CN101618156A - Medicine composition for treating hepatitis B and preparation method thereof - Google Patents
Medicine composition for treating hepatitis B and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a medicine composition for treating hepatitis B and a preparation method thereof. The medicine composition is prepared from the following raw materials and auxiliary materials which are pharmaceutically acceptable according to parts by weight: 5-60 parts of giant knotweed, 10-45 parts of oldenlandia diffusa, 5-30 parts of asiatic moonseed rhizome, 10-45 parts of bistort, 10-45 parts of oriental wormwood, 25-90 parts of rhizoma imperatae, 10-45 parts of madder, 5-30 parts of herba epimedii, 5-30 parts of licorice, 10-45 parts of smilax glabra rhizoma, 10-45 parts of silkworm excrement, 10-45 parts of wild chrysanthemum flower and 5-30 parts of red tangerine peel. The preparation method of the medicine composition comprises the following steps: (1) pulverizing the madder and the smilax glabra rhizoma according to parts by weight, adding water into coarse powder and the rest eleven medicinal materials, such as the giant knotweed and the like, decocting twice, merging decoction, taking clarifying liquor and concentrating the clarifying liquor into clear paste; (2) adding a right amount of auxiliary materials and the fine powder of the madder and the smilax glabra rhizoma into the clear paste obtained in the step (1), and preparing the required medicament form by using a conventional method. The medicine composition has favorable curative effect, safe use and no toxic or side reaction.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of hepatopathy and preparation method thereof, particularly pharmaceutical composition of treatment hepatitis B and preparation method thereof.
Background technology
Hepatitis B is caused, is served as main and can cause a kind of infectious disease of multiple organ injury with the liver inflammatory lesion by hepatitis B virus (HBV).Primary disease is widely current in countries in the world, mainly invades child and person between twenty and fifty, and small number of patients can be converted into liver cirrhosis or hepatocarcinoma.Therefore, it has become the worldwide disease of serious threat human health, also is that China's current popular is the most extensive, the most serious a kind of infectious disease of hazardness.Up to now, still lack the very effective medicine and the method for the treatment of hepatitis B.Though both at home and abroad the interferon and the lamivudine of generally acknowledging has stronger anti-HBV effect, only be to suppress hbv replication not remove virus, very easily recur after the drug withdrawal and need the long use course of treatment and cost an arm and a leg.Therefore, still need develop the medicine of effective treatment hepatitis B.
Summary of the invention
Primary and foremost purpose of the present invention provides a kind of pharmaceutical composition for the treatment of hepatitis B.
Another object of the present invention provides a kind of preparation of drug combination method for the treatment of hepatitis B.
The present invention relates to a kind of pharmaceutical composition for the treatment of hepatitis B, it is made by following parts by weight proportion raw material and acceptable accessories:
Rhizoma Polygoni Cuspidati 5-60 Herba Hedyotidis Diffusae 10-45 Rhizoma Menispermi 5-30
Rhizoma Bistortae 10-45 Herba Artemisiae Scopariae 10-45 Rhizoma Imperatae 25-90
Radix Rubiae 10-45 Herba Epimedii 5-30 Radix Glycyrrhizae 5-30
Rhizoma Smilacis Glabrae 10-45 silkworm excrement 10-45 Flos Chrysanthemi Indici 10-45
Tangerine 5-30.
According to pharmaceutical composition of the present invention, wherein each proportion of raw materials is preferably:
Rhizoma Polygoni Cuspidati 15-45 Herba Hedyotidis Diffusae 15-32 Rhizoma Menispermi 10-24
Rhizoma Bistortae 15-34 Herba Artemisiae Scopariae 15-35 Rhizoma Imperatae 30-80
Radix Rubiae 15-35 Herba Epimedii 10-25 Radix Glycyrrhizae 10-24
Rhizoma Smilacis Glabrae 15-35 silkworm excrement 15-32 Flos Chrysanthemi Indici 15-35
Tangerine 10-24.
Wherein each proportion of raw materials is more preferably:
Rhizoma Polygoni Cuspidati 20 Herba Hedyotidis Diffusaes 15 Rhizoma Menispermis 10
Rhizoma Bistortae 15 Herba Artemisiae Scopariaes 15 Rhizoma Imperataes 30
Radix Rubiae 15 Herba Epimedii 10 Radix Glycyrrhizaes 10
Rhizoma Smilacis Glabrae 15 silkworm excrements 15 Flos Chrysanthemi Indicis 15
Tangerine 10.
Wherein, described acceptable accessories can be the conventional adjuvant that uses in this area, and it comprises Icing Sugar, starch, dextrin, magnesium stearate, Pulvis Talci, Aspartane, microcrystalline Cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose sodium, film coating material and similar adjuvant.Described adjuvant is preferably Icing Sugar, dextrin, Aspartane, carboxymethyl starch sodium, magnesium stearate or film coating material.
In addition, pharmaceutical composition of the present invention can be made into to be fit to any pharmaceutically acceptable suitable dosage form that the patient takes, and for example can be dosage forms such as granule, tablet or capsule.Described granule can be that sugared granule or sugar free granule are arranged.
The invention still further relates to a kind of described preparation of drug combination method, it comprises:
(1) Radix Rubiae, the Rhizoma Smilacis Glabrae that takes by weighing described parts by weight pulverized, fine powder is standby, the Rhizoma Polygoni Cuspidati of coarse powder and described parts by weight, Herba Hedyotidis Diffusae, Rhizoma Menispermi, Rhizoma Bistortae, Herba Artemisiae Scopariae, Rhizoma Imperatae, Herba Epimedii, Radix Glycyrrhizae, silkworm excrement, Flos Chrysanthemi Indici, dried tangerine peel decoct with water twice, collecting decoction is got the clarification medicinal liquid and is concentrated into the clear paste that relative density is 1.15-1.30 (50 ℃);
(2) get clear paste in the step (1),, make required dosage form through conventional method.
In the above-mentioned preparation method, described conventional method is to point in the described clear paste to add appropriate amount of auxiliary materials, and the fine powder that adds Radix Rubiae and Rhizoma Smilacis Glabrae is granulated, drying, and granulate is made granule.For example, can in clear paste, add appropriate amount of auxiliary materials, as 1 part of clear paste add 3.5 portions of Icing Sugar or 0.4 part in dextrin, 0.1 part of starch, Aspartane is an amount of, granulates, drying, granulate have been made sugar or sugar free granule.
In above-mentioned preparation method, described conventional method is that granulation, granulate, tabletting, coating are made tablet with the fine powder and the appropriate amount of auxiliary materials of described clear paste drying, adding Radix Rubiae and Rhizoma Smilacis Glabrae.Described adjuvant can be preferably carboxymethyl starch sodium, magnesium stearate, the film coating material.
