CN102302502A - Compound glycyrrhizin preparation and preparation method thereof - Google Patents
Compound glycyrrhizin preparation and preparation method thereof Download PDFInfo
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- CN102302502A CN102302502A CN 201110184341 CN201110184341A CN102302502A CN 102302502 A CN102302502 A CN 102302502A CN 201110184341 CN201110184341 CN 201110184341 CN 201110184341 A CN201110184341 A CN 201110184341A CN 102302502 A CN102302502 A CN 102302502A
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Abstract
The invention refers to a compound glycyrrhizin preparation and a preparation method thereof, wherein the preparation includes glycyrrhizin and ornithine; and the weight ratio of the glycyrrhizin to the ornithine is (1-20):1, preferably (5-15):1, and most preferably 10:1. The prepared dosage forms include water injection and powder for injection. The preparation has the effects of protecting the liver and resisting viruses, can be used for apparently reducing blood ammonia level simultaneously, and is also helpful for treating hepatic encephalopathy.
Description
Technical field
The present invention relates to a kind of compound glycyrrbizic acid glycosides formulation and preparation method thereof.
Background technology
Hepatic disease is a kind of frequently-occurring disease and commonly encountered diseases.Its cause of disease and pathogeny are very complicated, still it are not had the control medicine of definite curative effect at present.Hepatic encephalopathy is one of the severe complication of hepatopathy in whole latter stage, and it is main to see through blood brain barrier because blood ammonia raises, and directly or indirectly causes neurotoxicity or disturbs the energy metabolism of brain.
Glycyrrhizic glycoside; Claim glycyrrhizic acid (Glycyrrhizicacid again; GA), glycyrrhizin (Glycyrrhizin; GL); Chemistry 3-O-(2 '-beta d glucopyranosiduronic acid base) by name-beta d glucopyranosiduronic acid glycosides 3 beta-hydroxies-11-carbonyl oxygen-18 β oleanolic acid-12-alkene-30-carboxylic acid; English chemical name: 3-O-(2 '-β-D-glucuronopyranosyl)-β-D-glucuronopyranoside3 β-hydroxy-11-oxo-18 β olean-12-en-30-oic acid, be the effective ingredient of separation and Extraction from Radix Glycyrrhizae.Natural isolating glycyrrhizic acid is 18 beta isomers, and 18 beta isomers can be converted into 18 αYi Goutis through specific method.Carboxyl in the glycyrrhizic acid molecule can become single salt, two salt or three salt with various cationes such as sodium ion, potassium ion, ammonium ion, zinc ion, magnesium ion etc.Research shows that glycyrrhizic acid has antiinflammatory, antiviral and functions such as protecting liver and detoxication and enhance immunity, is used to treat various acute, chronic hepatitis clinically.The kind of having gone on the market has the compound monoammonium glycyrrhizinate injection, and (commodity are called potenlin; Main component is a monoammonium glycyrrhizinate; Glycine, cysteine hydrochloride), diammonium glycyrrhizinate injection (commodity are called diammonium glycyrrhizinate, and main component is a diammonium glycyrrhizinate); Compound glycyrrhizin injection liquid (trade name: U.S. ability; Main component is a monoammonium glycyrrhizinate, glycine, cysteine hydrochloride), SNMC sheet (trade name: U.S. ability; Main component is a monoammonium glycyrrhizinate, glycine, methionine).
According to the disclosed data of listing product description, the ammonia that adopt are done the pH regulator agent, the risk that its direct intravenous injection has potential blood ammonia to raise more in the compound glycyrrhizin injection liquid.Describe in the taboo item in the SNMC sheet description, these article are forbidden in the liver cirrhosis patient in latter stage (metabolite of the methionine that is contained in the said preparation can suppress urea synthesis, and makes the disposal ability of ammonia low) that has blood ammonia to raise and be inclined to.
Ornithine is a kind of basic amino acid; Main and Aspartic Acid formation aspartic acid ornithine salt (trade name is auspicious sweet) in clinical; Be used for acute and chronic hepatitis and comprise liver cirrhosis, fatty liver, various viral 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.
Summary of the invention
Technical problem to be solved by this invention provides compound preparation of glycyrrhizic glycoside and ornithine and preparation method thereof.
In order to address the above problem, the present invention provides following technical proposals:
The present invention provides a kind of compound glycyrrbizic acid glycosides formulation, contains glycyrrhizic glycoside and ornithine, and the weight ratio of ornithine and glycyrrhizic glycoside is 1～20: 1, is preferably 5～15: 1, and more preferably 10: 1.
