CN101147757A - Traditional Chinese medicine for treating chronic hepatitis B and its preparation process - Google Patents
Traditional Chinese medicine for treating chronic hepatitis B and its preparation process Download PDFInfo
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- CN101147757A CN101147757A CNA2007101060387A CN200710106038A CN101147757A CN 101147757 A CN101147757 A CN 101147757A CN A2007101060387 A CNA2007101060387 A CN A2007101060387A CN 200710106038 A CN200710106038 A CN 200710106038A CN 101147757 A CN101147757 A CN 101147757A
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Abstract
The present invention discloses a Chinese medicine composition for curing chronic hepatitis B and its preparation method. It is made up by using Chinese medicinal materials of phyllanthus, pretty swertia and agrimony through a certain preparation process. Said Chinese medicine composition can be made into various oral preparations.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, relate to a kind of Chinese medicine composition and preparation method thereof, be specifically related to by Cacumen Securinegae Suffruticosae and be selected from Herba Swertiae Mileensis or the Herba Swertiae bimaculatae any crude drug composition and method of making the same of forming, said composition is mainly used in the treatment chronic hepatitis B.
Background technology
The current whole world has 2,000,000,000 people to suffer the invasion and attack of hepatitis B virus (HBV) approximately, and 3.5 hundred million person-times of persons that develop into the chronic HBV infection are wherein arranged.Chronic hepatitis B can develop into liver cirrhosis and hepatocarcinoma, and the whole world is annual to have 1,000,000 people to die from the relevant disease of HBV infection approximately.China is the high region of disease of hepatitis B, has 50% people to infect HBV approximately, and the Chronic HBV carrier accounts for 9.75% of national population.Current, the antiviral drugs that is used for the treatment of hepatitis B both at home and abroad mainly contains interferon and lamivudine, but effect is not really desirable, and is easy to generate drug resistance.Therefore, it is very necessary that safe, effective, stable medicine has seemed, and Chinese medicine has its unique curative effect in this respect.
Herba Swertiae Mileensis is the herb of Gentianaceae Swertia plant Herba Swertiae Mileensis Swertia mileensis T.N.Ho et W.L. Shih, claims little Herba Swertiae Mileensis in Yunnan again, walks the gallbladder medicine, the hepatitis medicine, Carassius auratus gallbladder, little Herba vallisneriae Spiralis.Herba Swertiae Mileensis is widely distributed, and herb liver heat removing function of gallbladder promoting, clearing away heat-damp and promoting diuresis are used for jaundice dark coloured urine, the puckery pain of pyretic stranguria, are that pharmacopeia is recorded kind.The used sweroside of Yunnan Province's drug inspection (sweroside content 10%, actually total bitter glycosides) be used for the treatment of the rat acute liver damage that carbon tetrachloride causes, find the most of reparation in central necrosis of hepatic lobule district, the cell that liver cytoplasm is loose, the balloon sample becomes and fatty becomes greatly reduces, hepatic glycogen is accumulated showed increased, can also obviously reduce the phagocytic function of glutamate pyruvate transaminase and reinforcement hepatic region macrophage, the human body immunity improving ability, increase hepatic blood flow, improve the liver microcirculation disturbance.
Herba Swertiae bimaculatae is the dry herb of Gentianaceae Gentianaceac Herba Swertiae bimaculatae Swertia L., among the peoplely is usually used in clearing away lung-heat, disease such as the subcutaneous ulcer of harnessing the Yellow River, acute enteritis and dysentery.Through clinical observation, this medicine has curative effect preferably to acute icterohepatitis.Main Han Tong, flavone, iridoid, triterpenes components in the Herba Swertiae bimaculatae, the effective ingredient that mainly works in hepatology is iridoid and glycosides thereof.
Cacumen Securinegae Suffruticosae (Phyllanthus urinaria L.) is the Euphorbiaceae phyllanthus plant, and the effect of calming liver and clearing heat, promoting diuresis to remove toxic substance is arranged, and is mainly used in treatment infectious hepatitis, enteritis, dysentery, oedema due to nephritis, infantile malnutrition etc.India scholar Thyagarajan had anti-HBV effect at Britain LANCET magazine reported first Phyllanthusamarus in 1988, and 59%HBV carrier hepatitis B s antibody (HBsAg) is turned out cloudy, and had caused both at home and abroad to pay close attention to greatly.Its main effective ingredient is total phenolic acid compound.
