CN100333751C - Chinese traditional medicine for curing cholestatic hepatitis and preparing method - Google Patents
Chinese traditional medicine for curing cholestatic hepatitis and preparing method Download PDFInfo
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- CN100333751C CN100333751C CNB2003101104917A CN200310110491A CN100333751C CN 100333751 C CN100333751 C CN 100333751C CN B2003101104917 A CNB2003101104917 A CN B2003101104917A CN 200310110491 A CN200310110491 A CN 200310110491A CN 100333751 C CN100333751 C CN 100333751C
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Abstract
The present invention discloses a Chinese traditional medicine for curing cholestatic hepatitis and a preparing method thereof. The Chinese traditional medicine of the present invention has the components by weight percentage: 5% to 80% of red peony root, 5% to 40% of radix rehmanniae, 5% to 50% of moutan bark, 0 to 40% of figwort root, 0 to 15% of liquorice and 0 to 20% of buffalo horn. The Chinese traditional medicine of the present invention combines a traditional Chinese medicine theory with a modern pharmaceutical research result; the red peony root is used as a main material; the radix rehmanniae and the moutan bark are used as assistant materials and are used for reinforcing the efficacy of cooling, activating and dissipating blood of the red peony root; the figwort root, the buffalo horn and the liquorice are used as the assistant materials; all the medicines are compounded and exert functions so that the Chinese traditional medicine of the present invention has the functions of resisting hepatic injury, improving hepatic microcirculation, benefiting the gallbladder, promoting bile excretion and quickly removing jaundice; the present invention has an obvious effect on curing cholestatic hepatitis.
Description
Technical field:
The present invention relates to a kind of Chinese medicine that is used for the treatment of cholestatic hepatitis and preparation method thereof.
Background technology:
Cholestatic hepatitis is long-term delay of bile acid to cause hepatocyte edema, necrosis and lobules of liver internal reaction inflammation, its clinical manifestation is body icteric sclera, yellowish urine, the scorching hot pruritus of skin, grab the petechia, back, skin ecchymosis, pharyngoxerosis, constipation, normal urination, nose bleeding from the gum blood, purplish tongue ecchymosis, Sublingual venation increase thick prolongation, slippery and rapid pulse, liver, splenomegaly etc.Adrenocortical hormone is effective in cure to the intrahepatic cholestasis of severe jaundice, but can not reduce the generation of complication, and its side effect simultaneously is big, thereby uses and limited to.And existing Chinese medicine is not obvious to the cholestatic hepatitis curative effect, and yet there are no the Chinese medicine of special for treating cholestatic hepatitis in the market.
Summary of the invention:
The object of the present invention is to provide a kind of evident in efficacy and Chinese medicine and preparation method thereof that is specifically designed to the treatment cholestatic hepatitis of having no side effect.
Chinese medicine of the present invention component by weight percentage is: Radix Paeoniae Rubra 5%-8%, Radix Rehmanniae 5%-40%, Cortex Moutan 5%-50%, Radix Scrophulariae 0-40%, Radix Glycyrrhizae 0-15%, Cornu Bubali 0-20%.
Chinese medicine of the present invention proportioning by weight is: Radix Paeoniae Rubra 1495, the Radix Rehmanniae 249, Cortex Moutan 498, Radix Scrophulariae 249, Radix Glycyrrhizae 125, Cornu Bubali 125.
The method for preparing this Chinese medicine: get the raw material of above-mentioned component,, collect distillate, obtain to contain the component of paeonol with the Cortex Moutan vapor distillation; Medicinal residues and surplus medical filtration, standby; Other flavour of a drug such as Radix Paeoniae Rubra, the Radix Rehmanniae mix, and extracting in water filters; Medicinal residues merge with the Cortex Moutan medicinal residues again, decoct with water extraction, filter, and merge the filtrate after twice gained filtrate and the Cortex Moutan distillation, are condensed into thick paste, add 95% ethanol precipitation, reclaim ethanol, are condensed into thick paste, add adjuvant and granulate; Get the component that contains paeonol of above-mentioned Cortex Moutan vapor distillation gained, add beta-cyclodextrin inclusion compound, make the Benexate Hydrochloride that contains paeonol, with above-mentioned granule mix homogeneously, promptly.
The best approach in above-mentioned preparation method is: gets the raw material of described component, Cortex Moutan added 14 times of water gaging distillations, collect the distillate that contains paeonol, and in about 24 hours of 2-5 ℃ of cold preservation, the crystallization of filter collection paeonol; The mother solution redistillation is once collected distillate, and cold preservation is about 24 hours under the same terms, the crystallization of filter collection paeonol; Cold drying below 40 ℃, the bottling sealing, standby; Medicinal residues and the medical filtration that does not distill out, standby; Other flavour of a drug such as Radix Paeoniae Rubra, the Radix Rehmanniae mix, adding 10 times of water gagings decocted 2 hours, filter, medicinal residues merge with the medicinal residues that Cortex Moutan steams behind the skin phenol again, add 8 times of water gagings and decocted 1.5 hours, filter, merge the filtrate after twice gained filtrate and Cortex Moutan distill out paeonol, vacuum concentration (temperature 60-70 ℃, vacuum 0.06-0.08Mpa) is about the thick paste of 1.25 (60 ℃) to relative density; This thick paste is added an amount of 95% ethanol, make Diluted Alcohol concentration be about 64%, fully stir, placement is spent the night, and filters; Filtrate, ethanol is reclaimed in decompression (temperature 50-60 ℃, vacuum is 0.06-0.08Mpa), being concentrated into relative density is the thick paste of 1.30-1.35 (60 ℃), adds the 300g dextrin, mixing, vacuum drying (temperature is 60-70 ℃, and vacuum is 0.08-0.09Mpa) to water content is less than 3%; Get dry extract, add sucrose, lactose, dextrin, pulverizing, cross 80 mesh sieves, with dehydrated alcohol granulation (crossing 14 mesh sieves), earlier be about 45 ℃ of dryings 1.5 hours in temperature, after treating most of ethanol volatilization, elevated temperature is dried to water content less than 3% at 70-80 ℃ to 50-60 ℃ of dry a period of time behind the granulate gradually; Get above-mentioned paeonol and measure 40% dissolve with ethanols with 24 times, add 8 times of amount beta-schardinger dextrin-s and carried out enclose in ultrasonic 40 minutes, 2-4 ℃ of cold preservation 24 hours, filter collection gained paeonol-Benexate Hydrochloride, 40 ℃ of hot air dryings, add 5 times of amount claim 1 or 2 described Chinese medicinal granule fine powders in the clathrate, behind the mixing, cross 14 mesh sieves with dehydrated alcohol and granulate, 40 ℃ hot air drying, gained granule and former grain color are roughly suitable like this, add in the former granule with the equivalent incremental method again, gained granule water content is qualified, mix homogeneously, promptly.
