CN1506098A - Medicine composition for treating liver fibrillation and liver cirrhosis and its prepn process - Google Patents
Medicine composition for treating liver fibrillation and liver cirrhosis and its prepn process Download PDFInfo
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Abstract
The Chinese medicine composition for treating liver fibrillation and liver cirrhosis has active components prepared from red sage, astragalus root, other medicine(s) with function of promoting blood circulation to disperse blood clots, spleen invigorating medicine(s) and vital energy regulating medicine(s). The active comprises are matched with pharmaceutically acceptable carrier or excipient to prepare various preparation forms. The Chinese medicine composition has high practical curative rate in treating liver fibrillation, no recurrence and no toxic side effect.
Description
(1) technical field
The present invention relates to a kind of pharmaceutical composition, specifically, is a kind of Chinese medicine composition, and this Chinese medicine composition has the hardened purposes of treatment hepatic fibrosis regulating liver-QI, and the preparation method of this Chinese medicine composition.
(2) background technology
Chronic hepatopathy (inflammation) belongs to the common clinical frequently-occurring disease, and hepatic fibrosis is the only stage which must be passed by that various chronic hepatopathys (inflammation) development causes liver cirrhosis, therefore prevention and reverse the generation of hepatic fibrosis and develop into the emphasis of research.Unsatisfactory curative effects such as " colchicine ", Beracilline, pentoxifylline and interferon, toxic and side effects is big, still difficulty be applied to clinical (edit referring to Yao Xixian: clinical digestion is sick to be learned " Tianjin science tech publishing house 1999, the 945-1009 pages or leaves; RuwartMT, Rush BD, SnyderKF, et al. 16,16-Dimethyl prostaglandin E 2 delays collagen formation innutritional injury rat liver.Hepatalogy, 1988,8 (1)-61-64; Shi z stewart TA, Rockey DC, Liver inury and fibrosis in interferon r gene knlck outmice.hepatology 1995,22:(4pt 2): 276A; Oberti f, pilitte C, Tifflet H.et al.Effects of simvastalin, pentoxifylline and spironolactone on hepatic fibrosisand portal hypertension in rabs wift bile duot ligation.J hepatol 1997,26 (6): 1363-1371; Rambidei A, Gluud C Colchicine for alcohol and nonalcoholliver fibrosis, civer, 2001,21 (2): 129-136).Much research in recent years, for example Xu Ruiyun, young tiger of reaching the clouds, Wang Beiliu etc., hepatitis B heptic fibrosis, " world Chinese digests magazine " 1999 are treated by liver fibre side; 7; 866; Zhao Jun, lucky neutralization, Xie Xianqing, the plus-minus bupleurum root decoction is to the preventive and therapeutic effect of rat liver fibrosis, " combination of Chinese and Western medicine hepatopathy magazine " 1997,7:160; Jia Jidong, Wang Baoen, Dong Zhong, Chinese medicine 861 mixture be to the preventive effect and the therapeutic effect of experimental hepatic fibrosis, " Chinese hepatopathy magazine " 1996; 4:28, these studies show that the treatment by Chinese herbs hepatic fibrosis has certain curative effect and do not have obvious toxic-side effects, but because medicine is formed and the consumption aspects is also unreasonable, still not having goes into operation is used for clinical person.
The hardened Chinese medicine of regulating liver-QI that many treatment hepatic fibrosis are also arranged in patent documentation, for example CN1268362A " a kind of medicine for the treatment of chronic hepatitis, hepatic fibrosis and early stage liver cirrhosis " and CN1346658A " Chinese medicine preparation of treatment hepatic fibrosis and liver cirrhosis ".