Described compound glycyrrbizic acid glycosides formulation can also contain glycine and cysteine hydrochloride, and wherein, the weight ratio of glycine, cysteine hydrochloride, glycyrrhizic glycoside is 10: 0.5: 1
Described compound glycyrrbizic acid glycosides formulation also contains antioxidant, and described antioxidant is selected from a kind of or combination in sodium sulfite, calcium disodium edetate, the disodium edetate.
The dosage form of compound glycyrrbizic acid glycosides formulation of the present invention comprises liquid drugs injection, powder pin and transfusion.
The method for preparing of SNMC liquid drugs injection of the present invention may further comprise the steps:
(1) takes by weighing glycyrrhizic glycoside, ornithine, add water for injection, stir and make its dissolving;
(2) add active carbon, stir, filter;
(3) with water for injection filtrating is diluted to cumulative volume, fills the nitrogen embedding;
(4) sterilization promptly gets.
The method for preparing of SNMC liquid drugs injection of the present invention may further comprise the steps
(1) takes by weighing glycyrrhizic glycoside, ornithine, glycine, cysteine hydrochloride, add water for injection, stir and make its dissolving;
(2) add active carbon, stir, filter;
(3) with water for injection filtrating is diluted to cumulative volume, fills the nitrogen embedding;
(4) sterilization promptly gets.
The method for preparing of SNMC powder pin of the present invention may further comprise the steps:
(1) takes by weighing glycyrrhizic glycoside, ornithine, add water for injection, stir and make its dissolving;
(2) add active carbon, stir, filter;
(3) with water for injection step (2) filtrating is diluted to cumulative volume, aseptic subpackaged;
(4) lyophilization promptly gets.
The method for preparing of SNMC powder pin of the present invention may further comprise the steps:
(1) takes by weighing glycyrrhizic glycoside, ornithine, glycine, cysteine hydrochloride, add water for injection, stir and make its dissolving;
(2) add active carbon, stir, filter;
(3) with water for injection step (2) filtrating is diluted to cumulative volume, aseptic subpackaged;
(4) lyophilization promptly gets.
The compound glycyrrbizic acid glycosides formulation of the present invention's preparation can significantly reduce liver ALT and AST level, has useful liver protection function, can significantly reduce the level of blood ammonia in the blood simultaneously, helps therapy for hepatic encephalopathy.
The specific embodiment
Illustrate in greater detail the present invention below in conjunction with embodiment, but the present invention is not subjected to any qualification of these records.
Embodiment 1 liquid drugs injection
Prescription
Technology: the monoammonium glycyrrhizinate, the ornithine that take by weighing recipe quantity place sterilized container; Add an amount of water for injection; Stirring makes its dissolving; The active carbon (W/V) that adds liquor capacity 0.1% weight is heated to 60 ℃ and stirred 30 minutes, removes by filter active carbon; Add to 1000ml with water for injection; Embedding, autoclaving promptly gets.
Embodiment 2 liquid drugs injections
Prescription
Technology: the monoammonium glycyrrhizinate, the ornithine that take by weighing recipe quantity place sterilized container; Add an amount of water for injection; Stirring makes its dissolving; The active carbon (W/V) that adds liquor capacity 0.1% weight is heated to 60 ℃ and stirred 30 minutes, removes by filter active carbon; Add to 1000ml with water for injection; Embedding, autoclaving promptly gets.
Embodiment 3 liquid drugs injections
Prescription
Technology: the monoammonium glycyrrhizinate, the ornithine that take by weighing recipe quantity place sterilized container; Add an amount of water for injection; Stirring makes its dissolving; The active carbon (W/V) that adds liquor capacity 0.1% weight is heated to 60 ℃ and stirred 30 minutes, removes by filter active carbon; Add to 1000ml with water for injection; Embedding, autoclaving promptly gets.
Embodiment 4 powder pins
Prescription
Technology: the monoammonium glycyrrhizinate, the ornithine that take by weighing recipe quantity place sterilized container; Add an amount of water for injection; Stirring makes its dissolving, adds the active carbon (W/V) of liquor capacity 0.1% weight, is heated to 60 ℃ and stirs 30 minutes; Remove by filter active carbon; Add to 1000ml with water for injection, through 0.22 μ m filtering with microporous membrane degerming, aseptic embedding; Lyophilization promptly gets.
