CN106266307A - Formica fusca bear gall pill and its preparation method and application - Google Patents

Formica fusca bear gall pill and its preparation method and application Download PDF

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CN106266307A
CN106266307A CN201610795304.0A CN201610795304A CN106266307A CN 106266307 A CN106266307 A CN 106266307A CN 201610795304 A CN201610795304 A CN 201610795304A CN 106266307 A CN106266307 A CN 106266307A
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formica fusca
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单晓春
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Abstract

The invention belongs to pharmaceutical technology field, be specifically related to a kind of Formica fusca bear gall pill and its preparation method and application.Described Formica fusca bear gall pill, is made up of the crude drug of following weight: Formica fusca 80 120 parts, Fel Ursi 40 60 parts, Pollen Typhae 20 40 parts, Oletum Trogopterori 20 40 parts, Rhizoma Corydalis 20 40 parts, Fructus Lycii 20 40 parts, Fructus Schisandrae Chinensis 20 40 parts, Borneolum Syntheticum 20 40 parts.Formica fusca bear gall pill has stronger replenishing YIN and removing heat, function of promoting blood circulation to disperse blood clots, can be clinically used for liver and gall stagnant heat, irritability and does not dredges caused chronic viral hepatitis B, liver cirrhosis, can improve liver function, and can promote that HBeAg turns out cloudy, and clinical efficacy is notable, and safety is high.

Description

Formica fusca bear gall pill and its preparation method and application
Technical field
The invention belongs to pharmaceutical technology field, be specifically related to a kind of Formica fusca bear gall pill and its preparation method and application.
Background technology
Chronic viral hepatitis B is lowly caused by hepatitis b virus infected human body and body's immunity Systemic disease based on hepar damnification, is the infectious disease that serious harm human life is healthy.Wide, the biography of primary disease Epidemic Scope Complicated, the sickness rate of approach of broadcasting high, hazardness is big, occupy first of various infectious disease.Chronic hepatitis B is almost at whole world model Enclosing interior distribution, whole world chronic hepatitis-B infection person is more than 3.5 hundred million people.The Chronic Asymptomatic hepatitis B virus carrier of China Person can exceed that 1.2 hundred million, and person is 28,000,000 people now to suffer from hepatitis B, and AIR is about 27,00/,100,000, and annual morbidity is 230/100000.Clinical treatment not yet obtains satisfactory effect at present, is one of big difficult diseases of three urgently captured.
Cirrhotic ascites is a kind of performance of Decompensated liver cirrhosis, is a kind of refractory disease.The formation of ascites not only shadow Ring the quality of life of patient, and add spontaneous peritonitis, renal failure equivalent risk, be the best index of prognosis. After cirrhotic ascites occurs, 2 annual survival rates only have 55%, and during Cirrhosis with Intractable ascites, 6 months survival rates are only 45%.
Chronic cholecystitis is gallbladder chronic inflammation disease, infects with antibacterial, and cholesterol metabolism is disorderly and the factor such as calculus Relevant.There is calculus in chronic cholecystitis patient about gallbladder, calculus can be damaged to gallbladder wall, produces biliary colic, and causes bile Acatharsia.Most patient cholelithiasis exists with inflammation simultaneously, between the two reciprocal causation.Cholelithiasis both can directly be made One-tenth gall bladder emptying is obstructed, cholestasis, the long-term pressurized of mucous membrane of gallbladder can be caused again to form topical ulcers, cicatrix reparation, make gallbladder Cervical region is narrow and affects bile emptying.This mechanical damage and cholestasis all can promote that bacterial growth is bred, thus form inflammation Disease.With the raising of modern life level, dietary structure there occurs change, and the sickness rate of Patients with Cholelithiasis becomes in rising in recent years Gesture.
The symptomatic treatments such as at present western medical treatment primary disease is with antiinflammatory, function of gallbladder promoting, relieving spasm to stop pain are main, there is no radical cure method, and hold Easily recurrence, medicine has certain toxic and side effects;Surgical operation with excision gallbladder as essential therapeutic arsenals, operative treatment primary disease It is painful big that patient is born, and Operative risk greatly and costly, and is easy to produce complication.
Summary of the invention
In order to solve above-mentioned technical problem, the invention provides a kind of Formica fusca bear gall pill and preparation method thereof.