However, the used raw material of CN1268362A is the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Flos Carthami, Rhizoma Chuanxiong, Rhizoma Cyperi, Radix Paeoniae Rubra, Radix Bupleuri, Pericarpium Citri Reticulatae and Caulis Spatholobi.As can be seen, this side has mainly used drug for invigorating blood circulation and eliminating stasis such as Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Flos Carthami, Radix Paeoniae Rubra, Caulis Spatholobi and the Radix Astragali, Rhizoma Chuanxiong, Rhizoma Cyperi, Radix Bupleuri and Pericarpium Citri Reticulatae QI regulating medicine from composition of raw materials.So this prescription mainly is a blood circulation promoting and blood stasis dispelling is main with regulating the flow of vital energy.The selected composition of raw materials of CN1346658A is Radix Salviae Miltiorrhizae, the Radix Astragali, Radix Paeoniae Rubra, Radix Stephaniae Tetrandrae, Folium Ginkgo, Rhizoma Polygoni Cuspidati, Radix Notoginseng, Squama Manis, Carapax Trionycis, Cordyceps, Folium et Fructus Helwingiae and Herba Portulacae Grandiflorae, wherein also mainly is drug for invigorating blood circulation and eliminating stasis such as Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati, Radix Notoginseng etc.The disclosed composition of raw materials of these patents has all used drug for invigorating blood circulation and eliminating stasis and resistance and supplementing qi medicine, though obtained some curative effects, cure rate is still undesirable, especially bounce-back property height at a specified future date, since lack clinical at random, blind method and experiment pathological study, actual effective percentage is also not obvious, also owes certain.
So people still demand seek and a kind ofly can and not have the Chinese medicine that does not have toxic and side effects of bounce-back at a specified future date to the treating liver fibrosis better effects if.
(3) summary of the invention
[problem that will solve]
One of purpose of the present invention just provides the hardened Chinese medicine composition of a kind of treatment hepatic fibrosis regulating liver-QI, and this Chinese medicine composition can effectively improve the actual cure rate of hepatic fibrosis, and at a specified future date do not have bounce-back, and have no side effect.
Another object of the present invention provides the preparation method of this Chinese medicine composition.
[technical scheme]
The inventor thinks that through clinical practice for many years and experimental study the basic pathogenesis of chronic hepatitis, hepatic fibrosis is that qi depression to blood stasis and incoordination between the liver and spleen cause, so founded the treatment rule of blood circulation promoting and blood stasis dispelling and regulating qi-flowing for strengthening spleen, prescription in addition under the guidance of this treatment rule.
Mainly select for use Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling and Radix Astragali replenishing QI to invigorate the spleen to be monarch drug altogether, and reuse Radix Salviae Miltiorrhizae to strengthen the effect of blood circulation promoting and blood stasis dispelling; And one or more of one or more and strengthening the spleen to promote digestion medicine in the adding drug for invigorating blood circulation and eliminating stasis, because, spleen is a blood bank, have only blood bank's cyclic metabolism normal, could guarantee the effect of invigorating blood circulation, so thereby increasing the effect that the strengthening the spleen to promote digestion medicine strengthened blood circulation promoting and blood stasis dispelling and replenishing QI to invigorate the spleen on the basis of drug for invigorating blood circulation and eliminating stasis reaches the Fibrotic effect of better healing hepatopathy regulating liver-QI.
Wherein said drug for invigorating blood circulation and eliminating stasis is meant with promoting blood circulation, promotes that blood is capable, the dissipation blood stasis is the Chinese medicine of main effect, these drug for invigorating blood circulation and eliminating stasis include but not limited to Rhizoma Chuanxiong, Olibanum, Myrrha, Rhizoma Corydalis, Radix Curcumae, Semen Persicae, Caulis Spatholobi, Flos Carthami, Oletum Trogopterori, Rhizoma Polygoni Cuspidati, Hirudo, Radix Angelicae Sinensis, Radix Paeoniae Rubra etc., preferred Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Polygoni Cuspidati, the best is Radix Angelicae Sinensis and Radix Paeoniae Rubra.The strengthening the spleen to promote digestion medicine is meant with the strengthening the spleen to promote digestion eliminate indigestion to be the Chinese medicine of main effect.This apoplexy due to endogenous wind medicine includes but not limited to the Rhizoma Atractylodis Macrocephalae, Poria, Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus, Massa Medicata Fermentata etc.Preferred strengthening the spleen to promote digestion medicine is the Rhizoma Atractylodis Macrocephalae, Poria, Endothelium Corneum Gigeriae Galli.