In this preparation method, described conventional method can also be that described clear paste is carried out drying, adds Radix Rubiae and the fine powder of Rhizoma Smilacis Glabrae and suitable adjuvant, makes granule, capsule charge; The fine powder that perhaps clear paste is added Radix Rubiae and Rhizoma Smilacis Glabrae is granulated, filled capsules, makes capsule.
The invention still further relates to a kind of described preparation of drug combination method, it comprises:
Take by weighing Rhizoma Polygoni Cuspidati, Herba Hedyotidis Diffusae, Rhizoma Menispermi, Rhizoma Bistortae, Herba Artemisiae Scopariae, Rhizoma Imperatae, Radix Rubiae, Herba Epimedii, Radix Glycyrrhizae, Rhizoma Smilacis Glabrae, silkworm excrement, Flos Chrysanthemi Indici, the tangerine raw material of described parts by weight, to wherein decocting with water twice, collecting decoction, get the clarification medicinal liquid and be concentrated into the clear paste that relative density is 1.15-1.30 (50 ℃), through conventional method, make required dosage form.
In this preparation method, described conventional method is that mixing, tabletting, coating are made tablet with described clear paste drying, granulation, adding appropriate amount of auxiliary materials; Wherein said adding adjuvant can also carry out when granulating.Described adjuvant can be preferably carboxymethyl starch sodium, magnesium stearate, film coating material.In this preparation method, described conventional method can also be that described clear paste is carried out drying, granulation, filled capsules, makes capsule.
In according to preparation of drug combination method provided by the invention, wherein saidly decoct with water twice and can be: add water 7-10 for the first time and doubly measures, soaked 0.5-1 hour, decocted 0.5-2 hour, add water 5-8 the second time doubly measures, and decocts 0.5-1.5 hour.Preferably, add 8 times of amounts of water for the first time, soaked 0.5 hour, decocted 1 hour, add 6 times of amounts of water for the second time, decocted 45 minutes.
In according to preparation of drug combination method provided by the invention, can adopt leave standstill, filtration, method such as centrifugal obtain clarifying medicinal liquid.
According to pharmaceutical composition provided by the invention is one of hepatitis B series Chinese medicine, and it is primarily aimed at, and dampness-heat in the liver and gallbladder is impatient, active stage at chronic type B viral hepatitis initial stage and hepatitis b virus carrier.
Adopt plurality of Chinese as main component according to pharmaceutical composition provided by the invention, have the liver heat removing function of gallbladder promoting, detoxify by the function of pestilence, can obviously improve jaundice, gastral cavilty feeling of fullness, the thick greasy or yellowish and greasy fur that disappears etc. damp and hot in the disease of resistance, and have stronger heat-clearing and toxic substances removing effect, have the hepatitis B virus of impelling index and turn out cloudy and recover effects such as liver function.Described pharmaceutical composition of while toxicity safe in utilization, no.Therefore, be a kind of pharmaceutical composition comparatively easily that can be used for the acute and chronic Type B viral hepatitis of liver gallbladder damp-heat type initial stage or active stage and hepatitis b virus carrier according to pharmaceutical composition provided by the invention.
Acute toxicity test in mice according to pharmaceutical composition provided by the invention shows that described pharmaceutical composition toxicity is very little.Demonstrate described pharmaceutical composition according to the clinical trial of pharmaceutical composition provided by the invention hepatitis B virus is had the obvious suppression effect.Described pharmaceutical composition has and impels the effect of turning out cloudy of hepatitis B virus index, recovers the liver function effect, obviously improves the effect of acute and chronic hepatitis B patient clinical symptoms, sign.
The using dosage of pharmaceutical composition provided by the invention is: sugared granule is arranged: one time 2 bags, every bag 10 the gram; Sugar free granule: one time 1 bag, every bag 6 the gram; Tablet: one time 5, every 0.5 the gram; Capsule: a 4-6 grain, every 0.4 gram.
The acute toxicity test of pharmaceutical composition of the present invention
One, medicine:
Use the granule of the described pharmaceutical composition of embodiment 1 preparation, to call hepatitis B heat-clearing and toxic substances removing granule in the following text
Two, animal and source:
Mice: the Kunming kind, body weight: 18-20 gram, male and female half and half are tested, and laboratory mice is all weighed after hungry 15 hours, normal feed before grouping, the experiment.Each is organized mice and all amounts to administration by body weight.Animal provides by Liaoning Province animal housing of medicine inspecting institute.
Three, toxicity test method
The acute toxicity test of footpath mouthful administration
(1) single dose administration: get 40 male and female half and half of mice, be divided into four groups, organize mice all with the dosage of per kilogram of body weight 20g, gastric infusion of volume of per 20 gram mouse stomach 0.8ml for every group 10, the activity and the body weight gain situation of observing white mice, its result such as following table 1:
The acute toxicity result of table 1 single dose mice footpath mouthful administration
The result: hepatitis B heat-clearing and toxic substances removing granule is pressed the dosage of 20g/kg and is given the mouse stomach administration, observes in three days and does not all have dead mouse, and each organizes the equal normal growth of mice body weight.Infer the LD of the mice footpath mouthful administration of hepatitis B heat-clearing and toxic substances removing granule
50All greater than 20g/kg.The toxicity that hepatitis B heat-clearing and toxic substances removing granule is described very little (this dosage has been 50 times of clinical consumption, is 5 times of mice dose,equivalent).The each 20g of selection that clinical dosage is described is safe.
(2) multidose administration: get 40 of mices, be divided into four groups, 10 every group, male and female half and half, each organizes mice all with dosage administration in 24 hours (filling stomach) of per kilogram of body weight 20g three times, and accumulated dose is per kilogram 60 grams.Observed seven days, respectively before administration, weighed up the body weight gain situation after the administration on the the 2nd, 4,7 day.Its result is as follows:
The acute toxicity result of table 2 multidose mice footpath mouthful administration
The result: hepatitis B heat-clearing and toxic substances removing granule is given mouse stomach by the dosage of each 20g/kg, irritates stomach 3 times in 24 hours, observed seven days, each organizes mice does not all have death, but slower than the body weight gain of single administration, multiple dosing in 24 hours continuously is described, the mice weight increase occurs and be affected.