A kind of Formica fusca bear gall pill, is made up of the crude drug of following weight:
Formica fusca 80-120 part, Fel Ursi 40-60 part, Pollen Typhae 20-40 part, Oletum Trogopterori 20-40 part, Rhizoma Corydalis 20-40 part, Chinese holly Fructus Lycii 20-40 part, Fructus Schisandrae Chinensis 20-40 part, Borneolum Syntheticum 20-40 part.
Preferably, above-mentioned Formica fusca bear gall pill, it is made up of the crude drug of following weight:
Formica fusca 90-110 part, Fel Ursi 45-55 part, Pollen Typhae 25-35 part, Oletum Trogopterori 25-35 part, Rhizoma Corydalis 25-35 part, Chinese holly Fructus Lycii 25-35 part, Fructus Schisandrae Chinensis 25-35 part, Borneolum Syntheticum 25-35 part.
It is furthermore preferred that above-mentioned Formica fusca bear gall pill, it is made up of the crude drug of following weight:
Formica fusca 100 parts, Fel Ursi 50 parts, Pollen Typhae 30 parts, Oletum Trogopterori 30 parts, Rhizoma Corydalis 30 parts, Fructus Lycii 30 parts, Fructus Schisandrae Chinensis 30 parts, Borneolum Syntheticum 30 parts.
In the composition described above of the present invention, the weight of each taste Chinese medicine calculates with crude drug, if in grams, as made Preparation, then can be made into 100-1000 agent because of varying in size of preparation.Described 100-1000 agent refers to the dosage form of unit dose, Such as tablet 100-1000 sheet, capsule 100-1000 grain, granule 100-1000g, oral liquid 100-1000ml, unguentum 100- 1000g, pill 100-1000 ball etc..
Composition described above is by weight as proportioning, can increase according to corresponding proportion when producing or reduce, as on a large scale Production can be in units of kg, or with t (ton) as unit;Preparation can also be in units of g on a small scale.Weight can increase or Reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, such as serious symptom or mild, obesity Or the patient of slight of stature, the proportioning of the amount of composition can be adjusted accordingly, be increased or decreased less than 100%, drug effect is basically unchanged.
The Formica fusca bear gall pill of the present invention, individually or as required can add some pharmaceutically acceptable adjuvants, permissible Galenic pharmacy routine techniques is used to prepare this pharmaceutical preparation.Any pharmaceutically useful oral agents can be made when making pharmaceutical preparation Type, these dosage forms are selected from: granule, tablet, capsule, oral liquid, suck agent, pill, powder, preferably pill.
The preparation method of above-mentioned Formica fusca bear gall pill, comprises the steps of:
(1) Borneolum Syntheticum, Fel Ursi finely ground one-tenth fine powder respectively, standby;
(2) Formica fusca is ground into fine powder, standby;
(3) Pollen Typhae, Oletum Trogopterori, Rhizoma Corydalis, Fructus Lycii, Fructus Schisandrae Chinensis powder are broken into fine powder, standby;
(4) the fine powder facing-up that step (1), (2), (3) obtain, sieves, mixing, and every 100g powder adds refined honey 90-100g, Make big honeyed pills 100 ball and get final product.
Above-mentioned Formica fusca bear gall pill merges the application in cholelithiasis medicine in preparation treatment chronic cholecystitis.
The application in preparation treatment chronic viral hepatitis B, liver cirrhosis medicine of the above-mentioned Formica fusca bear gall pill.
The usage and dosage of the Formica fusca bear gall pill of the present invention: oral, 1 ball, 1-2 time on the one;Or follow the doctor's advice.
In the prescription of the Formica fusca bear gall pill of the present invention, use the Formica fusca YIN nourishing dredging collateral of the title having " nutrition treasure-house ", invigorate blood circulation Pain relieving is monarch drug;Fel Ursi heat-clearing and toxic substances removing control pained and can hepatic cell growth promotion, repair liver cell blood sugar lowering be minister;Assistant is with Pu Huang, Oletum Trogopterori, Rhizoma Corydalis promoting blood circulation, removing blood stasis and relieving pain, Fructus Lycii, Fructus Schisandrae Chinensis yin nourishing qi-restoratives, Borneolum Syntheticum clearing away heat to alleviate pain;Mel relieving spasm to stop pain, adjusts With all medicines for making medicine.All medicine compatibilities, play replenishing YIN and removing heat altogether, and effect of blood circulation promoting and blood stasis dispelling makes nourishing for deficiency, and stasis of blood person is led to, all disease spontaneous recovery.With In liver and gall stagnant heat, irritability dredge and cause the liver rump, hypochondriac pain.Disease sees two side of body distending pains, and sore waist and aching in the waist and the back, xerostomia eye are puckery, general weakness, tongue Hidden green grass or young crops, stringy pulse or puckery.
