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Polyethylene glycol 12-hydroxy stearate-containing danshen root medicament injection preparation and preparation method thereof

A polyethylene glycol lauryl hydroxystearate and injection preparation technology, which is applied in the field of medicine, can solve the problems of poor water solubility of tanshinone and cannot meet the actual clinical needs, and achieve the effect of improving clarity, facilitating clinical medication and popularization

Active Publication Date: 2010-12-01
SICHUAN SUNNYHOPE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because the tanshinone in the main ingredient of this product is very poor in water solubility, and Tween-80 has strong hemolytic and allergic properties, so the above method to obtain the injection still cannot satisfactorily solve the problem of precipitation of Danshen injection during placement, Turbidity and other problems cannot meet the actual clinical needs

Method used

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  • Polyethylene glycol 12-hydroxy stearate-containing danshen root medicament injection preparation and preparation method thereof
  • Polyethylene glycol 12-hydroxy stearate-containing danshen root medicament injection preparation and preparation method thereof
  • Polyethylene glycol 12-hydroxy stearate-containing danshen root medicament injection preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A salvia miltiorrhiza drug injection preparation containing polyethylene glycol lauryl hydroxystearate, which is mainly prepared by dissolving salvia miltiorrhiza extract and polyethylene glycol lauryl hydroxystearate for improving the clarity of the injection in water for injection The finished medicine for injection, the dosage of the polyethylene glycol lauryl hydroxystearate is 0.1g~1.0g / 100ml.

[0028] The specific preparation method of this embodiment is as follows:

[0029] Danshen 1500g

[0030] Solutol HS- 2.0g

[0031] The dandelions were decocted in water three times, the first time was 2 hours, the second and third time were 1.5 hours respectively, the decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure to 750ml. Add ethanol for precipitation twice, the first time the alcohol content is 75%, the second time the alcohol content is 85%, each time it is refrigerated and then filtered. The filtrate recovers ethanol an...

Embodiment 2

[0033] Danshen 1000-2000g

[0034] Solutol HS- 1.0-10.0g

[0035] The dandelions were decocted in water three times, the first time was 2 hours, the second and third time were 1.5 hours respectively, the decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure to 750ml. Add ethanol for precipitation twice, the first time the alcohol content is 75%, the second time the alcohol content is 85%, each time it is refrigerated and then filtered. The filtrate recovers ethanol and concentrates it to about 250ml. Add water for injection to 400ml, mix well, refrigerate, filter, adjust the pH value to 6.8 with 10% sodium hydroxide solution, boil for half an hour, filter, add polyethylene glycol lauryl hydroxystearate to the filtrate, and add water for injection Prepare a solution with a certain concentration, stir evenly, adjust the pH value to 6.8 with 10% sodium hydroxide solution, filter, subpackage, and freeze-dry to make a freeze-dried powder. ...

Embodiment 3

[0037] Polysorbate 80 with Solutol HS- Comparative Test of Stability of Solubilized Danshen Injection

[0038] The solution stability of the salvia miltiorrhiza injection prepared by the invention is very good, which solves the problems that the salvia miltiorrhiza injection is prone to precipitation and solution turbidity during storage and high-temperature sterilization. Utilize the prepared Danshen injection of the present invention according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendices XI X C drug preparation stability test guiding principle, investigated respectively placed at 25 ℃ for 36 months, 40 ℃ for 6 months, 60 ℃ for 20 days of drug stability, the result is that the product quality is stable under the above-mentioned test conditions, and each test index meets the requirements of the quality standard of this product.

[0039] The results of pharmacological experiments show that the Danshen injection prepared by the present ...

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Abstract

The invention discloses a method for preparing polyethylene glycol 12-hydroxy stearate-containing danshen root medicament injection preparation. The preparation method comprises the following steps: adding water to 1500g of the root of red-rooted salvia and boiling for three times, the first time being 2h, the second time and the third time each being 1.5h, combining the boiled liquid, filtering, concentrating under decompression to 750ml, adding alcohol and precipitating twice, the alcohol content in the first time being 75% and in the second time being 85%, each all filtering after refrigerating, recovering the alcohol from filtrate and concentrating to 250ml, adding injection water to 400ml, blending, refrigerating, filtering, adjusting pH value to 6.8 by using 10% of sodium hydroxide solution, boiling for half an hour, filtering, adding 2.0g of polyethylene glycol 12-hydroxy stearate to the filtrate, and adding the injection water to 1000ml, mixing uniformly, adjusting the pH value to 6.8 by using the 10% of the sodium hydroxide solution, filtering, embedmenting, sterilizing and obtaining the product. The method of the invention solves the problems of easy precipitation and opacities during the storage and high temperature sterilization processes of the root of red-rooted salvia injection with satisfaction.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a salvia miltiorrhiza drug injection preparation containing polyethylene glycol lauryl hydroxystearate and a preparation method thereof. Background technique [0002] The standard of Danshen injection is recorded in the drug standard issued by the Ministry of Health (WS3-B-3766-98, Volume 20 of Traditional Chinese Medicine Preparations), and it is a sterilized aqueous solution made from the extract of Danshen medicinal material. Take 1500g of Salvia miltiorrhiza, add water and decoct three times, the first time for 2 hours, the second and third times for 1.5 hours each, combine the decoction, filter, and concentrate the filtrate to 750ml under reduced pressure. Add ethanol for precipitation twice, the first time the alcohol content is 75%, the second time the alcohol content is 85%, each time it is refrigerated and then filtered. The filtrate recovers ethanol and con...

Claims

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Application Information

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IPC IPC(8): A61K36/537A61K9/08A61K47/34A61P9/10A61K47/14
Inventor 郭成辉毛长兴陈开军舒赟蒋巧梅李萍
Owner SICHUAN SUNNYHOPE PHARM CO LTD
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