Kangfulingshuan medicine production technique

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...

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 "deep-fried" rhubarb , the temperature is at least above 200°C, and many medicinal ingredients are destroyed; the fourth is to use the fried rhubarb sesame oil to soak the comfrey, even if the comfrey is filtered out, the filtered comfrey will undoubtedly be stained with a lot of sesame oil, including The active ingredients of rhubarb, the efficacy will be greatly affected

[0003] There are two disadvantages of using only semi-synthetic fatty acid lipids as excipients: one is that it is difficult to produce and form medicines

Second, medicines are almost unavailable

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