Various hepatopathys, liver cirrhosis, cholecystitis, pancreatitis and heart disease, the every deficiency of YIN of diabetes have heat, and blood-stasis internal-depression is demonstrate,proved All can apply Formica fusca bear gall pill.
Formica fusca bear gall pill has stronger replenishing YIN and removing heat, function of promoting blood circulation to disperse blood clots, can be clinically used for liver and gall stagnant heat, irritability and does not dredge institute The chronic viral hepatitis B that causes, liver cirrhosis, can improve liver function, and can promote that HBeAg turns out cloudy, and clinical efficacy is notable, and safety is high.
Formica fusca bear gall pill clinic can also be used for chronic cholecystitis and merges Patients with Cholelithiasis, can improve clinical symptoms, alleviate inflammation Disease is reacted, and has certain calculus litholytic effect, and clinical efficacy is notable, and safety is high.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is further described, in order to those skilled in the art knows more about The present invention, but and it is not so limited the present invention.
Embodiment 1
A kind of Formica fusca bear gall pill, is made up of the crude drug of following weight proportion:
Formica fusca 100g, Fel Ursi 50g, Pollen Typhae 30g, Oletum Trogopterori 30g, Rhizoma Corydalis 30g, Fructus Lycii 30g, Fructus Schisandrae Chinensis 30g, ice Sheet 30g.
The preparation method of this Formica fusca bear gall pill:
(1) Borneolum Syntheticum, Fel Ursi finely ground one-tenth fine powder respectively, standby;
(2) Formica fusca is ground into fine powder, standby;
(3) Pollen Typhae, Oletum Trogopterori, Rhizoma Corydalis, Fructus Lycii, Fructus Schisandrae Chinensis powder are broken into fine powder, standby;
(4) the fine powder facing-up that step (1), (2), (3) obtain, sieves, mixing, and every 100g powder adds refined honey 90-100g, Make big honeyed pills 100 ball and get final product.
Embodiment 2
A kind of Formica fusca bear gall pill, is made up of the crude drug of following weight proportion:
Formica fusca 90g, Fel Ursi 55g, Pollen Typhae 25g, Oletum Trogopterori 35g, Rhizoma Corydalis 25g, Fructus Lycii 35g, Fructus Schisandrae Chinensis 25g, ice Sheet 35g.
The preparation method of this Formica fusca bear gall pill:
(1) Borneolum Syntheticum, Fel Ursi finely ground one-tenth fine powder respectively, standby;
(2) Formica fusca is ground into fine powder, standby;
(3) Pollen Typhae, Oletum Trogopterori, Rhizoma Corydalis, Fructus Lycii, Fructus Schisandrae Chinensis powder are broken into fine powder, standby;
(4) the fine powder facing-up that step (1), (2), (3) obtain, sieves, mixing, and every 100g powder adds refined honey 90-100g, Make big honeyed pills 100 ball and get final product.
Embodiment 3
A kind of Formica fusca bear gall pill, is made up of the crude drug of following weight proportion:
Formica fusca 110g, Fel Ursi 45g, Pollen Typhae 35g, Oletum Trogopterori 25g, Rhizoma Corydalis 35g, Fructus Lycii 25g, Fructus Schisandrae Chinensis 35g, ice Sheet 25g.
The preparation method of this Formica fusca bear gall pill:
(1) Borneolum Syntheticum, Fel Ursi finely ground one-tenth fine powder respectively, standby;
(2) Formica fusca is ground into fine powder, standby;
(3) Pollen Typhae, Oletum Trogopterori, Rhizoma Corydalis, Fructus Lycii, Fructus Schisandrae Chinensis powder are broken into fine powder, standby;
(4) the fine powder facing-up that step (1), (2), (3) obtain, sieves, mixing, and every 100g powder adds refined honey 90-100g, Make big honeyed pills 100 ball and get final product.