Summary of the invention
Research worker of the present invention is through great deal of experimental, and Cacumen Securinegae Suffruticosae and Herba Swertiae Mileensis or Cacumen Securinegae Suffruticosae and Herba Swertiae bimaculatae by certain proportion relation prescription, are found to have synergism aspect the treatment hepatopathy.Medical material gets effective ingredient through solvent extraction, upper prop or extracting and refining, adds pharmacy acceptable carrier or adjuvant in effective ingredient, makes preparation with conventional pharmaceutical methods.Process stabilizing of the present invention, safety range is big, and it is little that poison is paid effect, and environmental pollution is little, is applicable to big commercial production.Prove that through pharmacological testing the present composition has antiviral, transaminase lowering, malonaldehyde (MDA) content, improve superoxide dismutase (SOD) content.
One object of the present invention is to provide a kind of determined curative effect, big, the poison pair Chinese medicine composition that effect is little, steady quality is used for the treatment of chronic hepatitis B reliably of safety range.
Another object of the present invention is to provide a kind of preparation method for the treatment of the Chinese medicine composition of chronic hepatitis B.
An also purpose of the present invention is to provide the application of the present composition in preparation treatment chronic hepatitis B medicine.
Extracting method of the present invention comprises extraction, concentrated, refining, dry overall process.Extracting used medical material is decoction pieces or medicinal material coarse powder, preferred coarse powder, the more preferably coarse powder of mistake 12 mesh sieves.
The crude drug that the present invention is selected is the dry herb of Cacumen Securinegae Suffruticosae, Herba Swertiae Mileensis, Herba Swertiae bimaculatae.Prescription is formed by Cacumen Securinegae Suffruticosae and Herba Swertiae Mileensis, Cacumen Securinegae Suffruticosae and Herba Swertiae bimaculatae.Herba Swertiae bimaculatae and Herba Swertiae Mileensis are all gentianaceae plant, and aspect the icteric disease, among the peoplely often replace to use each other, effect is suitable.
The present composition can be that Cacumen Securinegae Suffruticosae and Herba Swertiae Mileensis, Cacumen Securinegae Suffruticosae and Herba Swertiae bimaculatae, Cacumen Securinegae Suffruticosae and Herba Swertiae Mileensis add Herba Swertiae bimaculatae; because of Herba Swertiae bimaculatae and Herba Swertiae Mileensis are equal plant; and it has much identical on composition; three kinds of compound mode drug effects are suitable; three medicines use simultaneously, are equal to the present invention's technical scheme required for protection.
Crude drug Herba Swertiae bimaculatae of the present invention can be the dry herb of Herba Swertiae bimaculatae Swertia davidi Franch., Swertia mussotii Franch. Swertia mussotii Franch., Swertia punicea Hemsl. Swertia Punicea, Swertia franchetiana H.Smith Swertiafranchtiana H.Smith, two leaf Herba Swertiae bimaculatae Swertia bifolia Batal., surrounded swertia herb Swertia cincta..
Solvent for use of the present invention can be water or contain alcoholic solvent, used contain alcoholic solvent and can be methanol or ethanol, and because of methanol is big than alcohol toxicity, preferred alcohol.
The used extracting method of the present invention can be conventional extracting method, as lixiviate, percolation, decoction, reflux, extract,, and preferred reflux, extract.The time that solvent for use soaks in lixiviate, the percolation method is each 12-36 hour, and extraction time is 2-4 time, and the number of times of decoction and reflux, extract, can be 2-4 time, and each extraction time is 0.5-3 hour.
The present invention is left standstill with the anti-molten medicinal substances extract thick paste of Diluted Alcohol, and purpose is to remove in the extract some such as low polar impurity component such as chlorophyll, oils and fats, reduces the dosage of taking in the process.Used rare alcohol is 5%-15%, and preferred 10% alcohol reflux is anti-molten, preferably leaves standstill 24 hours at 4 ℃ cold place in the low temperature put procedure, filters or the centrifugal impurity of removing.
Drying means of the present invention can be a vacuum drying, also can be spray drying, in when preparation test, and preferred vacuum drying, preferably spray drying when big commercial production.
Chinese medicine composition of the present invention studies have shown that through pharmacological testing, at antiviral, reduction serum NSC 334200 transaminase (GPT), malonaldehyde (MDA) content, improve the horizontal aspect of superoxide dismutase (SOD), extract of the present invention is compared with Cacumen Securinegae Suffruticosae extract, Herba Swertiae Mileensis extract or Herba Swertiae bimaculatae extract with PROCESS FOR TREATMENT, its active back three is strong, significant difference, explanation is formed compound recipe by Cacumen Securinegae Suffruticosae and Herba Swertiae Mileensis or Cacumen Securinegae Suffruticosae and Herba Swertiae bimaculatae, and the compositions that is prepared into by this compound recipe is having the obvious synergistic effect aspect anti-hepatitis virus and the liver protecting and ALT lowering.
Present composition preparation method is earlier through solvent extraction, and is extract obtained again through further refining, can obtain active ingredient compositions of the present invention.
