CN101721360A - Urapidil fructose injection and preparation method thereof - Google Patents
Urapidil fructose injection and preparation method thereof Download PDFInfo
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- CN101721360A CN101721360A CN200910224209A CN200910224209A CN101721360A CN 101721360 A CN101721360 A CN 101721360A CN 200910224209 A CN200910224209 A CN 200910224209A CN 200910224209 A CN200910224209 A CN 200910224209A CN 101721360 A CN101721360 A CN 101721360A
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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
The present invention relates to medical technical field, specifically, relate to a kind of Urapidil fructose injection and preparation method.
Background technology
At present, China hyperpietic is nearly 1.6 hundred million, and diabetics is nearly 3,000 ten thousand, and wherein 90% is type 2 diabetes mellitus, and the patient of hypertension complicated with diabetes mellitus about 1,500 ten thousand.Among the hyperpietic, the prevalence of diabetes is about 10%~20%, about 50% complicated hypertension in the diabetics.
Hypertension is the extremely common complication of diabetics, hypertensive prevalence is very high in the diabetic population, The World Health Organization (WHO) is reported in the diabetics, hypertensive prevalence is 20%~40%, China approximately is 40%~50%, and diabetics hypertension prevalence is 1.5~3 times of non-diabetic people.Otherwise the hyperpietic is than the easier generation diabetes of normotensive people.The prevalence of diabetes is 2~2.5 times of normal arterial pressure crowd in the Hypertensive Population, and diabetes easily take place 85% hyperpietic, and about 50% patients with hypertension also has type 2 diabetes mellitus (T2DM) simultaneously.
Hypertension and hyperglycemia all are the major reasons that causes cardiovascular and cerebrovascular disease, and the diabetics of complicated hypertension is the high-risk group of cardiovascular and cerebrovascular disease especially.In case mortality rate increases at double behind diabetes patient's complicated hypertension.According to " Chinese Medical Journal " on January 22nd, 2008, a national survey shows that China's Diabetes with Hypertension patient controlling of blood pressure is undesirable, and the control compliance rate has only 31% at the most.
During surgery anesthesia, the patient is regulated the influence of hormone, blood sugar increasing.In diabetes and ND, bigger operation often makes blood sugar increasing to 8.3~11.1mmol/L or higher, therefore diabetics insulin deficit or use quantity not sufficient person especially, the serious hyperglycemia of easier generation when carrying out than major operation, even bring out ketosis or ketoacidosis.
α receptor blocking agent selectivity retardance vascular smooth muscle α receptor, make small artery and venule diastole, side effect is little, the saccharifying metabolism is had no adverse effects, can improve carbohydrate tolerance, also can improve insulin sensitivity, prolonged application also has certain accent fat effect, is the alternative medicine of diabetic hypertension therefore; Urapidil is the urea pyrimidine derivant that the benzene piperazine replaces, and mainly is by activating 5-hydroxytryptamine receptor, reduce the oblongata cardiovascular and control the sympathetic feedback regulation of maincenter and play the blood pressure lowering effect, common reflex tachycardia not taking place; Peripheral action is mainly blocking-up postsynaptic α 1 receptor, and Peripheral resistance is descended and blood vessel dilating.Therefore to diabetics or ND, the general urapidil injection that adopts comes controlling blood pressure in the operation process.
The urapidil injection that uses is the urapidil small-volume injection at present, its drawback is mainly: 1) use glucose as the energy supplement agent, need to rely on just energy metabolism of insulin, cause the interior blood glucose of body to fluctuate widely easily, hyperglycemia is suppressed steatolysis but also can increase the weight of the diabetics symptom; 2) easily pollute, small-volume injection pollutes in dilution easily, makes thermal source defective; 3) to the emergency case patient with severe symptoms when using this kind, can not use in time in requisition for preparation, convenient inadequately.
For these reasons, the invention provides before, during and after a kind of hypertensive crisis that can be used for the treatment of diabetes and the art phase to the urapidil injection of the controlled hypotension of hypertension.
Summary of the invention
The purpose of this invention is to provide a kind of Urapidil fructose injection and preparation method thereof.