Embodiment 4
A kind of Formica fusca bear gall pill, is made up of the crude drug of following weight proportion:
Formica fusca 80g, Fel Ursi 60g, Pollen Typhae 20g, Oletum Trogopterori 40g, Rhizoma Corydalis 20g, Fructus Lycii 40g, Fructus Schisandrae Chinensis 20g, ice Sheet 40g.
The preparation method of this Formica fusca bear gall pill:
(1) Borneolum Syntheticum, Fel Ursi finely ground one-tenth fine powder respectively, standby;
(2) Formica fusca is ground into fine powder, standby;
(3) Pollen Typhae, Oletum Trogopterori, Rhizoma Corydalis, Fructus Lycii, Fructus Schisandrae Chinensis powder are broken into fine powder, standby;
(4) the fine powder facing-up that step (1), (2), (3) obtain, sieves, mixing, and every 100g powder adds refined honey 90-100g, Make big honeyed pills 100 ball and get final product.
Embodiment 5
A kind of Formica fusca bear gall pill, is made up of the crude drug of following weight proportion:
Formica fusca 120g, Fel Ursi 40g, Pollen Typhae 40g, Oletum Trogopterori 20g, Rhizoma Corydalis 40g, Fructus Lycii 20g, Fructus Schisandrae Chinensis 40g, ice Sheet 20g.
The preparation method of this Formica fusca bear gall pill:
(1) Borneolum Syntheticum, Fel Ursi finely ground one-tenth fine powder respectively, standby;
(2) Formica fusca is ground into fine powder, standby;
(3) Pollen Typhae, Oletum Trogopterori, Rhizoma Corydalis, Fructus Lycii, Fructus Schisandrae Chinensis powder are broken into fine powder, standby;
(4) the fine powder facing-up that step (1), (2), (3) obtain, sieves, mixing, and every 100g powder adds refined honey 90-100g, Make big honeyed pills 100 ball and get final product.
The Formica fusca bear gall pill of embodiment 1 preparation has been carried out clinical trial, and Details as Follows:
The clinical trial of Formica fusca bear gall pill treatment chronic viral hepatitis B
1. data and method
1.1 physical data
Choose and be diagnosed as Patients with Chronic Hepatitis B 160 example, be randomly divided into each 80 examples of matched group and observation group.Right According to organizing 80 example patients, male 45 example, women 35 example, age 22~78 years old, in year mean age (45.27 ± 15.46), the course of disease is 7 Individual month to 6 years, average course of disease was (4.47 ± 1.64) year.Observation group 80 example patient, male 48 example, women 32 example, age 25-74 Year, the mean age (46.29 ± 16.87) year, the course of disease is 8 months to 7 years, and average course of disease is (4.69 ± 2.05 years.Two groups of patients The basic documents such as age, sex, the course of disease compare not statistically significant (P > 0.05), have comparability.
1.1.2 diagnostic criteria:
Western medicine diagnose standard: combine with parasitic disease credit meeting, hepatopathy association with reference to Chinese Medical Association's infectious disease and to revise " viral hepatitis control prece " is formulated about the diagnostic criteria of chronic viral hepatitis B.
Tcm diagnosis standard: in reference " new Chinese medicine guideline of clinical investigations ", chronic viral hepatitis B is relevant Diagnostic criteria, belongs to liver and gall stagnant heat, irritability and does not dredge card, and disease sees two side of body distending pains, and sore waist and aching in the waist and the back, xerostomia eye are puckery, general weakness, tongue are hidden Blue or green, stringy pulse or puckery.
1.1.3 include case standard in
(1) age is in 18-75 year;
(2) clinical diagnosis meets Chinese and western medicine diagnostic criteria;
(3) tested in the know, and sign Informed Consent Form.
1.1.4 Excluded cases standard
(1) age is at under-18s (not including 18 years old), or more than 75 years old (not including 75 years old);
(2) gestation or women breast-feeding their children;
(4) all state of an illness are critical, it is impossible to judge curative effect or safety person;
(5) long-term steroid, the liver protecting and ALT lowering medicine simultaneously;
(6) allergic constitution and to test medicine prescription Chinese medicine allergy sufferers.
