CN102274166A - Medicinal composition containing ornithine aspartate - Google Patents
Medicinal composition containing ornithine aspartate Download PDFInfo
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- CN102274166A CN102274166A CN2011101949246A CN201110194924A CN102274166A CN 102274166 A CN102274166 A CN 102274166A CN 2011101949246 A CN2011101949246 A CN 2011101949246A CN 201110194924 A CN201110194924 A CN 201110194924A CN 102274166 A CN102274166 A CN 102274166A
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- acid
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- ornithine
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Abstract
The invention discloses a medicinal composition containing ornithine aspartate, which contains ornithine aspartate and pharmaceutically acceptable carrier auxiliary materials which can not increase the blood sugar, and does not contain bacteriostat or preservative. The medicinal composition containing ornithine aspartate can be made into granules, tablets, oral liquids, capsules, suspensions and powder by pharmaceutical technical means. The medicinal composition containing ornithine aspartate can be used for treating hyperammonemia caused by acute and chronic liver diseases, such as hepatocirrhosis, fatty liver and hepatitis, or treating early mental disorder or nervous system complications, or treating jaundice of newborn.
Description
Technical field
The present invention relates to contain the pharmaceutical composition of aspartic acid ornithine, belong to technical field of medicine, being specifically related to can be for the oral aspartic acid ornithine composition that contains, and containing does not increase the pharmaceutical acceptable carrier of blood glucose value adjuvant, does not contain the pharmaceutical composition of antibacterial or antiseptic.
Background technology
Hepatopathys such as viral hepatitis, fatty liver, alcoholic liver, hepatocarcinoma have become one of principal disease of current society threat human health in recent years, just have one to be the hepatopath in per 12 people of China.Secretion of insulin, metabolism all can occur unusually when medical research confirmed chronic hepatopathy, liver cirrhosis, and along with the deterioration of liver function develops gradually, main experience following several stages: the synthetic zero defect still of early insulin secretion, this moment is mainly because of the minimizing of hepatocyte quantity, hypofunction and the shunting of door-caval vein, liver picked-up and deactivation impaired insulin action, most of patient's insulin level increases, but because of insulin resistance material level also increases, so it is roughly normal to keep carbohydrate tolerance; Along with the state of an illness further develops, insulin resistant occurs and increases the weight of gradually, and beta Cell of islet can not the enough insulin secretions of corresponding increase.So insulin secretion lacks relatively, impaired glucose tolerance occurs; Secular beta Cell of islet compensatory secretion increases, and causes its nonfunction, and insulin secretion is definitely not enough, finally develops into hepatogenous diabetes.The hepatopathy complication with diabetes is the performance of a cause of disease two systems, is again two links of chain type vicious cycle.
Liver is the vitals of glucose metabolism, and the liver function impairment that a variety of causes causes all might cause the glucose metabolism disorder, impaired glucose tolerance even diabetes occur.As far back as 1906, just there is scholar's research to find that diabetes and hepatic lesions are in close relations.According to statistics, have 80% chronic hepatitis patients to have impaired glucose tolerance approximately, wherein about 35% finally develops into diabetes, and normal population onset diabetes rate only is about 10%.China's hepatogenous diabetes is secondary to chronic hepatitis, liver cirrhosis more; And in American-European developed country, non-ethanol fatty liver, ethanol liver cirrhosis, chronic hepatitis C infection etc. are than common cause.Have quite a few people to follow diabetes or impaired glucose tolerance clinically among the hepatopath, so the hepatopath that sacchariferous hepatic lesions medicine is combined diabetes is totally unfavorable.
