Medicinal composition for injection, used for improving stability of silymarin medicine injection preparation

A technology for silymarin and injection preparation, applied in the field of medicine, can solve the problems of high clinical application risk of injection, inconvenient clinical medication and promotion, easy rancidity, etc., and achieves convenient clinical medication and promotion, reduction of silymarin degradation substances, and pH value of medicinal solution. stable effect

Inactive Publication Date: 2016-09-14
成都市斯贝佳科技有限公司
View PDF1 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because polysorbate 80 has hemolysis and hypotensive effects, and is prone to rancidity during storage and high-temperature sterilization, the

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Medicinal composition for injection, used for improving stability of silymarin medicine injection preparation
  • Medicinal composition for injection, used for improving stability of silymarin medicine injection preparation
  • Medicinal composition for injection, used for improving stability of silymarin medicine injection preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A method for preparing a pharmaceutical composition for injection that improves the stability of silymarin drug injection preparations, comprising the following steps: (1) weighing 0.1 g to 100 g of the raw material drug calculated as silymarin, 9.0 g of sodium chloride, and 1 mg of citric acid ~2.0g, sodium citrate 1mg~2.0g; (2) citric acid and sodium citrate were prepared into 10%~20% solutions respectively, and set aside. (3) Add to 500ml of water for injection below 40°C, stir until completely dissolved, then add 0.02% (g / ml) activated carbon, stir for 15 minutes, filter and decarburize. (4) Use citric acid or sodium citrate solution to adjust the pH of the filtrate to 3.0-7.0, add water for injection below 40°C to 1000ml; (5) filter the medicinal solution until it is clear, fill it, and sterilize it.

[0025] The specific components and contents thereof of the present embodiment are as follows:

[0026]

[0027] Citric acid and sodium citrate were prepared into...

Embodiment 2

[0029] Alternatively, the above pharmaceutical composition for injection that improves the stability of silymarin drug injection preparations is prepared according to the following steps:

[0030] (1) Weigh 0.1g-100g of raw material medicine, 1mg-2.0g of citric acid, 1mg-2.0g of sodium citrate; (2) prepare 10%-100g of citric acid and sodium citrate 20% solution, spare. (3) Add to 500ml of water for injection below 40°C, stir until completely dissolved, then add 0.02% (g / ml) activated carbon, stir for 15 minutes, filter and decarburize. (4) Use citric acid or sodium citrate solution to adjust the pH of the filtrate to 3.0-7.0, add water for injection below 40°C to 1000ml; (5) filter the medicinal solution until it is clear, fill it, and sterilize it.

[0031] The specific components and contents thereof of the present embodiment are as follows:

[0032] Silymarin Hydrochloride 20g

[0033] Citric acid 1.0g

[0034] Sodium citrate 2.0g

[0035] Citric acid and sodium citrat...

Embodiment 3

[0037] Comparative Test of Stability of Silymarin Sodium Chloride Injection

[0038] The detection of visible foreign matter in the silymarin sodium chloride injection prepared by the present invention complies with the provisions of the drug quality standard, and the stability of the solution is very good. Under the condition of avoiding the use of other co-solvents that increase the risk of clinical application, the chlorination of silymarin is solved. Sodium injections are prone to problems such as small white spots, white lumps, and cloudy solutions during storage. Utilize the silymarin sodium chloride injection prepared by the present invention according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix Ⅺ XC drug preparation stability test guideline requirements, investigated respectively placed at 25 ℃ for 24 months, 40 ℃ for 6 months , Placed at 60°C for 10 days, and placed at 0-5°C for 20 days for drug stability. As a result, the produ...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

No PUM Login to view more

Abstract

The invention discloses a medicinal composition for injection, used for improving the stability of a silymarin medicine injection preparation. The medicinal composition for injection is prepared through the following steps: dissolving a silymarin salt in injection water, and adding citric acid and/or sodium citrate used as a pH regulator to regulate the pH value of the obtained medicinal solution, and the use amount of citric acid and/or sodium citrate is 0.1-200.0mg/100ml. The medicinal composition for injection makes the pH value of injections be stable, greatly reduces silymarin degrading substances, improves the clearness of silymarin injections without using other cosolvents increasing clinic application risks, especially solves the problems of small white spots, white blocks and solution turbidity of present silymarin injections in the prior art after long-time storage, can guarantee that the visible foreign matter inspection process of the product accords with medicine quality standard prescriptions, and can be conveniently and clinically used and promoted.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition for injection that improves the stability of silymarin drug injection preparations. Background technique [0002] Silymarin is a flavonoid extracted from the seed coat of the medicinal plant Silybum marianum, which has the following effects: protect liver cells from toxic substances, especially alcohol and environmental pollutants (pesticides, heavy metals, etc.) ) invades and damages the liver; has a strong antioxidant function, can protect liver cells from free radical damage, and is far more effective than vitamin E; promotes protein synthesis, accelerates the production of new liver cells, or makes damaged liver cells automatically repair. Therefore, it is called "natural liver protection medicine". In addition, silymarin has the effects of anti-radiation, anti-aging, prevention and treatment of arteriosclerosis, and delaying skin a...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
IPC IPC(8): A61K9/08A61K47/12A61K31/357A61P39/06A61P9/10A61P17/00A61P39/00
CPCA61K9/08A61K9/0019A61K31/357A61K47/12
Inventor 杨素坤
Owner 成都市斯贝佳科技有限公司
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap