CN100402038C - Use of ginseng saponin C-K in preparing medicine for treating or preventing liver fibrosis - Google Patents
Use of ginseng saponin C-K in preparing medicine for treating or preventing liver fibrosis Download PDFInfo
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- CN100402038C CN100402038C CNB2005100546346A CN200510054634A CN100402038C CN 100402038 C CN100402038 C CN 100402038C CN B2005100546346 A CNB2005100546346 A CN B2005100546346A CN 200510054634 A CN200510054634 A CN 200510054634A CN 100402038 C CN100402038 C CN 100402038C
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Abstract
The invention provides an use of ginseng saponin C-K in preparing medicine for treating or preventing liver fibrosis, especially generated by infection and chem. factor.
Description
Technical field
The present invention relates to a kind of ginsenoside application in the hepatic fibrosis in prevention or treatment, relate to particularly ginseng saponin C-K preparation prevention or treatment by infect and chemical factor due to the medicine of hepatic fibrosis in application.
Background technology:
Hepatic fibrosis is a chronic hepatopathy important pathological feature.The causes of disease such as virus, ethanol, autoimmune disease all can cause hepatic necrosis, regeneration and persistence fibroplasia, finally cause liver cirrhosis.Confirmed that now hepatic fibrosis is reversible pathological changes, liver cirrhosis then is irreversible.Therefore, in the therapeutic process of chronic hepatopathy, the control of hepatic fibrosis occupies the critical role Radix Ginseng and has strongly invigorating primordial QI, and multiple arteries and veins takes off admittedly, invigorating the spleen to benefit the lung, function such as promote the production of body fluid, calm the nerves.The ginsenoside is one of main active of Radix Ginseng.Contain in the medicine of the treatment hepatic fibrosis that has Radix Ginseng [Ji Guang, Cao Chenglou, Liu's equality. supporting vital QI and dispersing blood stasis side influences the pathology and the immunohistochemical study of rats with liver cirrhosis hepatocyte growth. Chinese TCM basis medical journal, 2001; 7 (2): 29]; The stem and leaf of Radix Ginseng saponin to hepatic fibrosis have preventive effect [Zou Liyi, Wu Tie. Mouse Liver sclerosis causes bone loss and stem and leaf of Radix Ginseng saponin's preventive and therapeutic effect. Acta Pharmaceutica Sinica, 2001; 36:886-890].
Radix Ginseng in the Chinese medicine is oral, and it is very low to go into the ratio of blood with prototype behind the multiple Radix Ginseng saponin oral liquor.Multinomial studies show that of Japan, all under the intestinal metabolism, produce ginseng saponin C-K behind the multiple Radix Ginseng saponin oral liquor, and then be absorbed into blood, so detected ginsenoside's prototype amount is very low in blood, but can examine C-K (ODANI T et al, Studies on absorption, distribution, excretion and metabolism of ginseng saponins.III.the absorption, distribution, excretion of ginsenoside Rb1 in the rats.Chem Pharm Bull 1983,31 (3): 1059-1066; AKAO T et al, Metabolic activation of crude drug components byintestinal bacterial enzymes.J Med Pharm Soc.WAKEN-YAKU 1992,9:1-13. (in Japanese); KARIKURA M et al, Studies on absorption, distribution, excretion and metabolism ofginseng saponins.V.the decomposition products of ginsenoside Rb2 in the large intestineof rats.Chem Pharm Bull 1990,38 (9): 2859-2861; KARIKURA M et al, Studies on absorption, distribution, excretion and metabolism of ginseng saponins.VII.comparison of thedecomposition modes of ginsenoside-Rbl and-Rb2 in the digestive tract of rats.ChemPharm Bull 1991,39 (9): 2357-2361).This shows that C-K may be that the Chinese medicine Radix Ginseng is in one of important component of bringing into play treatment usefulness.Studies show that C-K has the effect that new vessels generates, suppresses tumor growth and transfer that suppresses.But ginseng saponin C-K has or not inhibitory action not see bibliographical information to the hepatic fibrosis hypertrophy.
A large amount of studies have shown that of inventor's process, no matter ginseng saponin C-K is a drug administration by injection, or oral administration, the hepatic fibrosis hypertrophy all there is the obvious suppression effect, promptly ginseng saponin C-K has prevention or therapeutical effect to hepatic fibrosis.