Theory of Chinese medical science thinks that Radix Paeoniae Rubra has the effect of clearing away heat and cooling blood, stasis-dispelling and pain-killing.The Radix Rehmanniae has clearing away heat and cooling blood and yin nourishing effect, is applicable to the warm febrile disease diseases such as fever of the body xerostomia due to the blood, crimson tongue of joining the army, again can cooling blood for hemostasis, and the nosebleed of telling of treatment bleeding due to blood-heat is had blood in stool, and goes into the medicine commonly used of nutrient blood for heat, also can prevent the product blood trouble hematozemia of removing pathogenic heat from blood and dissipating blood stasis.Cortex Moutan has the effect of clearing away heat and cooling blood, promoting blood circulation to remove blood stasis.Radix Scrophulariae, the yin nourishing of Cornu Bubali clearing heat in YING system, inducing Ying heat into Qi phase.Radix Scrophulariae can the yin nourishing removing heat from blood, and the effect of clearing away heat-fire is arranged again.
And modern pharmacology studies show that the Radix Paeoniae Rubra animal experiment has effects such as spasmolytic, blood vessel dilating, analgesia, spasmolytic.Radix Paeoniae Rubra has protective effect to hepatocyte, and effects such as the liver microcirculation of improvement, reduction portal venous pressure are arranged, and can suppress the little gathering of blood, reduces TXA
2Synthesize and help bile excretion, zoopery proves tangible choleretic effect.Cortex Moutan has effects such as antipyretic-antalgic, antiinflammatory and immunomodulating, anticoagulant, antithrombotic formation, and the Cortex Moutan water decoction can make animal blood pressure reduce, and zoopery proves that it can reduce vascular permeability.The Cortex Moutan general glycoside has scavenging action to free radical, and can suppress H
2O
2The hemolytic reaction that causes by influencing the liver metabolism function, strengthens antioxidation, strengthens the anti-damaging action of detoxification ability mechanism performance.The Radix Rehmanniae has anti peroxidation of lipid damage and improves effect such as liver microcirculation.Radix Scrophulariae has blood vessel dilating, bring high blood pressure down and effect such as blood sugar lowering.Cornu Bubali has cardiotonic, and blood vessel is then presented of short duration contraction earlier then tangible dilating effect, and blood pressure is then fallen after rising, and continues then to rise, and illustrating has regulating action to body-internal-circulation.Radix Glycyrrhizae has the effect of pair anti-acetylcholine, has Detoxication, and enoxolone has the effect of adrenocortical hormone sample, and glycyrrhizin can promote the bile secretion of laboratory animal, and can reduce bilirubin.
Chinese medicine of the present invention combines traditional theory of Chinese medical science with the modern pharmacy result of study, reusing Radix Paeoniae Rubra is that monarch is aided with Radix Rehmanniae Cortex Moutan with it, be used to strengthen the effect of the diffusing blood of Radix Paeoniae Rubra removing heat from blood and promoting blood circulation, assistant is with Radix Scrophulariae, Cornu Bubali, Radix Glycyrrhizae is for making, all medicines are associated with and are brought out the best in each other, and make Chinese medicine of the present invention have anti-liver injury, improve liver microcirculation, the effect of function of gallbladder promoting, the rapid jaundice eliminating of promotion bile excretion, the treatment cholestatic hepatitis are had the effect of highly significant.
Be the drug effect that a step confirms Chinese medicine of the present invention, the inventor has carried out zoopery to this, and Chinese medicine of the present invention is used for the cholestatic hepatitis patient, and its experiment and result are as follows:
Test material:
1, experimental animal:
Mice: Kunming kind, 18-22g, ♀ ♂ dual-purpose, the Jiangxi College of Traditional Chinese Medicine Experimental Animal Center provides.
Rat: SD is male, and body weight is about 130-220 and 500-700 gram two kinds, and Jiangxi Province's Experimental Animal Center provides.
2, medicine and reagent:
(1) extractum of the present invention: specification: 4.69g crude drug/g extractum.
Mice with dosage is: low dose group 7.15g crude drug/Kg, middle dosage group 14.3g crude drug/Kg, high dose group 28.6g crude drug/Kg.
Extractum of the present invention: 4.69g crude drug/g extractum, proportion are 1.375, and the administration capacity of mice is 25ml/Kg.
So low dosage: 7.15g crude drug/25ml, promptly get 7.15/4.69/1.375
*4=4.4ml extractum adds normal saline to 100ml;
Middle dosage: 14.3g crude drug/25ml, promptly get 13.6/1.16
*4=8.8ml extractum adds normal saline to 100ml;
High dose: 28.6g crude drug/25ml, promptly get 27.2/1.16
*4=17.6ml extractum adds normal saline to 100ml;
Low dosage: 6.8g crude drug/Kg, promptly get 6.8/4.24/1.16
*4=5.53ml extractum adds normal saline to 100ml.