Embodiment 5 powder pins
Prescription
Technology: the monoammonium glycyrrhizinate, the ornithine that take by weighing recipe quantity place sterilized container; Add an amount of water for injection; Stirring makes its dissolving, adds the active carbon (W/V) of liquor capacity 0.1% weight, is heated to 60 ℃ and stirs 30 minutes; Remove by filter active carbon; Add to 1000ml with water for injection, through 0.22 μ m filtering with microporous membrane degerming, aseptic embedding; Lyophilization promptly gets.
Embodiment 6 liquid drugs injections
Prescription
Technology: the monoammonium glycyrrhizinate, ornithine, glycine and the cysteine hydrochloride that take by weighing recipe quantity place sterilized container; Add an amount of water for injection, stir and make its dissolving, add sodium sulfite; Stirring makes its dissolving; The active carbon (W/V) that adds liquor capacity 0.1% weight is heated to 60 ℃ and stirred 30 minutes, removes by filter active carbon; Add to 1000ml with water for injection; Embedding, autoclaving promptly gets.
Embodiment 7 liquid drugs injections
Prescription
Technology: the monoammonium glycyrrhizinate, ornithine, glycine and the cysteine hydrochloride that take by weighing recipe quantity place sterilized container; Add an amount of water for injection, stir and make its dissolving, add sodium sulfite and calcium disodium edetate; Stirring makes its dissolving; The active carbon (W/V) that adds liquor capacity 0.1% weight is heated to 60 ℃ and stirred 30 minutes, removes by filter active carbon; Add to 1000ml with water for injection; Embedding, autoclaving promptly gets.
Embodiment 8 powder pins
Prescription
Technology: the monoammonium glycyrrhizinate, ornithine, glycine, the cysteine hydrochloride that take by weighing recipe quantity place sterilized container, add an amount of water for injection, stir to make its dissolving; Add sodium sulfite; Stirring makes its dissolving, adds the active carbon (W/V) of liquor capacity 0.1% weight, is heated to 60 ℃ and stirs 30 minutes; Remove by filter active carbon; Add to 1000ml with water for injection, through 0.22 μ m filtering with microporous membrane degerming, aseptic embedding; Lyophilization promptly gets.
Embodiment 9 powder pins
Prescription
Technology: the monoammonium glycyrrhizinate, ornithine, glycine, the cysteine hydrochloride that take by weighing recipe quantity place sterilized container, add an amount of water for injection, stir to make its dissolving; Add sodium sulfite; Disodium edetate stirs and makes its dissolving, adds the active carbon (W/V) of liquor capacity 0.1% weight, is heated to 60 ℃ and stirs 30 minutes; Remove by filter active carbon; Add to 1000ml with water for injection, through 0.22 μ m filtering with microporous membrane degerming, aseptic embedding; Lyophilization promptly gets.
Embodiment 10 liquid drugs injections
Prescription
Technology: the monoammonium glycyrrhizinate, glycine and the cysteine hydrochloride that take by weighing recipe quantity place sterilized container, add an amount of water for injection, stir to make its dissolving; Add sodium sulfite, stir and make its dissolving, add ammonia; Regulating pH is 6.8～7.2; The active carbon (W/V) that adds liquor capacity 0.1% weight is heated to 60 ℃ and stirred 30 minutes, removes by filter active carbon; Add to 1000ml with water for injection; Embedding, autoclaving promptly gets.
Embodiment 11 transfusions
Prescription
Technology: the monoammonium glycyrrhizinate, ornithine, the glucose that take by weighing recipe quantity place sterilized container; Add an amount of water for injection; Stirring makes its dissolving; The active carbon (W/V) that adds liquor capacity 0.1% weight is heated to 60 ℃ and stirred 30 minutes, removes by filter active carbon; Add to 1000ml with water for injection; Embedding, autoclaving promptly gets.
Embodiment 12 transfusions
Prescription
Technology: the monoammonium glycyrrhizinate, ornithine, the glucose that take by weighing recipe quantity place sterilized container; Add an amount of water for injection; Stirring makes its dissolving; The active carbon (W/V) that adds liquor capacity 0.1% weight is heated to 60 ℃ and stirred 30 minutes, removes by filter active carbon; Add to 1000ml with water for injection; Embedding, autoclaving promptly gets.