Another one preferred version of the present invention is to add QI regulating medicine.Thereby tend to make incoordination between the liver and spleen to cause symptoms such as distension and fullness in the abdomen and inappetence because help digestion to the blood circulation promoting and blood stasis dispelling of liver with to the QI invigorating of spleen.Add QI regulating medicine and just in time eliminated above-mentioned symptom.In addition, add the blood circulation invigorating efficacies that the depressed liver-energy dispersing and QI regulating medicine can help medicines such as Radix Salviae Miltiorrhizae, can assist the Radix Astragali to be good for activating the spleen gas again, make invigoration spleen qi and be not jammed.This class depressed liver-energy dispersing and QI regulating medicine includes but not limited to Cortex Magnoliae Officinalis, Radix Aucklandiae (Radix Vladimiriae), Radix Bupleuri, Pericarpium Citri Reticulatae Viride, Fructus Citri Sarcodactylis, Fructus Citri, Rhizoma Cyperi, Fructus Akebiae etc., preferably nurse one's health temper with Cortex Magnoliae Officinalis, recover transformation and transportation of the spleen and stomach, unclog and readjust irritability with Radix Bupleuri, Radix Bupleuri finds also to have the effect of the liver protecting and ALT lowering in modern study simultaneously.
Weight ratio in the pharmaceutical composition of the present invention between the component is: Radix Salviae Miltiorrhizae 9-12, Radix Astragali 3-6, except that Radix Salviae Miltiorrhizae one or more drug for invigorating blood circulation and eliminating stasis altogether 4-12, one or more drugs strengthening spleens 3-12 and one or more QI regulating medicine are total to 2-7 altogether.
Best preferred embodiment of the present invention is that to select the Radix Salviae Miltiorrhizae and the Radix Astragali for use be principal agent, and is aided with the effect that Radix Angelicae Sinensis and Radix Paeoniae Rubra are strengthened blood circulation promoting and blood stasis dispelling; Select for use the spleen invigorating medicine Rhizoma Atractylodis Macrocephalae, Endothelium Corneum Gigeriae Galli and Poria to come the spleen reinforcing spleen invigorating then, for the effect of strengthening invigorating blood circulation, also with addition of qi-activating drug Cortex Magnoliae Officinalis and Radix Bupleuri, because the capable then blood of gas is capable, thereby strengthen invigorating blood circulation effect better, and Radix Bupleuri is mainly regulated the QI and blood of liver, but circulation of qi promoting must consume gas, so the QI invigorating medicine Radix Astragali has guaranteed the effect of circulation of qi promoting.Thereby like this with the collaborative focus of improving liver microcirculation realization hard masses softening and resolving elimination hepatic fibrosis between each herbal medicine compound action.
The source of the Chinese crude drug that above-mentioned best preferred embodiment is mentioned is as follows:
Radix Salviae Miltiorrhizae, the root for Labiatae herbaceos perennial Radix Salviae Miltiorrhizae Salvia miltiorrhiza Bge. has the effect of blood circulation promoting and blood stasis dispelling, removing heat from blood eliminating carbuncle and nourishing blood to tranquillize the mind.
The Radix Astragali is the root of pulse family herbaceos perennial Radix Astragali Astragalusmembranaceus (Fisch.) Bge. and Inner Mongolia Astragalis A.Mongholicus Bge., has the effect that tonifying Qi and lifting yang, benefit are defended consolidating superficial resistance, promoting pus discharge and tissue regeneration strengthening and diuretic detumescent.
Radix Angelicae Sinensis is the root of Umbelliferae herbaceos perennial Radix Angelicae Sinensis Angelica sinensis (Oliv.) Diels., have enrich blood, invigorate blood circulation, the effect of pain relieving and intestine moistening, wherein the effect of Radix Angelicae Sinensis biases toward activity.
Radix Paeoniae Rubra, the root for Ranunculaceae herbaceos perennial comospore Radix Paeoniae Rubra Paeonia veitchii Lynch. and ovum leaf Radix Paeoniae P. Obovata Maxim. or Radix Paeoniae P. Lactiflora Pall. has the effect of clearing away heat and cooling blood and stasis-dispelling and pain-killing.
The Rhizoma Atractylodis Macrocephalae is Compositae herbaceos perennial Rhizoma Atractylodis Macrocephalae Atractylodes macrocephala Koidz. rhizome.Have air making-up and spleen enlivening, dampness diuretic and the antiabortive effect of hidroschesis.
Endothelium Corneum Gigeriae Galli is the cutin inwall of the ballast of Phasianidae animal chicken Gallus gallus domesticus Brisson., has that activating the spleen helps digestion and controlling nocturnal emission with astringent drugs ends the effect of losing.