The present invention specifically can be achieved through the following technical solutions:
(1) prescription raw material medicines in portions by weight proportioning:
Cacumen Securinegae Suffruticosae 2-8 part, Herba Swertiae Mileensis 2-8 part
(2) take by weighing Cacumen Securinegae Suffruticosae, Herba Swertiae Mileensis medical material by last prescription proportioning;
(3) raw material pulverizing adds the alcohol amount that contains that 8-16 doubly measures for the solvent extraction of 0-60% 1-4 time, each 0.5-3 hour, filters the filtrate merging;
(4) filtrate is evaporated to the thick paste shape under 40-70 ℃, the ethanol that adds 5%-15%, addition is the 2-4mL/g thick paste, and backflow 0.5-1 hour, room temperature cooled, going to cold place placed 12-36 hour, filtrate or supernatant are got in filtration or centrifugal, and 40-70 ℃ is evaporated to nothing alcohol flavor, making the concentrated solution relative density is 1.05-1.30, gets concentrated solution;
(5) with macroporous adsorptive resins on the concentrated solution, now wash with water to the eluent color thin outly, use the ethanol elution of 45%-95% instead, show negative to the eluent ferric chloride reaction, merge eluent, 40-70 ℃ of concentrating under reduced pressure, vacuum or spray drying, extract; Or the water saturated n-butanol extraction of concentrated solution, the n-butyl alcohol consumption is 0.5-1.5 a times of concentrated medicament, extraction times is 2-6 time, merges butanol extraction liquid, and 40-70 ℃ of concentrating under reduced pressure, 45-65 ℃ of vacuum drying gets extract;
(6) will go up extract and pulverize, sieve, be principal agent, in principal agent, add pharmaceutic adjuvant acceptable on the pharmaceutics, and adopt conventional pharmaceutical technology to be prepared into capsule, granule, tablet, pill, drop pill, oral liquid, syrup.
The macroporous adsorbent resin that the present invention is used, can be styrene tyle macroporous adsorption resin (as Diaion HP-20 type, XDA type), polystyrene type macroporous adsorbent resin (as AB-8 type, NKN-9 type, S-8 type, Xinhua's macroporous resin), ethyl styrene type (as the D-101 type).
The used acceptable accessories of the present invention comprises that binding agent (can be a polyvidone, starch slurry, cellulose etc.), disintegrating agent (can be a dry starch, sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, polyethylene is than pyrrolidone etc.), lubricant (can be a Pulvis Talci, stearic acid, calcium stearate magnesium, calcium stearate etc.), correctives (can be a sucrose, A Siba is sweet, steviosin, fructose etc.), stabilizing agent (can be a methyl parahydroxybenzoate, propyl p-hydroxybenzoate etc.), diluent (can be a starch, dextrin, Icing Sugar, lactose etc.), wetting agent (can be water or ethanol), fluidizer (can be micropowder silica gel), excipient (can be carbohydrate derivative such as lactose, sucrose, glucose, mannitol, sorbitol; Starch based derivant such as corn starch, potato starch, dextrin or carboxymethyl starch; Cellulose derivative such as crystalline fibers, hydroxy propyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, carboxymethylcellulose calcium; Silicate derivative such as aluminium-magnesium silicate; Phosphate derivative such as calcium phosphate; Sulfate-derivatives such as calcium sulfate; Carbonate derivative such as calcium carbonate; Arabic gum; Dextran).
Chinese medicine composition of the present invention has function of gallbladder promoting and protects the liver, antiviral, transaminase lowering and malonaldehyde, and the effect of rising serum superoxide dismutases content is used for the treatment of chronic hepatitis B.
Specific embodiment
One, pharmacology embodiment
1, external anti-HBV activity
Reagent: Chinese medicine composition extract 1 of the present invention (Cacumen Securinegae Suffruticosae+Herba Swertiae Mileensis), Chinese medicine composition of the present invention 2 (Cacumen Securinegae Suffruticosae+Herba Swertiae bimaculatae), Cacumen Securinegae Suffruticosae extract, Herba Swertiae Mileensis extract, Herba Swertiae bimaculatae extract (, providing) by Beijing XingHao JiaYu Pharmaceutical Technology Co., Ltd's mesothecium by preparation technology's preparation of the present invention.
Cell strain: 2.2.15 cell strain: institute of materia medica pharmacological room of Chinese medicine research institute provides.
Reagent: RPMI1640 culture medium, Japan day water Pharmaceutical Co., Ltd; Hepatitis B s antibody (HBsAg), hepatitis B e antibody (HBeAg) ELISA detection kit, Huamei Bio-Engrg Co., produces.