Rat with dosage is: low dose group 4.9g crude drug/Kg, middle dosage group 9.8g crude drug/Kg, high dose group 19.6g crude drug/Kg.
Extractum of the present invention: 4.69g crude drug/g extractum, proportion are 1.375, and the administration capacity of rat is 10ml/Kg.
So low dosage: 4.9g crude drug/10ml, promptly get 4.9/4.69/1.375
*10=7.6ml extractum adds normal saline to 100ml;
Middle dosage: 9.8g crude drug/10ml, promptly get 9.8/4.69/1.375
*10=15.2ml extractum adds normal saline to 100ml;
High dose: 19.6g crude drug/10ml, promptly get 19.6/4.69/1.375
*10=30.4ml extractum adds normal saline to 100ml.
(2) the grand electuary of sharp liver: Luzhou Baoguang Pharmaceutical Industrey Co., Ltd., every bag of 10g of specification, people's 30 gram/orders, convert to such an extent that mice dosage is: 3.88g crude drug/Kg by body surface area method and people's dosage, administration volume: 25ml/Kg, compound method: accurately take by weighing the grand granule of the sharp liver of 15.52g and add normal saline to 100ml.Convert to such an extent that rat dosage is: 2.7g crude drug/Kg by body surface area method and people's dosage; Administration volume: 10ml/Kg, compound method: accurately take by weighing the grand granule of the sharp liver of 54g and add normal saline to 200ml.
(3) carbon tetrachloride: AR, Shanghai chemical reagent factory, 0.1%CCl
4, 0.1mlCCl
4Add vegetable oil to 100ml, the administration capacity is: 10ml/Kg, the mouse peritoneal injection is made the acute liver damage model and is used.
(4) Cyclophosphamide for injection: 0.2g * 5 bottle, adult 0.2g, once a day, 1 bottle of cyclophosphamide (200mg) is got by the permanent auspicious medical limited company in Jiangxi, adds the injection water to 50ml, and is now with the current.
(5) Dou Shi reagent: sodium bicarbonate 1.0g, potassium cyanide 0.05g, high-potassium ferricyanide 0.2g, distilled water 1000ml surveys hemoglobin and uses.
(6) complement: be guinea pig serum: get healthy guinea pig blood, separation of serum, with being for experiment after the normal saline dilution in 1: 10, former serum is preserved standby in-20 ℃ of refrigerators.
(7) 20% urethanes: chemical plant, sun middle school, business section, Shanghai product, take by weighing urethane 20 grams, adding distil water is to 100ml.
(8) α-ANIT (ANIT): the Sigma product is made into product 2.5% (W/V) with vegetable oil.
(9) SRBC (sheep red blood cell (SRBC)): the male doctor of Nanchang City's remittance inspection center.
(10) SGPT test kit: give birth to Bioisystech Co., Ltd in Beijing.
3, administration capacity: mouse stomach is the 25ml/kg body weight, and rat oral gavage is the 10ml/kg body weight.
4, statistical disposition: experimental data is carried out statistical disposition with the SPSS system, checks with t according to the distribution situation of data, or t ' check, to draw corresponding conclusion.
One, Chinese medicine of the present invention is to the influence of carbon tetrachloride induced mice acute liver damage
1, animal grouping: get 60 of mices, be divided into 6 groups at random, 10 every group, Chinese medicine low dose group promptly of the present invention (7.15g crude drug/Kg), middle dosage group (14.3g crude drug/Kg), high dose group (28.6 g crude drugs/Kg); The sharp grand group of liver (3.88g/Kg); Carbon tetrachloride model group and normal control group.
2, each treated animal carries out gastric infusion respectively, concentration medicine, high dose group of the present invention in the dosage group filling stomach in normal matched group, model group filling stomach normal saline, Chinese medicine low dose group of the present invention filling stomach low concentration medicine, the Chinese medicine of the present invention are irritated stomach high concentration medicine, the grand grand suspension of filling stomach profit liver of organizing of sharp liver, the administration volume is 25ml/Kg, once a day, successive administration 6 days, administration in morning every day.1 hour all the other mices at different levels chambeies injection 0.1%CCl except that the normal control group behind the last filling stomach
4, capacity is 10ml/Kg, each treated animal is plucked eyeball and is got blood after 24 hours, places, and distinguishes serum, carries out SGPT (glutamate pyruvate transaminase) and puts to death animal, takes out liver and carries out the pathomorphology inspection, the results are shown in Table 1, table 2:
Table 1 Chinese medicine of the present invention is to the influence of carbon tetrachloride induced mice acute liver damage
| Group | Number of animals | Dosage (/Kg) | SGPT(U) | |
| The normal control group | 9 | 25ml | 58.89±45.23 | |
| CCl 4Model group | 8 | 10ml | 298.75±222.49 △ | |
| Chinese drug-treated group of the present invention | Low | 10 | 6.8g crude drug | 261.89±231.25 |
| In | 10 | 13.6g crude drug | 79.50±22.50 ▲ | |
| High | 9 | 37.2g crude drug | 74.33±31.59 ▲ | |
| The grand group of sharp liver | 10 | 3.88g | 57.80±30.35 ▲ | |
Adopt the t check, compare with the normal control group,
△P＜0.001; Compare with model group,
▲P＜0.01.
As can be seen from Table 1, CCl
4Model group animal serum GPT value obviously raises, illustrate that modeling is successful, except that Chinese medicine low dose group of the present invention, the grand group of the Chinese medicine of the present invention of middle and high dosage group and sharp liver all can reduce serum GPT value, illustrate acute liver damage effect due to the antagonism carbon tetrachloride (10 persons of less than be because of have the haemolysis specimen fill need not).
