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Preparation method of phaseolin injection preparation pharmaceutical composition

An injection preparation, phaseolin technology, applied in the field of medicine, can solve the problems of easy precipitation of fine white spots, no better solution, and unqualified inspection items of visible foreign matter, so as to facilitate clinical drug use and promotion, and stabilize pH value , Phaseolin degradation substances reduction effect

Inactive Publication Date: 2018-02-27
成都源来来科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But when preparing the above injection, the pH value of the medicinal liquid must be adjusted to a certain range suitable for human injection administration. The pH value regulators used in current literature reports are sodium hydroxide solution or use hydrochloric acid solution and phosphoric acid solution, but The phaseolin injection prepared by using the above-mentioned pH value regulator is easy to precipitate fine white spots, white lumps, solution turbidity and other precipitates under long-term storage and low temperature conditions in winter, resulting in the failure of the visible foreign matter inspection item of the product
There is no better solution

Method used

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  • Preparation method of phaseolin injection preparation pharmaceutical composition
  • Preparation method of phaseolin injection preparation pharmaceutical composition
  • Preparation method of phaseolin injection preparation pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] A method for preparing a pharmaceutical composition for injection that improves the stability of phaseolin drug injection preparations, comprising the following steps: (1) weighing 0.1 g to 100 g of raw materials calculated as phaseolin, 9.0 g of fructose, and phthalic acid 1mg~2.0g, sodium phthalate 1mg~2.0g; (2) Phthalic acid and sodium phthalate are respectively prepared into 10%~20% solutions for later use. (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 phthalic acid or sodium phthalate 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 to obtain .

[0021] The specific components and contents thereof of the present embodiment are as follows:

[0022]

[0023] Phthalic acid and sodium phthalate were prepare...

Embodiment 2

[0025] Alternatively, the pharmaceutical composition for injection that improves the stability of phaseolin pharmaceutical injection preparations is prepared according to the following steps:

[0026] (1) Weigh 0.1g-100g of raw material medicine calculated by phaseolin, 1mg-2.0g of phthalic acid, 1mg-2.0g of sodium phthalate; (2) Prepare phthalic acid and sodium phthalate respectively 10% to 20% solution for later use. (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 phthalic acid or sodium phthalate 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 to obtain .

[0027] The specific components and contents thereof of the present embodiment are as follows:

[0028] Phaseolin Hydrochloride 20g

[0029] Phthalic acid 1.0g ...

Embodiment 3

[0033] Comparative test on the stability of Phaseolin Fructose Injection

[0034] The detection of visible foreign matter in the phaseolin fructose injection prepared by the present invention meets the requirements of the drug quality standard, and the stability of the solution is very good. In the case of avoiding the use of other co-solvents that increase the risk of clinical application, the phaseolin fructose injection is solved. The solution is prone to problems such as small white spots, white blocks, and cloudy solution during storage. The Phaseolin Fructose Injection prepared by utilizing the present invention was investigated respectively in 25 DEG C for 24 months, 40 DEG C for 6 months, The stability of the drug was stored at 60°C for 10 days and at low temperature of 0-5°C for 20 days. As a result, the product quality was stable under the above test conditions, and all the test indicators were in line with the quality standards of this product.

[0035] The results...

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Abstract

The invention discloses a preparation method of a phaseolin injection preparation pharmaceutical composition. The preparation method comprises the steps of dissolving phaseolin salt into injection water, adding phthalic acid and / or sodium phthalate as a pH adjusting agent, and adjusting the pH value of medicine liquid, so as to obtain the pharmaceutical composition for injection, wherein the use amounts / amount of phthalic acid and / or sodium phthalate are / is 0.1mg / ml-200.0mg / ml. According to the preparation method, the pH value of an injection is relatively stable; compared with the prior art,the preparation method has the advantages that a phaseolin degradation product is greatly reduced, the clarity of the phaseolin injection is increased without using other cosolvents which can increasethe clinical application risk, particularly, the problems that small white particles and white blocks appear, and the solution is turbid when the phaseolin injection is stored by virtue of products in the prior art for a long time are solved, the visible foreign matter detection of the product can meet the specifications of the drug quality standard, and the composition is convenient for clinicalmedication and popularization.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of a phaseolin injection pharmaceutical composition. Background technique [0002] Phaseolin is a secondary metabolite induced by kidney beans by external stimuli (biological and abiotic factors), and is a plant defenser. It can inhibit the action of α-amylase and reduce the starch decomposition rate in the digestive tract, so it can reduce the absorption of raw sugar in the small intestine and reduce the release of insulin. It is suitable for diabetics. It also has estrogen activity and anti-tumor activity . [0003] Since Phaseolin has very poor solubility in aqueous solution, it is made into Phaseolin Hydrochloride or Phaseolin Phosphate to increase its water solubility. At present, the phaseolin injections on the market mainly include small-volume injections of phaseolin hydrochloride and phaseolin phosphate, and those prepared by adding gl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/48A61K9/08A61K47/12A61P3/10
CPCA61K36/48A61K9/0019A61K9/08A61K47/12
Inventor 杨利华
Owner 成都源来来科技有限公司