Urapidil fructose injection of the present invention is made up of urapidil, fructose, water for injection and acidity-basicity regulator, and wherein, the quality volumetric concentration of described urapidil is 0.01%~0.05% (to be every 100ml water dissolution 0.01~0.05g); The quality volumetric concentration of described fructose is 5%~10% (to be every 100ml water dissolution 5~10g); PH value is 3.1~6.1.
Described acidity-basicity regulator can adopt this area bronsted lowry acids and bases bronsted lowry commonly used, the sodium hydroxide solution of preferred 0.05-0.2mol/l and the hydrochloric acid of 0.5-2mol/l, the more preferably hydrochloric acid of the sodium hydroxide solution of 0.1mol/l and 1mol/l is adjusted into 3.1~6.1 with the pH value of described injection.
Fructose is a kind of left-handed hexose, is the isomer of glucose.The fructose pharmacological action is identical with glucose basically, the effect of have direct heat supply, replenishing body fluid and nutrition whole body.But metabolism is faster than glucose in vivo behind the fructose intravenously administrable, easily absorbed by body, the fructose metabolism is not mainly by relying on the fructokinase of insulin regulation and control, therefore it can walk around glucolytic rate-limiting enzyme---and phosphofructokinase carries out autonomous metabolism, so the metabolism intensity of fructose depends mainly on the concentration of fructose, whether no matter the adjusting of insulin arranged, can metabolism be glycogen, therefore, the fast characteristics of fructose accretion rate can make the fluctuation of its effective blood sugar control concentration when replenishing the diabetics energy i (in vivo).
Therefore, this injection be particularly suitable for treating with the phase before, during and after the hypertensive crisis of diabetes and the art to the controlled hypotension of hypertension.
The present invention also aims to provide the preparation method of Urapidil fructose injection, this method is simple to operate, is suitable for industrialized great production.
The preparation method of described Urapidil fructose injection comprises the steps:
1) takes by weighing fructose, add the water for injection of formula ratio 5~15%, add the active carbon of quality, boiled filtered while hot 10~20 minutes for prescription gross mass 0.1%~0.15%;
2) take by weighing urapidil, the water for injection that adds formula ratio 5-15%, regulating pH value with concentration for the 0.5-2mol/l hydrochloric acid solution is 3.1~4.0, heated and stirred makes solution pass through in the step 1) to filter the carbon-coating of fructose soln, and filtrate is mixed with fructose soln, add to the full amount of water for injection 70~80%, mixing, regulating pH value with the 0.05-0.2mol/l sodium hydroxide solution is 4.5~5.5, adds to the full amount of water for injection mixing;
3) fine straining, embedding;
4) sterilized 30 minutes down at 115 ℃.
Wherein, step 2) afterwards, before the step 3), also comprise i) measure intermediate content, as intermediate content be labelled amount ± 5%, think qualified, carry out next step.
After the step 4), also comprise 5) lamp inspection.
The present invention has determined the important technical parameter of Urapidil fructose injection, the scope of pH value, and the preparation method of this injection is provided, for the quality control produced and reasonably the technological process of production useful help is provided; Compare with existing urapidil injection, need not consider patient's intravital amount of insulin when advantage is to use, be specially adapted to the hyperpietic of diabetes and the hyperpietic of peri-operation period; And in using injection process of the present invention, can avoid the intermediate link in the present existing product use to infect and pollute, safer, convenient and quick.
The specific embodiment
Following examples are used to illustrate the present invention, but are not used for limiting the scope of the invention.
Embodiment 1
Investigate the relation of pH value and dissolubility, prepare the aqueous solution of different pH value, test the dissolubility situation of investigation urapidil according to two solubility test methods of Chinese Pharmacopoeia version in 2005 by phosphate buffer.The results are shown in Table 1:
The relation of table 1pH value and dissolubility
PH value | ??2.8 | ??3.2 | ??4.1 | ??5.0 | ??5.5 | ??6.1 | ??6.8 |
Dissolubility (mg/ml) | ??10.94 | ??10.88 | ??9.71 | ??8.98 | ??8.33 | ??7.68 | ??5.01 |
Obviously, pH value is low more, and dissolubility is big more, and when pH value=6.8, dissolubility obviously reduces.
Secondly, investigate the influence of different pH value to urapidil stability, by preparing the Urapidil fructose solution of different pH value, embedding in 100 ℃ of heating 6 hours, is measured urapidil content and the urapidil related substance is arranged with the HPLC method in ampoule, the results are shown in Table 2.