Table 2 Chinese medicine of the present invention is to the pathological examination result of carbon tetrachloride induced mice acute liver damage
| Group | Number of animals | No focus | The point-like lamellar necrosis of several visuals field | Each visual field point-like lamellar necrosis | The visual field a plurality of point-like lamellar necrosis | |
| Normal saline | 10 | 10 | 0 | 0 | 0 | |
| CCl 4Model group | 10 | 0 △ | 0 △ | 5 △ | 10 △ | |
| Chinese drug-treated group of the present invention | Low | 10 | 0 | 2 ▲ | 7 | 7 ▲ |
| In | 9 | 0 | 2 ▲ | 6 | 2 ▲ | |
| High | 10 | 1 | 4 ▲ | 5 | 2 ▲▲▲ | |
| The grand group of sharp liver | 10 | 0 | 0 | 7 | 6 ▲▲ | |
Adopt X 2 test, compare with the normal saline group,
△P＜0.001; Compare with model group,
▲P＜0.05,
▲ ▲P＜0.01,
▲ ▲ ▲P＜0.001.
Murine liver tissue 10% formalin fixed, the routine paraffin wax section, HE dyeing, 10 * 10 times of mirrors are observed down, and find: normal saline treated animal liver organization structure is normal, and the model group liver organization is popularity, some property or lamellar focus, be distributed in around the central vein more, focus shows as hepatocellular degeneration, swelling, necrosis, structural fuzzy, and with inflammatory cell infiltration.The grand group of sharp liver focus has gentlier with model group and changes, and the low group of Chinese medicine of the present invention and model group relatively have light obviously change; The Organization Department of the CPC Central Committee of the present invention divides the murine liver tissue focus to improve, and the high group of the present invention liver tissue injury obviously alleviates, and focus is dwindled, and has a mice to recover normal substantially.
Two, the influence of mice serum hemolysin
1, animal grouping: get 72 of mices, be divided into 6 groups at random, 12 every group, Chinese medicine low dose group promptly of the present invention (7.15g crude drug/Kg), middle dosage group (14.3g crude drug/Kg), high dose group (the 28.6g crude drug/Kg); The sharp grand group of liver (3.88g/Kg); Cyclophosphamide model group and normal control group.
2, observation index: each treated animal carries out gastric infusion respectively: promptly the dosage group is irritated concentration medicine in the stomach in normal control group, model group filling stomach normal saline, Chinese medicine low dose group of the present invention filling stomach low concentration medicine, the Chinese medicine of the present invention, Chinese medicine high dose group of the present invention is irritated stomach high concentration medicine, the grand grand suspension of the sharp liver of filling stomach of organizing of sharp liver, the administration volume is 25ml/Kg, once a day, successive administration 7 days, administration in morning every day.Except that the normal control group, other each treated animal subcutaneous injection 4mg/ml cyclophosphamide 10ml/Kg, for three days on end; Got in the 4th day and dilute good SRBC0.2ml ip in mice, 1 hour mice is plucked eyeball and gets blood behind the last filling stomach, with drop of blood to centrifuge tube, placed 1 hour under the room temperature, with thin Glass rod solidification blood and tube wall are peeled off, serum is fully oozed out, after 1 hour with 2000 rev/mins centrifugal 10 minutes, get upper serum; Isolated serum is diluted 250 times with normal saline, and (20ul to 5ml) in 56 ℃ of water-baths, 30 minutes deactivation complements are got this blood serum sample 1ml and are added in the reaction tube, add 0.5mlSRBC (2 * 10 again
9/ ml), put in the ice bath cooling after, in every pipe, add the 1ml complement, 37 ℃ of insulations 10 minutes, after the insulation reaction tube is moved in the ice bath, with cessation reaction immediately then.With reaction tube with 2000 rev/mins centrifugal 10 minutes, get supernatant and carry out hemoglobin colour comparison and measure.The sample blank control tube, outside 1ml physiologic saline for substitute blood serum sample, all same reaction tube of SRBC and complement addition and operating procedure.Get above-mentioned centrifugal gained supernatant 1ml and 3ml Dou Shi reagent and place test tube fully to shake up, put 10 minutes after because whole hemoglobin that haemolysis produces become cyanohemoglobin, be stable redness, in the 540nm colorimetric.The trap value of determination test during: the trap value of hemoglobin when each test all should be measured used SRBC HD50 with the SRBC HD50.Promptly get the SRBC through washing and dilution of 0.25ml test usefulness, be diluted to 4ml, shake up, placed 10 minutes with Dou Shi reagent, in the 540nm colorimetric, record trap value.Trap value when this value is used SRBC HD50 in the test.The half hemolysis value of sample (HC50) calculates by following formula, and result of the test sees Table 3:
Trap value * extension rate during Hc=50 sample light absorption value/SRBC HD50.
Table 3 Chinese medicine of the present invention is to the influence of mice serum hemolysin
| Group | Number of animals | Dosage (/Kg) | Hemolysin | |
| The normal control group | 12 | 25ml | 132.48±34.54 | |
| The cyclophosphamide group | 12 | 40mg | 52.05±6.43 △ | |
| Chinese drug-treated group of the present invention | Low | 12 | 7.15g crude drug | 61.60±5.64 |
| In | 12 | 14.3g crude drug | 50.59±4.28 | |
| High | 11 | 28.6g crude drug | 80.45±19.51 ▲▲▲ | |
| The grand group of sharp liver | 12 | 3.88g | 27.63±4.10 | |
Adopt t ' check, compare with the normal control group,
△P＜0.001; Compare with model group,
▲P＜0.01.
As can be seen from Table 3, cyclophosphamide can cause the mice serum hemolysin level to descend, the modeling success is described, Chinese medicine high dose group of the present invention can very obviously improve the mice serum hemolysin level, the mouse humoral immune function is had obvious facilitation, and the grand medicine of the Chinese medicine of the present invention of low, middle dosage group and sharp liver there is not tangible influence (Chinese medicine high dose group of the present invention has a sample hemolysis) to the mouse humoral immune function.