1.2 method
1.2.1 Therapeutic Method
Observation group gives the Formica fusca bear gall pill of the present invention, oral, 1 ball, 1-2 time on the one, or follows the doctor's advice.
Matched group gives oral hepatitis B Qingrejiedu tablets (by Rhizoma Polygoni Cuspidati, Herba Hedyotidis Diffusae, Rhizoma Menispermi, Rhizoma Bistortae, Herba Artemisiae Scopariae, Herba Imperatae Root, Radix Rubiae, Herba Epimedii, Radix Glycyrrhizae, Rhizoma Smilacis Glabrae, silkworm excrement, Flos Chrysanthemi Indici, Exocarpium Citri Rubrum composition, Shandong Hai Sen pharmaceutcal corporation, Ltd produces).Should Medicine energy heat-clearing and toxic substances removing removing dampness, function cures mainly with to test medication close, is current domestic curative effect legal similar drugs more certainly, Meet and generally acknowledge effective, safety, comparable principle.
It within 2 weeks, it is a course for the treatment of.
1.2.2 parameters for observation on effect
1) symptom, sign: use integration method record.By without, light, in, be designated as 0,1,2,3 points the most respectively.
2) nosetiology index: HBeAg negative conversion rate.
3) liver function index: observe glutamate pyruvate transaminase (ALT), glutamic oxaloacetic transaminase, GOT (AST), paddy amine acyl transpeptidase (GGT) and Total bilirubin (TBIL).
4) safety indexes: three big conventional, kidney merit and electrocardiograms.
1.2.3 curative effect determinate standard
With reference to " new Chinese medicine guideline of clinical investigations ", it is divided into healing, effective, effective and invalid.
Recovery from illness: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=90%;
Effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=70%;
Effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces >=30%;
Invalid: tcm clinical practice symptom, sign are all not improved, even increase the weight of, syndrome integral reduces less than 30%.
1.2.4 statistical procedures
Using SPSS16.0 software that data carry out statistical procedures, enumeration data uses t inspection, with P < 0.05 for having The significance difference opposite sex, points out statistically significant.
2. result
Liver function index change before and after 2.1 liang of group treatments
Treat the liver function comparing difference not statistically significant (P > 0.05) of first two groups, there is comparability;After treatment two groups Patient's liver function is the most preoperative to be obviously improved, and difference has statistical significance (P < 0.05), but the improvement degree of observation group is the brightest Showing and be better than matched group, difference has statistical significance (P < 0.05);It is shown in Table 1.
Liver function index change before and after table 1 treatment
Note: * represent with treatment before compare P < 0.05;# represents and compares P < 0.05 after treatment of control group.
2.2 liang of group Clinical efficacy comparisons
Substantially reducing before after treatment, the syndrome integral of two groups is the most relatively treated, difference has statistical significance (P < 0.05);See Examining group reduction degree and be substantially better than matched group, difference has statistical significance (P < 0.05);Observation group's clinic obvious effective rate and always having Efficiency is obviously higher than matched group, and difference has statistical significance (P < 0.05), is shown in Table 2,3.
Before and after the group treatment of 2 liang of table, syndrome integral compares
Note: * represent with treatment before compare P < 0.05;# represents and compares P < 0.05 after treatment of control group
3 liang of table group Clinical efficacy comparison (example)
Group n Cure Effective Effectively Invalid Cure-remarkable-effectiveness rate (%) Total effective rate (%)
Observation group 80 41 30 9 0 88.75* 100.0**
Matched group 80 19 15 20 16 55.00% 75.0
Note: * represents and compares with matched group, P < 0.05.
2.3 liang of group HBeAg negative conversion rates compare
The HBeAg negative conversion rate of observation group and matched group is respectively 46.25% (37/80) vs 21.25% (17/80);Observe Group is apparently higher than matched group, and difference has statistical significance (P < 0.05).
2.4 safety observations
Having no after treatment that three big conventional, kidney merits and electrocardiogram have significant change, safety is high.
