CN101427999A - Frusemide oral solution and method of producing the same - Google Patents
Frusemide oral solution and method of producing the same Download PDFInfo
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- CN101427999A CN101427999A CNA2008102371392A CN200810237139A CN101427999A CN 101427999 A CN101427999 A CN 101427999A CN A2008102371392 A CNA2008102371392 A CN A2008102371392A CN 200810237139 A CN200810237139 A CN 200810237139A CN 101427999 A CN101427999 A CN 101427999A
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- frusemide
- purified water
- furosemide
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Abstract
The invention relates to frusemide oral solution and a preparation method thereof. The oral solution comprises 2 to 10 g of frusemide, 10 to 100 g of sorbierite, 100 to 200 g of propylene glycol, 1 to 20 g of sweetening agent and 0.5 to 3.0 g of sodium carbonate, the volume of which is fixed to 1,000 milliliters through purified water after dissolution; or, 2 to 10 g of frusemide, 10 to 100 g of sorbierite, 100 to 200 g of propylene glycol, 1 to 20 g of sweetening agent, 0.5 to 3.0 g of sodium carbonate and pigment and/or essence, the volume of which is fixed to 1,000 milliliters through purified water after dissolution. The oral solution has good taste and good compliance and is convenient for taking, and the dosage thereof can be accurately determined. The preparation method has the advantage of simple operation and dispenses with special equipment.
Description
Technical field
The invention belongs to medical technical field, particularly a kind of Frusemide oral solution and preparation method thereof.
Background technology
Furosemide has another name called furosemide, furosemide etc., is the crystalline powder of white or off-white color; Odorless, almost tasteless.Dissolve in acetone, absorptance is 565～595.Be mainly used in edema that treatment congestive heart failure, liver cirrhosis and kidney disease cause, hypertension etc. clinically.Furosemide is a high ceiling diuretic, and clinical other diuretic curative effects that can be used for are bad and be badly in need of the diuretic situation.All can use adult, child and baby.Furosemide belongs to potent quick-acting class diuretic, and its outstanding feature is that diuresis is powerful, rapid and of short duration, and oral back 30～60min begins onset, and 1～2h reaches the peak, continues 6～8h.
During clinical practice, furosemide needs to carry out dose titration according to its diuretic effect usually.When furosemide is used for children's, its dosage need calculate according to children's's kg body weight, and the Frusemide oral preparation is mainly the furosemide tablet in the market, can not make things convenient for and divided dose exactly, in addition, tablet has the shortcoming of poor compliance for children's, old man and the patient of tablet inconvenience that swallows.
Summary of the invention
The object of the present invention is to provide a kind of Frusemide oral solution, its good mouthfeel, taking convenience, compliance are good, accurately divided dose.
Another object of the present invention provides a kind of preparation method of Frusemide oral solution, and described method has simple to operate, need not the advantage of special installation.
Technical scheme of the present invention is as follows:
Frusemide oral solution is: furosemide 2～10 grams, sorbitol 10～100 grams, propylene glycol 100～200 grams, and sweeting agent 1～20 gram, sodium carbonate 0.5～3.0 gram, the dissolving back is settled to 1000 milliliters with purified water; Or furosemide 2～10 gram, sorbitol 10～100 grams, propylene glycol 100～200 grams, sweeting agent 1～20 gram, sodium carbonate 0.5～3.0 gram adds 1.0～2.0 milliliters in pigment 0.02～0.05 gram and/or essence, and the dissolving back is settled to 1000 milliliters with purified water.
Frusemide oral solution is preferably: furosemide 4～8 grams, sorbitol 30～50 grams, propylene glycol 100～150 grams, and sweeting agent 5～15 grams, sodium carbonate 1.0～2.0 grams, the dissolving back is settled to 1000 milliliters with purified water; Or furosemide 4～8 gram, sorbitol 30～50 grams, propylene glycol 100～150 grams, sweeting agent 5～15 grams, sodium carbonate 1.0～2.0 grams add 1.0～2.0 milliliters in pigment 0.02～0.05 gram and/or essence, and the dissolving back is settled to 1000 milliliters with purified water.
Described sweeting agent be in aspartame or sucralose or the cyclamate any one or multiple, wherein preferred cyclamate.
Described essence is fruity flavor, preferred water honey peach essence, and pigment is selected from pharmaceutically acceptable pigment, as sunset yellow etc.
The preferable prescription of Frusemide oral solution is: furosemide 4 grams, sorbitol 50 grams, propylene glycol 150 grams, and cyclamate 10 grams, sodium carbonate 2.0 grams, 2 milliliters in pigment sunset yellow 0.02 gram and honey peach essence, the dissolving back is settled to 1000 milliliters with purified water.
Prepare the method for Frusemide oral solution, following steps arranged:
(1) take by weighing above-mentioned formula ratio sodium carbonate, add the dissolving of an amount of purified water after, add the formula ratio furosemide, constantly stir and it dissolved fully;
(2) add formula ratio sorbitol, sweeting agent, propylene glycol in the above-mentioned solution, fully stirring dissolves it and mix homogeneously fully;
(3) add purified water and be settled to 1000 milliliters;
Behind (4) 0.22～1.0 μ m washing membrane filtration, obtain filtrate;
(5) according to the trimmed size fill filtrate of dispatching from the factory, promptly get described oral administration solution.