Three, Chinese medicine of the present invention causes the influence of cholestasis type jaundice rat to α-ANIT (ANIT)
1, animal grouping: be divided into 6 groups at random, every group 10, be Chinese medicine low dose group of the present invention (4.9g crude drug/Kg), middle dosage group (9.8g crude drug/Kg), high dose group (19.6g crude drug/Kg), the grand group of sharp liver (2.7g/Kg), ANIT model group and normal control group.
2, observation index: each treated animal carries out gastric infusion respectively: promptly concentration medicine, Chinese medicine high dose of the present invention are irritated the stomach high concentration medicine in the dosage filling stomach in normal control group, model group filling stomach normal saline, Chinese medicine low dose group of the present invention filling stomach low concentration medicine, the Chinese medicine of the present invention, profit has the grand grand suspension of filling stomach profit liver of organizing, the administration volume is 10ml/Kg, once a day, successive administration 6 days, administration in morning every day.Last filling stomach after 1 hour except that the normal control group, press 100mg/Kg and irritate stomach ANIT once by other each treated animals; Water is can't help in each treated animal fasting; After rat is anaesthetized with urethane 60mg/Kgip after 24 hours, facing upward the position is fixed on the fixing head, cut about 2cm along the abdomen median line, open the abdominal cavity, find stomachus pyloricus, the upset duodenum, in the descendant duodenum mesentery, find white flexible bile duct, under it, wear 2 rhizoid lines, the ligation pars papillaris, each is organized rat and gives normal saline by duodenum respectively, the Chinese medicine of the present invention of variable concentrations and sharp liver are swelled each 1ml/100g of electuary, make (V) shape otch to the liver direction after 30 minutes, insert plastic tube, promptly visible faint yellow bile flows out, ligation fixed plastics pipe is collected bile with small beaker.Used after operation hemostasis clamp closes stomach wall, covers with saline gauze, collects bile once every 30min, and totally 8 times, the record bile flow.After having collected bile, animal hearts is got blood, carries out SGPT, total bilirubin determination; The results are shown in Table 4, table 5.
Table 4 Chinese medicine of the present invention causes the influence of cholestasis type jaundice rat bile to α-ANIT (ANIT)
| Group | Number of animals | Dosage (/Kg) | Bile flow (ml) | |
| Normal saline | 9 | 25ml | 3.80±0.33 | |
| The ANIT group | 9 | 100mg | 2.10±0.66 △△ | |
| Chinese drug-treated group of the present invention | Low | 9 | 4.9g crude drug | 3.54±0.19 ▲ |
| In | 9 | 9.4g crude drug | 3.85±0.36 ▲▲ | |
| High | 8 | 18.8g crude drug | 4.50±0.35 ▲▲▲ | |
| The grand group of sharp liver | 8 | 2.7g | 2.45±0.69 | |
Adopt the t check, compare with the normal control group,
△P＜0.05,
△ △P＜0.01,
△ △ △P＜0.001; Compare with model group,
▲P＜0.05,
▲ ▲P＜0.01, P＜0.001.
Table 5 Chinese medicine of the present invention causes the influence of cholestasis type jaundice rat to α-ANIT (ANIT)
| Group | Number of animals | Dosage (/Kg) | SGPT(U) | Tbil | |
| Normal saline | 10 | 25ml | 14.70±8.50 | 0.94±0.11 | |
| The ANIT group | 9 | 100mg | 168.44±36.37 △△△ | 2.96±0.43 △△△ | |
| Chinese drug-treated group of the present invention | Low | 9 | 4.9g crude drug | 84.00±43.97 ▲▲▲ | 2.15±0.57 ▲▲▲ |
| In | 8 | 9.4g crude drug | 91.78±33.15 ▲▲▲ | 1.82±0.23 ▲▲▲ | |
| High | 8 | 18.8g crude drug | 62.00±20.99 ▲▲▲ | 1.57±0.24 ▲▲▲ | |
| The grand group of sharp liver | 8 | 2.7g | 45.00±52.42 ▲▲▲ | 1.07±0.37 ▲▲▲ | |
Adopt the t check, compare with the normal control group,
△P＜0.05,
△ △P＜0.01,
△ △ △P＜0.001; Compare with model group,
▲P＜0.05,
▲ ▲P＜0.01, P＜0.001.Normal control group, ANIT group, basic, normal, high group of Chinese medicine of the present invention and the grand group of sharp liver have 1,1,1,1,2,2 animal to insert the bile duct failure respectively, so do not obtain gallbladder juice; Remove the normal control group, other each groups all have the haemolysis test tube, so there are not 10 specimen.
As can be seen from the above table, ANIT group rat bile flow obviously reduces, and serum GPT, Tbil obviously raise, the modeling success is described, the basic, normal, high dose drug of Chinese medicine of the present invention all can very obviously increase the rat bile flow, reduce serum GPT, Tbil, illustrate that this medicine has the effect of good promoting the function of the gallbladder to alleviate jaundice.
Conclusion:
1, Chinese medicine of the present invention has the certain protection effect for the chmice acute hepatic injury due to the carbon tetrachloride, and can reduce serum GPT value;
2, Chinese medicine high dose of the present invention can improve the mouse humoral immune function, can obviously improve mice serum hemolysin value;
3, Chinese medicine of the present invention has the effect of tangible promoting the function of the gallbladder to alleviate jaundice, can obviously increase α-ANIT (ANIT) and cause cholestasis type jaundice rat bile flow, for serum GPT, total bilirubin, the bilirubin direct of its rising the decline effect is arranged.
Four, toxicity test:
1, acute toxicity test:
The overt toxicity reaction is not seen in the mouse stomach administration acute toxicity test of taking Chinese medicine of the present invention, and maximum tolerated dose (MTD) is 495.24g crude drug amount/Kg, is equivalent to intend 323.97 times of people's consumption.The result shows that the medication under clinical medicine dose of this medicine is safe.