Hepatic lesions can cause that simultaneously blood ammonia raises except that causing abnormal carbohydrate metabolism, blood ammonia absorbs and derives from intestinal product ammonia, during the liver function obstacle, digestive function is reduced, cause the intestinal bacteria function active, the aminoacid that produces in the intestinal increases, and makes blood ammonia raise; On the other hand during hepatic lesions, supply with the ATP deficiency of ornithine cycle and the enzyme system of ornithine cycle and be badly damaged to wait all to cause by the blood ammonia urea synthesis and reduce, ammonia is removed not enough, causes the blood ammonia rising.Known at present, various hepatitis, liver cirrhosis, fatty liver, syndrome can cause that all blood ammonia raises after the hepatitis, and blood ammonia raises can influence central nervous system function, and main clinical manifestation is disturbance of consciousness, behavioral disorder and stupor, therefore the hepatopath is except that needing strict control blood ammonia levels targetedly to the liver disease therapy.
(chemical name is (S)-2 to aspartic acid ornithine, 5-diaminovaleric acid (s)-2-aminosuccinic acid salt), be used for clinical the seventies in 20th century in Germany, recorded Deutscher Arzneibucs in 1991, import listing at home in 2000, domestic manufacturer produced listing in 2006, was used for the treatment of the hyperammonemia that hepatic lesions causes, aspartic acid ornithine can be supplied urea and the synthetic substrate of glutamine in vivo.Glutamine is the detoxifcation product of ammonia, also is the storage and the types of transportation of ammonia simultaneously.Under physiology and pathological conditions, the synthetic meeting synthetic and glutamine of carbamide is subjected to the influence of ornithine, Aspartic Acid and other dicarboxylic compounds.Ornithine almost relates to the activation of ornithine cycle and the antidotal overall process of ammonia.In this process, form arginine, isolate carbamide then and form ornithine.Aspartic Acid participates in the synthetic of the interior nucleic acid of hepatocyte, is beneficial to repair the hepatocyte that is damaged.In addition,, be beneficial to the hepatocellular reparation of damage, accelerate the recovery of liver function because Aspartic Acid, has promoted that the energy in the hepatocyte is synthetic to the indirect facilitation of tricarboxylic acid cycle metabolic process in the hepatocyte.Therefore, aspartic acid ornithine is applicable to that clinically acute and chronic hepatopathy comprises liver cirrhosis, fatty liver, various viral and toxic hepatitis and hyperammonemia, particularly because of the improvement of the caused central nervous system's symptom of hepatic disease and the treatment of hepatic encephalopathy.Its determined curative effect, untoward reaction is less, is the clinical main medication of the hyperammonemia that causes of treatment hepatic lesions.
Be well known that at present, the clinical employed pharmaceutical preparation that contains the aspartic acid ornithine composition, aspartic acid ornithine granule, powder ampoule agent for injection and 3 kinds of preparation formulations of injection are arranged, (specification: 3g) preparation with respect to injection administration has easy to use oral granular formulation, do not have advantages such as injection misery, more be adapted to realize the clear patient that can independently take medicine at hospital's medicine for external use.After testing, the aspartic acid ornithine oral drug preparation that has gone on the market at present can make blood glucose value raise for containing sugared preparation, does not see public use or open report relevant for aspartic acid ornithine sugar-free oral formulations so far both at home and abroad as yet.
Clinical see the hepatopath who follows diabetes more, contain sugared aspartic acid ornithine oral formulations the patient is had harmful effect, limited the hepatopath that follows diabetes use aspartic acid ornithine.Therefore, need to solve the problem that exists, selecting does not increase the pharmaceutical composition that blood glucose value pharmaceutical acceptable carrier or excipient and aspartic acid ornithine are made does not increase blood glucose value, makes its broader applications in the hepatopath.