Formica fusca bear gall pill treatment chronic cholecystitis merges the clinical trial of cholelithiasis
1. data and method
1.1 physical data
Choose case 120 example meeting chronic cholecystitis merging cholelithiasis diagnostic criteria, be randomly divided into matched group and observation Organize each 60 examples.Matched group 60 example patient, male 36 example, women 24 example, age 24~72 years old, the mean age (44.24 ± 13.22) In year, the course of disease is 1 month to 6 years, and average course of disease is (1.47 ± 1.25) year.Observation group 60 example patient, male 35 example, women 25 Example, age 32~73 years old, in year mean age (43.26 ± 14.26), the course of disease is 3 months to 7 years, average course of disease be (1.45 ± 1.24) year.The basic documents such as two groups of patient ages, sex, courses of disease compare not statistically significant (P > 0.05), have comparability.
1.1.2 diagnostic criteria:
Western medicine diagnose standard: formulate with reference to chronic cholecystitis and cholelithiasis diagnostic criteria in " practical internal medicine ".
Tcm diagnosis standard: by chronic cholecystitis system in State Administration of Traditional Chinese Medicine's " disease of tcm Standardization of diagnosis and curative effect " Fixed.Disease sees two side of body distending pains, sore waist and aching in the waist and the back, xerostomia eye are puckery, the hidden green grass or young crops of general weakness, tongue, stringy pulse or puckery.
1.1.3 include case standard in
1. Western medicine diagnose standard and tcm diagnosis standard are met;
2. the range of age is 18-75 year;
3. agree to that cooperation completes present study, and sign Informed Consent Form.
1.1.4 Excluded cases standard
1. get rid of severe malnutrition person, those who are allergic to this drug, or companion's cardiovascular, liver, kidney and hemopoietic system etc. are serious complete Body disease patient;
2. psychotic;
3. the person that do not signs Informed Consent Form;
1.2 method
1.2.1 Therapeutic Method
Observation group gives the Formica fusca bear gall pill of the present invention, 1 ball, 1-2 time on the one;Or follow the doctor's advice.
Matched group is given XIAOYAN LIDAN PIAN (Guangdong LuoFoshan Medicine Co., Ltd, the quasi-word of traditional Chinese medicines: Z44021422), often Secondary 400mg, three times a day.This medicine function cures mainly with to test medication close, is current domestic curative effect legal similar medicine more certainly Thing, meets and generally acknowledges effective, safety, comparable principle.
It within 2 weeks, it is a course for the treatment of.
1.2.2 observation index
1) curative effect observation:
1. disease integration: symptom and sign scoring with without, light, in, be chosen as 0,1,2,3 points the most respectively.
2. ultrasound diagnosis, observes size and the change of gall-bladder wall thickness of calculus.
2) safety indexes: three big conventional, Liver and kidney merit and electrocardiograms.
1.2.3 curative effect determinate standard
" the new Chinese medicine guideline of clinical investigations " that efficacy determination is issued according to Ministry of Health of the People's Republic of China.
1. recovery from illness: clinical symptoms, somatic feature score value reduce >=95%.B ultrasonic is normal.
The most effective: clinical symptoms, somatic feature score value reduce >=70%.B ultrasonic is obviously improved.
The most effective: clinical symptoms, somatic feature score value reduce >=30%.B ultrasonic has improvement.
The most invalid: not up to above standard person, integrated value reduces less than 30%.B ultrasonic is without improving.
1.2.4 statistical procedures
Using SPSS16.0 software that data carry out statistical procedures, enumeration data uses X 2 test, and measurement data is adopted Check with t, with P < 0.05 for there were significant differences property, point out statistically significant.
2. result
2.1 liang of group Clinical efficacy comparisons
Treat the symptom and sign integral contrast no significant difference (P > 0.05) of first two groups, there is comparability.Treatment The symptom and sign integration of latter two groups substantially reduces before the most relatively treating, and difference has statistical significance (P < 0.05);Observation group reduces Degree is substantially better than matched group, and difference has statistical significance (P < 0.05);Observation group's clinic cure-remarkable-effectiveness rate and total effective rate are the brightest Aobvious higher than matched group, difference has statistical significance (P < 0.05), is shown in Table 1,2.
Symptom and sign integral contrast before and after the group treatment of 1 liang of table
Note: * represent with treatment before compare P < 0.05;# represents and compares P < 0.05 after treatment of control group.
