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Honeysuckle and baical skullcap root pharmaceutical preparation containing polyethylene glycol 12-hydroxy stearate and preparation method thereof

A technology of polyethylene glycol dodecyl stearate and pharmaceutical preparations, applied in the field of medicine, can solve problems such as being unable to meet actual clinical needs, and achieve the effects of facilitating clinical medication and promotion, and improving clarity

Inactive Publication Date: 2013-12-11
SICHUAN SUNNYHOPE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, using the above methods to obtain injections still cannot satisfactorily solve the problems of precipitation and turbidity of Danshen injection during placement, and cannot meet the actual clinical needs.

Method used

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  • Honeysuckle and baical skullcap root pharmaceutical preparation containing polyethylene glycol 12-hydroxy stearate and preparation method thereof
  • Honeysuckle and baical skullcap root pharmaceutical preparation containing polyethylene glycol 12-hydroxy stearate and preparation method thereof
  • Honeysuckle and baical skullcap root pharmaceutical preparation containing polyethylene glycol 12-hydroxy stearate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] A silver yellow pharmaceutical preparation containing polyethylene glycol lauryl hydroxy stearate, which is mainly composed of honeysuckle extract, scutellaria baicalensis extract and polyethylene glycol lauryl hydroxy stearate for improving the clarity of injection The dosage of the polyethylene glycol lauryl hydroxystearate is 0.1g-1.0g / 100ml for the medicine for injection made from water for injection.

[0030] The preparation method of the silver yellow pharmaceutical preparation is as follows:

[0031] Scutellaria baicalensis extract 20.0g (calculated as baicalin)

[0032] Honeysuckle extract 12.5g (calculated as chlorogenic acid)

[0033] 2.0g

[0034] The above two flavors, respectively add water for injection and 80% sodium hydroxide solution to dissolve them, mix, add water for injection to about 980ml, adjust the pH value to 7.2 with 80% sodium hydroxide solution, add an appropriate amount of activated carbon, and heat on a water bath for 1 After hours, l...

Embodiment 2

[0036] Scutellaria baicalensis extract 20.0g (calculated as baicalin)

[0037] Honeysuckle extract 12.5g (calculated as chlorogenic acid)

[0038] 2.0g

[0039] The above two flavors, respectively add water for injection and 80% sodium hydroxide solution to dissolve them, mix, add water for injection to about 500ml, adjust the pH value to 7.2 with 80% sodium hydroxide solution, add an appropriate amount of activated carbon, and heat it on a water bath for 1 After hours, let cool, add polyethylene glycol lauryl stearate, adjust to a certain volume with water for injection. Adjust the pH value to 7.2 with 80% sodium hydroxide solution, and filter the solution through a microporous membrane. Dispense, freeze-dry, and get ready.

Embodiment 3

[0041] Polysorbate 80 (ie Tween 80) and Comparative test on the stability of solubilized Yinhuang injection

[0042] The solution stability of the Yinhuang injection prepared by the present invention is very good, which solves the problems of small white spots, precipitation and turbidity of the solution during storage and high-temperature sterilization of the Yinhuang injection. The Yinhuang injection obtained in accordance with the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix XIXC drug formulation stability test guidelines, respectively inspected at 25 ℃ for 36 months, 40 ℃ for 6 months, 60 ℃ for 20 days The stability of the drug, the result is that the product quality is stable under the above-mentioned test conditions, and all the test indicators meet the requirements of this quality standard.

[0043] The pharmacological experiment results show that the Yinhuang injection prepared by the invention has no hemolysis, no allergy, and no irritation...

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Abstract

The invention discloses a honeysuckle and baical skullcap root pharmaceutical preparation containing polyethylene glycol 12-hydroxy stearate and a preparation method thereof. The honeysuckle and baical skullcap root pharmaceutical preparation is a drug for injection prepared by dissolving a honeysuckle extract, a baical skullcap root extract and polyethylene glycol 12-hydroxy stearate which is used for improving the limpid degree of an injection liquid into water for injection, wherein the amount of polyethylene glycol 12-hydroxy stearate is 0.1 g-1.0 g / 100ml. Under the condition that the honeysuckle and baical skullcap root pharmaceutical preparation is stored for a long time (more than 24 months), the limpid degree of the honeysuckle and baical skullcap root pharmaceutical preparation can be improved, the detection of visible foreign matters of the injection liquid can be stably kept to meet stipulation of drug quality standards, the problems that the injection liquid has a small number of small white dots, white blocks and solution turbidness which are occurring under the condition that a honeysuckle and baical skullcap root pharmaceutical preparation adopts a conventional cosolvent (Twain-80) and is stored for a long time are solved, the detection of the visible foreign matters of the product can be ensured to meet the stipulation of the drug quality standards, and convenience is brought to clinical administration and popularization.

Description

[0001] This application is a divisional application of application No. 201010221274.5 "A silver yellow pharmaceutical preparation containing polyethylene glycol lauryl hydroxystearate and its preparation method" filed on July 8, 2010. Technical field [0002] The present invention relates to the present invention in the field of medical technology, in particular to a silver yellow pharmaceutical preparation containing polyethylene glycol lauryl hydroxystearate and a preparation method thereof. Background technique [0003] The standard for Yinhuang injection is included in the Pharmaceutical Standards issued by the Ministry of Health (WS3-B-3691-98, Traditional Chinese Medicine Prescriptions). The raw materials are Scutellaria baicalensis extract 20.0g (calculated as baicalin) and Honeysuckle extract 12.5g Chlorogenic acid meter). The above two flavors, respectively add water for injection and 80% sodium hydroxide solution to dissolve them, mix, add water for injection to about 98...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/539A61K47/34A61K9/08A61K9/19A61P29/00A61P11/14A61P11/04A61P11/00A61P31/00A61K36/355
Inventor 郭成辉毛长兴陈开军
Owner SICHUAN SUNNYHOPE PHARM CO LTD
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