At present, the nutritional factors of microorganism has six kinds, promptly is carbon source, nitrogenous source, the energy, somatomedin, inorganic salt and water.The nitrogenous source spectrum of microorganism has many characteristics.Microorganism is that " NCHO " or " NCHOX " class is better than " NH " class to the order of nitrogenous source utilization, more is better than " NO " class.Though the carbon source of microorganism spectrum is very wide, concerning microorganism, its suitableeest carbon source is " CHO " type, aldehydes, organic acid and lipid relatively, saccharide be the most extensive also be the carbon source of the easiest utilization.The reason that most aminoacid oral formulations majorities all add antiseptic or antibacterial in the existing market that Here it is.Aspartic acid ornithine is the complex salt that Aspartic Acid and ornithine form, and from well " NCHO " source is provided as microbial growth, thus, aspartic acid ornithine contains sugar composite and compares easier nourishing microorganism with no sugar composite.Be warrantor's body and function medicine safety, pharmaceutical preparation needs microbial limit level in the strict control preparation, and should reduce even avoid using antiseptic or antibacterial.
Summary of the invention
Ideal pharmaceutical preparation need possess the characteristics of triple effect (efficient, quick-acting, long-acting), three little (dosage is little, toxicity is little, side effect little), five convenience (produce, transport, use, carry, preserve conveniently).
Purpose of the present invention is to select not increase the pharmaceutically acceptable carrier adjuvant of blood glucose value, adopt the pharmaceutical technology means to be made into oral formulations, enlarge the adaptation population, make the hepatopath who follows diabetes be fit to use this product, aspartic acid ornithine sugar-free pharmaceutical compositions, compare with present known technology have substantial different.
Another object of the present invention is after aspartic acid ornithine is made the pharmaceutical composition that does not increase blood glucose value, can reduce the risk that microorganism is nourished, need not to add antibacterial or antiseptic, the long-term stability that can satisfy preparation stores, avoid the harmful effect of antibacterial or antiseptic to human body, more help the stable and quality control of product, this compares the progress with significance with present known technology.Contain the citric acid component in the pharmaceutical composition of the present invention and more help the stable of aspartic acid ornithine composition, make compositions possess good stable, help ensuring drug quality.
The present invention selects not increase the pharmaceutical acceptable carrier adjuvant of blood glucose value from the compliance of patient's medication, adopts the preparation of pharmaceutical technology means to contain the pharmaceutical composition of aspartic acid ornithine.
The pharmaceutical acceptable carrier adjuvant that does not increase blood glucose value of the present invention, be meant oral enter human body after, do not changed into glucose and cause and be converted and utilize the material that does not need insulin to participate in after blood sugar increasing or the absorption of human body by body metabolism.
The pharmaceutical composition that contains aspartic acid ornithine of the present invention adopts suitable pharmaceutical technology means can make granule, tablet, solution, capsule, powder.According to material properties, usage and dosage, production cost and according to patient's medication compliance, preferred particulates agent.
The pharmaceutical acceptable carrier that does not increase blood glucose value of the present invention mainly comprises excipient, PH regulator, stabilizing agent, correctives, binding agent, wetting agent, lubricant.Preferred water solubleness carrier adjuvant in practical operation.
The acceptable excipient of pharmacy that does not increase blood glucose value of the present invention can be cellulose derivatives such as mannitol, microcrystalline Cellulose; Silicate derivatives such as calcium silicates, aluminosilicate magnesium; Phosphate such as calcium hydrogen phosphate; Alginate; Carbonate such as calcium carbonate; Wherein one or more combinations of mineral-type excipient such as sulfate such as calcium sulfate, preferred mannitol.
The acceptable PH regulator of pharmacy that does not increase blood glucose value of the present invention can be wherein one or more combinations such as citric acid, malic acid, tartaric acid, fumaric acid, preferably citric acid.
The acceptable stabilizing agent of pharmacy that does not increase blood glucose value of the present invention can be wherein one or more combinations such as citric acid, malic acid, anhydrous sodium sulfite, sodium sulfite, sodium pyrosulfite, vitamin C, preferably citric acid.
The acceptable correctives of pharmacy that does not increase blood glucose value of the present invention can be wherein one or more the combination of steviosin, sodium cyclamate, Herba Hedyotis cantonensis acid, aspartame, amino sugar, xylitol, Sorbitol, erythritol, preferred steviosin.