Summary of the invention
The invention provides the application of ginseng saponin C-K in preparation prevention or treatment hepatic fibrosis.
The invention provides ginseng saponin C-K and preparing prevention or treatment by the application in the medicine of the hepatic fibrosis due to the infection.
The invention provides ginseng saponin C-K in preparation treatment or prevention because of the application in the hepatic fibrosis medicines due to the chemical factor.
The present invention also provides the pharmaceutical composition of being made up of ginseng saponin C-K and pharmaceutically acceptable carrier or adjuvant, this pharmaceutical composition can be prepared into tablet, capsule, drop pill, injection, freeze-dried powder or injectable emulsion with the pharmacy conventional method, preferably exists with tablet, drop pill or freeze-dried powder form.Said composition can be passed through oral or drug administration by injection, and drug administration by injection can intravenous injection or intramuscular injection.
Ginseng saponin C-K adopts different means to obtain from natural ginsenoside's degraded usually at present.We are according to the ginseng saponin C-K that prepared purification of the method among the Chinese publication CN1417345, be that method in 200410002110.8 has been prepared into C-K oral formulations and C-K freeze-dried powder with it with the number of patent application of pharmaceutics conventional method and my company respectively, and carried out the research of the effect of ginseng saponin C-K in prevention or treatment hepatic fibrosis with it.The result show the oral and drug administration by injection of ginseng saponin C-K all can effectively suppress by chemical factor or due to the hepatic fibrosis hypertrophy.To studies have shown that of hepatic fibrosis, hepatic fibrosis can cause by infecting (virus, antibacterial etc.) or chemical factor.Though cause the factor difference of hepatic fibrosis, but its basic pathology evolutionary process is quite similar, therefore with animal experiment study hepatic fibrosis and anti-hepatic fibrosis medicines the time, usually with the hepatic fibrosis due to the chemical damage as infecting and the common representative of chemical factor liver fibrosis due, and as preventing and the common model of medicine for treatment.Below be model with chemical factor institute liver fibrosis due, prove the effect of ginseng saponin C-K to hepatic fibrosis.
According to the routine result of test, the clinical dosage when we recommend ginseng saponin C-K as injecting drug use is 1-75mg/ day, preferred 5-50mg/ day.Clinical dosage during as oral medication is 2-200mg/ day, preferred 6-54mg/ day, more preferably 6-18mg/ day.
Be described in detail below in conjunction with the invention of preparation example and experimental example, but be not limited only to this us.
The specific embodiment
The preparation of preparation example 1 ginseng saponin C-K freeze-dried powder
Take by weighing the 1.00g ginseng saponin C-K, add 20ml ethanol saponin is melted fully, add 40ml glycerol mix homogeneously again.The EDTA-2Na of 0.02g is joined in the 40ml water for injection, adjuvant is dissolved fully.And above-mentioned aqueous solution joined in the drug solution mix homogeneously.Sodium hydroxide and dilute hydrochloric acid adjusting pH value with 0.01mol/L are 5.5 ± 1.0.The needle-use activated carbon 85 degree insulations of adding 0.1% 15 minutes, the G3 sintered glass funnel filters, the filtering with microporous membrane of 0.22um.Filtrate is sub-packed in the 7ml cillin bottle, every loading amount 2ml.Divide injection half tamponade install, in freeze dryer, freeze in, jewelling covers into lyophilized injectable powder, 20mg/ props up.
Preparation example 2 ginseng saponin C-K preparation of soft capsule
Take by weighing gelatin 100g, glycerol 30g and water 130g.Get an amount of water of gelatin adding and make its imbibition.In addition the water of glycerol and remainder is put and be heated to 70 ~ 80 ℃ in the glue pot, mix homogeneously adds expansible gelatin and stirs fusion.Be incubated 1 ~ 2 hour, leave standstill, make the foam come-up, scrape off the foam of come-up, filter, add 0.0075mgr Fe to clean calico
2O
3Powder, mixing, heat preservation for standby use.The gelatin viscosity that is made into is generally 2.8 ~ 3.2 degree.