(3) successive administration: get 40 of mices, be divided into four groups, 10 every group, male and female half and half, each group all once with dosage gastric infusion every day of 20g/ kilogram, continuous irrigation stomach five days is observed mice active situation and body weight gain situation in five days.Its result is as follows:
Table 3 is the acute toxicity result of mice footpath mouthful administration continuously
The result shows: the dosage of pressing 20g/kg, irritate stomach every day once, continuous irrigation stomach five days, it is normal that it respectively organizes weight of mice, increase obviously than the mice that is administered three times in 24 hours, illustrate that administration accumulated dose on the five reaches 100g/kg, gently than the toxicity performance due to the accumulated dose 60g/kg that is administered three times in 24 hours, the metabolism that hepatitis B heat-clearing and toxic substances removing granule is described is very fast, is unlikely to have influence on the normal feed of mice and the increase of body weight.
Medicine composite for curing 340 routine hepatitis B clinical observations of the present invention are summed up
One, case is selected
(1), diagnostic criteria:
The acute and chronic hepatitis diagnostic criteria (clinical diagnosis, etiological diagnosis, histopathology diagnostic criteria) of uniting revision according in JIUYUE, 2000 China infectious disease parasitic disease association of medical association, hepatopathy association.
Hepatitis B:
1, following any one positive is arranged, diagnosable is that existing disease HBV infects:
1. the serum HBsAg positive;
2. the serum HBV DNA positive;
3. serum resists-the HBcIgM positive;
4. the HBcAg and/or the HBsAg positive in the liver, or the HBV DNA positive.
(1) acute hepatitis B diagnosis:
The diagnosing acute hepatitis B can be with reference to following dynamic indicator:
1. the HBsAg titre resists after HBsAg disappears-commentaries on classics of HBs sun from high to low.
2. acute stage, resist-HBcIgM titre height, and anti--HBcIgG is negative or low-level.
(2) diagnosis of chronic hepatitis B:
The clinical chronic hepatitis that meets, and there have more than one existing disease HBV to infect sign to be positive.
2, differential diagnosis in tcm standard:
Acute and chronic hepatitis (resistive in damp and hot) differential diagnosis in tcm standard according to the revision in 1991 of Chinese Chinese medicine internal medicine liver-gallbladder disease Professional Committee of association:
(1) acute hepatitis (comprising icteric and non-icteric type) clinical manifestation:
Yellowish urine, the jaundice of body order, bright and lustrous, feel sick and detest oil, indigestion and loss of appetite, the xerostomia hardship, heaviness sensation over the head and body, the bloated gastral cavity of the side of body is vexed, weak, big dry stool or half congealed rushing down, yellow and greasy fur.The stringy and rolling pulse number.
Main symptom: (1) yellowish urine, the jaundice of body order, bright and lustrous; (2) feel sick, detest oil, indigestion and loss of appetite; (3) yellow and greasy fur.
Inferior card: (1) xerostomia hardship; (2) big dry stool or half congealed rushing down; (3) heaviness sensation over the head and body; (4) the bloated gastral cavity of the side of body is vexed.
Dialectical requirement: 1.1, possess main symptom (1) and (2), a person in (3) two, promptly belong to assertive evidence;
1.2, possess main symptom (1) and time card (1), (2), (3), any two persons in (4) four, promptly belong to assertive evidence;
(2), the chronic hepatitis clinical manifestation is:
The side of body gastral cavity that expands is vexed, feels sick and detests oil, and is indigestion and loss of appetite, body order jaundice and bright and lustrous, and yellowish urine, mouthful sticking bitter taste, stool viscous is dirty smelly or to do the back earlier half congealed, and thirst with desire to drink or drink are and few, and it is heavy that limbs are stranded, fatigue and weakness, yellowish fur, pulse condition stringy and rapid pulse or stringy and rolling pulse number.
Main symptom: the jaundice of (1) body order, bright and lustrous; (2) yellow and greasy fur.
Inferior card: feel sick (1), detests oil, indigestion and loss of appetite; (2) the bloated gastral cavity of the side of body is vexed; (3) yellowish urine.
Dialectical requirement: 2.1, possess main symptom (1), (2) person, promptly belong to assertive evidence;
2.2, possess main symptom (2) and time any two persons of card in three, promptly belong to assertive evidence;
2.3, possess main symptom (1) and time the card (1), (2) person, promptly belong to assertive evidence.
(2), include standard in:
Meet that above-mentioned Western medicine diagnose standard and tcm diagnosis standard and aspiration are tried and the patient that can cooperate (outpatient service and in hospital all can), include observation in.
1, liver function index: can or multinomial unusual.(chronic hepatitis ALT continues or is unusual repeatedly, and 〉=normal value is more than 1 times, but≤below 10 times; Serum total bilirubin≤3 times)
2, viral index: acute hepatitis HBsAg, HBeAg, HBV-DNA can one or the multinomial positive.
Anti--HBcIgM titre height, anti--HBcIgG is negative or low-level.
Chronic hepatitis HBsAg, HBeAg, anti--HBe, anti--HBc, HBV-DNA
Can one or the multinomial positive.
(3), exclusion standard:
Acute hepatitis
1, the acute viral hepatitis of other type;
2, gestation or women breast-feeding their children;
3, the acute viral hepatitis that merges other type;
4, the age is below 15 years old, person more than 70 years old;
5, all types of chronic viral hepatitis;
6, liver cirrhosis and liver cancer patient;
7, merge chronic nephropathy and diabetes.
Chronic hepatitis
1, the chronic viral hepatitis of other type;
2, gestation or women breast-feeding their children;
3, the viral hepatitis that merges other type;
4, the age is below 15 years old, person more than 70 years old;
5, primary biliary cirrhosis, autoimmune hepatitis;
6, cirrhosis patients in decompensation and liver cancer patient;
7, merge chronic nephropathy and diabetes;
8, used antiviral drugs (interferon and/or lamivudine) in 6 months.
Two, the observational technique medication and the course of treatment
(1), medicine: use embodiment 1 described medicament composition granule agent, to call hepatitis B heat-clearing and toxic substances removing granule in the following text
Specification: 10g * 20 bag
Main component: Rhizoma Polygoni Cuspidati Herba Artemisiae Scopariae Rhizoma Imperatae Radix Rubiae Rhizoma Smilacis Glabrae silkworm excrement Flos Chrysanthemi Indici etc.
Function with cure mainly: the liver heat removing function of gallbladder promoting, detoxifcation is used for acute and chronic Type B viral hepatitis initial stage of liver gallbladder damp-heat type or active stage by pestilence; Hepatitis b virus carrier.Disease is seen jaundice (or not having jaundice), fever, (or low grade fever), red tongue, the greasy stringy and rolling pulse number of thick fur, and xerostomia is bitter or mouth is sticking smelly, detests oil, gastrointestinal upset etc.
(2) medication and the course of treatment
1, acute hepatitis: 2 bags of hepatitis B heat-clearing and toxic substances removing granules, 3 times on the 1st, taking medicine after meal serve on 3 months.Followed up a case by regular visits to 12 months.
