CN1739536A - A kind of compound formulation that contains monopotassium glycyrrhizunate and preparation method thereof and application - Google Patents
A kind of compound formulation that contains monopotassium glycyrrhizunate and preparation method thereof and application Download PDFInfo
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- CN1739536A CN1739536A CN 200510044582 CN200510044582A CN1739536A CN 1739536 A CN1739536 A CN 1739536A CN 200510044582 CN200510044582 CN 200510044582 CN 200510044582 A CN200510044582 A CN 200510044582A CN 1739536 A CN1739536 A CN 1739536A
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Abstract
The invention discloses a kind of compound formulation that contains monopotassium glycyrrhizunate, make by following components in weight percentage: monopotassium glycyrrhizunate 20-75 part, glycine 1-800 part, L-cysteine hydrochloride 10-28 part, with sodium chloride 10-30 part, anhydrous sodium sulfite 10-28 part, the mixing of one or more in disodium edetate 1-9 part.The invention also discloses the preparation method and the application in preparation treatment viral hepatitis, chronic persistent hepatitis, chronic active hepatitis, acute or chronic hepatitis B, liver poisoning, first cirrhosis medicine thereof of this compound formulation.Compound formulation of the present invention compare with existing monopotassium glycyrrhizunate folk prescription oral formulations have good effect, side effect is low, rapid-action, bioavailability advantages of higher.
Description
Technical field
The present invention relates to a kind of compound formulation that contains monopotassium glycyrrhizunate and preparation method thereof and its application in preparation treatment viral hepatitis, chronic persistent hepatitis, chronic active hepatitis, acute or chronic hepatitis B, liver poisoning, first cirrhosis medicine; Belong to medical technical field.
Background technology
Hepatitis is a kind of commonly encountered diseases and frequently-occurring disease of serious harm human health.Acute hepatitis is caused by hepatitis virus that generally the cause of disease of chronic hepatitis is a lot, as hepatitis virus, other hepatopathys, medicine factor etc., in the hepatitis of China based on viral hepatitis.The heaviest with hepatitis B and hepatitis C in all kinds of viral hepatitis of having found to human health risk.
Hepatitis is the chronic hepatitis that is called of above liver chronic inflammatory disease in June, and chronic hepatitis can be divided into chronic persistent hepatitis and active hepatitis two classes again.
Monopotassium glycyrrhizunate is the potassium salt form of the active component glycyrrhizic acid that extracts from Radix Glycyrrhizae, has effects such as antiviral, antiinflammatory, antiallergic action, immunomodulating, hepatocyte protection, is a kind of treatment hepatopathy obvious results medicine.The monopotassium glycyrrhizunate oral formulations that has gone on the market at present is the single preparations of ephedrine of monopotassium glycyrrhizunate, deposits the low shortcoming of bioavailability in vivo.
Summary of the invention
At the deficiencies in the prior art, the object of the present invention is to provide a kind of monopotassium glycyrrhizunate compositions, a kind of compound formulation that contains monopotassium glycyrrhizunate promptly is provided, for by monopotassium glycyrrhizunate, glycine, L-cysteine hydrochloride or/and sodium chloride or/and anhydrous sodium sulfite or/and the compound preparation that the disodium edetate drug regimen forms, this pharmaceutical composition have protect the liver, effect such as antiinflammatory, antiallergic, detoxifcation, and it is little to have a side effect, the bioavailability height, advantage such as indication is extensive.
Another object of the present invention is to provide the described preparation method that contains the compound formulation of monopotassium glycyrrhizunate.
Another purpose of the present invention is to provide the described new dosage form that contains the compound formulation of monopotassium glycyrrhizunate.
A further object of the present invention is to provide the described application of compound formulation in preparation treatment viral hepatitis, chronic persistent hepatitis, chronic active hepatitis, acute or chronic hepatitis B, liver poisoning, first cirrhosis medicine that contains monopotassium glycyrrhizunate.
A kind of compound formulation that contains monopotassium glycyrrhizunate that the present invention relates to, make by following components in weight percentage:
Monopotassium glycyrrhizunate 20-75 part, glycine 1-800 part, L-cysteine hydrochloride 10-28 part and sodium chloride 10-30 part, anhydrous sodium sulfite 10-28 part, the mixing of one or more in disodium edetate 1-9 part.
Wherein, described component is preferably made by the following weight proportioning:
Monopotassium glycyrrhizunate 30-55 part, glycine 300-600 part, L-cysteine hydrochloride 15-19 part, sodium chloride 13-25 part, anhydrous sodium sulfite 13-18 part, disodium edetate 2-6 part.