The different pH value of table 2 are to the influence of urapidil stability
PH value | Concentration (mg/ml) before the heating | Heating back concentration (mg/ml) | Related substance (%) |
??3.1 | ??0.6214 | ??0.6203 | Less than 1.0 |
??4.2 | ??0.6214 | ??0.6211 | Less than 1.0 |
??4.5 | ??0.6214 | ??0.6215 | Less than 1.0 |
??5.0 | ??0.6214 | ??0.6208 | Less than 1.0 |
??5.5 | ??0.6214 | ??0.6201 | Less than 1.0 |
??6.1 | ??0.6214 | ??0.6203 | Less than 1.0 |
Obviously, urapidil is stable between pH value 3.1~6.1.
Embodiment 2
Prescription: fructose 50g; Urapidil 0.1g; 1mol/l hydrochloric acid solution and 0.1mol/l sodium hydroxide solution; Active carbon 1g; The about 1000ml of water for injection.
Take by weighing fructose 50g, add injection water 100ml, add active carbon 1g, boiled filtered while hot 15 minutes;
Other takes by weighing urapidil 0.1g, add injection water 100ml, regulating pH value with concentration for the 1mol/l hydrochloric acid solution is 3.3, heated and stirred makes solution by filtering the carbon-coating of fructose soln, and filtrate is mixed with fructose soln, add to the full amount of water for injection 70%, mixing, regulating pH value with the 0.1mol/l sodium hydroxide solution is 4.5, adds the injection water to 1000ml, mixing;
Measure intermediate content, qualified back fine straining, embedding;
Sterilized 30 minutes lamp inspection down at 115 ℃.
Embodiment 3
Prescription: fructose 100g; Urapidil 0.32g; 2mol/l hydrochloric acid solution and 0.2mol/l sodium hydroxide solution; Active carbon 1.1g; The about 1000ml of water for injection.
Take by weighing fructose 100g, add injection water 100ml, add the 1.1g active carbon, boiled filtered while hot 20 minutes;
Other takes by weighing urapidil 3.2g, add injection water 100ml, regulating pH value with concentration for the 2mol/l hydrochloric acid solution is 3.5, heated and stirred makes solution by filtering the carbon-coating of fructose soln, and filtrate is mixed with fructose soln, add to the full amount of water for injection 80%, mixing, regulating pH value with the 0.2mol/l sodium hydroxide solution is 4.6, adds the injection water to 1000ml, mixing;
Measure intermediate content, qualified back fine straining, embedding;
Sterilized 30 minutes lamp inspection down at 115 ℃.
Embodiment 4
Prescription: fructose 50g; Urapidil 0.5g; 0.5mol/l hydrochloric acid solution and 0.05mol/l sodium hydroxide solution; Active carbon 1g; The about 1000ml of water for injection.
Take by weighing fructose 50g, add injection water 100ml, add 0.1% active carbon, boiled filtered while hot 15 minutes;
Other takes by weighing urapidil 0.5g, add injection water 100ml, regulating pH value with concentration for the 0.5mol/l hydrochloric acid solution is 3.1, heated and stirred makes solution by filtering the carbon-coating of fructose soln, and filtrate is mixed with fructose soln, add to the full amount of water for injection 70%, mixing, regulating pH value with the 0.05mol/l sodium hydroxide solution is 4.7, adds the injection water to 1000ml, mixing;
Measure intermediate content, qualified back fine straining, embedding;
Sterilized 30 minutes lamp inspection down at 115 ℃.
Embodiment 5
Prescription: fructose 100g; Urapidil 0.1g; 1mol/l hydrochloric acid solution and 0.1mol/l sodium hydroxide solution; Active carbon 1g; The about 1000ml of water for injection.
Take by weighing fructose 100g, add injection water 100ml, add 0.1% active carbon, boiled filtered while hot 15 minutes;
Other takes by weighing urapidil 0.1g, add injection water 100ml, regulating pH value with concentration for the 1mol/l hydrochloric acid solution is 3.8, heated and stirred makes solution by filtering the carbon-coating of fructose soln, and filtrate is mixed with fructose soln, add to the full amount of water for injection 80%, mixing, regulating pH value with the 0.1mol/l sodium hydroxide solution is 4.9, adds the injection water to 1000ml, mixing;
Measure intermediate content, qualified back fine straining, embedding;
Sterilized 30 minutes lamp inspection down at 115 ℃.
