbitan fatty acid ester, heating to 45 DEG C, stirring, adding fine powder of borneol and catechu and rhubarb powdered extract, uniformly stirring, encapsulating, 2.5g each, preparing into 1,000 suppositories. The technique is environment-friendly and meets requirements of GMP standard; the suppositories have reliable curative effect and are more conveniently used.

Description

technical field [0001] The invention relates to a preparation method of a traditional Chinese medicine preparation, which is a preparation process for producing Fufuling Suppository. Background technique [0002] In the prior art, Fufuling Suppository was developed by the Jilin Provincial Academy of Traditional Chinese Medicine in the early 1990s, and was included in the eighth volume of "Prescriptions of Traditional Chinese Medicine of the Ministry of Health of the People's Republic of China". It has been sixteen years since the drug was approved for marketing. Due to major defects in the production process and the ratio of excipients, the drug is almost impossible to produce and cannot be sold. The original process stipulates: "Take rhubarb and chop it into pieces, fry it in the same pot with 650ml sesame oil, remove the residue, then add comfrey to soak for 72 hours, filter off comfrey, if the remaining sesame oil is less than 365ml, use heated sesame oil Make up to 365...

Claims

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Application Information

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IPC IPC(8): A61K36/708A61K9/02A61K47/44A61P15/02A61P31/02A61P31/10A61P33/02A61K31/045A61K47/06
Inventor 霍成斌
Owner TONGHUA BAIXIN PHARMA
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