In the above-mentioned compound formulation that contains monopotassium glycyrrhizunate, described component is most preferably made by the following weight proportioning:
40 parts of monopotassium glycyrrhizunates, 400 parts of glycine, 18 parts of L-cysteine hydrochlorides, 16 parts in sodium chloride, 16 parts of anhydrous sodium sulfite, 3 parts of disodium edetate.
Weight portion of the present invention can be the known mass units of field of medicaments such as μ g, mg, g, kg.
Composition in the monopotassium glycyrrhizunate compositions of the present invention: monopotassium glycyrrhizunate, glycine, L-cysteine hydrochloride, sodium chloride, anhydrous sodium sulfite, disodium edetate all adopt the raw material that meets medicinal standard or can be used for pharmaceutical production, and wherein monopotassium glycyrrhizunate needs to be further purified raising purity through recrystallization.
The compound formulation that contains monopotassium glycyrrhizunate of the present invention, its dosage form are the acceptable injection type of routine techniques method preparation on the pharmaceutics, as one of small-volume injection, bulk capacity injection, powder injection formulation, freeze-dried powder.Preferably small-volume injection, freeze-dried powder, most preferred is small-volume injection.
The various dosage forms that contain the compound formulation of monopotassium glycyrrhizunate of the present invention can be according to the conventional production method preparation of pharmaceutical field.Such as using said composition to mix, make required dosage form then with one or more carriers.
The compound formulation that contains monopotassium glycyrrhizunate of the present invention is made the preparation method of small-volume injection, comprises the steps:
In percent by volume, in dense preparing tank, add up 82 ℃ of-88 ℃ of waters for injection of amount of preparation 75%-90%, in dense preparing tank, add disodium edetate then by weight ratio successively, the L-cysteine hydrochloride, glycine, sodium chloride, anhydrous sodium sulfite, monopotassium glycyrrhizunate, fully stir and make dissolving fully, amount by preparation cumulative volume 0.025%-0.035% adds active carbon again, be heated to 82 ℃-88 ℃, be incubated 25-35 minute, be cooled to 35 ℃-45 ℃ with the medicinal liquid decarbonization filtering to dilute preparing tank, in dilute preparing tank, add water for injection to the dosing amount, accent pH is 6.3-6.5, medicinal liquid is again through conventional end-filtration, and embedding is in ampoule, and ampoule fills nitrogen by propping up during embedding, sterilization promptly gets injection;
Wherein, the monopotassium glycyrrhizunate raw material needs to improve purity through recrystallization, makes the monopotassium glycyrrhizunate that is applicable to injection.
The compound formulation that contains monopotassium glycyrrhizunate that utilizes method of the present invention to prepare is compared with existing monopotassium glycyrrhizunate folk prescription oral formulations has following advantage:
(1) glycine and L-cysteine hydrochloride two seed amino acids have been added in the prescription, than folk prescription oral formulations better efficacy, side effect is lower, can suppress or alleviate owing to giving for a long time the unusual pseudo-aldosterone disease that causes of electrolyte metabolism that glycyrrhetate causes in a large number.
Problem such as (2) ejection preparation bioavailability rapid-action, easy to use, that solved the monopotassium glycyrrhizunate oral formulations is low.
Utilize the compound formulation of monopotassium glycyrrhizunate that contains of the present invention in the application for preparing in the treatment for the treatment of viral hepatitis, chronic persistent hepatitis, chronic active hepatitis, acute or chronic hepatitis B, liver poisoning, first cirrhosis medicine and improving abnormal liver function.
Use the compound formulation that contains monopotassium glycyrrhizunate of the present invention and can obviously alleviate hepatocyte qualitative change and necrosis, alleviate matter inflammatory reaction between hepatocyte, suppress hepatocyte fibroplasia, thereby reduce the incidence rate of liver cirrhosis and promote hepatocellular regeneration.This pharmaceutical composition also can suppress the activation of fibrinolysin system, stops the promotion of serum to capillary permeability, suppresses the hyperfunction of membrane permeability, and the effect that suppresses granuloma formation is arranged, and retardance anaphylaxis disease is also had inhibitory action.