Cortex Magnoliae Officinalis is dried bark, root bark and the branch skin of Magnoliaceae deciduous tree plant Cortex Magnoliae Officinalis Magnolia officinalis Rehd.Et Wils. or magnolia officinalis rehd.et wils.var.biloba rehd.et wils. M.biloba (Rehd.Et Wils) Cheng, the effect that has circulation of qi promoting, dampness, removing food stagnancy and relieving asthma.
Poria is the sclerotium of Polyporaceae fungus Poria Poria coco (Schw.) Wolf, and multiparasitization has promoting diuresis to eliminate damp pathogen, spleen invigorating and the effect of calming the nerves on tree roots such as pinaceae plant Pinus densiflora or Pinus massoniana Lamb.
Radix Bupleuri, root or herb for Umbelliferae herbaceos perennial Radix Bupleuri Bupleurum chinense DC. and Radix Bupeuri Scorzonerfolii. B.Scorzonerifolfium Willd. have the effect of reducing fever by reconciliation, soothing liver-QI for relieving depression and elevate a turnable ladder yang-energy.
The weight ratio relation of these components of pharmaceutical composition is preferably:
Radix Salviae Miltiorrhizae 9-16, Radix Angelicae Sinensis 2-6, Radix Astragali 3-6, Radix Paeoniae Rubra 2-6, Rhizoma Atractylodis Macrocephalae (parched) 1-4, Poria 1-4, Endothelium Corneum Gigeriae Galli 1-4, Cortex Magnoliae Officinalis 1-3 and Radix Bupleuri 1-4;
More preferred weight ratio is:
Radix Salviae Miltiorrhizae 10, Radix Angelicae Sinensis 2, the Radix Astragali 4, Radix Paeoniae Rubra 3, Rhizoma Atractylodis Macrocephalae (parched) 2, Poria 2, Endothelium Corneum Gigeriae Galli 2, Cortex Magnoliae Officinalis 2 and Radix Bupleuri 2.
Above-mentioned prescription of the present invention can directly be pulverized or be refining as the active component for the treatment of hepatic fibrosis and liver cirrhosis medicine through the extraction of the conventional extractive technique in this area such as decoction and alcohol sedimentation technique or ethanol extract from water precipitation.Described active component can be made various pharmaceutical formulations such as powder, tablet, oral liquid, granule, injection, capsule or the like with the combination of pharmaceutically acceptable carrier or excipient.Wherein said pharmaceutically acceptable carrier or excipient are selected according to different dosage forms.These used carriers or excipient can determine for the those of ordinary skill of pharmaceutical field.
Active ingredient in pharmaceutical of the present invention can prepare according to following three kinds of methods:
First method, it contains the following step: take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption; Above-mentioned Chinese crude drug is dried and crushed into fine powder as active component; Then above-mentioned active component is made various dosage forms with pharmaceutically acceptable excipient.
Second method, it contains the following step: take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption; Above-mentioned pulverizing medicinal materials is become coarse powder, with the ethanol of 50-60% be solvent 60-70 ℃ of reflux, extract,, extracting solution is after reclaiming ethanol, cryoconcentration becomes thick extractum, drying is ground into fine powder as active component; Above-mentioned active component is made various dosage forms with pharmaceutically acceptable excipient.
The third method, it contains the following step: take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption; Decoct with water twice, 2-3 hour for the first time, 1-2 hour for the second time, filter, merging filtrate leaves standstill clarification, and low-temperature evaporation is concentrated into the thick paste shape, and the proportion of thick paste is surveyed 80-90 ℃ of heat and is 1.30-1.35; Above-mentioned thick paste is made various dosage forms as active component and pharmaceutically acceptable carrier or excipient.