The acceptable binding agent of pharmacy that does not increase blood glucose value of the present invention can be one or more the combination in hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvidone, sodium carboxymethyl cellulose, arabic gum and the above-mentioned material that has adhesive effect concurrently, and use preferred 30 POVIDONE K 30 BP/USP 30 after making aqueous solution.
The acceptable lubricant of pharmacy that does not increase blood glucose value of the present invention can be Metallic stearates such as stearic acid, calcium stearate, magnesium stearate; Pulvis Talci; Wax classes such as Cera Flava; Boric acid; Adipic acid; Sulfate such as sodium sulfate; Ethylene glycol; Fumaric acid; Lauryl sulfates such as sodium lauryl sulfate; Wherein one or more combinations such as silicic acid class, silicon dioxide such as hydrate of silicic acid, preferred magnesium stearate.
Aspartic acid ornithine used in the present invention can obtain through chemical synthesis process by Aspartic Acid and ornithine, and its content is no less than 99.0% in dry product.
The pharmaceutical composition that contains aspartic acid ornithine of the present invention can adopt high performance liquid chromatography to detect wherein aspartic acid ornithine content, need not to use 2 in the testing process, hypertoxic derivatization reagent such as 4-dinitrofluorobenzene, method for monitoring and analyzing is more easy, and operational approach is as follows:
(4.6mm * 250mm, 5 μ m) are detached dowel with the amino bonded silica gel chromatographic column; With 0.05mol/L potassium dihydrogen phosphate-acetonitrile (60:40) is mobile phase; The detection wavelength is 200nm, and flow velocity is 1ml/min.Number of theoretical plate calculates by Aspartic Acid should be not less than 3000, and the separating degree at ornithine peak and Aspartic Acid peak should meet the requirements.
Algoscopy: it is an amount of that precision is measured this product, makes the solution that every 1ml contains aspartic acid ornithine 1mg approximately with the dilution of 50% acetonitrile solution, and as need testing solution, precision is measured need testing solution 10 μ L, injects chromatograph of liquid, the record chromatogram; Precision takes by weighing the aspartic acid ornithine reference substance in addition, measures with method, calculates by external standard method with Aspartic Acid and ornithine peak area summation, promptly.
The pharmaceutical composition that contains aspartic acid ornithine of the present invention can be tested by prescription screening, stability with taste, granularity, angle of repose, aspartic acid ornithine influence factor test is evaluation index, determine that each composition parts by weight is in the compositions, aspartic acid ornithine 10%-99.5%, mannitol 0-60%, citric acid 0.1%-5%, steviosin 0.1%-5%, 30 POVIDONE K 30 BP/USP 30 0-3%, magnesium stearate 0-2%.
But the invention provides the pharmaceutical composition that contains aspartic acid ornithine of industrialization, have following advantage:
The pharmaceutical composition that contains aspartic acid ornithine of the present invention, be with aspartic acid ornithine composition and the pharmaceutical acceptable carrier adjuvant that does not increase blood glucose value, adopt the pharmaceutical technology means make can be for oral administration pharmaceutical preparation, can be used for treating because of the hyperammonemia due to acute and chronic hepatopathy such as liver cirrhosis, fatty liver, the hepatitis, be fit to treatment early stage consciousness imbalance or neurological complication, be particularly suitable for above-mentioned disease and follow the patient of diabetes, enlarge the adaptation population, reduced untoward reaction.
The pharmaceutical composition that contains aspartic acid ornithine of the present invention, bacteriostatic agent or antiseptic more do not help warrantor's body and function medicine safety.
The pharmaceutical composition that contains aspartic acid ornithine of the present invention prepares granule according to embodiment 4 methods, and according to the method inspection down of two appendix I of Pharmacopoeia of the People's Republic of China N granule [granularity] item, this product granularity is 4.5%, and preparations shaping is good; Adopting the fixed funnel method to measure angle of repose is 21.4 °, and this product is better mobile, need not to add lubricant, and production cost is low.