Extract of the present invention is made into the aqueous solution of 200 μ g/mL with distilled water, crosses the microporous filter membrane degerming of 0.22 μ m, 4 ℃ of preservations, the time spent is diluted to the solution of 200,160,100,50,25,13 μ g/mL with RPMI1640.Well-established law behind the 2.2.15 cell thawing is inoculated on 96 orifice plates 37 ℃ of 5%CO
2Cultivated 4 days under the condition, change the RPMI1640 complete medium that contains Cacumen Securinegae Suffruticosae 13,25,50,100,160,200 μ g/mL, each concentration is inoculated 6 holes, continue to cultivate after 10 days and measure (the 5th day time change liquid 1 time), results averaged, the highest drug level of obtaining pair cell and do not have the overt toxicity effect is 160 μ g/mL, select the avirulent substantially concentration 100 μ g/mL of pair cell for use, Ah former times's network Wei, Cacumen Securinegae Suffruticosae extract, Herba Swertiae Mileensis extract, Herba Swertiae bimaculatae extract are all selected this concentration for use, all establish 4 multiple holes, and establish the contrast that does not add medicine, results averaged.Import the 2.2.15 cell into 24 orifice plates, 5%CO according to a conventional method
2Cultivate under the condition after 4 days, each hole is changed respectively with the variable concentrations pharmaceutical culture medium, continues to cultivate 10 days and collected respectively behind the drug effect culture supernatant of 5 days and 10 days, makes HBsAg and HBeAg mensuration respectively.Operation is undertaken by the test kit description, the results are shown in Table 1
The result shows that Chinese medicine composition of the present invention, Cacumen Securinegae Suffruticosae extract, Herba Swertiae Mileensis extract, Herba Swertiae bimaculatae extract all have certain inhibitory action to the expression of the HBeAg of HBV in the HepG2.2.15 cell strain, compare with Cacumen Securinegae Suffruticosae, Herba Swertiae Mileensis, Herba Swertiae bimaculatae group, Chinese medicine composition group of the present invention has at anti-virus aspect and significantly improves (P＜0.05), shows that two medicines are combined together use hepatitis B virus is suppressed to have synergism.
Table 1 Chinese medicine composition of the present invention is to the vitro inhibition effect of 2.2.15 cell HBsAg and HBeAg
| Group | Dosage μ g/mL | HBsAg suppression ratio (%) | HBeAg suppression ratio (%) | ||
| 5 days | 10 days | 5 days | 10 days | ||
| Ah former times's network Wei group Chinese medicine composition 1 Chinese medicine composition 2 Herba Swertiae Mileensis extract Cacumen Securinegae Suffruticosae extract Herba Swertiae bimaculatae extracts of the present invention of the present invention | 100 100 100 100 100 100 | 51.27 49.25 50.11 33.54 39.72 35.26 | 28.36 27.62 26.43 12.36 12.16 12.79 | 69.56 * 67.31 * 68.37 * 38.98 44.56 40.21 | 73.95 * 71.62 * 72.19 * 40.02 48.27 41.98 |
Adopting group with Herba Swertiae Mileensis, Cacumen Securinegae Suffruticosae, river deer tooth compares:
*P＜0.05
2, to the hepatic injury experimental study
Reagent: Chinese medicine composition extract 1 of the present invention (Cacumen Securinegae Suffruticosae+Herba Swertiae Mileensis), Chinese medicine composition of the present invention 2 (Cacumen Securinegae Suffruticosae+Herba Swertiae bimaculatae), Herba Swertiae Mileensis extract are (by preparation technology's preparation of the present invention, provide by Beijing XingHao JiaYu Pharmaceutical Technology Co., Ltd's mesothecium), Cacumen Securinegae Suffruticosae capsule (commercially available product, Kunming four initiative medicine company limiteies); Bifendate (BPD) (Beijing XieHe medicine Factory); Colchicine (analyzing alcohol, West Germany's import packing); NSC 334200 transaminase (GPT) (production of Sichuan Mai Ke Science and Technology Ltd.).
Animal: male Kunming kind healthy mice, body weight (18 ± 2) g
2.1, the acute liver damage processing method
60 mices are divided into matched group, CCl at random
4Totally 6 groups of model group, Chinese medicine composition group of the present invention, Cacumen Securinegae Suffruticosae extract group, Herba Swertiae Mileensis extract group, bifendate group, 10 every group.Behind the laboratory rearing 2 days, except that matched group and model group mice usefulness distilled water 0.5ml/ Mus filling stomach, all the other each groups are all according to dosage irritated stomach, and 1 time/day, continuous 1 week.2h after the last administration is except that control group mice, all by 10ml/kg disposable celiac injection 0.1%CCl
4The Oleum Arachidis hypogaeae semen solvent, water is can't help in fasting, and the 16h posterior orbit is got blood, and centrifuging and taking serum the results are shown in Table 2.
