Preparaton of banlangen and method for controlling quality

A quality control method, the technology of Radix Radix, applied in the direction of testing pharmaceutical preparations, pharmaceutical formulas, measuring devices, etc., can solve problems such as quality fluctuations, poor controllability of Radix Radix Radix preparations, complex Radix Radix Radix components, etc., and achieve high reproducibility and stable preparations Effect

Inactive Publication Date: 2004-10-27
四川禾亿制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Safe, effective, stable, and controllable are the standards of modern pharmaceutical preparations. At present, Radix Radix Radix has been reported to have antiviral, antibacterial, and anti-endotoxin effects, and it has been clinically proven to be safe and effective. However, due to the The complex ingredients make the Radix isatidis medicinal material and its preparations less stable, different medicinal materials and finished product batches, and the quality also fluctuates greatly, which makes the controllability of the Radix isatidis preparation poor.

Method used

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  • Preparaton of banlangen and method for controlling quality
  • Preparaton of banlangen and method for controlling quality

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0028] Preparation of Experimental Example 1 Radix Radix Radix Original Medicinal Material Powder

[0029] Radix isatidis is dried at low temperature (below 60°C), cut into pieces, powdered, and passed through a No. 2 sieve.

experiment example 2

[0030] Preparation of Experimental Example 2 Radix Radix Eye Drops

[0031] Take 500g of Radix Radix, add 10 times the amount of water and decoct twice, the first time for 2 hours, the second time for 1 hour, combine the decoction, filter, concentrate the filtrate to about 750ml, cool, add ethanol to make the alcohol content reach 70% , stir well, refrigerate for 24 hours, filter, recover the ethanol from the filtrate to 350-500ml, refrigerate overnight, filter, adjust the pH value of the filtrate to 8.0-8.5 with ammonia test solution, stir well, refrigerate for 48 hours, filter, and remove by heating For ammonia, add 1g of ethylparaben, add distilled water to 1000ml, sterilize, filter with a G4 vertical melting funnel and a 0.22um filter membrane, and pot it to obtain.

experiment example 3

[0032] Experimental Example 3 Preparation of Isatidis in-situ Gelling Eye Drops

[0033] Take 500g of Radix Radix, add 10 times the amount of water and decoct twice, the first time for 2 hours, the second time for 1 hour, combine the decoction, filter, concentrate the filtrate to about 750ml, cool, add ethanol to make the alcohol content reach 70% , stir well, refrigerate for 24 hours, filter, recover the ethanol from the filtrate to 350-500ml, refrigerate overnight, and filter; take another 3g of carbomer and add appropriate amount of distilled water to fully swell, 12g of hydroxypropyl methylcellulose and ethylparaben Add 1g of distilled water to dissolve, combine the above solutions, add 8.5g of sodium chloride to adjust the osmotic pressure, add distilled water to 1000ml, adjust the pH to 5.5-6.0 with sodium hydroxide, sterilize, and filter with a G4 vertical melting funnel and a 0.22um filter membrane. Potting, that is.

[0034] The so-called in-situ gelling eye drops re...

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Abstract

A Chinese medicine is prepared from Radix isatidis or its extract and contains adenosine (0.075-2 mg per unit). Its quality control method features that the content of adenosine in medicine is controlled.

Description

technical field [0001] The invention provides a Radix isatidis preparation and a quality control method thereof, belonging to the field of traditional Chinese medicines. Background technique [0002] Isatis root is the dried root of Isatis indigotica Fort., a cruciferous plant. It tastes bitter and cold, and enters the heart and stomach meridians. It has the effects of clearing heat and detoxifying, cooling blood and reducing swelling. The main chemical components are indigoside, indirubin, sitosterol, various amino acids, adenosine, polysaccharides, etc. Clinically, it is widely used in the treatment of influenza, mumps, acute and chronic pharyngitis, herpes simplex keratitis, and Japanese encephalitis. Pharmacological activities include anti-endotoxin, anti-virus, anti-tumor, immune regulation, etc. Banlangen preparations include Banlangen Injection, Banlangen Granules, Banlangen Capsules, Banlangen Oral Liquid, Banlangen Syrup, Banlangen Tablets,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/7076A61P27/02G01N30/90G01N33/15
Inventor 阳向波郭力谢永平梁恒兴
Owner 四川禾亿制药有限公司
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