Embodiment 13 transfusions
Prescription
Technology: the monoammonium glycyrrhizinate, ornithine, glycine and the cysteine hydrochloride that take by weighing recipe quantity place sterilized container; Add an amount of water for injection, stir and make its dissolving, add sodium sulfite; Sodium chloride stirs and makes its dissolving; The active carbon (W/V) that adds liquor capacity 0.1% weight is heated to 60 ℃ and stirred 30 minutes, removes by filter active carbon; Add to 1000ml with water for injection; Embedding, autoclaving promptly gets.
Embodiment 14 transfusions
Prescription
Technology: the monoammonium glycyrrhizinate, ornithine, glycine and the cysteine hydrochloride that take by weighing recipe quantity place sterilized container; Add an amount of water for injection, stir and make its dissolving, add sodium sulfite; Sodium chloride stirs and makes its dissolving; The active carbon (W/V) that adds liquor capacity 0.1% weight is heated to 60 ℃ and stirred 30 minutes, removes by filter active carbon; Add to 1000ml with water for injection; Embedding, autoclaving promptly gets.
Embodiment 15 medicines are to the influence test of hepatic encephalopathy rats'liver function and blood ammonia
Laboratory animal: male Winstar rat, body weight 250～300g.
Hepatic encephalopathy rat molding method: carry out lumbar injection next day of adopting the thioacetamide (TAA) of 250mg/kg dosage, inject twice method modeling continuously.
Divide into groups: be divided into following 7 groups at random, 10 every group.
Blank control group: healthy rat gives water for injection.
Model group: give water for injection.
Experimental group 1: glycyrrhizic glycoside and ornithine weight ratio are 1: 1, do not contain glycine and cysteine hydrochloride.
Experimental group 2: glycyrrhizic glycoside and ornithine weight ratio are 1: 20, do not contain glycine and cysteine hydrochloride.
Experimental group 3: glycyrrhizic glycoside and ornithine weight ratio are 1: 10, do not contain glycine and cysteine hydrochloride.
Experimental group 4: glycyrrhizic glycoside, ornithine, glycine, cysteine hydrochloride weight ratio are 1: 10: 10: 0.5
Experimental group 5: glycyrrhizic glycoside: glycine: the weight ratio of cysteine hydrochloride is 1: 10: 0.5, does not contain ornithine.
Experimental group 1～5 dosage: in glycyrrhizic glycoside, 200mg/kg.
Administering mode: lumbar injection, once a day, continuous 4 days.
Adopt the blood biochemical method to detect rats'liver function (ALT, AST), blood ammonia (BA) level.
The result shows; Blank control group ALT; AST compares with model group respectively with BA all has utmost point significant difference; The ALT of experimental group 1～5 compares with model group respectively; Utmost point significant difference is all arranged, and the AST of experimental group 1～5 compares with model group respectively, and all there were significant differences; The BA level of experimental group 1 compares with model group that there were significant differences, and the BA level of experimental group 2,3,4 is compared with model group all has utmost point significant difference.
Table 1 hepatic encephalopathy rats'liver function (ALT, AST), blood ammonia (BA) are measured result (n=10)
Compare * P＜0.05, * * P＜0.01 with model group
Claims (10)
1. a compound glycyrrbizic acid glycosides formulation contains glycyrrhizic glycoside, it is characterized in that, also contains ornithine, and the weight ratio of ornithine and glycyrrhizic glycoside is 1～20: 1.
2. according to the said compound glycyrrbizic acid glycosides formulation of claim 1, it is characterized in that the weight ratio of ornithine and glycyrrhizic glycoside is 5～15: 1.
3. according to the said compound glycyrrbizic acid glycosides formulation of claim 2, it is characterized in that the weight ratio of ornithine and glycyrrhizic glycoside is 10: 1.
4. compound glycyrrbizic acid glycosides formulation according to claim 1 is characterized in that, also contains glycine and cysteine hydrochloride, and the weight ratio of glycine, cysteine hydrochloride, glycyrrhizic glycoside is 10: 0.5: 1.
5. compound glycyrrbizic acid glycosides formulation according to claim 4 is characterized in that, also contains antioxidant, and described antioxidant is selected from a kind of or combination in sodium sulfite, calcium disodium edetate, the disodium edetate.
6. compound glycyrrbizic acid glycosides formulation of the present invention is characterized in that, described dosage form is liquid drugs injection or powder pin or transfusion.