2.2, the chronic hepatic injury processing method
60 mices are divided into 6 groups at random, 10 every group.Remove colchicine and be made into 0.01mg/ml, press outside the 0.2mg/kg administration, all the other medications are tested processing method with acute liver damage.Laboratory rearing after 2 days except that matched group is injected isopyknic Oleum Arachidis hypogaeae semen, all with 5ml/kg subcutaneous injection 20%CCl
4The Oleum Arachidis hypogaeae semen solvent, injection in per 5 days 1 time is injected 6 times altogether, gives Drug therapy simultaneously, weighed 1 time in per 5 days, along with the increase of mice body weight, the also corresponding increase of dosage.After the medication the 42nd day, eye socket is got blood, and centrifuging and taking serum the results are shown in Table 3.
Table 2 Chinese medicine composition of the present invention is to CCl
4Due to the influence (x ± s) of acute liver damage mice serum GPT, SOD, MDA
| Group | Dosage (mg/kg.d -1) | GPT(U/L) | SOD(NU/mL) | MDA(μmol/L) |
| Matched group CCl 4Model group bifendate group Herba Swertiae Mileensis extract group Herba Swertiae bimaculatae extract Cacumen Securinegae Suffruticosae extract group Chinese medicine composition group 1 Chinese medicine composition group 2 of the present invention of the present invention | 0.5ml water 0.5ml water 200 200 200 200 200 200 | 56.27±6.38 498.56±59.61 160.32±49.68 238.36±47.69 243.54±45.68 286.32±49.68 128.35±43.68 *& 135.29±41.62 *& | 620.32±74.65 280.16±42.63 450.31±51.24 469.75±49.67 462.75±50.56 450.31±51.24 589.61±52.27 *&# 600.29±53.67 *&# | 7.56±1.23 20.26±3.69 15.26±2.65 16.37±2.35 17.16±2.18 15.26±2.65 10.65±2.14 *&# 11.84±2.31 *&# |
With CCl
4Model is compared,
*P＜0.01; Compare ， ﹠amp with Cacumen Securinegae Suffruticosae, Herba Swertiae Mileensis, Herba Swertiae bimaculatae group; P＜0.05; Compare #P＜0.05 with the BPD group
Traditional Chinese medicine composition for treating group of the present invention can significantly reduce GPT in the serum, MDA content, and the SOD in the serum is raise (with CCl
4Model group is compared, P＜0.01).Compare with Herba Swertiae Mileensis group, Cacumen Securinegae Suffruticosae, Herba Swertiae bimaculatae group, the effect of Chinese medicine composition group increased SOD of the present invention and reduction GPT, MDA is better than Herba Swertiae Mileensis, Cacumen Securinegae Suffruticosae, Herba Swertiae bimaculatae group (P＜0.05), compare with the BPD group, Chinese medicine composition of the present invention reduce MDA, increased SOD active aspect than BPD strong (P＜0.05), and it is similar to BPD to reduce the GPT effect.
Table 3 Chinese medicine composition of the present invention is to CCl
4Due to the influence (x ± s) of chronic hepatic injury mice serum GPT, SOD, MDA
| Group | Dosage (mg/kg.d -1) | GPT(U/L) | SOD(NU/mL) | MDA(μmol/L) |
| Matched group CCl 4Model group colchicine group Herba Swertiae Mileensis extract group Herba Swertiae bimaculatae extract group Cacumen Securinegae Suffruticosae Capsules group Chinese medicine composition group 1 Chinese medicine composition group 2 of the present invention of the present invention | 0.5ml water 0.5ml water 0.2 200 200 200 200 200 | 62.56±7.31 600.27±51.32 326.47±47.31 335.47±42.36 328.17±41.11 387.62±45.23 228.35±41.64 *&# 235.17±40.29 *&# | 556.87±70.21 264.32±49.65 391.24±48.21 400.69±54.72 410.75±51.23 362.15±48.36 498.49±61.24 *&# 510.37±62.41 *&# | 4.51±0.89 22.47±3.68 13.78±3.42 15.76±2.63 13.89±2.87 17.87±2.68 12.15±2.34 *&# 13.94±2.49 *&# |
With CCl
4Model is compared,
*P＜0.01; Compare ， ﹠amp with Cacumen Securinegae Suffruticosae, Herba Swertiae Mileensis, Herba Swertiae bimaculatae group; P＜0.05; Compare #P＜0.05 with the colchicine group
Chinese medicine composition of the present invention can significantly reduce GPT and the MDA content in the chronic hepatic injury mice serum, and can improve SOD content in the serum, Chinese medicine composition group of the present invention is to reducing GPT, and the effect of MDA and increased SOD is better than Herba Swertiae Mileensis, Cacumen Securinegae Suffruticosae group, Herba Swertiae bimaculatae group and colchicine group (P＜0.05).