The pharmaceutical composition that contains aspartic acid ornithine of the present invention, the citric acid that it contained not only plays the PH modulator effect, also has stabilizing agent and correctives effect concurrently.
Utilize hot test and exposure experiments to light relatively to contain citric acid component and the stability that does not contain the compositions of citric acid component, after carrying out 60 ℃ of high temperature and 4500LX ± 500 illumination processing in 10 days respectively, measure the aspartic acid ornithine composition in the compositions, the compositions that contains the citric acid component is more stable to light, heat, does not contain the compositions instability of citric acid component.When not containing the citric acid component, hot test is the result show, aspartic acid ornithine content descends 5.4%, and exposure experiments to light is the result show, aspartic acid ornithine content descends 8.3%, so contains the citric acid component in the compositions and more help stable components.
The specific embodiment
Below, the present invention is described in more detail, but the present invention is not limited only to these embodiment by specific embodiment.
Embodiment 1
[prescription]
[method for making]
Get aspartic acid ornithine, add recipe quantity citric acid, steviosin mixing, with 5% 30 POVIDONE K 30 BP/USP, 30 aqueous solution 300ml, stir, 16 orders are granulated, drying, and 14 order granulate, promptly.
[specification] 3g
[usage and dosage] every day 1-3 time, each 1 bag.
Resulting composition granule of the present invention is a white particle, be used for the treatment of because of the hyperammonemia due to acute and chronic hepatopathy such as liver cirrhosis, fatty liver, the hepatitis, be fit to treatment early stage consciousness imbalance or neurological complication, be particularly suitable for above-mentioned disease and follow the patient of diabetes.
Embodiment 2
[prescription]
[method for making]
Get aspartic acid ornithine, add recipe quantity mannitol, citric acid, steviosin mixing, with 5% 30 POVIDONE K 30 BP/USP, 30 aqueous solution 300ml, stir, 16 orders are granulated, drying, and 14 order granulate, promptly.
[specification] 3g
[usage and dosage] every day 1-3 time, each 1 bag.
Resulting composition granule of the present invention is a white particle, be used for the treatment of because of the hyperammonemia due to acute and chronic hepatopathy such as liver cirrhosis, fatty liver, the hepatitis, be fit to treatment early stage consciousness imbalance or neurological complication, be particularly suitable for above-mentioned disease and follow the patient of diabetes.
Embodiment 3
[prescription]
[method for making]
Get aspartic acid ornithine, add recipe quantity mannitol, citric acid, steviosin mixing, with 5% 30 POVIDONE K 30 BP/USP, 30 aqueous solution 1200ml, stir, 16 orders are granulated, drying, and 14 order granulate, promptly.
[specification] 3g
[usage and dosage] every day 1-3 time, each 1 bag.
Resulting composition granule of the present invention is a white particle, be used for the treatment of because of the hyperammonemia due to acute and chronic hepatopathy such as liver cirrhosis, fatty liver, the hepatitis, be fit to treatment early stage consciousness imbalance or neurological complication, be particularly suitable for above-mentioned disease and follow the patient of diabetes.
Embodiment 4
[prescription]
[method for making]
Get aspartic acid ornithine, add recipe quantity mannitol, citric acid, steviosin mixing, with 15% 30 POVIDONE K 30 BP/USP, 30 aqueous solution 500ml, stir, 16 orders are granulated, drying, and 14 order granulate, promptly.
[specification] 3g
[usage and dosage] every day 1-3 time, each 1 bag.
Resulting composition granule of the present invention is a white particle, be used for the treatment of because of the hyperammonemia due to acute and chronic hepatopathy such as liver cirrhosis, fatty liver, the hepatitis, be fit to treatment early stage consciousness imbalance or neurological complication, be particularly suitable for above-mentioned disease and follow the patient of diabetes.
Embodiment 5
[prescription]
[method for making]
Get aspartic acid ornithine, add recipe quantity mannitol, citric acid, steviosin mixing, with 15% 30 POVIDONE K 30 BP/USP, 30 aqueous solution 500ml, stir, 16 orders are granulated, drying, and 14 order granulate, promptly.