[beneficial effect]
Pharmaceutical composition of the present invention has powerful activating blood circulation to dissipate blood stasis, improves liver microcirculation, spleen invigorating circulation of qi promoting, hard masses softening and resolving, the effect of human body immunity improving power.The pharmaceutical treatment hepatic fibrosis of making as active component with said composition powder or its extract and the total effects of liver cirrhosis disease are 88.33%, 87.51% patient ALT descends with multiple normal, meanwhile, hyaluronic acid (173.97,121.53), laminin (165.27,125.40), III procollagen type (145.50,115.95) etc., hepatic fibrosis index obviously descends; Can also eliminate I, III Collagen Type VI deposition, have the good resistance fibrosis effect and can eliminate fatty degeneration of liver, necrosis, promote liver cell regeneration, repair liver cell lesion, recover liver function.Through acute and long term toxicity test, be increased to usual amounts and show for 200 times and have no side effect.Be expounded through peer review and No.2 Hospital, Hebei Medical Univ.'s more than ten years clinical research experiment showed, that the preparation of pharmaceutical composition of the present invention is fairly obvious to chronic hepatitis, hepatic fibrosis curative effect, pathological changes total cure rate nearly 90% through Hebei province hygiene department tissue.
(4) specific embodiment
Be used for further describing the present invention with the test example by the following examples.
Embodiment 1: the preparation of granule
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
Radix Salviae Miltiorrhizae 50 grams, Radix Angelicae Sinensis 10 grams, the Radix Astragali 20 grams, Radix Paeoniae Rubra 15 grams, Rhizoma Atractylodis Macrocephalae (parched) 10 grams, Poria 10 grams, Endothelium Corneum Gigeriae Galli 10 grams, Cortex Magnoliae Officinalis 10 grams and Radix Bupleuri 10 grams;
Decoct with water twice, 2-3 hour for the first time, 1-2 hour for the second time, filter, merging filtrate leaves standstill clarification, and low-temperature evaporation is concentrated into the thick paste shape, and the proportion of thick paste is surveyed 80-90 ℃ of heat and is 1.30-1.35;
The above-mentioned thick paste that makes and Icing Sugar and the dextrin amount with 1: 3: 1 is mixed, in case of necessity, add an amount of 60% ethanol and adjust humidity and make soft material; push 11 mesh sieves with granulator and became granule; dry back is heavily crossed once with 9 mesh sieves, and reuse 65 mesh sieves sieve removes fine powder, makes.
Embodiment 2: the preparation of powder
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
Radix Salviae Miltiorrhizae 90 grams, Radix Angelicae Sinensis 20 grams, the Radix Astragali 30 grams, Radix Paeoniae Rubra 20 grams, Rhizoma Atractylodis Macrocephalae (parched) 10 grams, Poria 10 grams, Endothelium Corneum Gigeriae Galli 10 grams, Cortex Magnoliae Officinalis 10 grams and Radix Bupleuri 10 grams;
Endothelium Corneum Gigeriae Galli is dried and crushed into fine powder;
All the other Chinese crude drugs are dried and crushed into fine powder;
The above-mentioned fine powder mix homogeneously that makes is made.
Embodiment 3: the preparation of capsule
A) take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
Radix Salviae Miltiorrhizae 160 grams, Radix Angelicae Sinensis 50 grams, the Radix Astragali 60 grams, Radix Paeoniae Rubra 40 grams, Rhizoma Atractylodis Macrocephalae (parched) 40 grams, Poria 40 grams, Endothelium Corneum Gigeriae Galli 40 grams, Cortex Magnoliae Officinalis 30 grams and Radix Bupleuri 40 grams;
B) above-mentioned pulverizing medicinal materials is become coarse powder, the ethanol with 60% be solvent 70 ℃ of reflux, extract,, extracting solution is after reclaiming ethanol, cryoconcentration becomes thick extractum, drying is worn into fine powder, the hard capsule case of packing into.
Embodiment 4: the preparation of capsule
A) take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
Radix Salviae Miltiorrhizae 160 grams, Flos Carthami 50 grams, the Radix Astragali 60 grams, Radix Paeoniae Rubra 40 grams, Fructus Hordei Germinatus 40 grams, Poria 40 grams, Endothelium Corneum Gigeriae Galli 40 grams, Rhizoma Cyperi 30 grams, Rhizoma Polygoni Cuspidati 20 grams and Radix Bupleuri 40 grams;
B) above-mentioned pulverizing medicinal materials is become coarse powder, the ethanol with 60% be solvent 70 ℃ of reflux, extract,, extracting solution is after reclaiming ethanol, cryoconcentration becomes thick extractum, drying is worn into fine powder, the hard capsule case of packing into.
