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Urapidil fructose injection and preparation method thereof

A technology of urapidil fructose and injection, applied in the field of medicine, can solve the problems of aggravating the symptoms of diabetic patients, unqualified heat source, blood sugar fluctuation, etc., and achieve the effect of avoiding infection and pollution

Inactive Publication Date: 2010-06-09
BENGBU BBCA MEDICINE SCI DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The currently used urapidil injection is a small urapidil injection, and its disadvantages are mainly as follows: 1) Glucose is used as an energy supplement, which needs to rely on insulin to metabolize, which can easily lead to large fluctuations in blood sugar in the body, and high blood sugar can inhibit fat decomposition And also can increase the weight of diabetes patient's symptom; 2) easily polluted, small injection is in the dilution process, easily causes pollution, makes heat source unqualified; Not convenient enough

Method used

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  • Urapidil fructose injection and preparation method thereof
  • Urapidil fructose injection and preparation method thereof
  • Urapidil fructose injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Investigate the relationship between pH value and solubility, prepare aqueous solutions with different pH values ​​through phosphate buffer solution, and conduct tests according to the solubility test method of Part II of the Chinese Pharmacopoeia 2005 edition to investigate the solubility of urapidil. The results are shown in Table 1:

[0026] Table 1 The relationship between pH value and solubility

[0027]

[0028] Obviously, the lower the pH value, the greater the solubility, and when the pH value = 6.8, the solubility decreased significantly.

[0029] Secondly, to investigate the influence of different pH values ​​on the stability of urapidil, by preparing urapidil fructose solutions with different pH values, filling them in ampoules, heating them at 100°C for 6 hours, and measuring the content and activity of urapidil by HPLC method. Uradil related substances, the results are shown in Table 2.

[0030] The influence of table 2 different pH values ​​on ...

Embodiment 2

[0034] Formula: fructose 50g; urapidil 0.1g; 1mol / l hydrochloric acid solution and 0.1mol / l sodium hydroxide solution; activated carbon 1g; water for injection about 1000ml.

[0035] Weigh 50g of fructose, add 100ml of water for injection, add 1g of activated carbon, boil for 15 minutes, and filter while hot;

[0036] In addition, weigh 0.1 g of Urapidil, add 100 ml of water for injection, adjust the pH value to 3.3 with a hydrochloric acid solution with a concentration of 1 mol / l, heat and stir to make the solution pass through the carbon layer of the fructose solution, mix the filtrate with the fructose solution, and add water for injection to 70% of the total amount, mix well, adjust the pH value to 4.5 with 0.1mol / l sodium hydroxide solution, add water for injection to 1000ml, mix well;

[0037] Determination of the content of intermediates, fine filtration and potting after passing the test;

[0038] Sterilize at 115°C for 30 minutes and check with light.

Embodiment 3

[0040] Formula: fructose 100g; urapidil 0.32g; 2mol / l hydrochloric acid solution and 0.2mol / l sodium hydroxide solution; activated carbon 1.1g; water for injection about 1000ml.

[0041] Weigh 100g of fructose, add 100ml of water for injection, add 1.1g of activated carbon, boil for 20 minutes, and filter while hot;

[0042] Weigh 3.2g of urapidil, add 100ml of water for injection, adjust the pH value to 3.5 with a hydrochloric acid solution with a concentration of 2mol / l, heat and stir to make the solution pass through the carbon layer of the fructose solution, mix the filtrate with the fructose solution, and add water for injection to 80% of the total amount, mix well, adjust the pH value to 4.6 with 0.2mol / l sodium hydroxide solution, add water for injection to 1000ml, mix well;

[0043] Determination of the content of intermediates, fine filtration and potting after passing the test;

[0044] Sterilize at 115°C for 30 minutes and check with light.

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Abstract

The invention relates to an urapidil fructose injection and a preparation method thereof. The injection consists of urapidil, fructose, water for injection and an acidity and alkalinity regulator, wherein the mass and volume concentration of urapidil is 0.01-0.05%, the mass and volume concentration of fructose is 5-10% and the pH value is 3.1-6.1. Compared with the traditional urapidil injection, the invention has the advantages that the amount of insulin in vivo of a patient is not needed to consider when the urapidil injection is applied, wherein the urapidil injection is particularly suitable for the hypertension patient suffering from diabetes and the hypertension patient in a perioperative period; infection and pollution in the intermediate link in the use process of the traditional product can be avoided in the process of applying the urapidil injection, thereby the urapidil injection is safer, faster and more convenient. The preparation method of the urapidil fructose injection has simple operation and is suitable for industrial production in large scale.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a urapidil fructose injection and a preparation method thereof. Background technique [0002] At present, there are nearly 160 million hypertensive patients in my country, nearly 30 million diabetic patients, 90% of which are type 2 diabetes, and about 15 million hypertensive patients with diabetes. Among hypertensive patients, the prevalence of diabetes is about 10% to 20%, and about 50% of diabetic patients have hypertension. [0003] Hypertension is an extremely common complication of diabetic patients. The prevalence rate of hypertension in diabetic population is very high. The World Health Organization (WHO) reports that among diabetic patients, the prevalence rate of hypertension is 20% to 40%. In my country, it is about 40% to 50%, the prevalence of hypertension in diabetic patients is 1.5 to 3 times that of non-diabetic people. Conversely, people with high blood pressur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/513A61K47/26A61P9/12A61P3/10
Inventor 徐荣明陈文婕顾攀赵辉魏珺璇杨廷
Owner BENGBU BBCA MEDICINE SCI DEV
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