Above result shows that Chinese medicine composition of the present invention reducing serum GPT, MDA content, on the rising SOD in serum level, compares with independent every flavor medicine, and compound of the present invention has collaborative enhanced effect.
Two, specific embodiment
Following examples only are that the invention will be further described, and non-limiting giving an example, and in an embodiment Herba Swertiae Mileensis are changed into the compositions embodiment that Herba Swertiae bimaculatae is Cacumen Securinegae Suffruticosae of the present invention and Herba Swertiae bimaculatae.
Embodiment 1
(1) takes by weighing Cacumen Securinegae Suffruticosae 200g, Herba Swertiae Mileensis 800g;
(2) raw material pulverizing adds 8 times of amount deionized water reflux, extract, 4 times, and each 0.5 hour, to filter, filtrate merges;
(3) filtrate is evaporated to the thick paste shape under 70 ℃, the ethanol of adding 5%, addition is the 2mL/g thick paste, refluxes 0.5 hour, and room temperature cools, going to cold place low temperature placed 12 hours, filtrate or supernatant are got in filtration or centrifugal, and 70 ℃ are evaporated to nothing alcohol flavor, making the concentrated solution relative density is 1.05, gets concentrated solution;
(4) with Diaion HP-20 type macroporous adsorptive resins on the concentrated solution, wash with water to the eluent color thin outly earlier, use 45% ethanol elution instead, show negative to the eluent ferric chloride reaction, merge eluent, 40 ℃ of concentrating under reduced pressure, 62 ℃ of vacuum dryings get extract;
(5) will go up extract and pulverize, sieve, be principal agent, in principal agent, add pharmaceutic adjuvant acceptable on the pharmaceutics, and adopt conventional pharmaceutical technology to be prepared into capsule, granule, tablet, pill, drop pill, oral liquid, syrup.
Embodiment 2:
(1) takes by weighing Cacumen Securinegae Suffruticosae 800g, Herba Swertiae Mileensis 200g;
(2) raw material pulverizing adds 16 times of amount ethanol extraction reflux, extract, of 60% 1 time, refluxes 3 hours, filters, must filtrate;
(3) filtrate is evaporated to the thick paste shape under 40 ℃, the ethanol of adding 15%, addition is the 4mL/g thick paste, refluxes 1 hour, and room temperature cools, going to cold place low temperature placed 36 hours, filtrate or supernatant are got in filtration or centrifugal, and 40 ℃ are evaporated to nothing alcohol flavor, making the concentrated solution relative density is 1.30, gets concentrated solution;
(4) the water saturated n-butanol extraction of concentrated solution, n-butyl alcohol consumption are 0.5 times of concentrated medicament, and extraction times is 6 times, merge butanol extraction liquid, 40 ℃ of concentrating under reduced pressure, and 45 ℃ of vacuum dryings get extract;
(5) will go up extract and pulverize, sieve, be principal agent, in principal agent, add pharmaceutic adjuvant acceptable on the pharmaceutics, and adopt conventional pharmaceutical technology to be prepared into capsule, granule, tablet, pill, drop pill, oral liquid, syrup.
Embodiment 3
(1) takes by weighing Cacumen Securinegae Suffruticosae 500g, Herba Swertiae Mileensis 500g;
(2) raw material pulverizing adds 12 times of amount alcohol reflux of 30% 2 times, and each 2 hours, to filter, filtrate merges;
(3) filtrate is evaporated to the thick paste shape under 60 ℃, the ethanol of adding 10%, addition is the 3mL/g thick paste, backflow 45min, and room temperature cools, going to cold place low temperature placed 24 hours, filtrate or supernatant are got in filtration or centrifugal, and 60 ℃ are evaporated to nothing alcohol flavor, making the concentrated solution relative density is 1.20, gets concentrated solution;
(4) with AB-8 type macroporous adsorptive resins on the concentrated solution, wash with water to the eluent color thin outly earlier, use 75% ethanol elution instead, show negative to the eluent ferric chloride reaction, merge eluent, 60 ℃ of concentrating under reduced pressure, 58 ℃ of vacuum dryings, extract;
(5) will go up extract and pulverize, sieve, be principal agent, in principal agent, add pharmaceutic adjuvant acceptable on the pharmaceutics, and adopt conventional pharmaceutical technology to be prepared into capsule, granule, tablet, pill, drop pill, oral liquid, syrup.