Embodiment 5: the preparation of powder
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
Radix Salviae Miltiorrhizae 90 grams, Rhizoma Chuanxiong 20 grams, the Radix Astragali 30 grams, Caulis Spatholobi 20 grams, Rhizoma Atractylodis Macrocephalae (parched) 10 grams, Fructus Hordei Germinatus 10 grams, Endothelium Corneum Gigeriae Galli 10 grams, Fructus Akebiae 10 grams, Hirudo 10 grams and Radix Bupleuri 10 grams;
Endothelium Corneum Gigeriae Galli and Hirudo are dried and crushed into fine powder respectively;
All the other Chinese crude drugs are dried and crushed into fine powder;
The above-mentioned fine powder mix homogeneously that makes is made.
Test example 1: the liver benefiting health is to the Fibrotic clinical efficacy of chronic viral hepatitis B regulating liver-QI
Method: totally 90 routine chronic viral hepatitis B reception tests, be divided into two groups at random, wherein 60 examples are organized in treatment, matched group 30 examples.It was a course of treatment in twice, 6 month on the one that the treatment group gives the embodiment of the invention 1 prepared the liver benefiting recovering particles agent; Matched group gives glucuronolatone and compound vitamin B, vitamin C treatment 6 months.Treat preceding 3 months with this treats in back one month eventually, do liver function, the detection of serum hepatic fibrosis index respectively, carry out therapeutic evaluation.The result:
1. serum hepatic fibrosis index: the treatment group selects before and after the treatment that phaneroplasm acid (HA) is respectively 73.97,121.53ng/ml except that IV type abdomen former (70.57,66.35 P＞0.05); Laminin (LN) is respectively 165.27,125.40ng/ml; Abdomen former (PCIII) is respectively 145.50,115.95 before the III type all obvious decline (P is all＜0.05,0.01), and no significant difference (P＞0.05) before and after the treatment of matched group These parameters;
2. treatment back treatment group total effects 88.33% liver function is clearly better, and 87.51% patient ALT descends or be multiple normal; Patient's haemproteins of 45.95% raises, and is excellent far beyond matched group.
The material method:
(1) object of study: totally 90 routine chronic viral hepatitis Bs, be the 1997.7-1999.12 out-patient, diagnosis is by Chinese Medical Association's infectious disease and parasitic disease branch, hepatopathy association unites the formulation standard, is respectively 2 groups at random, and wherein 60 examples are organized in treatment, matched group 30 examples, treatment group male 43 examples, women's 17 examples, 34.3 years old mean age, the course of disease 3.27, Serum ALT rising person 32 examples, haemproteins reduction person 37 examples, male 21 examples in the matched group, woman's 9 examples, 31.1 years old mean age, average course of disease 3.12, Serum ALT rising person 16 examples, haemproteins reduction person 17 examples, treatment group and matched group are at the age, sex, the course of disease, the liver function aspect does not all have significant difference (P＞0.05).
(2) Therapeutic Method
The treatment group gives the liver benefiting recovering particles decoct one day twice of the embodiment of the invention 1, and 6 months courses of treatment, matched group gives glucuronolatone and compound vitamin, vitamin C, treatment 6 months
(3) observational technique:
Treat front and back the clinical common sympton of patient, appetite, abdominal distention and pain in the hepatic region are observed, do liver function, the detection of serum hepatic fibrosis index in back 1 month respectively with treating before the treatment, serum hepatic fibrosis index etc. are measured with conventional method.
(4) curative effect index:
Formulate as follows with reference to Hangzhou viral hepatitis academic conference and the bright standard of Qin Shao (3): 1. clinical cure: symptom disappears substantially, and liver function recovery is normal, and enlargement liver spleen recovers normal (liver bounces back to just and can touch, and matter degree softness or liver spleen all do not touch); 2. evident in efficacy: symptom is clearly better, and liver function is recovered substantially, retraction＞2cm, and spleen does not touch; 3. effective: symptom takes a turn for the better, and liver function is obviously improved, liver and/or spleen retraction＜2cm; 4. invalid or worsen: symptom, liver function all do not have and improve or worsen, and the liver spleen does not have retraction.
The result
(1) total effects: " the liver benefiting health " total effects reaches 88.33%, is high than matched group 46.66% (P＜0.01).