In the component of the compound formulation that contains monopotassium glycyrrhizunate of the present invention: monopotassium glycyrrhizunate is hydrolyzed to glucuronic acid and enoxolone by glycuronidase in vivo, steroid metabolism enzyme (Δ 5-β-reductase) in enoxolone and the liver has stronger affinity, thereby hinder the deactivation of hydrocortisone and aldosterone, so tangible 17-hydroxy-11-dehydrocorticosterone sample and aldosterone sample effect are arranged, use the back to show tangible 17-hydroxy-11-dehydrocorticosterone sample effect, as antiinflammatory, antiallergic, protecting film structure, immunomodulating and the metabolism of promotion bile pigments etc.; Monopotassium glycyrrhizunate is decomposed into enoxolone and glucuronic acid at liver in addition, can combine with toxicant and a Detoxication.Simultaneously, use the compound formulation that contains monopotassium glycyrrhizunate of the present invention,, can avoid similar medicine to produce hypokalemic side effect because of containing potassium ion in the described preparation.
Glycine has detoxifcation, anti-allergy action, can offset the side effect of glycyrrhizic acid water-sodium retention simultaneously.
The L-cysteine hydrochloride can be exchanged into methionine in vivo, is a kind of essential amino acids, can synthesize choline and creatine in human body; Choline is a kind of anti-fattyliver substance, and to the toxic hepatitis that is caused by arsenical, barbiturate, carbon tetrachloride etc., methionine has treatment and liver function protecting effect; The L-cysteine hydrochloride can alleviate potential aldosterone sample effect of glycyrrhizic acid list potassium and hormonelike side effect in addition
Sodium chloride is isoosmotic adjusting agent, body osmotic pressure balance when being used for guaranteeing to use this medicine.
Anhydrous sodium sulfite and disodium edetate keep the finished product preparation that contains the compound formulation of monopotassium glycyrrhizunate of the present invention to have stability in the useful life as antioxidant and stabilizing agent.
Utilize the compound formulation of monopotassium glycyrrhizunate that contains of the present invention by monopotassium glycyrrhizunate, glycine and L-cysteine hydrochloride; the effect that stresses that sodium chloride, anhydrous sodium sulfite and disodium edetate are different separately; replenish mutually and act synergistically on body; give full play to antiinflammatory, antiallergic, protecting film structure, regulate effects such as immunity and antiviral, obtain excellent curative.
The specific embodiment
Further describe the present invention with embodiment below, understand the present invention and advantage and effect, but described embodiment only is used to illustrate the present invention rather than restriction the present invention in order to more deep.
Embodiment 1:
Get ethyl acetate 10L, acetic acid 10L mix homogeneously.Under the aseptic condition, getting the glycyrrhizic acid list potassium M raw material 500g that meets the national drug standards is added in ethyl acetate-acetic acid mixed liquor, stirring makes the monopotassium glycyrrhizunate dissolving, conventional filtration is removed insoluble matter, filtrate is left standstill, after waiting to separate out crystallization fully, conventional filtration is collected the solid that crystallization is separated out, and promptly gets the aseptic raw material of monopotassium glycyrrhizunate high-purity.
Embodiment 2:
The aseptic raw material 200g of extracting liquorice acid monopotassium salt, glycine 2000g, L-cysteine hydrochloride 100g, sodium chloride 80g, anhydrous sodium sulfite 80g, disodium edetate 15g (in order to preparation 100000ml small-volume injection) are standby.
In dense preparing tank, add 85 ℃ of water for injection 85L, in dense preparing tank, add disodium edetate then by weight ratio successively, the L-cysteine hydrochloride, glycine, sodium chloride, anhydrous sodium sulfite, monopotassium glycyrrhizunate, fully stir and make dissolving fully, amount by preparation cumulative volume 0.03% adds active carbon again, be heated to 86 ℃, be incubated 25 minutes, be cooled to 40 ℃ with the medicinal liquid decarbonization filtering to dilute preparing tank, add water for injection to the dosing amount in dilute preparing tank, transferring pH is 6.5, and medicinal liquid is again through conventional end-filtration, embedding is in ampoule, ampoule fills nitrogen by propping up during embedding, and sterilization promptly gets injection.
Embodiment 3:
The aseptic raw material 150g of extracting liquorice acid monopotassium salt, glycine 1500g, L-cysteine hydrochloride 75g, sodium chloride 60g, anhydrous sodium sulfite 60g, disodium edetate 11g (in order to prepare 1000 bottles of 250ml specification bulk capacity injections) are standby.
In dense preparing tank, add 88 ℃ of water for injection 210L, in dense preparing tank, add disodium edetate, L-cysteine hydrochloride, glycine, sodium chloride, anhydrous sodium sulfite, monopotassium glycyrrhizunate then by weight ratio successively, fully stir and make dissolving fully, amount by preparation cumulative volume 0.035% adds active carbon again, be heated to 88 ℃, be incubated 30 minutes, be cooled to 45 ℃ with the medicinal liquid decarbonization filtering to dilute preparing tank, in dilute preparing tank, add water for injection to the dosing amount, transferring pH is 6.3, and through conventional end-filtration, embedding is in infusion bottle again for medicinal liquid, sterilization promptly gets infusion products.