2, chronic hepatitis: 2 bags of hepatitis B heat-clearing and toxic substances removing granules, 3 times on the 1st, taking medicine after meal serve on 3 months.Followed up a case by regular visits to 6 months.
Whole cases are all given up alcohol during the drug withdrawal follow-up observation, avoid spicy food.
The medicine that can take is VitC, VitBco etc.The medicine of forbidding is that antiviral agents such as interferon etc. reach the alt-reducing and liver-protecting medicine as containing five tastes subclass medicine.
Three, observation item and index
(1), leading indicator
1, acute hepatitis B
(1), clinical symptoms, sign: each observed and recorded once before the treatment, when treating two weeks, treatment 1 month and following up a case by regular visits to 3,6 months.
Disease is seen: yellowish urine, and the jaundice of body order, bright and lustrous, feel sick and detest oil, indigestion and loss of appetite, the xerostomia hardship, heaviness sensation over the head and body, the bloated gastral cavity of the side of body is vexed, weak, big dry stool or half congealed rushing down, yellow and greasy fur.The stringy and rolling pulse number.
(2), viral index: HBsAg, HBeAg, anti--HBe, anti--HBc, HBV-DNA.Before anti--the HBcIgM titre, anti--HBcIgg titre treatment, during the treatment per 1 month and each observed and recorded is once when following up a case by regular visits to 3,6,12 months.
(3), liver function index: ALT, AST, total bilirubin, bilirubin direct, unconjugated bilirubin, albumin, globulin, r-globulin, prothrombin time.Per 1 month, treatment 3 months and each detection record is once when following up a case by regular visits to every month before the treatment, during the treatment.
3, chronic hepatitis B
(1), clinical symptoms, sign: each observed and recorded once before the treatment, when treating two weeks, treatment 3 months and following up a case by regular visits to 1,3,6 month.
Disease is seen: the side of body gastral cavity that expands is vexed, feels sick and detests oil, and is indigestion and loss of appetite, body order jaundice and bright and lustrous, yellowish urine, mouthful sticking bitter taste, stool viscous dirty smelly or not well, to do the back earlier half congealed, thirst with desire to drink or drink are and few, it is heavy that limbs are stranded, fatigue and weakness, yellowish fur, pulse condition stringy and rapid pulse or stringy and rolling pulse number.Sign: liver palm, spider angioma, liver, splenomegaly.
(2), viral index: HBsAg, HBeAg, anti--HBe, anti--HBc, HBV-DNA.Per 1 month, treatment 3 months and each observed and recorded is once when following up a case by regular visits to 1,3,6 month before the treatment, during the treatment.
(3), liver function index: ALT, AST, total bilirubin, bilirubin direct, unconjugated bilirubin, albumin, globulin, r-globulin, prothrombin time.Every two weeks before the treatment, during the treatment, treatment 3 months and each detection record is once when following up a case by regular visits to every month.
Four, statistical procedures
Carry out statistical procedures with the SPSS10.0 statistical software.To the every index before and after two groups of patient treatments relatively, carry out the t check.
Five, result
This observes case 410 examples, wherein qualified case 340 examples, invalid case 70 examples.Acute hepatitis 71 examples in the qualified case, chronic hepatitis 269 examples.63 examples of being in hospital in acute hepatitis 71 examples, outpatient service 8 examples, the ratio of being in hospital accounts for 88.73%; Inpatient's 97 examples in chronic hepatitis 269 examples, clinic case 172 examples, the ratio of being in hospital accounts for 36.06%.
(1), acute hepatitis B
Table 4 patient physical data (X ± SD)
Observation of symptoms table before and after table 5 treatment
The result shows: after the treatment, clinical cardinal symptom disappears substantially, and is evident in efficacy.
Changes of liver function before and after table 6 treatment (X ± SD)
P
1For treat back 3 months with the treatment before comparison, P
2For follow up a case by regular visits to after 12 months with treatment before comparison.
The result shows that there is significant difference treatment front and back (comprising treatment 3 months and treatment 12 months).
HBV changes before and after table 7 treatment
The result shows: behind the hepatitis B heat-clearing and toxic substances removing granule treatment acute hepatitis B 3 months and follow up a case by regular visits to 12 months its HB
SAg, HB
eThe negative conversion rate of Ag, HBVDNA is as above shown listed, illustrates that this medicine has the obvious suppression effect to hepatitis B virus.
Curative effect determinate standard:
The acute hepatitis traditional Chinese medical science curative effect determinate standard of curative effect determinate standard and Chinese Chinese medicine internal medicine liver-gallbladder disease Professional Committee of association revision in 1991 of uniting the acute hepatitis B of revision according in JIUYUE, 2000 China infectious disease parasitic disease association of medical association, hepatopathy association:
(1), acute hepatitis B
The basic healing:
1, the card of the primary and secondary in this syndrome disappears;
2, liver recovers normal or obviously bounces back, and the hepatic region does not have obvious tenderness or kowtows pain;
3, liver function recovery is normal;
4, HB
SAg is cloudy to be changeed;
5, above every 1 year no recidivist that follows up a case by regular visits to.
Curative effect when table 8 treatment finishes, after following up a case by regular visits to
Above result shows: the cure rate that hepatitis B heat-clearing and toxic substances removing granule is treated 67 routine acute hepatitis Bs is 94.37%, and is evident in efficacy.
(2), chronic hepatitis B
Table 9 patient physical data (X ± SD)
Changes of liver function before and after table 10 treatment (X ± SD)
P
1For treat back 3 months with the treatment before comparison, P
2For follow up a case by regular visits to after 6 months with treatment before comparison.
The result shows that there were significant differences in treatment front and back (comprise and treated 3 months and followed up a case by regular visits to 6 months).
Above result shows that hepatitis B heat-clearing and toxic substances removing granule improves significantly to chronic hepatitis B patient's liver function.
Observation of symptoms table before and after table 11 treatment
Before table 12 treatment, finish, follow up a case by regular visits to the back sign and change
Table 11, table 12 result show that hepatitis B heat-clearing and toxic substances removing granule improves significantly to chronic hepatitis B patient's clinical symptoms and sign.
HBV changes before and after table 13 treatment
The result shows: behind the hepatitis B heat-clearing and toxic substances removing granule treatment chronic hepatitis B 3 months and follow up a case by regular visits to 6 months its HB
SAg, HB
eThe negative conversion rate of Ag, HBVDNA is as above shown listed, illustrates that this medicine has the obvious suppression effect to hepatitis B virus.