Take by weighing ginseng saponin C-K 10g and be dissolved in poly-7 glycol of 90g, heating is fully dissolved it, puts to room temperature.
The compacting soft capsule: gelatin glycerol that will make and Radix Angelicae Sinensis oil are packed into and are rotated in the rolling capsule machine automatically, and temperature is controlled at 40 ~ 50 ℃, suppresses the soft capsule that every capsule contains 100mg medicinal liquid oil, and every soft capsule contains ginseng saponin C-K 10mg.
The preparation of preparation example 3 ginseng saponin C-K 10mg sheets
Prescription:
Ginseng saponin C-K 10.0g
Microcrystalline Cellulose 57.0g
Lactose 100.0g
Carboxymethyl starch sodium 10.0g
3%PVP
K30Aqueous solution is an amount of
Magnesium stearate 1.0g
Make 1000 altogether
Operation: take by weighing the abundant mix homogeneously of ginseng saponin C-K, lactose, microcrystalline Cellulose and carboxymethyl starch sodium of recipe quantity, add 3%PVP
K30Aqueous solution is made soft material in right amount, and 28 mesh sieves are granulated, 60 ℃ of dryings 3 hours, and 26 mesh sieve granulate add the magnesium stearate of recipe quantity, φ 8mm scrobicula stamping behind the mix homogeneously, the heavily about 180mg of adjustment sheet.
The capsular preparation of preparation example 4 ginseng saponin C-K 50mg
Prescription:
Ginseng saponin C-K 50.0g
Starch 150.0g
Dextrin 35.0g
3%PVP
K30Aqueous solution an amount of
Make 1000 altogether
Operation: the starch that takes by weighing ginseng saponin C-K 50.0g and equivalent (50.0g), abundant mix homogeneously, add the abundant mix homogeneously of recipe quantity dextrin after adding 100.0g starch mixing again, the PVPk30 aqueous solution that adds 3% behind the starch mix homogeneously of this mixed-powder and surplus is made soft material in right amount, and 28 mesh sieves are granulated, about 3 hours of 60 ℃ of dryings, 26 mesh sieve granulate, adorn capsule No. 1, regulate the about 230mg of loading amount, promptly.
Test example 1: the ginseng saponin C-K drug administration by injection is to the influence of hepatic fibrosis
Material:
Laboratory animal and grouping, male SD rat, Shandong Green Leaf Pharmaceutical Co., Ltd's Experimental Animal Center provides, and body weight 170-230g is divided into normal control group, model group, ginseng saponin C-K various dose group, 10 every group at random with laboratory animal.
Ginseng saponin C-K freeze-dried powder: by the preparation of preparation example method, with before being made into injection.
Experimental technique:
The rat liver fibrosis model copy reaches and respectively organizes method of disposal: with reference to the superfine method [Wu Mengchao that duplicates the rat liver fibrosis model of Wu Meng, Yang Guangshun. the research of rats'liver cirrhosis model copy. Chinese experimental surgery magazine, 1984,1 (4): 145-147], the every 100g body weight of every 4d subcutaneous injection 60% carbon tetrachloride oil solution 0.3ml, with 5% ethanol water as solvent.The every 4d subcutaneous injection of rats in normal control group oil solution 0.3ml/100g body weight, after 1 week, the next day gavage tap water 0.3ml/100g body weight, lumbar injection aquesterilisa 0.1ml/100g body weight every day (6 times weekly), with tap water as beverage; Hepatic fibrosis group rat is as stated above after 1 week of modeling, the next day gavage tap water 0.3ml/100g body weight, lumbar injection aquesterilisa 0.1ml/100g body weight every day (6 times weekly); Ginseng saponin C-K group rat is as stated above after 1 week of modeling, the next day gavage tap water 0.3ml/100g body weight, lumbar injection ginsenoside injection every day (6 times weekly).4th, 8 weekends, each group is randomly drawed 6 animals, presses 150mg/100g body weight intraperitoneal injection of anesthesia with 25% urethane solution, dissects, and hepatic tissue is left and taken in the portal vein blood sampling, and part is fixed with 10% neutral formalin solution, system paraffin mass in the 24-48h.