Embodiment 6
(temperature is 40 ℃ by three batches of pilot product accelerated tests, relative humidity is 75 ± 1%) (temperature is 25 ± 2 ℃ for 6 months and long term test, relative humidity is 60 ± 1%) 24 months research, accelerated test 1,2,3,6 months and long term test 3,6,9,12,18,24 months important indicator (outward appearance, clarity, pH value, content, related substance) is investigated respectively, the every investigation index of result there is no significant change, shows that this product has good stability.See Table 3-4.
Table 3 Urapidil fructose injection accelerated test result
Table 4 Urapidil fructose injection long-term test results
Embodiment 7
Urapidil fructose injection to embodiment 1 preparation has carried out blood vessel irritation, anaphylaxis and hemolytic test.
One experiment purpose
Observe the systemic administration toxicity of Urapidil fructose injection, for data for clinical drug use provides foundation.
The experiment of two blood vessel irritations
Getting body weight is 12 of the healthy rabbits of 2.0-2.5kg, is divided into 2 groups at random, 6 every group.Adopt rabbit ear edge vein slowly to inject 5ml/kg, use Urapidil fructose injection for one group, another group urapidil glucose injection, once a day, successive administration 7 days is cut off the rabbit ear in last administration after 24 hours, places 10% formalin fixed preparation, send pathology to carry out histological examination (5 places at rabbit ear edge venous different parts draw materials, and promptly begin entad to hold every 1cm from first position of injection beginning and do a section) then.
Through rabbit ear edge vein pathological examination, Urapidil fructose injection group rabbit ear edge vein tube wall is complete, and the endotheliocyte structure is clear, does not have obvious pathological changes, the slight dilatation and congestion of blood vessel, no cell infiltration.The histology of urapidil glucose injection matched group auricular vein changes similar to the medication group.The result shows that medication group vein blood vessel is normal, do not see degeneration is arranged, the reaction of obvious stimulation such as necrosis.
The hypersensitive test of three Urapidil fructose injections
Get 18 of healthy guinea pigs about body weight 230g, be divided into 3 groups, 6 every group, i.e. Urapidil fructose injection group, Radix Trichosanthis group, normal saline matched group.Respectively every other day injection Urapidil fructose injection 1ml, etc. capacity normal saline and Radix Trichosanthis 2.5mg, inject altogether 3 times, and then be divided into two groups, 3 every group.Injecting in the first time respectively had lumbar injection Urapidil fructose injection 0.2ml in back 14 days and 21 days, waited capacity normal saline and Radix Trichosanthis 0.25mg, observed the anaphylaxis situation then.Table 5 is the anaphylaxis grade scale.Experimental result sees Table 6, table 7.
Table 5 Cavia porcellus anaphylaxis hierarchical table
Reaction after the 14th day Cavia porcellus of table 6 excites
Reaction after the 21st day Cavia porcellus of table 7 excites
The result shows: Urapidil fructose injection does not cause the Cavia porcellus anaphylaxis.
Four hemolytic experiments
The preparation of (1) 2% Sanguis Leporis seu oryctolagi suspension
Get one of rabbit, the small beaker from heart extracting blood 10ml to clean dried, stir except that defibrinating, add normal saline 3ml with Glass rod, centrifugal supernatant discarded night adds the 10ml normal saline again, shakes up gently, centrifugal, abandon supernatant, till not taking on a red color to supernatant so several times; Measuring blood cell 2ml adds normal saline and is diluted to 2% suspension to 100ml and uses for test.
(2) test
Get 7 in test tube, according to the form below adds each solution, shakes up, and Urapidil fructose injection concentration is urapidil 0.01%, fructose 5%, and respectively at being incubated 0.5,1,2,3 hour in 37 ℃ of waters bath with thermostatic control, observed result sees Table 8.
Table 8 Urapidil fructose injection hemolytic test result
Annotate: +++complete hemolysis; ++ part haemolysis; + cohesion;-do not condense, there is not cohesion
From table 8 result as seen, Urapidil fructose injection did not cause haemolysis and cell condensation in 3 hours.