2, long term toxicity test:
The rat long term toxication uses 128.98,64.49 respectively, 25.76g crude drug/Kg administration, be equivalent to 82.15 times, 41.08 times, 16.43 times of the clinical consumption of people, continuous irrigation stomach six months, phase of administration as a result and restorative observation period (2 week) compare with the blank group, and each treated animal shows no obvious abnormalities at aspects such as diet, activity, drainage, the mental status; Organ coefficient, hematology's testing result are all in normal range; Blood biochemical is learned and is detected Non Apparent Abnormality; Histopathologic slide does not have specificity and changes.Show that it is safe using in the Chinese medicine clinical application scope of the present invention.
Five, Chinese medicine of the present invention is used for the treatment of the curative effect that the cholestatic hepatitis patient has observed highly significant.Clinical example is as follows:
Case 1:
Huang, man, 53 years old, doctor, admission number 24460.Because of positive 4 years of HBsAg, yellowish urine 20 days, body icteric sclera 10 days were in hospital 28 days on February 19th, 2002 to March 19.Once suffering from " acute icterohepatitis (cause of disease is ominous) " in 1984 heals through controlling.At the beginning of 1999 the clothes heptodin altogether a year and a half be admitted to hospital before drug withdrawal 4 months.Look into abnormal liver function before being admitted to hospital with diammonium glycyrrhizinate, matrine treatment 10 days outside institute, jaundice deepens to be in hospital, companion's abdominal distention when being admitted to hospital, receive food still can, have a medical check-up skin and sclera severe xanthochromia, both hands liver palm, no spider angioma, red tongue, yellow fur, stringy pulse.Be admitted to hospital and look into liver function ALT621IV/L, AST580IV/L, TBiL394.5umol/L, DBiL253.4umol/L, hepatitis B HBsAg, HBeAg, the HBcAb positive, HBV-DNA4.2 * 10
5Cpov/ml, PTA52%.Be diagnosed as the heavy liver tendency of chronic viral hepatitis B, B ultrasonic shows liver cirrhosis.Be admitted to hospital the back with Chinese medicine agreement Fang Weizhu of the present invention, day potion, decocting divides secondary oral, cooperates treatments such as tiopronin tablets, solcoseryl, vein makeup energy.Symptom is alleviated gradually, jaundice alleviates gradually, and to check on March 18 ALT70IV/L, AST106IV/L, TBiL73umol/L, PTA52%, improvement is left hospital, and continues to take traditional Chinese medicine after leaving hospital 21 days, and liver function ALT, AST, TbiL are all normal, withdraw.
Case 2:
Soup, man, 30 years old, security personnel.Admission number 25356.Because of positive 13 years of HBsAg, poor appetite, weak, abdominal distention first quarter moon, be in hospital 50 days in 1 week of body icteric sclera on May 14th, 2002 to July 3.Ugly, sleep poor, have a medical check-up skin and sclera severe xanthochromia of companion's tooth blood when being admitted to hospital, injection site skin ecchymosis, abdominal part is flat soft, 2cm under the right rib of liver, the blunt no tenderness in limit in the 1cm matter under the sword, spleen is little, the murphy sign feminine gender, the both hands liver palm is suspicious.Be admitted to hospital and look into liver function ALT668IV/L, AST512IV/L, TBiL295umol/L, DBiL208umol/L, PTA70%, five indexes of hepatitis b HBsAg, HBeAg, the HBcAb positive, HBV-DNA7.2 * 10
8Cpoy/ml.AD chronic hepatitis B severe, heavy liver tendency, B ultrasonic show that the liver luminous point increases slightly.With treatments such as Chinese medicine agreement Fang Weizhu of the present invention, day potion, decocting, branch secondary clothes, cooperation Energy mixture, branched-chain amino acid, vitk1, solcoseryls, to check on July 2 liver function ALT55IV/L, AST35IV/L, TBiL38.1umol/L, PTA92%, the cloudy commentaries on classics of five indexes of hepatitis b HbeAg, remission, jaundice disappear substantially, do not reach the band Chinese medicine after treatment of leaving hospital under the right rib of the liver of having a medical check-up.
Case 3:
Huang, man, 34 years old, individuality.Admission number 24869.Because of being in hospital 43 days altogether to November 4 in poor appetite, weak, yellowish urine January in JIUYUE in 2002 22 days.1 week of premorbid is because of 2 bags of " benefit health " plasma transfusions.The morbidity back protects the liver, falls enzyme, symptomatic treatment outside institute, jaundice deepens to come my institute.Human health screening skin and sclera degree of depth xanthochromia, no spider angioma, both hands liver palm, flat soft, the no tenderness of abdomen and rebound tenderness, the right rib of liver reach the limit down, pain is kowtowed in the hepatic region, the murphy sign positive, the sign of ascites feminine gender, chemical examination liver function ALT650IV/L, AST245IV/L, TBiL372umol/L, DBiL250umol/L, PTA33%, five indexes of hepatitis b HBsAg, HBeAg, the HBcAb positive, HBV-DNA8.5 * 10
6Cpoy/ml.Give Chinese medicine agreement Fang Weizhu of the present invention, day potion, decocting, branch secondary clothes after being admitted to hospital, cooperate tiopronin tablets, TAD, solcoseryl, Energy mixture, vitk
1Deng treatment, symptom is alleviated gradually, and jaundice fades away.To check on October 22 ALT, AST normal, TBiL29.4umol/L, PTA59%, continued to take traditional Chinese medicine 10 days, liver function is normally left hospital.