Curative effect determinate standard:
The chronic hepatitis traditional Chinese medical science curative effect determinate standard of curative effect determinate standard and Chinese Chinese medicine internal medicine liver-gallbladder disease Professional Committee of association revision in 1991 of uniting the chronic hepatitis B of revision according in JIUYUE, 2000 China infectious disease parasitic disease association of medical association, hepatopathy association:
The doctor trained in Western medicine standard:
1, it is normal again to reply (produce effects): ALT fully, and HBVDNA, HBeAg are all cloudy to be changeed;
2, part is replied all cloudy commentaries on classics of (effectively): HBVDNA, HBeAg, but ALT is multiple normal; Or HBVDNA
Turn out cloudy, HBeAg do not turn out cloudy, ALT is normal again.
3, no response (invalid): do not reach above-mentioned standard person;
4, continue to reply: reply (produce effects) fully or partly reply (effectively) person, 6-12 month still is produce effects or responder after the drug withdrawal;
5, recurrence: be produce effects or effective during the treatment end, occur ALT after the drug withdrawal in 6-12 month and reach HBVDNA sun commentaries on classics person unusually for recurring.
Traditional Chinese medical science standard:
1, clinical basic healing: 1., the primary and secondary of this syndrome card disappears;
2., liver enlargement obviously retraction or stable no change, the hepatic region does not have tenderness or kowtows pain;
3., the liver function index inspection recovers normal;
4., the cloudy HBsAg that transfers of hepatitis B virus duplication index still can be positive; More than every index kept stablize 6-12 individual month.
2, produce effects: 1., the primary and secondary of this syndrome card disappears to account for more than half or take a turn for the better and account for more than 2/3rds;
2., liver enlargement retraction or stablize no change, the hepatic region does not have tenderness or kowtows pain;
3., the liver function index inspection recovers normal or slight abnormality.
4., the hepatitis B virus duplication index has a moon then the HBsAg still can be positive.
1., the primary and secondary card of this syndrome disappears and account for 1/3rd or more or improvement accounts for more than half 3, take a turn for the better:;
2., liver enlargement retraction or stablize no change, the hepatic region does not have tenderness or kowtows pain;
8., the liver function index inspection is than more than the initial value drop by half; , the hepatitis B virus duplication index descends to some extent and HBsAg still can be positive.
4, invalid: as not reach above-mentioned standard person.
Curative effect when table 14 treatment finishes, after following up a case by regular visits to
Safety indexes:
Erythrocyte, hemoglobin, leukocyte before and after the table 15 liang group patient treatment
(blood) blood urea nitrogen, creatinine, electrocardiogram before and after the table 16 liang group patient treatment
Acute hepatitis B 71 examples are observed in this treatment, and chronic hepatitis B 269 examples have all been carried out blood, urine, just conventional before and after treatment, and any untoward reaction does not appear in renal function and Electrocardiographic inspection in drug administration process.The results are shown in Table 15, table 16, illustrate that hepatitis B heat-clearing and toxic substances removing granule treats acute and chronic hepatitis B and have no side effect, safety is good.
Discuss and conclusion
1, this clinical summary shows: hepatitis B heat-clearing and toxic substances removing granule has following effect:
1. the effect that impels the hepatitis B virus index to turn out cloudy.Its HB of this medicine treatment acute hepatitis B
SA
gNegative conversion rate be 94.36%, the positive rate of rotation of HBsAb is 64.8%, the negative conversion rate of HBeAg is 96.78%, the HBVDNA negative conversion rate is 95.77%.The negative conversion rate of its HBeAg of treatment chronic hepatitis B is 38.83%, and the HBVDNA negative conversion rate is 29.76%.
2. recover the effect of liver function.More all be significantly improved before and after the treatments such as its leading indicator ALT, AST, BiL.
The effect of acute and chronic hepatitis B patient clinical symptoms, the sign of 3. having clear improvement.
2, before and after the hepatitis B heat-clearing and toxic substances removing granule treatment to all treatment group patient blood, urine, just projects such as routine, blood urea nitrogen, electrocardiogram compare inspection, its hemogram is the result show: erythrocyte, hematochrome, leukocyte treatment front and back no significant difference.Blood urea nitrogen, creatinine, electrocardiogram are treated forward and backward patient and do not see any untoward reaction in drug administration process, illustrate that hepatitis B heat-clearing and toxic substances removing granule has no side effect to the human body main organs, and be safe in utilization.
3, hepatitis B heat-clearing and toxic substances removing granule is a main component with Rhizoma Polygoni Cuspidati Herba Artemisiae Scopariae Rhizoma Imperatae Radix Rubiae Rhizoma Smilacis Glabrae silkworm excrement Flos Chrysanthemi Indici etc.
Be used for acute and chronic Type B viral hepatitis initial stage of liver gallbladder damp-heat type or active stage; Hepatitis b virus carrier.Disease sees that jaundice (or not having jaundice), fever (or low grade fever), red tongue, thick fur are greasy, the stringy and rolling pulse number, and xerostomia is bitter or mouthful sticking smelly, detests oil, gastrointestinal upset etc.Hepatitis B heat-clearing and toxic substances removing granule II phase clinical treatment observation result: recent clinical cure rate 89/356=25%; Effective percentage 70/356=47.7%; Total effective rate 72.7%.HBsAg negative conversion rate 32/356=8.99%, HBeAg negative conversion rate 145/356=42.26%, HBV-DNA negative conversion rate 12/34=35.29%.
Hepatitis B heat-clearing and toxic substances removing granule is with the liver heat removing function of gallbladder promoting, detoxifcation is its outstanding feature by the pestilence function, can obviously improve jaundice, gastral cavilty feeling of fullness, the card of resistance during the thick greasy or yellowish and greasy fur etc. of disappearing is damp and hot, and the power of its heat-clearing and toxic substances removing is stronger impels the hepatitis B virus index to turn out cloudy and recovers effect such as liver function, safe in utilization, no toxicity is a kind of new comparatively easily Chinese medicine preparation of the acute and chronic hepatitis B of treatment, is worth of widely use.
4, every bag 10 gram of this product (sugared granule is arranged) is obeyed 2 bags at every turn, and three times on the one, totally 6 bags.
Every bag 6 gram of this product (sugar-free granule) is obeyed 1 bag at every turn, and three times on the one, totally 3 bags.
The specific embodiment
Come sets forth in detail the present invention with reference to specific embodiment.
Below the raw medicinal material of each embodiment buy from the legal marketer of country, adopt extract, concentrate, granulate, dry, choosing grain etc. is prepared.