[specification] 3g
[usage and dosage] every day 1-3 time, each 1 bag.
Resulting composition granule of the present invention is a white particle, be used for the treatment of because of the hyperammonemia due to acute and chronic hepatopathy such as liver cirrhosis, fatty liver, the hepatitis, be fit to treatment early stage consciousness imbalance or neurological complication, be particularly suitable for above-mentioned disease and follow the patient of diabetes.
Embodiment 6
[prescription]
[method for making]
Get aspartic acid ornithine, add recipe quantity mannitol, citric acid, steviosin mixing, with 25% 30 POVIDONE K 30 BP/USP, 30 aqueous solution 420ml, stir, 16 orders are granulated, drying, and 14 order granulate, promptly.
[specification] 3g
[usage and dosage] every day 1-3 time, each 1 bag.
Resulting composition granule of the present invention is a white particle, be used for the treatment of because of the hyperammonemia due to acute and chronic hepatopathy such as liver cirrhosis, fatty liver, the hepatitis, be fit to treatment early stage consciousness imbalance or neurological complication, be particularly suitable for above-mentioned disease and follow the patient of diabetes.
Embodiment 7
[prescription]
[method for making]
Get aspartic acid ornithine, add recipe quantity mannitol, citric acid, steviosin mixing, with 20% 30 POVIDONE K 30 BP/USP, 30 aqueous solution 1000ml, stir, 16 orders are granulated, drying, and 14 order granulate, promptly.
[specification] 3g
[usage and dosage] every day 1-3 time, each 1 bag.
Resulting composition granule of the present invention is a white particle, be used for the treatment of because of the hyperammonemia due to acute and chronic hepatopathy such as liver cirrhosis, fatty liver, the hepatitis, be fit to treatment early stage consciousness imbalance or neurological complication, be particularly suitable for above-mentioned disease and follow the patient of diabetes.
Embodiment 8
[prescription]
[method for making]
Get aspartic acid ornithine, add recipe quantity mannitol, citric acid, steviosin, cross 80 mesh sieves, mix homogeneously is with 15% 30 POVIDONE K 30 BP/USP, 30 aqueous solution 100ml, stir, 24 orders are granulated, drying, 20 order granulate, add the recipe quantity magnesium stearate, mixing, tabletting, promptly.
[specification] 0.75g
[usage and dosage] every day 1-3 time, each 2-4 sheet.
Resulting composition tablet of the present invention is white tablet, do not contain disintegrating agent, good water solubility, but buccal, take after water-soluble, warm water takes or chew and take, be used for the treatment of because of the hyperammonemia due to acute and chronic hepatopathy such as liver cirrhosis, fatty liver, the hepatitis, be fit to treatment early stage consciousness imbalance or neurological complication, be particularly suitable for above-mentioned disease and follow the patient of diabetes.
Embodiment 9
[prescription]
[method for making]
Get aspartic acid ornithine, add recipe quantity mannitol, citric acid, steviosin, cross 80 mesh sieves, mix homogeneously is with 15% 30 POVIDONE K 30 BP/USP, 30 aqueous solution 75ml, stir, 24 orders are granulated, drying, 20 order granulate, add the recipe quantity magnesium stearate, mixing, No. 0 capsule is filled, promptly.
[specification] 0.5g
[usage and dosage] every day 1-3 times, each 2-6.
Resulting composition of the present invention is a capsule, content is a white particle, this product does not contain disintegrating agent, take with warm water, easy to use, be used for the treatment of because of the hyperammonemia due to acute and chronic hepatopathy such as liver cirrhosis, fatty liver, the hepatitis, be fit to treatment early stage consciousness imbalance or neurological complication, be particularly suitable for above-mentioned disease and follow the patient of diabetes.