Claims (7)
1. a Urapidil fructose injection is characterized in that, is made up of urapidil, fructose, water for injection and acidity-basicity regulator, and wherein, the quality volumetric concentration of described urapidil is 0.01%~0.05%; The quality volumetric concentration of described fructose is 5%~10%; PH value is 3.1~6.1.
2. Urapidil fructose injection as claimed in claim 1 is characterized in that, described acidity-basicity regulator is the sodium hydroxide solution of 0.05~0.2mol/l and the hydrochloric acid of 0.5~2mol/l.
3. Urapidil fructose injection as claimed in claim 2 is characterized in that, described acidity-basicity regulator is the sodium hydroxide solution of 0.1mol/l and the hydrochloric acid of 1mol/l.
4. as the application of the arbitrary described Urapidil fructose injection of claim 1~3, it is characterized in that, be used for the treatment of with the phase before, during and after the hypertensive crisis of diabetes and the art to the controlled hypotension of hypertension.
5. as the preparation method of the arbitrary described Urapidil fructose injection of claim 1~3, it is characterized in that, comprise the steps:
1) takes by weighing fructose, add the water for injection of formula ratio 5~15%, add the active carbon of quality, boiled filtered while hot 10~20 minutes for prescription gross mass 0.1~0.15%;
2) take by weighing urapidil, the water for injection that adds formula ratio 5~15%, with concentration is that 0.5~2mol/l hydrochloric acid solution adjusting pH value is 3.1~4.0, heated and stirred makes solution pass through in the step 1) to filter the carbon-coating of fructose soln, and filtrate is mixed with fructose soln, add to the full amount of water for injection 70~80%, mixing, regulating pH value with 0.05~0.2mol/l sodium hydroxide solution is 4.5~5.5, adds to the full amount of water for injection mixing;
3) fine straining, embedding;
4) sterilized 30 minutes down at 115 ℃.
6. preparation method as claimed in claim 5 is characterized in that step 2) afterwards, before the step 3), also comprise i) mensuration intermediate content.
7. preparation method as claimed in claim 5 is characterized in that, after the step 4), also comprises 5) lamp inspection.
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102078296A (en) * | 2010-12-22 | 2011-06-01 | 蚌埠丰原医药科技发展有限公司 | Reserpine fructose injection and preparation method thereof |
CN102440949A (en) * | 2010-10-09 | 2012-05-09 | 江苏正大丰海制药有限公司 | Preparation method of fructose injection |
CN104173281A (en) * | 2014-09-05 | 2014-12-03 | 河北一品制药有限公司 | Urapidil hydrochloride injection and preparation method thereof |
CN114652675A (en) * | 2020-12-23 | 2022-06-24 | 燃点(南京)生物医药科技有限公司 | Preparation method of urapidil hydrochloride injection |
CN115770215A (en) * | 2022-12-13 | 2023-03-10 | 南京正科医药股份有限公司 | Urapidil hydrochloride injection and preparation method thereof |
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2009
- 2009-11-25 CN CN200910224209A patent/CN101721360A/en active Pending
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102440949A (en) * | 2010-10-09 | 2012-05-09 | 江苏正大丰海制药有限公司 | Preparation method of fructose injection |
CN102440949B (en) * | 2010-10-09 | 2013-06-05 | 江苏正大丰海制药有限公司 | Preparation method of fructose injection |
CN102078296A (en) * | 2010-12-22 | 2011-06-01 | 蚌埠丰原医药科技发展有限公司 | Reserpine fructose injection and preparation method thereof |
CN104173281A (en) * | 2014-09-05 | 2014-12-03 | 河北一品制药有限公司 | Urapidil hydrochloride injection and preparation method thereof |
CN114652675A (en) * | 2020-12-23 | 2022-06-24 | 燃点(南京)生物医药科技有限公司 | Preparation method of urapidil hydrochloride injection |
CN115770215A (en) * | 2022-12-13 | 2023-03-10 | 南京正科医药股份有限公司 | Urapidil hydrochloride injection and preparation method thereof |
CN115770215B (en) * | 2022-12-13 | 2024-02-23 | 南京正科医药股份有限公司 | Urapidil hydrochloride injection and preparation method thereof |
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