The preparation that sugared granule is arranged of the pharmaceutical composition of embodiment 1 treatment hepatitis B
Take by weighing each raw material of following weight:
Rhizoma Polygoni Cuspidati 20g Herba Hedyotidis Diffusae 15g Rhizoma Menispermi 10g
Rhizoma Bistortae 15g Herba Artemisiae Scopariae 15g Rhizoma Imperatae 30g
Radix Rubiae 15g Herba Epimedii 10g Radix Glycyrrhizae 10g
Rhizoma Smilacis Glabrae 15g silkworm excrement 15g Flos Chrysanthemi Indici 15g
Tangerine 10g
(1) Radix Rubiae, the Rhizoma Smilacis Glabrae of above-mentioned amount are pulverized, fine powder is standby, coarse powder and Rhizoma Polygoni Cuspidati, Herba Hedyotidis Diffusae, Rhizoma Menispermi, Rhizoma Bistortae, Herba Artemisiae Scopariae, Rhizoma Imperatae, Herba Epimedii, Radix Glycyrrhizae, silkworm excrement, Flos Chrysanthemi Indici, tangerine ten decoct twice simply, add 8 times in water for the first time, soak 0.5 hour, decocted 1 hour, for the second time add 6 times in water, decocted collecting decoction 45 minutes, left standstill 12 hours, and got the clarification medicinal liquid and be concentrated into the clear paste that relative density is 1.15-1.30 (50 ℃);
(2) get 2 parts of Icing Sugar, add Rhizoma Smilacis Glabrae, Radix Rubiae fine powder, behind 0.5 part of mix homogeneously of dextrin, granulate for 1 part with the clear paste in the step (1), drying, granulate has obtained sugared granule.
The preparation that sugared granule is arranged of the pharmaceutical composition of embodiment 2 treatment hepatitis ies
Adopt method similar to Example 1, just proportioning raw materials wherein is
Rhizoma Polygoni Cuspidati 15g Herba Hedyotidis Diffusae 32g Rhizoma Menispermi 16g
Rhizoma Bistortae 26g Herba Artemisiae Scopariae 35g Rhizoma Imperatae 55g
Radix Rubiae 25g Herba Epimedii 25g Radix Glycyrrhizae 16g
Rhizoma Smilacis Glabrae 35g silkworm excrement 24g Flos Chrysanthemi Indici 20g
Tangerine 18g
Obtained sugared granule.
The preparation that sugared granule is arranged of the pharmaceutical composition of embodiment 3 treatment hepatitis ies
Adopt method similar to Example 1, just proportioning raw materials wherein is
Rhizoma Polygoni Cuspidati 45g Herba Hedyotidis Diffusae 24g Rhizoma Menispermi 24g
Rhizoma Bistortae 34g Herba Artemisiae Scopariae 20g Rhizoma Imperatae 80g
Radix Rubiae 35g Herba Epimedii 18g Radix Glycyrrhizae 24g
Rhizoma Smilacis Glabrae 25g silkworm excrement 32g Flos Chrysanthemi Indici 35g
Tangerine 24g
Obtained sugared granule.
The preparation that sugared granule is arranged of the pharmaceutical composition of embodiment 4 treatment hepatitis ies
Adopt method similar to Example 1, just proportioning raw materials wherein is
Rhizoma Polygoni Cuspidati 5g Herba Hedyotidis Diffusae 45g Rhizoma Menispermi 5g
Rhizoma Bistortae 10g Herba Artemisiae Scopariae 45g Rhizoma Imperatae 90g
Radix Rubiae 10g Herba Epimedii 30g Radix Glycyrrhizae 5g
Rhizoma Smilacis Glabrae 10g silkworm excrement 45g Flos Chrysanthemi Indici 10g
Tangerine 30g
Obtained sugared granule.
The preparation that sugared granule is arranged of the pharmaceutical composition of embodiment 5 treatment hepatitis ies
Adopt method similar to Example 1, just wherein proportioning raw materials is:
Rhizoma Polygoni Cuspidati 60g Herba Hedyotidis Diffusae 10g Rhizoma Menispermi 30g
Rhizoma Bistortae 45g Herba Artemisiae Scopariae 10g Rhizoma Imperatae 25g
Radix Rubiae 45g Herba Epimedii 5g Radix Glycyrrhizae 30g
Rhizoma Smilacis Glabrae 45g silkworm excrement 10g Flos Chrysanthemi Indici 45g
Tangerine 5g
Obtained sugared granule.
The preparation that sugared granule is arranged of the pharmaceutical composition of embodiment 6 treatment hepatitis ies
Adopt method similar to Example 1, just preparation method wherein is:
(1) Radix Rubiae, Rhizoma Smilacis Glabrae are pulverized, fine powder is standby, coarse powder and Rhizoma Polygoni Cuspidati, Herba Hedyotidis Diffusae, Rhizoma Menispermi, Rhizoma Bistortae, Herba Artemisiae Scopariae, Rhizoma Imperatae, Herba Epimedii, Radix Glycyrrhizae, silkworm excrement, Flos Chrysanthemi Indici, tangerine ten decoct twice simply, add 8 times in water for the first time, soak 1 hour, decocted 1.5 hours, for the second time add 7 times in water, decocted collecting decoction 0.5 hour, left standstill 12 hours, and got the clarification medicinal liquid and be concentrated into the clear paste that relative density is 1.15-1.28 (50 ℃);
(2) Icing Sugar is 3.5 parts, adds Rhizoma Smilacis Glabrae, Radix Rubiae fine powder, and 0.1 part of starch is granulated for 1 part with the clear paste in the step (1), drying, and granulate has obtained sugared granule.
The preparation of the sugar free granule of the pharmaceutical composition of embodiment 7 treatment hepatitis ies
Adopt method similar to Example 1, just step (2) wherein is:
1 part in dextrin, 0.5 part of starch adds Rhizoma Smilacis Glabrae and Radix Rubiae fine powder, granulates for 1 part with the clear paste in the step (1), drying, granulate obtains sugar free granule.
The preparation of the sugar free granule of the pharmaceutical composition of embodiment 8 treatment hepatitis ies
Adopt method similar to Example 1, just step (2) wherein is:
0.5 part in dextrin, 1 part of starch adds Rhizoma Smilacis Glabrae and Radix Rubiae fine powder, adds 0.3% Aspartane of preparation inventory, with 1 part of the clear paste in the step (1), granulate, drying, granulate obtains sugar free granule.