Case 4:
Jiang, man, 61 years old, workman.Admission number 23622.Because of weak January, increase the weight of body body icteric sclera 4 days and be in hospital 36 days altogether October 18 calendar year 2001 to November 23.Because of the most of excision of the capable stomach of gastric ulcer massive hemorrhage, art is also transfused blood hundreds of milliliters before 12 years.Receive when being admitted to hospital food still can, big dry stool, red tongue, yellow fur, wiry and frequent pulse.Have a medical check-up skin and sclera severe xanthochromia.1cm, soft, the no tenderness of matter, both hands liver palm under the right rib of liver.Chemical examination liver function ALT587IV/L, AST873IV/L, TBiL457umol/L, A/G 32.4/33.3g/L, PTA48%, five indexes of hepatitis b HBsAg, HBeAg, the HBcAb positive are diagnosed as chronic viral hepatitis B and accompany intrahepatic cholestasis, heavy liver tendency, spleen not to have.B ultrasonic shows the liver luminous point, increases thick, spleen enlargement.Give Chinese medicine agreement Fang Weizhu of the present invention, day potion, decocting divides the secondary clothes, cooperates vitBco, vitc, citk
1, treatments such as branched-chain amino acid, Energy mixture 1 month, transference cure, jaundice obviously alleviates.ALT, AST are normal in check on November 19, TBiL59umol/l, the band medicine after treatment of leaving hospital.
Case 5:
Tang, man, 39 years old, cadre.Admission number 23561.Because of positive 14 years of HBsAg unusual 1 year of ALT repeatedly, feel sick, detest oil 5 days and be in hospital 76 days in 25th October 10 calendar year 2001 to December.History of drinking history is 20 years before being admitted to hospital, and 1-2 time weekly, each 3-4 two Chinese liquor.Companion's poor appetite when being admitted to hospital, epigastric discomfort.Have a medical check-up skin and sclera do not have xanthochromia, no spider angioma, and the both hands liver palm, abdomen is flat soft, and the liver spleen is little, the sign of ascites feminine gender.Chemical examination liver function ALT657IV/L, AST367IV/L, TBiL27.5umol/L, five indexes of hepatitis b HBsAg, HBeAg, the HBcAb positive, HBV-DNA8.9 * 10
8Cpoy/ml.B ultrasonic shows the liver diffuse lesion.AD is a chronic viral hepatitis B.Successively give treatments such as potenlin, diammonium glycyrrhizinate, TAD, liver peace, jaundice occurs to deepen gradually, looked into liver function ALT123IV/L, AST164IV/L, TBiL304umol/L November 5, PLA56%, diagnosis considers to have heavy liver tendency.Change the Fang Weizhu that reaches an agreement on into the present invention, day potion, decocting divides the secondary clothes, cooperates vitk
1, treatment such as branched-chain amino acid, solcoseryl, TAD, transference cure, jaundice fades away.December check on the 13rd liver function ALT, AST are normal, TBiL32umol/L, PTA100%, five indexes of hepatitis b HBsAg, the HBcAb positive, HBV-DNA2.98 * 10
5Cpoy/ml.Continue to strengthen treatment left hospital in 10 days.
Confirm all that from above-mentioned zoopery result and clinical treatment case Chinese medicine of the present invention is very strong to the treatment specific aim of cholestatic hepatitis, promoting the function of the gallbladder to alleviate jaundice effect highly significant, and have no side effect, prescription is simple in addition, with low cost, be the special-purpose medicine of a kind of good cholestatic hepatitis.
The specific embodiment:
Embodiment one:
Get Radix Paeoniae Rubra 1495g, Radix Rehmanniae 249g, Cortex Moutan 498g, Radix Scrophulariae 249g, Radix Glycyrrhizae 125g, Cornu Bubali 125g.Cortex Moutan is added 14 times of water gaging distillations, collect the about 2000ml of distillate that contains paeonol, in about 24 hours of 2-5 ℃ of cold preservation, the crystallization of filter collection paeonol.The mother solution redistillation is once collected the about 500ml of distillate, and cold preservation is about 24 hours under the same terms, the crystallization of filter collection paeonol.Cold drying below 40 ℃, the bottling sealing, standby.Medicinal residues and the medical filtration that does not distill out, standby.Other flavour of a drug such as Radix Paeoniae Rubra, the Radix Rehmanniae mix, adding 10 times of water gagings decocted 2 hours, filter, medicinal residues merge with the medicinal residues that Cortex Moutan steams behind the skin phenol again, add 8 times of water gagings and decocted 1.5 hours, filter, merge the filtrate after twice gained filtrate and Cortex Moutan distill out paeonol, vacuum concentration (temperature 60-70 ℃, vacuum 0.06-0.08Mpa) is about the thick paste of 1.25 (60 ℃) to relative density.This thick paste is added an amount of 95% ethanol, make Diluted Alcohol concentration be about 64%, fully stir, placement is spent the night, and filters.Filtrate, ethanol is reclaimed in decompression (temperature 50-60 ℃, vacuum is 0.06-0.08Mpa), being concentrated into relative density is the thick paste of 1.30-1.35 (60 ℃), adds the 300g dextrin, mixing, vacuum drying (temperature is 60-70 ℃, and vacuum is 0.08-0.09Mpa) to water content is less than 3%.About 700g gets dry extract, add sucrose 120g, lactose 120g, dextrin 43g, pulverizing, cross 80 mesh sieves, with the about 320ml granulation of dehydrated alcohol (crossing 14 mesh sieves), earlier be about 45 ℃ of dryings 1.5 hours in temperature, after treating most of ethanol volatilization, elevated temperature is dried to water content less than 3% at 70-80 ℃ to 50-60 ℃ of dry a period of time behind the granulate gradually.Get above-mentioned paeonol and measure 40% dissolve with ethanols with 24 times, add 8 times of amount beta-schardinger dextrin-s and carried out enclose in ultrasonic 40 minutes, 2-4 ℃ of cold preservation 24 hours, filter collection gained paeonol-Benexate Hydrochloride, 40 ℃ of hot air dryings, add 5 times of amount granule fine powders of the present invention in about 17g clathrate, behind the mixing, cross 14 mesh sieves with dehydrated alcohol and granulate, 40 ℃ hot air drying, gained granule and former grain color are roughly suitable like this, add in the former granule with the equivalent incremental method again, gained granule water content is qualified, and mix homogeneously gets the 1000g finished product approximately.With the aluminum-plastic composite membrane packing, every dress 13g, promptly.Obey every day three times, each one bag, a day dosing is equivalent to crude drug 107g (2.74g crude drug/g granule).