Observation index and assay method:
HE dyeing is adopted in the liver histopathology inspection, the fibroplasia degree be divided into the 0-4 level [Li Kun, Zhao Yuzhen, Zhu Qiushuan etc. ligustrazine is to the influence of the aged mouse heart, liver superoxide dismutase activity. Heilungkiang medical science, 1998; 21:4-5].Measure Serum hyaluronic acid content with radioimmunoassay, hyaluronic acid radioimmunoassay determination box grinds the medical biotechnology center available from Shang Haihai, and used instrument is that SN-695A type intelligence is put and exempted from the γ measuring instrument.Hydroxyproline determination adopts oxidizing process in the hepatic tissue, and detection kit is built up bio-engineering research institute available from Nanjing.
Pathological examination:
The rats in normal control group liver structure is normal; Tangible fibrosis all appears at 4 weekends of model group rat liver and 8 weekends; Fibrosis is all light than model group in each dosage group of C-K.
Hyaluronic acid contents in the rat blood serum:
4 weekends and 8 weekends, except that heavy dose was organized 8 time-of-week points, C-K other times point rat blood serum hyaluronic acid contents was all low than model group, significant difference (table 1).
Table 1 ginseng saponin C-K is to the influence of hepatic fibrosis rats hematohyaloid acid content (μ g/L)
△ compares P＜0.05 with the normal control group; ▲, compare P＜0.05 with model group; ▲ ▲, compares P＞0.05 with model group.Collagen content in the liver tissues of rats:
At 4 weekends, collagen content is lower than hepatic fibrosis group, significant difference in each dosage group liver tissues of rats of C-K; Also low during 8 weekends than model group, but heavy dose of difference not remarkable (seeing Table 2) of organizing.
Table 2 ginseng saponin C-K is to the influence of hepatic fibrosis rats hepatic tissue collagen content (mg/g hepar siccatum)
△ compares P＜0.05 with the normal control group; ▲, compare P＜0.05 with model group; ▲ ▲, compares P＞0.05 with model group.
Test example 2 ginseng saponin C-K oral administrations are to the influence of hepatic fibrosis
1, experiment grouping and processing:
50 male SD rats are divided at random: normal control group, model control group, ginseng saponin C-K group, every group of 10 rats.Subcutaneous injection 40% carbon tetrachloride (CCl
4) modeling, dosage is 0.3ml/kg (first dose doubles), per 3 days 1 time, and totally 15 times.The normal control group is then in kind injected the refining olive oil of equivalent.Modeling finishes the back and rose in the 2nd day, and the ginseng saponin C-K that gives model treatment group various dose is irritated stomach, every day 1 time, totally 42 times.Model control group then gives 0.5% carboxymethyl cellulose of equivalent and irritates stomach.Treatment finishes the back and puts to death animal, gets serum and hepatic tissue respectively and carries out every mensuration.
2, detect: (1) hepatic tissue HYP content assaying method see document [Zheng Shaoxiong is etc. the method improvement of hematuria hydroxyproline determination. Chinese journal of medical examination, 1983,6:133-136]; (2) serum HA, LN and PCIII assay: adopt and put the method for exempting from, press HA, LN and PcIII radioimmunology analysis and measure the operation of test kit description.(3) pathomorphology detects: adopt HE normal dyeing, VG collagen staining, and carry out liver fibrosis classification [Zhai Weirong, etc. the diagnosis of chronic hepatitis, classification and by stages. China's digestion magazine, 1996,16::277-281]; Transmission electron microscope is observed down and is respectively organized the rat Change of Ultrastructure.
3, result:
3.1 ginseng saponin C-K is to the influence of hepatic fibrosis rats hepatic tissue HYP content and serum HA, LN and PCIII content
Compare with the normal control group, Liver Fibrosis Model group hepatic tissue HYP content and serum HA, LN and PCIII content is significantly rising (P＜0.01) all; Each dosage group of ginseng saponin C-K all can reduce this four kinds of index levels, during heavy dose of group of effect seemingly is not so good as, low dose of obviously (table 3).When showing heavy dose medication for a long time, in the hepatic fibrosis that chemically resistant material is caused, C-K itself also may cause the damage of liver.Point out its dosage can not be too big.