The preparation of the tablet of the pharmaceutical composition of embodiment 9 treatment hepatitis ies
Take by weighing each raw material of following weight:
Rhizoma Polygoni Cuspidati 20g Herba Hedyotidis Diffusae 15g Rhizoma Menispermi 10g Rhizoma Bistortae 15g
Herba Artemisiae Scopariae 15g Rhizoma Imperatae 30g Radix Rubiae 15g Herba Epimedii 10g
Radix Glycyrrhizae 10g Rhizoma Smilacis Glabrae 15g silkworm excrement 15g Flos Chrysanthemi Indici 15g
Tangerine 10g
Rhizoma Polygoni Cuspidati with above-mentioned amount, Herba Hedyotidis Diffusae, Rhizoma Menispermi, Rhizoma Bistortae, Herba Artemisiae Scopariae, Rhizoma Imperatae, Radix Rubiae, Herba Epimedii, Radix Glycyrrhizae, Rhizoma Smilacis Glabrae, silkworm excrement, Flos Chrysanthemi Indici, tangerine 13 flavor medical materials decoct twice, add for the first time 10 times in water, soaked 45 minutes, decocted 2 hours, add for the second time 5 times in water, decocted 0.5 hour, collecting decoction, centrifugal, get the clarification medicinal liquid and be evaporated to the clear paste that relative density is 1.15-1.30 (50 ℃), 90% clear paste is carried out spray drying (inlet temperature 150-180 ℃, outlet temperature 90-100 ℃), spray powder is done end powder, clear paste with residue 10% is granulated, and adds the carboxymethyl starch sodium of the 5-10% of granulation amount, the magnesium stearate mixing of 0.5-1%, tabletting, coating makes tablet.
The preparation of the capsule of the pharmaceutical composition of embodiment 10 treatment hepatitis ies
Take by weighing each raw material of following weight:
Rhizoma Polygoni Cuspidati 20g Herba Hedyotidis Diffusae 15g Rhizoma Menispermi 10g Rhizoma Bistortae 15g
Herba Artemisiae Scopariae 15g Rhizoma Imperatae 30g Radix Rubiae 15g Herba Epimedii 10g
Radix Glycyrrhizae 10g Rhizoma Smilacis Glabrae 15g silkworm excrement 15g Flos Chrysanthemi Indici 15g
Tangerine 10g
Rhizoma Polygoni Cuspidati with above-mentioned amount, Herba Hedyotidis Diffusae, Rhizoma Menispermi, Rhizoma Bistortae, Herba Artemisiae Scopariae, Rhizoma Imperatae, Radix Rubiae, Herba Epimedii, Radix Glycyrrhizae, Rhizoma Smilacis Glabrae, silkworm excrement, Flos Chrysanthemi Indici, tangerine 13 flavor medical materials (silkworm excrement is packed) decoct twice, add for the first time 9 times in water, soaked 0.5 hour, decocted 1.5 hours, add for the second time 7 times in water, decocted 1 hour, collecting decoction, left standstill 12 hours, get the clarification medicinal liquid and be evaporated to the clear paste that relative density is 1.15-1.30 (50 ℃), 90% clear paste is carried out spray drying (inlet temperature 150-180 ℃, outlet temperature 90-100 ℃), spray powder is done end powder, clear paste with residue 10% is granulated hot blast airpillow-dry below 75 ℃, filled capsules, packing makes capsule.
The preparation of the tablet of the pharmaceutical composition of embodiment 11 treatment hepatitis ies
Take by weighing each raw material of following weight:
Rhizoma Polygoni Cuspidati 20g Herba Hedyotidis Diffusae 15g Rhizoma Menispermi 10g Rhizoma Bistortae 15g
Herba Artemisiae Scopariae 15g Rhizoma Imperatae 30g Radix Rubiae 15g Herba Epimedii 10g
Radix Glycyrrhizae 10g Rhizoma Smilacis Glabrae 15g silkworm excrement 15g Flos Chrysanthemi Indici 15g
Tangerine 10g
Radix Rubiae, Rhizoma Smilacis Glabrae are pulverized, fine powder is standby, coarse powder and Rhizoma Polygoni Cuspidati, Herba Hedyotidis Diffusae, Rhizoma Menispermi, Rhizoma Bistortae, Herba Artemisiae Scopariae, Rhizoma Imperatae, Herba Epimedii, Radix Glycyrrhizae, silkworm excrement, Flos Chrysanthemi Indici, tangerine ten decoct twice simply, add 7 times in water for the first time, soak 1 hour, decocted 0.5 hour, for the second time add 8 times in water, decocted collecting decoction 1.5 hours, left standstill 12 hours, and got the clarification medicinal liquid and be concentrated into the clear paste that relative density is 1.15-1.28 (50 ℃); 90% clear paste is carried out (inlet temperature 150-180 ℃ of spray drying, outlet temperature 90-100 ℃), spray powder is done end powder, granulate with remaining clear paste, the carboxymethyl starch sodium of the fine powder of adding Radix Rubiae, Rhizoma Smilacis Glabrae, the 5-10% of granulation amount, the magnesium stearate mixing of 0.5-1%, tabletting, coating makes tablet.
The preparation of the capsule of the pharmaceutical composition of embodiment 12 treatment hepatitis ies
Take by weighing each raw material of following weight:
Rhizoma Polygoni Cuspidati 20g Herba Hedyotidis Diffusae 15g Rhizoma Menispermi 10g Rhizoma Bistortae 15g
Herba Artemisiae Scopariae 15g Rhizoma Imperatae 30g Radix Rubiae 15g Herba Epimedii 10g
Radix Glycyrrhizae 10g Rhizoma Smilacis Glabrae 15g silkworm excrement 15g Flos Chrysanthemi Indici 15g
Tangerine 10g
Radix Rubiae, Rhizoma Smilacis Glabrae are pulverized, fine powder is standby, coarse powder and Rhizoma Polygoni Cuspidati, Herba Hedyotidis Diffusae, Rhizoma Menispermi, Rhizoma Bistortae, Herba Artemisiae Scopariae, Rhizoma Imperatae, Herba Epimedii, Radix Glycyrrhizae, silkworm excrement, Flos Chrysanthemi Indici, tangerine ten decoct twice simply, add 7 times in water for the first time, soak 1 hour, decocted 0.5 hour, for the second time add 8 times in water, decocted collecting decoction 1.5 hours, left standstill 12 hours, and got the clarification medicinal liquid and be concentrated into the clear paste that relative density is 1.15-1.28 (50 ℃); 90% clear paste is carried out spray drying (inlet temperature 150-180 ℃, outlet temperature 90-100 ℃), and the fine powder of spray powder and Radix Rubiae, Rhizoma Smilacis Glabrae is done end powder, is granulated with remaining clear paste, hot blast airpillow-dry below 75 ℃, filled capsules, packing makes capsule.