Embodiment 4
(1) takes by weighing Cacumen Securinegae Suffruticosae 400g, Herba Swertiae Mileensis 600g;
(2) raw material pulverizing adds 10 times of amount alcohol reflux of 20% 3 times, and each 1.5 hours, to filter, filtrate merges;
(3) filtrate is evaporated to the thick paste shape under 55 ℃, the ethanol of adding 8%, addition is the 2.8mL/g thick paste, refluxes 0.5 hour, and room temperature cools, going to cold place low temperature placed 18 hours, filtrate or supernatant are got in filtration or centrifugal, and 55 ℃ are evaporated to nothing alcohol flavor, making the concentrated solution relative density is 1.15, gets concentrated solution;
(4) with D-101 type macroporous adsorptive resins on the concentrated solution, wash with water to the eluent color thin outly earlier, use 60% ethanol elution instead, show negative to the eluent ferric chloride reaction, merge eluent, 55 ℃ of concentrating under reduced pressure, 50 ℃ of vacuum dryings, extract;
(5) will go up extract and pulverize, sieve, be principal agent, in principal agent, add pharmaceutic adjuvant acceptable on the pharmaceutics, and adopt conventional pharmaceutical technology to be prepared into capsule, granule, tablet, pill, drop pill, oral liquid, syrup.
Embodiment 5
(1) takes by weighing Cacumen Securinegae Suffruticosae 300g, Herba Swertiae Mileensis 700g;
(2) raw material pulverizing adds 9 times of amount alcohol reflux of 10% 3 times, and each 1 hour, to filter, filtrate merges;
(3) filtrate is evaporated to the thick paste shape under 50 ℃, the ethanol of adding 6%, addition is the 2.5mL/g thick paste, refluxes 1 hour, and room temperature cools, going to cold place low temperature placed 16 hours, filtrate or supernatant are got in filtration or centrifugal, and 50 ℃ are evaporated to nothing alcohol flavor, making the concentrated solution relative density is 1.10, gets concentrated solution;
(4) with NKN-9 type macroporous adsorptive resins on the concentrated solution, wash with water to the eluent color thin outly earlier, use 95% ethanol elution instead, show negative to the eluent ferric chloride reaction, merge eluent, 50 ℃ of concentrating under reduced pressure, 55 ℃ of vacuum dryings, extract;
(5) will go up extract and pulverize, sieve, be principal agent, in principal agent, add pharmaceutic adjuvant acceptable on the pharmaceutics, and adopt conventional pharmaceutical technology to be prepared into capsule, granule, tablet, pill, drop pill, oral liquid, syrup.
Embodiment 6
(1) takes by weighing Cacumen Securinegae Suffruticosae 700g, Herba Swertiae Mileensis 300g;
(2) raw material pulverizing adds 14 times of amount alcohol reflux of 40% 2 times, and each 2.5 hours, to filter, filtrate merges;
(3) filtrate is evaporated to the thick paste shape under 65 ℃, the ethanol of adding 12%, addition is the 3.4mL/g thick paste, backflow 50min, and room temperature cools, going to cold place low temperature placed 30 hours, filtrate or supernatant are got in filtration or centrifugal, and 65 ℃ are evaporated to nothing alcohol flavor, making the concentrated solution relative density is 1.25, gets concentrated solution;
(4) the water saturated n-butanol extraction of concentrated solution, n-butyl alcohol consumption are 1.5 times of concentrated medicament, and extraction times is 2 times, merge butanol extraction liquid, 40 ℃ of concentrating under reduced pressure, and 65 ℃ of vacuum dryings get extract;
(5) will go up extract and pulverize, sieve, be principal agent, in principal agent, add pharmaceutic adjuvant acceptable on the pharmaceutics, and adopt conventional pharmaceutical technology to be prepared into capsule, granule, tablet, pill, drop pill, oral liquid, syrup.
Embodiment 7
(1) takes by weighing Cacumen Securinegae Suffruticosae 600g, Herba Swertiae Mileensis 400g;
(2) raw material pulverizing adds 15 times of amount alcohol reflux of 50% 3 times, and each 1.2 hours, to filter, filtrate merges;
(3) filtrate is evaporated to the thick paste shape under 62 ℃, the ethanol of adding 14%, addition is the 3.6mL/g thick paste, backflow 25min, and room temperature cools, going to cold place low temperature placed 32 hours, filtrate or supernatant are got in filtration or centrifugal, and 62 ℃ are evaporated to nothing alcohol flavor, making the concentrated solution relative density is 1.28, gets concentrated solution;
(4) the water saturated n-butanol extraction of concentrated solution, n-butyl alcohol consumption are 1 times of concentrated medicament, and extraction times is 4 times, merge butanol extraction liquid, 62 ℃ of concentrating under reduced pressure, and 60 ℃ of vacuum dryings get extract;
(5) will go up extract and pulverize, sieve, be principal agent, in principal agent, add pharmaceutic adjuvant acceptable on the pharmaceutics, and adopt conventional pharmaceutical technology to be prepared into capsule, granule, tablet, pill, drop pill, oral liquid, syrup.