2 liang of table group Clinical efficacy comparison (example)
Group n Cure Effective Effectively Invalid Cure-remarkable-effectiveness rate (%) Total effective rate (%)
Observation group 60 32 20 7 1 86.67* 98.33**
Matched group 60 16 21 8 15 61.67 75.00
Note: * represents and compares with matched group, P < 0.05.
2.2 liang of group ultrasound diagnosis results contrast
Before treatment, the calculus size of two groups and gall-bladder wall thickness comparing difference not statistically significant (P > 0.05), having can Compare property.After treatment, calculus size and the gall-bladder wall thickness of two groups the most relatively treat front substantially reduction, and difference has statistical significance (P < 0.05);Observation group reduces degree and is substantially better than matched group, and difference has statistical significance (P < 0.05);It is shown in Table 3.
3 liang of table group ultrasound diagnosis results contrast
2.3 safety observations
Having no after treatment that three big conventional, Liver and kidney merits and electrocardiogram have significant change, safety is high.

Claims (8)

1. a Formica fusca bear gall pill, is made up of the crude drug of following weight:
Formica fusca 80-120 part, Fel Ursi 40-60 part, Pollen Typhae 20-40 part, Oletum Trogopterori 20-40 part, Rhizoma Corydalis 20-40 part, Fructus Lycii 20-40 part, Fructus Schisandrae Chinensis 20-40 part, Borneolum Syntheticum 20-40 part.
Formica fusca bear gall pill the most according to claim 1, it is characterised in that be made up of the crude drug of following weight:
Formica fusca 90-110 part, Fel Ursi 45-55 part, Pollen Typhae 25-35 part, Oletum Trogopterori 25-35 part, Rhizoma Corydalis 25-35 part, Fructus Lycii 25-35 part, Fructus Schisandrae Chinensis 25-35 part, Borneolum Syntheticum 25-35 part.
Formica fusca bear gall pill the most according to claim 2, it is characterised in that be made up of the crude drug of following weight:
Formica fusca 100 parts, Fel Ursi 50 parts, Pollen Typhae 30 parts, Oletum Trogopterori 30 parts, Rhizoma Corydalis 30 parts, Fructus Lycii 30 parts, Fructus Schisandrae Chinensis 30 Part, Borneolum Syntheticum 30 parts.
4. according to the Formica fusca bear gall pill described in claim 1 or 2 or 3, it is characterised in that its dosage form is oral formulations.
Formica fusca bear gall pill the most according to claim 4, it is characterised in that its dosage form is pill.
6. the preparation method of the Formica fusca bear gall pill described in claim 1 or 2 or 3, comprises the steps of:
(1) Borneolum Syntheticum, Fel Ursi finely ground one-tenth fine powder respectively, standby;
(2) Formica fusca is ground into fine powder, standby;
(3) Pollen Typhae, Oletum Trogopterori, Rhizoma Corydalis, Fructus Lycii, Fructus Schisandrae Chinensis powder are broken into fine powder, standby;
(4) the fine powder facing-up that step (1), (2), (3) obtain, sieves, mixing, and every 100g powder adds refined honey 90-100g, makes Big honeyed pills 100 ball and get final product.
7. the application in preparation treatment chronic viral hepatitis B, liver cirrhosis medicine of the Formica fusca bear gall pill described in claim 1 or 2 or 3.
8. the Formica fusca bear gall pill described in claim 1 or 2 or 3 merges answering in cholelithiasis medicine in preparation treatment chronic cholecystitis With.
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1672702A (en) * 2004-03-26 2005-09-28 张言军 Compound liver-nourishing ant tablet and bolus
CN1686397A (en) * 2005-04-11 2005-10-26 王奉友 Health care food possessing liver boosting function
CN103845539A (en) * 2012-11-30 2014-06-11 孙玉建 Traditional Chinese medicine for treating acute viral hepatitis

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1672702A (en) * 2004-03-26 2005-09-28 张言军 Compound liver-nourishing ant tablet and bolus
CN1686397A (en) * 2005-04-11 2005-10-26 王奉友 Health care food possessing liver boosting function
CN103845539A (en) * 2012-11-30 2014-06-11 孙玉建 Traditional Chinese medicine for treating acute viral hepatitis

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
吴志道 等: "玄驹胶囊治疗慢性乙型肝炎40 例疗效观察", 《开封医专学报》 *

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