Claims (10)
1, a kind of pharmaceutical composition for the treatment of hepatitis B, it is made by following parts by weight proportion raw material and acceptable accessories:
Rhizoma Polygoni Cuspidati 5-60 Herba Hedyotidis Diffusae 10-45 Rhizoma Menispermi 5-30
Rhizoma Bistortae 10-45 Herba Artemisiae Scopariae 10-45 Rhizoma Imperatae 25-90
Radix Rubiae 10-45 Herba Epimedii 5-30 Radix Glycyrrhizae 5-30
Rhizoma Smilacis Glabrae 10-45 silkworm excrement 10-45 Flos Chrysanthemi Indici 10-45
Tangerine 5-30;
Preferred each raw materials in part by weight proportioning is:
Rhizoma Polygoni Cuspidati 15-45 Herba Hedyotidis Diffusae 15-32 Rhizoma Menispermi 10-24
Rhizoma Bistortae 15-34 Herba Artemisiae Scopariae 15-35 Rhizoma Imperatae 30-80
Radix Rubiae 15-35 Herba Epimedii 10-25 Radix Glycyrrhizae 10-24
Rhizoma Smilacis Glabrae 15-35 silkworm excrement 15-32 Flos Chrysanthemi Indici 15-35
Tangerine 10-24;
More preferably each raw materials in part by weight proportioning is:
Rhizoma Polygoni Cuspidati 20 Herba Hedyotidis Diffusaes 15 Rhizoma Menispermis 10
Rhizoma Bistortae 15 Herba Artemisiae Scopariaes 15 Rhizoma Imperataes 30
Radix Rubiae 15 Herba Epimedii 10 Radix Glycyrrhizaes 10
Rhizoma Smilacis Glabrae 15 silkworm excrements 15 Flos Chrysanthemi Indicis 15
Tangerine 10.
2, pharmaceutical composition as claimed in claim 1, wherein said acceptable accessories is Icing Sugar, starch, dextrin, magnesium stearate, Pulvis Talci, Aspartane, microcrystalline Cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose sodium and film coating material, preferred Icing Sugar, dextrin, Aspartane, carboxymethyl starch sodium, magnesium stearate or film coating material.
3, pharmaceutical composition as claimed in claim 1, its dosage form that has is granule, tablet or capsule; Wherein said granule is for having sugared granule or sugar free granule.
4, a kind of as each described preparation of drug combination method in the claim 1 to 3, it comprises the steps:
(1) takes by weighing Radix Rubiae, the Rhizoma Smilacis Glabrae of described parts by weight, with its pulverizing, fine powder is standby, the Rhizoma Polygoni Cuspidati of coarse powder and described parts by weight, Herba Hedyotidis Diffusae, Rhizoma Menispermi, Rhizoma Bistortae, Herba Artemisiae Scopariae, Rhizoma Imperatae, Herba Epimedii, Radix Glycyrrhizae, silkworm excrement, Flos Chrysanthemi Indici, dried tangerine peel decoct with water twice, collecting decoction is got the clarification medicinal liquid and is concentrated into relative density (under 50 ℃) and is the clear paste of 1.15-1.30;
(2) get clear paste described in the step (1),, make required dosage form through conventional method.
5, preparation method as claimed in claim 4, the described conventional method of wherein said step (2) comprises one of following method:
A) in described clear paste, add appropriate amount of auxiliary materials, add fine powder granulation, drying, the granulate of Radix Rubiae and Rhizoma Smilacis Glabrae, make granule;
B) described clear paste drying, the fine powder that adds Radix Rubiae and Rhizoma Smilacis Glabrae and appropriate amount of auxiliary materials, granulation, granulate, tabletting, coating are made tablet;
C) add Radix Rubiae and the fine powder of Rhizoma Smilacis Glabrae and suitable adjuvant, granulation to described clear paste, capsule charge is made capsule.
D) fine powder that clear paste is added Radix Rubiae and Rhizoma Smilacis Glabrae granulate, filled capsules, make capsule.
6, a kind of as each described preparation of drug combination method in the claim 1 to 3, it comprises the steps:
Take by weighing Rhizoma Polygoni Cuspidati, Herba Hedyotidis Diffusae, Rhizoma Menispermi, Rhizoma Bistortae, Herba Artemisiae Scopariae, Rhizoma Imperatae, Radix Rubiae, Herba Epimedii, Radix Glycyrrhizae, Rhizoma Smilacis Glabrae, silkworm excrement, Flos Chrysanthemi Indici, the tangerine raw material of described parts by weight, to wherein decocting with water twice, collecting decoction is got the clarification medicinal liquid and is concentrated into relative density (under 50 ℃) and is the clear paste of 1.15-1.30; Through conventional method, described clear paste is made required dosage form.
7, preparation method as claimed in claim 6, wherein said conventional method are with described clear paste drying, granulate, add appropriate amount of auxiliary materials, mixing, tabletting, coating, make tablet; The described appropriate amount of auxiliary materials that adds also can be carried out when granulating.
8, preparation method as claimed in claim 6, wherein said conventional method are that described clear paste is carried out drying, granulation, filled capsules, make capsule.
9, as claim 5,7 or 8 described preparation methoies, wherein said drying is drying under reduced pressure or spray drying.
10, as claim 4 or 6 described methods, wherein said decocting with water is meant that adding water 7-10 for the first time doubly measures for twice, soaked 0.5-1 hour, decocted 0.5-2 hour, add water 5-8 for the second time and doubly measure, decocted 0.5-1.5 hour, add 8 times of amounts of water the preferred first time, soaked 0.5 hour, decocted 1 hour, for the second time add 6 times of amounts of water, decocted 45 minutes.
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| CN200910137507A CN101618156A (en) | 2009-04-28 | 2009-04-28 | Medicine composition for treating hepatitis B and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104474401A (en) * | 2014-12-03 | 2015-04-01 | 西宁意格知识产权咨询服务有限公司 | Traditional Chinese medicine composition for treating hepatitis B and preparation method thereof |
| CN104622935A (en) * | 2015-03-23 | 2015-05-20 | 傅宇晓 | Traditional Chinese medicine composition for treating hepatitis and preparation method thereof |
| CN104645082A (en) * | 2015-03-23 | 2015-05-27 | 傅宇晓 | Capsule for treating hepatitis and preparation method thereof |
-
2009
- 2009-04-28 CN CN200910137507A patent/CN101618156A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104474401A (en) * | 2014-12-03 | 2015-04-01 | 西宁意格知识产权咨询服务有限公司 | Traditional Chinese medicine composition for treating hepatitis B and preparation method thereof |
| CN104622935A (en) * | 2015-03-23 | 2015-05-20 | 傅宇晓 | Traditional Chinese medicine composition for treating hepatitis and preparation method thereof |
| CN104645082A (en) * | 2015-03-23 | 2015-05-27 | 傅宇晓 | Capsule for treating hepatitis and preparation method thereof |
| CN104645082B (en) * | 2015-03-23 | 2017-12-15 | 应瑶琪 | A kind of capsule for treating hepatitis and preparation method thereof |
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