Furosemide is prepared into oral administration solution, and its dissolubility, mouthfeel and stability are key problem in technology of the present invention.Because furosemide is the crystalline powder of white or off-white color, and is insoluble in water.For solving its solubility problem, make the solution clarification that makes, the present invention adopts pH regulator agent such as sodium carbonate, potassium carbonate to regulate pH can make the solution clarification to alkalescence, and does not also see in put procedure and separate out phenomenon.Add propylene glycol in the oral liquid of the present invention, not only can increase the stability of furosemide in aqueous solution, and have the antiseptic and inhibiting bacteria function effect.
In described oral liquid, add an amount of correctives,, can obviously improve the mouthfeel of the furosemide solution that makes, be particularly suitable for the child and the old man takes as sweeting agent and/or aromatic (as: essence).
In addition,, further increase the compliance that children's and old man take medicine, in described oral administration solution, can add an amount of pigment for obtaining good product appearance.
The beneficial effect of Frusemide oral solution of the present invention is, good mouthfeel, steady quality are arranged, because liquid dosage form can accurately be calculated dose, be convenient to during application take and dosage administration exactly, thereby when guaranteeing curative effect of medication, reduce generation because of the inaccurate untoward reaction that may cause of dosage.
The preparation method of oral administration solution of the present invention is simple to operate, need not sterilization steps, need not special installation, and manufacturing cycle is short, and cost is lower.
The specific embodiment
Following embodiment is used for explanation and further explains the present invention, but never limits the present invention.
Reagent of the present invention all is commercially available reagent, and wherein, furosemide is a crude drug; Sorbitol, propylene glycol, cyclamate, sucralose, aspartame, sodium carbonate all adopt pharmaceutical grade; Honey peach essence, sunset yellow, flavoring pineapple essence are food stage.
Employing is according to " the purified water of the standard fabrication of two purified water of Chinese pharmacopoeia version in 2005.
Explanation of nouns:
Related substance: the related substance in the medicine is made a general reference process contaminants or the catabolite that produces in the production of medicine and storage process, may be known or unknown, volatile or fixedness.Because its chemical constitution is general and active component is similar or tool origin relation, so be referred to as related substance.
Limit test of microbe: microbial limit test system non-regulation sterilization preparation of inspection and raw material thereof, adjuvant are subjected to the microbial contamination degree methods.Inspection item comprises bacterial population, fungi count, yeast count and the inspection of control bacterium.
Indicate content: content of drug is meant the amount that contains active ingredient in the medicine, generally represents with the percentage ratio of its labelled amount, is referred to as to indicate content.
One. embodiment
Embodiment 1 Frusemide oral solution prescription 1 sees Table 1:
Table 1
Furosemide 4g
Sorbitol 50g
Propylene glycol 150g
Cyclamate 10g
Sodium carbonate 2.0g
Sunset yellow 0.02g
Honey peach essence 2ml
Purified water is to 1000ml
Take by weighing the formula ratio sodium carbonate, add the dissolving of an amount of purified water after, add the formula ratio furosemide, constantly stir and it dissolved fully; Add formula ratio sorbitol, cyclamate, propylene glycol, sunset yellow and honey peach essence again, fully stir and make fully also mix homogeneously of its dissolving, add purified water and be settled to 1000ml, 0.8 behind the μ m washing membrane filtration, obtain filtrate, trimmed size fill filtrate according to dispatching from the factory promptly gets described oral liquid.
Embodiment 2 Frusemide oral solutions prescription 2 sees Table 2:
Table 2
Furosemide 2g
Sorbitol 10g
Propylene glycol 100g
Sucralose 1g
Sodium carbonate 1.0g
Purified water is to 1000ml
Take by weighing the formula ratio sodium carbonate, add the dissolving of an amount of purified water after, add the formula ratio furosemide, constantly stir and it dissolved fully; Add formula ratio sorbitol, sucralose, propylene glycol again, fully stir and make fully also mix homogeneously of its dissolving, add purified water and be settled to 1000ml, 0.45 behind the μ m washing membrane filtration, obtain filtrate, the trimmed size fill filtrate according to dispatching from the factory promptly gets described oral liquid.
Embodiment 3 Frusemide oral solutions prescription 3 sees Table 3:
Table 3
Furosemide 10g
Sorbitol 100g
Propylene glycol 200g
Cyclamate 15g
Sodium carbonate 3.0g
Flavoring pineapple essence 2ml
Purified water is to 1000ml
Take by weighing the formula ratio sodium carbonate, add the dissolving of an amount of purified water after, add the formula ratio furosemide, constantly stir and it dissolved fully; Add formula ratio sorbitol, cyclamate, propylene glycol and flavoring pineapple essence again, fully stir and make fully also mix homogeneously of its dissolving, add purified water and be settled to 1000ml, 1.0 behind the μ m washing membrane filtration, obtain filtrate, the trimmed size fill filtrate according to dispatching from the factory promptly gets described oral liquid.
