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Compound angelica medicament injection preparation containing polyethylene glycol 12-hydroxystearate 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 white lumps, solution turbidity, small white spots, etc., and achieve the effect of improving clarity, facilitating clinical medication and popularization

Inactive Publication Date: 2010-11-17
SICHUAN SUNNYHOPE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The compound angelica drug injection preparation uses polyethylene glycol lauryl hydroxystearate to help dissolve the components of the compound angelica injection, and through creative labor, it is found that only a certain concentration of polyethylene glycol lauryl hydroxystearate can While maximizing the solubility of the active ingredient, that is, the extract of traditional Chinese medicine, it improves the clarity of the injection, and satisfactorily solves the problem of small white spots, white lumps, and turbidity of the solution during storage and high-temperature sterilization of the compound angelica injection. question

Method used

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  • Compound angelica medicament injection preparation containing polyethylene glycol 12-hydroxystearate and preparation method thereof
  • Compound angelica medicament injection preparation containing polyethylene glycol 12-hydroxystearate and preparation method thereof
  • Compound angelica medicament injection preparation containing polyethylene glycol 12-hydroxystearate and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Angelica 100g

[0025] Chuanxiong 100g

[0026] Safflower 100g

[0027] Solutol HS- 2.0g

[0028]Add water to decoct the above three flavors, Angelica and Chuanxiong twice, each time for 2 hours, combine the decoction, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.27-1.30 (80°C), let it cool, add ethanol to make the ethanol content 65%, stand overnight, filter, the filtrate is decompressed to recover ethanol and concentrate to a relative density of 1.30 (80°C), add 3 times the amount of water, stir well, refrigerate for 48 hours, filter, and the filtrate is concentrated to a relative density under reduced pressure About 1.15 (80°C), the medicinal liquid is for later use; add water to decoct the safflower twice, 1 hour each time, combine the decoction, filter, and concentrate the filtrate to a relative density of 1.25-1.30 (80°C), let it cool, add Ethanol so that the ethanol content is 65%, let stand overnight, filter, the fi...

Embodiment 2

[0030] Angelica 50-150g

[0031] Chuanxiong 50-150g

[0032] Safflower 50-150g

[0033] Solutol HS- 1-10g

[0034] Add water to decoct the above three flavors, Angelica and Chuanxiong twice, each time for 2 hours, combine the decoction, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.27-1.30 (80°C), let it cool, add ethanol to make the ethanol content 65%, stand overnight, filter, the filtrate is decompressed to recover ethanol and concentrate to a relative density of 1.30 (80°C), add 3 times the amount of water, stir well, refrigerate for 48 hours, filter, and the filtrate is concentrated to a relative density under reduced pressure About 1.15 (80°C), the medicinal liquid is for later use; add water to decoct the safflower twice, 1 hour each time, combine the decoction, filter, and concentrate the filtrate to a relative density of 1.25-1.30 (80°C), let it cool, add Ethanol so that the ethanol content is 65%, let stand overnight, fil...

Embodiment 3

[0036] Polysorbate 80 with Solutol HS- Comparative Test of Stability of Solubilized Compound Angelica Injection

[0037] The detection of visible foreign matter of the compound angelica injection prepared by the present invention complies with the provisions of the drug quality standard and the solution stability is good, which solves the problem that small white spots and white lumps are easy to appear in the compound angelica injection during storage and high-temperature sterilization , solution turbidity and other problems. Utilize the compound angelica injection that the present invention makes according to the relevant requirements of Chinese Pharmacopoeia 2005 edition two appendices XI XC pharmaceutical preparation stability test guiding principle, have investigated respectively placing 36 months at 25 ℃, 6 months at 40 ℃, The stability of the drug was placed at 60°C for 20 days. As a result, the quality of the product was stable under the above test conditions, and al...

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Abstract

The invention discloses a compound angelica medicament injection preparation containing polyethylene glycol 12-hydroxystearate and a preparation method thereof. The compound angelica medicament injection preparation is the injection medicament mainly prepared by dissolving an angelica extract, a rhizoma chuanxiong extract, a safflower extract and polyethylene glycol 12-hydroxystearate for improving the clarity of the injection in injection water, wherein the using amount of the polyethylene glycol 12-hydroxystearate is 0.1g-1.0g / 100ml. The compound angelica medicament injection preparation of the invention can improve the clarity of compound angelica injection, stably ensure that the detection for visible foreign matters of the injection complies with the medicament quality standard especially under the condition that the compound angelica injection is preserved for a longer time (over 24 months), solve the problems of small white spots, white blocks and turbidity of the compound angelica medicament injection which adopts the conventional cosolvent (Tween-80) and is preserved for a longer time, and ensure that the detection of the visible foreign matters of the injection complies with the medicament quality standard so as to facilitate clinic administration and popularization.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a compound angelica drug injection preparation containing polyethylene glycol lauryl hydroxystearate and a preparation method thereof. Background technique [0002] The standard of compound angelica injection is recorded in the drug standard issued by the Ministry of Health (WS3-B-3905-98, traditional Chinese medicine preparation), and the raw materials are angelica, chuanxiong and safflower. Add water to decoct the above three flavors, Angelica and Chuanxiong twice, each time for 2 hours, combine the decoction, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.27-1.30 (80°C), let it cool, add ethanol to make the ethanol content 65%, stand overnight, filter, the filtrate is decompressed to recover ethanol and concentrate to a relative density of 1.30 (80°C), add 3 times the amount of water, stir well, refrigerate for 48 hours, fil...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/286A61K47/34A61K9/08A61K9/19A61P15/00A61P19/00A61P29/00A61K47/14
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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