(2) symptom is influenced
Treatment group inappetence (94.23%), feel sick (91.67%), abdominal distention (94.67%), pain in the hepatic region symptoms such as (85.19%) began to alleviate in the treatment back in 7-10 days, and 2-3 week is clearly better, and is that excellent (P＜0.01) is as table one far beyond matched group
(3) liver and spleen retraction situation: treatment is organized in 60 examples, and 59 examples have hepatomegaly treatment back 51 examples (86.44%) that retraction is in various degree arranged, and matched group liver retraction is not obvious, and only 4 examples have liver retraction (18.79%), see Table two
(4) to liver function influence
60 examples are organized in treatment, and (normally＜40u), the treatment back descends (3438%) and again normal (53.13%) person 87.51%, is that excellent (P＜0.01) sees Table three than matched group more than 40u to treat preceding 32 routine ALT
Serum albumin is lower than 3g person's 37 examples before the treatment of this group, and treatment back 17 examples (45.95%) are increased to more than the 3g, and 7 examples (18.92%) raise to some extent, effective percentage 64.87%.
(5) hepatic fibrosis index is influenced
Remove the outer HA of IV Collagen Type VI (70.57 and 66.35, P＞0.05) before and after the treatment group treatment and be respectively 173.97 and 121.53ng/ml; LN is respectively 165.27 and 125.40ng/ml; PCIII is respectively 145.50 and 115.95, and obvious decline (P is all arranged
All＜0.05) 0.01), and no significant difference (P＞0.05) before and after the matched group These parameters treatment sees Table four.
Table one: the liver benefiting health influences symptom
| The example number | Clinical cure (%) | Show number (%) | Effectively (%) | Invalid, deterioration (%) | |
| The liver benefiting health group | ????60 | ????2(3.33) | ????38(63.33) | ????13(21.67) | ????7(11.67) |
| Matched group | ????30 | ????0(0) | ?????1(3.33) | ????13(43.33) | ????16(53.33) |
Table two: the treatment back is to the influence of liver retraction
| Hepatomegaly example number | ????＜2 | Treatment back (cm) no change | ????＞2 | |
| The liver benefiting health group | ????59/60 | ??37(62.71) | ????8(14.91) | ????14(23.75) |
| Matched group | ????29/30 | ??4(13.79) | ????25(86.21) | ????0(0) |
Table three: the treatment back is to the influence of ALT
| Several unusually before the treatment | Multiple normal | The treatment back changes and descends | No change or rising | |
| The liver benefiting health group | ????32/60 | ????17(53.13) | ????11(34.38) | ????4(12.50) |
| Matched group | ????16/30 | ????2(12.50) | ????6(37.50) | ????6(50.0) |
Table four: the liver benefiting health influences the serum hepatic fibrosis index
| The example number | Before and after the treatment of treatment group | Before and after the treatment of control group | ||||||
| ??HA | ??LN | ?PCM | ????HA | ????LN | ?PCM | |||
| The liver benefiting health group | 60 | ?173.97 | ??165.27 | ?145.50 | ????121.53 | ??125.40 | ??115.95 | ??P All＜0.05、 ??0.01 |
| Matched group | 30 | ?180.10 | ??169.22 | ?144.22 | ????178.24 | ??167.13 | ??145.10 | ??P＞0.05 |
The total effects of " the liver benefiting health " treatment chronic hepatopathy (inflammation), anti-hepatic fibrosis is 88.33%, symptoms such as treatment back inappetence, abdominal distention and pain in the hepatic region are obviously improved, 87.51% patient ALT descends with multiple normal, patient's albumin of 45.95% rises to more than the 3g, with doing well,improving, liver function takes a turn for the better simultaneously, and liver, spleen bounce back to some extent, and hepatic fibrosis index takes an evident turn for the better.
Test example 2: the liver benefiting health is to hepatocellular protective effect of experimental hepatic fibrosis rats and Ultrastructural observation
Concrete test material and method is auspicious sees " Chinese combination of Chinese and Western medicine digestion magazine " 2002,10 (2): 76-78 (document data is write description), it has obvious effect of anti hepatic fibrosis the result of the test proof, can obviously reduce I, III collagen mRNA level in the liver.Most (87.51%) ALT in this group case treatment back descend with multiple normal, and clinical symptoms is obviously improved, and liver retraction, albumin raise and＞3g person accounts for 64.87%.