Embodiment 4:
The aseptic raw material 2g of extracting liquorice acid monopotassium salt adds 83 ℃ of water for injection 800ml, is stirred to dissolving fully; Add glycine 20g, L-cysteine hydrochloride 1.5g, anhydrous sodium sulfite 0.8g, stir and make dissolving fully, add the Dextran 40 excipient of convention amount, add water for injection to 1000ml, transferring pH is 6.4; Add the active carbon (through 115 ℃-120 ℃ activation 2h) of preparation cumulative volume 0.025%, place rustless steel container, 85 ℃ of insulated and stirred absorption 32 minutes, coarse filtration was taken off charcoal; Extremely clear and bright, aseptic subpackaged with the compound membrane filtration that 0.45 μ m and 0.22 μ m form, pre-freeze 6 hours dry 30 hours, promptly gets freeze-dried powder.
Embodiment 5:
The aseptic raw material 40g of extracting liquorice acid monopotassium salt, glycine 400g, L-cysteine hydrochloride 18g, sodium chloride 16g, anhydrous sodium sulfite 16g, disodium edetate 3g (in order to preparation 20000ml small-volume injection) are standby.In dense preparing tank, add 87 ℃ of water for injection 17L, in dense preparing tank, add disodium edetate then by weight ratio successively, the L-cysteine hydrochloride, glycine, sodium chloride, anhydrous sodium sulfite, monopotassium glycyrrhizunate, fully stir and make dissolving fully, amount by preparation cumulative volume 0.025% adds active carbon again, be heated to 84 ℃, be incubated 35 minutes, be cooled to 35 ℃ with the medicinal liquid decarbonization filtering to dilute preparing tank, add water for injection to the dosing amount in dilute preparing tank, transferring pH is 6.4, and medicinal liquid is again through conventional end-filtration, embedding is in ampoule, ampoule fills nitrogen by propping up during embedding, and sterilization promptly gets injection.
Embodiment 6:
The low capacity composite injection that contains monopotassium glycyrrhizunate of Application Example 5 preparations carries out anti-carbon tetrachloride hepatic injury experiment.
Get 40 of Kunming kind white mice, body weight 25～30g, male and female have concurrently, are divided into 4 groups at random, 10 every group.One group is normal group: with salad oil 0.01ml (g.d) lumbar injection, and per 3 days 1 time, continuous 2 times, and irritate stomach, continuous 6 days with normal saline 0.03ml (g.d).Its excess-three group prepares the hepatic injury mouse model: with 0.2%CCl4 oil solution lumbar injection, and every 10g body weight consumption 0.1ml, injection in per 3 days 1 time, continuous 2 times.Hepatic injury gives normal saline 0.03ml (g.d) simultaneously and irritates stomach, continuous 6 days, is the blank group.Hepatic injury is irritated stomach with the preparation 0.03ml (g.d) of embodiment 5 preparations simultaneously, continuous 6 days, is the medication group.Hepatic injury gives compound glycyrrhizin injection liquid 0.03ml (g.d) simultaneously and irritates stomach, continuous 6 days, positive matched group.
After the administration the 7th day, the white mice broken end is got blood, adopt biochemistry analyzer to measure Serum ALT and AST, and get liver immediately and claim weight in wet base.With hepatic tissue formaldehyde fixed, dyeing, perusal hepatocyte pathological change under the light microscopic.Not having obvious hepatic injury represents with (-); The hepatic injury area is slight hepatic injury less than 1/3, with (+) expression; The hepatic injury area is the moderate hepatic injury 1/3～2/3, with (++) expression; The hepatic injury area is a severe liver injury greater than 2/3, with (+++) expression.
Testing result is as follows:
Each organizes mice biochemical indicator measurement result (n=10)
| Group normal group blank group medication group positive controls | ALT(IUL) 45.23±10.58 226.02±9.14 122.63±10.37 125.27±9.31 | AST(IUL) 141.13±13.21 327.26±32.17 220.28±27.64 221.46±42.72 | Liver index 45.24 ± 3.54 58.32 ± 4.95 47.18 ± 5.92 47.63 ± 6.13 |
Each organizes murine liver tissue pathological change situation (n=10)
| Group | Hepatocellular degeneration | Hepatic necrosis | The portal area inflammation | Central vein congestion | ||||||||||||
| Normal group blank group medication group positive controls | (-) 4 0 1 1 | (+) 6 0 4 4 | (++) 0 3 4 3 | (+++) 0 7 1 2 | (-) 7 0 3 3 | (+) 3 0 3 2 | (++) 0 1 2 3 | (+++) 0 9 2 2 | (-) 6 0 0 0 | (+) 4 0 5 4 | (++) 0 2 5 5 | (+++) 0 8 0 1 | (-) 3 0 1 2 | (+) 5 0 5 3 | (++) 2 3 3 4 | (+++) 0 7 1 1 |
The result shows: the low capacity composite injection good effect that contains monopotassium glycyrrhizunate of Application Example 5 preparations.