7. the method for preparing of the arbitrary described compound glycyrrbizic acid glycosides formulation of claim 1～3 is characterized in that may further comprise the steps:
(1) takes by weighing glycyrrhizic glycoside, ornithine, add water for injection, stir and make its dissolving;
(2) add active carbon, stir, filter;
(3) with water for injection filtrating is diluted to cumulative volume, fills the nitrogen embedding;
(4) sterilization promptly gets.
8. the method for preparing of the arbitrary described compound glycyrrbizic acid glycosides formulation of claim 1～3 is characterized in that may further comprise the steps:
(1) takes by weighing glycyrrhizic glycoside, ornithine, add water for injection, stir and make its dissolving;
(2) add active carbon, stir, filter;
(3) with water for injection step (2) filtrating is diluted to cumulative volume, aseptic subpackaged;
(4) lyophilization promptly gets.
9. the method for preparing of the described compound glycyrrbizic acid glycosides formulation of claim 4 is characterized in that may further comprise the steps:
(1) takes by weighing glycyrrhizic glycoside, ornithine, glycine, cysteine hydrochloride, add water for injection, stir and make its dissolving;
(2) add active carbon, stir, filter;
(3) with water for injection filtrating is diluted to cumulative volume, fills the nitrogen embedding;
(4) sterilization promptly gets.
10. the method for preparing of the described compound glycyrrbizic acid glycosides formulation of claim 4 is characterized in that may further comprise the steps:
(1) takes by weighing glycyrrhizic glycoside, ornithine, glycine, cysteine hydrochloride, add water for injection, stir and make its dissolving;
(2) add active carbon, stir, filter;
(3) with water for injection step (2) filtrating is diluted to cumulative volume, aseptic subpackaged;
(4) lyophilization promptly gets.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102670633A (en) * | 2012-05-29 | 2012-09-19 | 海南卫康制药(潜山)有限公司 | Compound ammonium glycyrrhizinate S lyophilized powder composition for injection and preparation method of compound ammonium glycyrrhizinate S lyophilized powder composition |
| CN103622981A (en) * | 2012-08-27 | 2014-03-12 | 康阳润和（北京）医药科技有限公司 | Compound glycyrrhizin oral liquid and preparation method thereof |
| CN103819530A (en) * | 2013-12-12 | 2014-05-28 | 吉林长舜制药有限公司 | Monoammonium glycyrrhizinate compound and pharmaceutical composition containing monoammonium glycyrrhizinate |
| CN105343016A (en) * | 2015-11-10 | 2016-02-24 | 瑞阳制药有限公司 | Compound glycyrrhizin lyophilized powder for injection and preparation method of compound glycyrrhizin lyophilized powder for injection |
| WO2016203499A1 (en) | 2015-06-19 | 2016-12-22 | Chigurupati Harsha | Synergistic beverage composition |
-
2011
- 2011-06-30 CN CN 201110184341 patent/CN102302502A/en active Pending
Non-Patent Citations (1)
| Title |
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| 《传染病信息》 20071231 王淑平等 复方甘草酸苷联合门冬氨酸-鸟氨酸治疗慢性乙型肝炎高胆红素血症48例临床观察 51-52 1-10 第20卷, 第1期 * |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102670633A (en) * | 2012-05-29 | 2012-09-19 | 海南卫康制药(潜山)有限公司 | Compound ammonium glycyrrhizinate S lyophilized powder composition for injection and preparation method of compound ammonium glycyrrhizinate S lyophilized powder composition |
| CN103622981A (en) * | 2012-08-27 | 2014-03-12 | 康阳润和（北京）医药科技有限公司 | Compound glycyrrhizin oral liquid and preparation method thereof |
| CN103819530A (en) * | 2013-12-12 | 2014-05-28 | 吉林长舜制药有限公司 | Monoammonium glycyrrhizinate compound and pharmaceutical composition containing monoammonium glycyrrhizinate |
| WO2016203499A1 (en) | 2015-06-19 | 2016-12-22 | Chigurupati Harsha | Synergistic beverage composition |
| CN107920577A (en) * | 2015-06-19 | 2018-04-17 | 哈沙·奇古鲁帕蒂 | Cooperate with beverage composition for treating dental erosion |
| US10456359B2 (en) | 2015-06-19 | 2019-10-29 | Harsha Chigurupati | Synergistic beverage composition |
| CN105343016A (en) * | 2015-11-10 | 2016-02-24 | 瑞阳制药有限公司 | Compound glycyrrhizin lyophilized powder for injection and preparation method of compound glycyrrhizin lyophilized powder for injection |
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