Table 3 ginseng saponin C-K is to the influence of hepatic fibrosis rats hepatic tissue HYP content and serum HA, LN and PCIII content
△ compares P＜0.05 with the normal control group; ▲, compare P＜0.05 with model group; ▲ ▲, compares P＞0.05 with model group.
3.2 ginseng saponin C-K is to the influence of hepatic fibrosis rats pathomorphology
3.2.1 om observation: HE normal dyeing and VG collagen staining hepatic tissue section show, visible hepatic cell fattydegeneration in the Liver Fibrosis Model control rats hepatic tissue, necrosis, cell infiltration; Collagen fiber deposition in the portal area, Henny manages hypertrophy; The fibrous connective tissue hypertrophy is obvious, and the fibrous septum increases slightly, and has typical pseudolobuli to form.C-K treatment group liver tissues of rats fibrous connective tissue hyperplasia degree alleviates, and the fibrous septum attenuates, and pseudolobuli forms not obvious, and is obvious with middle dosage group especially, with the model control group comparing difference significance (P＜0.05) is arranged.
Table 4 ginseng saponin C-K is to the influence of rat liver fibrosis pathomorphism
Each treatment group of C-K and model group compare, P＜0.05.
3.2.2 electron microscopic observation: closely link to each other between the rats in normal control group hepatocyte, the interior various organelles of cell distribute regular, structure typical case.The blood sinus marshalling, the visible fat-storing cells of liver of Disse intracavity has fat to drip in the Cytoplasm.Typical hepatocyte injury structure then appears in the model control group liver tissues of rats, the gap broadening of adjacent hepatocyte, and the hepatocellular degeneration necrosis, karyopycnosis, the irregular fat that occurs in the Cytoplasm differing in size, distributing drips.The fibrosis lesion that exists weight not wait in the hepatic tissue.The sinus hepaticus blood capillaryization, visible more fibroblast (activatory fat-storing cells of liver) in the Disse gap, and a large amount of collagen fiber depositions are arranged on every side.A large amount of collagen fiber can appear in the portal area.In the ginseng saponin C-K treatment group, hepatocyte injury has alleviating in various degree, and the hepatocyte gap is tightr, and lipid droplet reduces in the Cytoplasm, and cell inner structure trend is normal.The hepatic fibrosis pathological changes is not obvious, and collagen fiber deposition and fibroblast-like cells quantity reduce in hepatic sinusoid and the Disse gap.
Claims (5)
1. the application of ginseng saponin C-K in the medicine of preparation treatment or prevention hepatic fibrosis.
2. application according to claim 1, ginseng saponin C-K in preparation treatment or prevention because of the application in the medicine of the hepatic fibrosis due to infecting.
3. application according to claim 1, ginseng saponin C-K in preparation treatment or prevention because of the application in the medicine of the hepatic fibrosis due to the chemical factor.
4. according to the arbitrary described application of claim 1-3, ginseng saponin C-K and pharmaceutically acceptable carrier or adjuvant are formed pharmaceutical composition.
5. application according to claim 4, pharmaceutical composition is made tablet, capsule, drop pill, injection, freeze-dried powder or injectable emulsion.
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| CNB2005100546346A CN100402038C (en) | 2004-03-09 | 2005-03-07 | Use of ginseng saponin C-K in preparing medicine for treating or preventing liver fibrosis |
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| ES2739203T3 (en) * | 2014-05-16 | 2020-01-29 | Wellhead Biological Tech Corp | Use of ginsenoside M1 for the inhibition of renal fibrosis |
| CN105012326B (en) * | 2015-08-13 | 2018-02-27 | 云南与诺生物工程有限责任公司 | Ginsenoside compound K, Rh1 and combinations thereof are preparing the application in improving nonalcoholic fatty liver fibrosis and insulin resistance medicine |
| WO2021164723A1 (en) * | 2020-02-20 | 2021-08-26 | Lee Sheau Long | Ginsenoside m1 as a modulator of angiotensin regulating enzymes and its use for treating diseases or conditions including symptoms caused by coronavirus |
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| Title |
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| 人参皂甙的活性综述. 刘欣等著.中国微生态学杂志，第17卷第1期卷. 2005 |
| 人参皂甙的活性综述. 刘欣等著.中国微生态学杂志，第17卷第1期卷. 2005 * |
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