Claims (7)
1. compound formulation that contains monopotassium glycyrrhizunate is characterized in that it is made by following components in weight percentage:
Monopotassium glycyrrhizunate 20-75 part, glycine 1-800 part, L-cysteine hydrochloride 10-28 part and sodium chloride 10-30 part, anhydrous sodium sulfite 10-28 part, the mixing of one or more in disodium edetate 1-9 part.
2. the compound formulation that contains monopotassium glycyrrhizunate according to claim 1 is characterized in that described component made by the following weight proportioning:
Monopotassium glycyrrhizunate 30-55 part, glycine 300-600 part, L-cysteine hydrochloride 15-19 part, sodium chloride 13-25 part, anhydrous sodium sulfite 13-18 part, disodium edetate 2-6 part.
3. the compound formulation that contains monopotassium glycyrrhizunate according to claim 2 is characterized in that described component made by the following weight proportioning:
40 parts of monopotassium glycyrrhizunates, 400 parts of glycine, 18 parts of L-cysteine hydrochlorides, 16 parts in sodium chloride, 16 parts of anhydrous sodium sulfite, 3 parts of disodium edetate.
4. according to claim 1, the 2 or 3 described compound formulations that contain monopotassium glycyrrhizunate, it is characterized in that described preparation is one of small-volume injection, bulk capacity injection, injectable powder, lyophilized injectable powder.
5. the compound formulation that contains monopotassium glycyrrhizunate according to claim 4 is characterized in that described preparation is a small-volume injection.
6. the described preparation method that contains the compound formulation of monopotassium glycyrrhizunate of claim 5 is characterized in that, comprises the steps:
In percent by volume, in dense preparing tank, add up 82 ℃ of-88 ℃ of waters for injection of amount of preparation 75%-90%, in dense preparing tank, add disodium edetate then by weight ratio successively, the L-cysteine hydrochloride, glycine, sodium chloride, anhydrous sodium sulfite, monopotassium glycyrrhizunate, fully stir and make dissolving fully, amount by preparation cumulative volume 0.025%-0.035% adds active carbon again, be heated to 82 ℃-88 ℃, be incubated 25-35 minute, be cooled to 35 ℃-45 ℃ with the medicinal liquid decarbonization filtering to dilute preparing tank, in dilute preparing tank, add water for injection to the dosing amount, accent pH is 6.3-6.5, medicinal liquid is again through conventional end-filtration, and embedding is in ampoule, and ampoule fills nitrogen by propping up during embedding, sterilization promptly gets injection;
Wherein, the monopotassium glycyrrhizunate raw material needs to improve purity through recrystallization, makes the monopotassium glycyrrhizunate that is applicable to injection.
7. any described application of compound formulation in preparation treatment viral hepatitis, chronic persistent hepatitis, chronic active hepatitis, acute or chronic hepatitis B, liver poisoning, first cirrhosis medicine that contains monopotassium glycyrrhizunate among the claim 1-3.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510044582 CN1739536A (en) | 2005-09-12 | 2005-09-12 | A kind of compound formulation that contains monopotassium glycyrrhizunate and preparation method thereof and application |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100341515C (en) * | 2006-03-31 | 2007-10-10 | 山东山大康诺制药有限公司 | Film-coated tablet of glycyrrhizinic acid monopotassiium salt and method for preparing the same |
| CN104138385A (en) * | 2014-08-14 | 2014-11-12 | 广州一品红制药有限公司 | Composition containing compound ammonium glycyrrhetate S |
-
2005
- 2005-09-12 CN CN 200510044582 patent/CN1739536A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100341515C (en) * | 2006-03-31 | 2007-10-10 | 山东山大康诺制药有限公司 | Film-coated tablet of glycyrrhizinic acid monopotassiium salt and method for preparing the same |
| CN104138385A (en) * | 2014-08-14 | 2014-11-12 | 广州一品红制药有限公司 | Composition containing compound ammonium glycyrrhetate S |
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