Claims (7)
1. Chinese medicine composition that is used for chronic hepatitis B, it is characterized in that this Chinese medicine composition is to be made by following raw materials by weight proportions: Cacumen Securinegae Suffruticosae and be selected from Herba Swertiae Mileensis or the Herba Swertiae bimaculatae any, Cacumen Securinegae Suffruticosae 2-8 part wherein, Herba Swertiae Mileensis 2-8 part, Herba Swertiae bimaculatae 2-8 part.
2. method for preparing the described Chinese medicine composition of claim 1, it is characterized in that comprising following operation: at first be the extraction process of crude drug, weighting raw materials is ground into coarse powder by weight ratio, extract with polar solvent, extract; Next is the extract process for refining, the said extracted thing through concentrate, after the aqueous dispersion, adopt adsorption resin column or solvent extraction further refining active component.
3. method as claimed in claim 2, take by weighing the described crude drug of claim 1 by weight ratio, it is characterized in that crude drug after crushed, mix, the alcohol amount that contains that adding 8-16 doubly measures is extracted 1-4 time for the pure aqueous solvent of 0-60%, filter, merging filtrate, filtrate is evaporated to the thick paste shape under 40-70 ℃, the alcohol reflux 0.5-1 hour dispersion extractum that adds 5%-15%, amount of alcohol added is the 2-4ml/g thick paste, and room temperature cools, and goes to cold place and places 12-36 hour, filter, merging filtrate, 40-70 ℃ is evaporated to after relative density is 1.05-1.30 last macroporous adsorptive resins, it is thin out earlier to be eluted to the effluent color with deionized water, use the ethanol elution of 45%-95% instead, show negative, merge alcohol eluen to the eluent ferric chloride reaction, 40-70 ℃ of concentrating under reduced pressure, vacuum or spray drying must be made with extra care extract, are active component.
4. method as claimed in claim 2, take by weighing the described crude drug of claim 1 by weight ratio, it is characterized in that crude drug after crushed, mix, add the alcohol amount that contains that 8-16 doubly measures and be the ethanol extraction of 0-60% 1-4 time, filter, merging filtrate, filtrate are evaporated to the thick paste shape under 40-70 ℃, add 5%-15% disperseed extractum in alcohol reflux 0.5-1 hour, amount of alcohol added is the 2-4ml/g thick paste, room temperature cools, and goes to cold place and places 12-36 hour, filters, merging filtrate, 40-70 ℃ is evaporated to after relative density is 1.05-1.30, uses water saturated n-butanol extraction, and the consumption of n-butyl alcohol is a 0.5-1.5 times of volume of concentrated solution, it is thin out to be extracted to the n-butanol layer color, merge each time butanol extraction liquid, concentrating under reduced pressure, drying, must make with extra care extract, be active component.
5. pharmaceutical preparation that contains claim 3 or 4 described active component.
6. pharmaceutical preparation as claimed in claim 5 is characterized in that described preparation is mainly oral formulations.
7. the application of Chinese medicine composition as claimed in claim 1 in preparation treatment chronic hepatitis B medicine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101060387A CN101147757A (en) | 2006-09-22 | 2007-05-30 | Traditional Chinese medicine for treating chronic hepatitis B and its preparation process |
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| CN200610113310 | 2006-09-22 | ||
| CN200610113310.X | 2006-09-22 | ||
| CNA2007101060387A CN101147757A (en) | 2006-09-22 | 2007-05-30 | Traditional Chinese medicine for treating chronic hepatitis B and its preparation process |
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| CN101147757A true CN101147757A (en) | 2008-03-26 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102085237A (en) * | 2011-02-11 | 2011-06-08 | 云南植物药业有限公司 | Medicine for treating liver disease and preparation thereof |
| CN102526168A (en) * | 2012-02-21 | 2012-07-04 | 华南理工大学 | Micro-capsules of anti-influenza-virus effective part of phyllanthus urinaria, and preparation method and application thereof |
-
2007
- 2007-05-30 CN CNA2007101060387A patent/CN101147757A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102085237A (en) * | 2011-02-11 | 2011-06-08 | 云南植物药业有限公司 | Medicine for treating liver disease and preparation thereof |
| CN102526168A (en) * | 2012-02-21 | 2012-07-04 | 华南理工大学 | Micro-capsules of anti-influenza-virus effective part of phyllanthus urinaria, and preparation method and application thereof |
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Open date: 20080326 |