Embodiment 10
[prescription]
[method for making]
Get aspartic acid ornithine, add recipe quantity mannitol, citric acid, steviosin, pulverize, cross 100 mesh sieves, mix homogeneously, packing, promptly.
[specification] 3g
[usage and dosage] every day 1-3 times, each 1 bag.
Resulting composition of the present invention is a powder, be white powder, take with warm water, or take after water-soluble, easy to use, be used for the treatment of because of the hyperammonemia due to acute and chronic hepatopathy such as liver cirrhosis, fatty liver, the hepatitis, be fit to treatment early stage consciousness imbalance or neurological complication, be particularly suitable for above-mentioned disease and follow the patient of diabetes.
Embodiment 11
[prescription]
[method for making]
Get aspartic acid ornithine, be dissolved in 10 premium on currency, adding recipe quantity mannitol, citric acid, steviosin stir and make dissolving, filter, with the brown oral liquid bottle fill of 10ml, jump a queue, and gland, promptly.
[specification] 3g
[usage and dosage] every day 1-3 time, each 1 bottle.
Resulting composition oral solution of the present invention is a colourless transparent liquid, be used for the treatment of because of the hyperammonemia due to acute and chronic hepatopathy such as liver cirrhosis, fatty liver, the hepatitis, be fit to treatment early stage consciousness imbalance or neurological complication, be particularly suitable for above-mentioned disease and follow the patient of diabetes.
Claims (10)
1. the pharmaceutical composition that contains aspartic acid ornithine, it is characterized in that containing the aspartic acid ornithine parts by weight is 10%-99.5%, containing does not increase the pharmaceutical acceptable carrier of blood glucose value adjuvant, and do not contain antibacterial or antiseptic, adopt the pharmaceutical technology means to can be made into granule, tablet, oral administration solution, capsule, suspensoid, powder, be used for the treatment of because of the hyperammonemia due to acute and chronic hepatopathy such as liver cirrhosis, fatty liver, the hepatitis, or be used for the treatment of early stage consciousness imbalance or neurological complication, or be used for the treatment of neonatal jaundice disease.
2. pharmaceutical composition according to claim 1, it is characterized in that the pharmaceutical acceptable carrier adjuvant that does not increase blood glucose value that is contained be meant oral enter human body after, do not changed into glucose and cause to be converted or to utilize after blood sugar increasing or the absorption of human body and do not need insulin to participate in, be selected from one or more the combination in the acceptable excipient of pharmacy, PH regulator, stabilizing agent, correctives, binding agent, the lubricant by body metabolism.
3. the acceptable excipient of pharmacy that does not increase blood glucose value according to claim 2, be selected from wherein one or more combinations of sulfate such as carbonate such as phosphate such as silicate derivative, calcium hydrogen phosphate, calcium carbonate, calcium sulfate such as cellulose derivatives such as mannitol, microcrystalline Cellulose, alginate and calcium silicates, aluminosilicate magnesium, the more excellent mannitol that selects.
4. the acceptable PH regulator of pharmacy that does not increase blood glucose value according to claim 2 is selected from wherein one or more the combination of citric acid, malic acid, tartaric acid, fumaric acid, the more excellent citric acid that selects.
5. the acceptable stabilizing agent of pharmacy that does not increase blood glucose value according to claim 2 is selected from wherein one or more combinations such as citric acid, malic acid, anhydrous sodium sulfite, sodium sulfite, sodium pyrosulfite, vitamin C, the more excellent citric acid that selects.
6. the acceptable correctives of pharmacy that does not increase blood glucose value according to claim 2, be selected from wherein one or more the combination of steviosin, sodium cyclamate, Herba Hedyotis cantonensis acid, aspartame, amino sugar, xylitol, Sorbitol, erythritol, the more excellent steviosin that selects.
7. the acceptable binding agent of pharmacy that does not increase blood glucose value according to claim 2, be selected from one or more the combination in hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvidone, sodium carboxymethyl cellulose, arabic gum and the above-mentioned material that has adhesive effect concurrently, and use more excellent 30 POVIDONE K 30 BP/USP 30 aqueous solutions that select after making aqueous solution.