Embodiment 4 Frusemide oral solutions prescription 4 sees Table 4:
Table 4
Furosemide 8g
Sorbitol 100g
Propylene glycol 100g
Aspartame 2g
Sodium carbonate 2.5g
Purified water is to 1000ml
Take by weighing the formula ratio sodium carbonate, add the dissolving of an amount of purified water after, add the formula ratio furosemide, constantly stir and it dissolved fully; Add formula ratio sorbitol, aspartame, propylene glycol again, fully stir and make fully also mix homogeneously of its dissolving, add purified water and be settled to 1000ml, 0.8 behind the μ m washing membrane filtration, obtain filtrate, the trimmed size fill filtrate according to dispatching from the factory promptly gets described oral liquid.。
Two. 6 months accelerated tests of Frusemide oral solution
The prepared Frusemide oral solution sample of embodiment 1-4 is through 6 months accelerated tests, institute's mass metering index and relatively do not have significant change in 0 month.The result sees table 5 for details:
Table 5 Frusemide oral solution accelerated stability test result
Conclusion: Frusemide oral solution good mouthfeel of the present invention, steady quality.
Though; the present invention is clearly demonstrated by above embodiment; yet under the situation that does not deviate from spirit of the present invention and essence thereof; the person of ordinary skill in the field works as can make various corresponding variations and correction according to the present invention, but these corresponding variations and correction all should belong to the protection domain of claim of the present invention.
Claims (6)
1. Frusemide oral solution is characterized in that described oral administration solution is: furosemide 2～10 grams, sorbitol 10～100 grams, propylene glycol 100～200 grams, and sweeting agent 1～20 gram, sodium carbonate 0.5～3.0 gram, the dissolving back is settled to 1000 milliliters with purified water; Perhaps, furosemide 2～10 grams, sorbitol 10～100 grams, propylene glycol 100～200 grams, sweeting agent 1～20 gram, sodium carbonate 0.5～3.0 gram adds pigment and/or essence, wherein pigment 0.02～0.05 gram, 1.0～2.0 milliliters in essence, the dissolving back is settled to 1000 milliliters with purified water.
2. Frusemide oral solution according to claim 1, it is characterized in that described oral administration solution is: furosemide 4～8 grams, sorbitol 30～50 grams, propylene glycol 100～150 grams, sweeting agent 5～15 grams, sodium carbonate 1.0～2.0 grams, the dissolving back is settled to 1000 milliliters with purified water; Perhaps, furosemide 4～8 grams, sorbitol 30～50 grams, propylene glycol 100～150 grams, sweeting agent 5～15 grams, sodium carbonate 1.0～2.0 grams add pigment and/or essence, wherein pigment 0.02～0.05 gram, 1.0～2.0 milliliters in essence, the dissolving back is settled to 1000 milliliters with purified water.
3. Frusemide oral solution according to claim 1 and 2 is characterized in that: described sweeting agent be in aspartame or sucralose or the cyclamate any one or multiple.
4. Frusemide oral solution according to claim 1 and 2 is characterized in that: described essence is honey peach essence, and pigment is a sunset yellow.
5 Frusemide oral solutions according to claim 1 and 2, it is characterized in that described oral administration solution is: furosemide 4 grams, sorbitol 50 grams, propylene glycol 150 grams, cyclamate 10 grams, sodium carbonate 2.0 grams, 2.0 milliliters in pigment sunset yellow 0.02 gram and honey peach essence, the dissolving back is settled to 1000 milliliters with purified water.
6. the method for preparing the arbitrary described Frusemide oral solution of claim 1-5 is characterized in that following steps are arranged:
(1) take by weighing above-mentioned formula ratio sodium carbonate, add the dissolving of an amount of purified water after, add the formula ratio furosemide, constantly stir and it dissolved fully;
(2) add formula ratio sorbitol, sweeting agent, propylene glycol in the above-mentioned solution, fully stirring dissolves it and mix homogeneously fully;
(3) add purified water and be settled to 1000 milliliters;
After the aseptic filtration of (4) 0.22～1.0 μ m washing filter membrane, obtain filtrate;
(5) according to the specification fill filtrate of the finished product that dispatches from the factory, promptly get described oral administration solution.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2008102371392A CN101427999B (en) | 2008-12-19 | 2008-12-19 | Frusemide oral solution and method of producing the same |
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| CN2008102371392A CN101427999B (en) | 2008-12-19 | 2008-12-19 | Frusemide oral solution and method of producing the same |
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| CN101427999A true CN101427999A (en) | 2009-05-13 |
| CN101427999B CN101427999B (en) | 2010-11-10 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111467305A (en) * | 2020-05-13 | 2020-07-31 | 健民药业集团股份有限公司 | Furosemide oral solution and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111467305A (en) * | 2020-05-13 | 2020-07-31 | 健民药业集团股份有限公司 | Furosemide oral solution and preparation method thereof |
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