Chinese medicine of the present invention should be made use, preservation, peroral dosage form easy to carry, as granule, tablet, capsule etc.According to square Chinese medicine character and dose, preferably select granule, on the one hand help overcoming the difficulty in extract dry, granulation, the packing, solve the problem of thermoplastic, the moisture absorption, can reach the curative effect height simultaneously, store, carry, purpose easy to use.
The component of Chinese medicine according to the present invention below also provides 4 embodiments to the optimum ratio of Chinese medicine of the present invention:
Claims (4)
1, a kind of Chinese medicine that is used for the treatment of cholestatic hepatitis, component by weight percentage is: Radix Paeoniae Rubra 5%-80%, Radix Rehmanniae 5%-40%, Cortex Moutan 5%-50%, Radix Scrophulariae 0-40%, Radix Glycyrrhizae 0-15%, Cornu Bubali 0-20%.
2, the Chinese medicine of treatment cholestatic hepatitis according to claim 1 is characterized in that this Chinese medicine proportioning by weight is: Radix Paeoniae Rubra 1495, the Radix Rehmanniae 249, Cortex Moutan 498, Radix Scrophulariae 249, Radix Glycyrrhizae 125, Cornu Bubali 125.
3, prepare the method for claim 1 or the described Chinese medicine of claim 2, comprising: get the raw material of above-mentioned component,, collect distillate, obtain to contain the component of paeonol the Cortex Moutan vapor distillation; Medicinal residues and surplus medical filtration, standby; Other flavour of a drug such as Radix Paeoniae Rubra, the Radix Rehmanniae mix, and extracting in water filters; Medicinal residues merge with the Cortex Moutan medicinal residues again, decoct with water extraction, filter, and merge the filtrate after twice gained filtrate and the Cortex Moutan distillation, are condensed into thick paste, add 95% ethanol precipitation, reclaim ethanol, are condensed into thick paste, add adjuvant and granulate; Get the component that contains paeonol of above-mentioned Cortex Moutan vapor distillation gained, add beta-cyclodextrin inclusion compound, make the Benexate Hydrochloride that contains paeonol, with above-mentioned granule mix homogeneously, promptly.
4, the preparation method of Chinese medicine of treatment cholestatic hepatitis according to claim 3 comprises: gets the raw material of described component, Cortex Moutan added 14 times of water gaging distillations, collect the distillate that contains paeonol, and in about 24 hours of 2-5 ℃ of cold preservation, the crystallization of filter collection paeonol; The mother solution redistillation is once collected distillate, and cold preservation is about 24 hours under the same terms, the crystallization of filter collection paeonol; Cold drying below 40 ℃, the bottling sealing, standby; Medicinal residues and the medical filtration that does not distill out, standby; Other flavour of a drug such as Radix Paeoniae Rubra, the Radix Rehmanniae mix, adding 10 times of water gagings decocted 2 hours, filter, medicinal residues merge with the medicinal residues that Cortex Moutan steams behind the paeonol again, add 8 times of water gagings and decoct 1.5 hours, filter, merge the filtrate after twice gained filtrate and Cortex Moutan distill out paeonol, at temperature 60-70 ℃, vacuum concentration under the condition of vacuum 0.06-0.08Mpa, be concentrated into relative density and be about 1.25,60 ℃ of thick pastes of measuring down; This thick paste is added an amount of 95% ethanol, make Diluted Alcohol concentration be about 64%, fully stir, placement is spent the night, and filters; Filtrate is decompressed to temperature 50-60 ℃, and vacuum is 0.06-0.08Mpa, reclaims ethanol, being concentrated into relative density is 1.30-1.35, and 60 ℃ of thick pastes of measuring down add the 300g dextrin, mixing is 60-70 ℃ in temperature, and vacuum is that vacuum drying to water content is less than 3% under the 0.08-0.09Mpa; Get dry extract, add sucrose, lactose, dextrin, pulverizing, cross 80 mesh sieves, granulate with dehydrated alcohol, cross 14 mesh sieves, earlier be about 45 ℃ of dryings 1.5 hours in temperature, treat most of ethanol volatilization after, elevated temperature is dried to water content less than 3% at 70-80 ℃ to 50-60 ℃ of dry a period of time behind the granulate gradually; Get above-mentioned paeonol and measure 40% dissolve with ethanols with 24 times, add 8 times of amount beta-schardinger dextrin-s and carried out enclose in ultrasonic 40 minutes, 2-4 ℃ of cold preservation 24 hours, filter collection gained paeonol-Benexate Hydrochloride, 40 ℃ of hot air dryings, add 5 times of amount claim 1 or 2 described Chinese medicinal granule fine powders in the clathrate, behind the mixing, cross 14 mesh sieves with dehydrated alcohol and granulate, 40 ℃ hot air drying, gained granule and former grain color are roughly suitable like this, add in the former granule with the equivalent incremental method again, gained granule water content is qualified, mix homogeneously, promptly.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1105256A (en) * | 1994-08-05 | 1995-07-19 | 李秋礼 | Pellet for detoxication of hepatitis B and producing process thereof |
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| CN1105256A (en) * | 1994-08-05 | 1995-07-19 | 李秋礼 | Pellet for detoxication of hepatitis B and producing process thereof |
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| Title |
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| 中西医结合治疗重症病毒性肝炎探讨 北京中医，第4期 1999 * |
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| CN105597026A (en) * | 2016-03-03 | 2016-05-25 | 青岛市黄岛区中医医院 | Traditional Chinese medicine decoction for treating cholestatic hepatitis |
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