8. the acceptable lubricant of pharmacy that does not increase blood glucose value according to claim 2, be selected from wherein one or more combinations of silicic acid class, silicon dioxide such as lauryl sulfates such as sulfate such as Metallic stearates such as stearic acid, calcium stearate, magnesium stearate, Pulvis Talci, boric acid, adipic acid, sodium sulfate, ethylene glycol, fumaric acid, sodium lauryl sulfate, hydrate of silicic acid, the more excellent magnesium stearate of selecting.
9. pharmaceutical composition according to claim 1, the parts by weight that it is characterized in that each component are aspartic acid ornithine 10%-99.5%, mannitol 0-60%, citric acid 0.1%-5%, steviosin 0.1%-5%, 30 POVIDONE K 30 BP/USP
300-3%, magnesium stearate 0-2%.
10. pharmaceutical composition according to claim 1, the parts by weight that it is characterized in that each component are aspartic acid ornithine 60%, mannitol 30%, citric acid 6%, steviosin 2%, 30 POVIDONE K 30 BP/USP
302%.
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| CN103239434A (en) * | 2012-12-26 | 2013-08-14 | 辽宁亿灵科创生物医药科技有限公司 | Ornithine aspartate composition |
| CN103860517A (en) * | 2012-12-18 | 2014-06-18 | 北大方正集团有限公司 | Ornithine aspartate effervescent tablets and preparing process thereof |
| CN104721808A (en) * | 2014-05-13 | 2015-06-24 | 北京京卫信康医药科技发展有限公司 | Pharmaceutical composition for treating neonatal jaundice |
| CN107573404A (en) * | 2017-09-22 | 2018-01-12 | 南京优科生物医药研究有限公司 | The active salt of the dipeptide compound of ornithine and L-aminobutanedioic acid and its application |
| CN110314132A (en) * | 2018-03-28 | 2019-10-11 | 上海贵之言医药科技有限公司 | A kind of ornithine aspartate injection and preparation method thereof |
| RU2734417C2 (en) * | 2015-07-24 | 2020-10-16 | Эвоник Оперейшенс ГмбХ | Fizzy compositions based on ornithine aspartate |
| EP3795650A4 (en) * | 2018-08-31 | 2022-02-23 | CJ Cheiljedang Corporation | Adhesive composition, and method for preparing same |
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2011
- 2011-07-13 CN CN2011101949246A patent/CN102274166A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103860517A (en) * | 2012-12-18 | 2014-06-18 | 北大方正集团有限公司 | Ornithine aspartate effervescent tablets and preparing process thereof |
| CN103239434A (en) * | 2012-12-26 | 2013-08-14 | 辽宁亿灵科创生物医药科技有限公司 | Ornithine aspartate composition |
| CN104721808A (en) * | 2014-05-13 | 2015-06-24 | 北京京卫信康医药科技发展有限公司 | Pharmaceutical composition for treating neonatal jaundice |
| RU2734417C2 (en) * | 2015-07-24 | 2020-10-16 | Эвоник Оперейшенс ГмбХ | Fizzy compositions based on ornithine aspartate |
| CN107573404A (en) * | 2017-09-22 | 2018-01-12 | 南京优科生物医药研究有限公司 | The active salt of the dipeptide compound of ornithine and L-aminobutanedioic acid and its application |
| CN110314132A (en) * | 2018-03-28 | 2019-10-11 | 上海贵之言医药科技有限公司 | A kind of ornithine aspartate injection and preparation method thereof |
| CN110314132B (en) * | 2018-03-28 | 2022-11-04 | 上海贵之言医药科技有限公司 | Ornithine aspartate injection and preparation method thereof |
| EP3795650A4 (en) * | 2018-08-31 | 2022-02-23 | CJ Cheiljedang Corporation | Adhesive composition, and method for preparing same |
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