Claims (9)
1. treat the hardened Chinese medicine composition of hepatic fibrosis regulating liver-QI for one kind, it is characterized in that the preparation raw material of the active component that it is contained comprises (weight ratio): Radix Salviae Miltiorrhizae 9-12, Radix Astragali 3-6, one or more drug for invigorating blood circulation and eliminating stasis except that Radix Salviae Miltiorrhizae are total to 4-12, one or more drugs strengthening spleens are total to 3-12 and one or more QI regulating medicine are total to 2-7.
2. according to the described Chinese medicine composition of claim 1, wherein said drug for invigorating blood circulation and eliminating stasis is selected from one or more in Rhizoma Chuanxiong, Olibanum, Myrrha, Rhizoma Corydalis, Radix Curcumae, Semen Persicae, Caulis Spatholobi, Flos Carthami, Oletum Trogopterori, Rhizoma Polygoni Cuspidati, Hirudo, Radix Angelicae Sinensis, the Radix Paeoniae Rubra.
3. according to the described Chinese medicine composition of claim 2, wherein said strengthening the spleen to promote digestion medicine is selected from one or more in the Rhizoma Atractylodis Macrocephalae, Poria, Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus, the Massa Medicata Fermentata.
4. according to the described Chinese medicine composition of claim 3, wherein said QI regulating medicine is selected from one or more in Cortex Magnoliae Officinalis, Radix Aucklandiae (Radix Vladimiriae), Radix Bupleuri, Pericarpium Citri Reticulatae Viride, Fructus Citri Sarcodactylis, Fructus Citri, Rhizoma Cyperi, the Fructus Akebiae.
5. according to the described Chinese medicine composition of claim 4, the weight ratio of the preparation raw material of the active component that it is contained is: Radix Salviae Miltiorrhizae 9-16, Radix Angelicae Sinensis 2-6, Radix Astragali 3-6, Radix Paeoniae Rubra 2-6, Rhizoma Atractylodis Macrocephalae (parched) 1-4, Poria 1-4, Endothelium Corneum Gigeriae Galli 1-4, Cortex Magnoliae Officinalis 1-3 and Radix Bupleuri 1-4.
6. according to the described Chinese medicine composition of claim 5, wherein said raw material weight is than being Radix Salviae Miltiorrhizae 10, Radix Angelicae Sinensis 2, the Radix Astragali 4, Radix Paeoniae Rubra 3, Rhizoma Atractylodis Macrocephalae (parched) 2, Poria 2, Endothelium Corneum Gigeriae Galli 2, Cortex Magnoliae Officinalis 2 and Radix Bupleuri 2.
7. the preparation method of any one described Chinese medicine composition among the claim 1-6, it contains the following step:
A) take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption;
B) above-mentioned Chinese crude drug is dried and crushed into fine powder as active component;
C) above-mentioned active component is made various dosage forms with pharmaceutically acceptable excipient.
8. the preparation method of any one described Chinese medicine composition among the claim 1-6, it contains the following step:
A) take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption;
B) above-mentioned pulverizing medicinal materials is become coarse powder, with the ethanol of 50-60% be solvent 60-70 ℃ of reflux, extract,, extracting solution is after reclaiming ethanol, cryoconcentration becomes thick extractum, drying is ground into fine powder as active component;
C) above-mentioned active component is made various dosage forms with pharmaceutically acceptable excipient.
9. the preparation method of any one described Chinese medicine composition among the claim 1-6, it contains the following step:
A) take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption;
B) decoct with water twice, 2-3 hour for the first time, 1-2 hour for the second time, filter, merging filtrate leaves standstill clarification, and low-temperature evaporation is concentrated into the thick paste shape, and the proportion of thick paste is surveyed 80-90 ℃ of heat and is 1.30-1.35;
C) above-mentioned thick paste is made various dosage forms as active component and pharmaceutically acceptable carrier or excipient.
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| CNB021552185A CN1245173C (en) | 2002-12-10 | 2002-12-10 | Medicine composition for treating liver fibrillation and liver cirrhosis and its prepn process |
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| CNB021552185A CN1245173C (en) | 2002-12-10 | 2002-12-10 | Medicine composition for treating liver fibrillation and liver cirrhosis and its prepn process |
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| CN1245173C CN1245173C (en) | 2006-03-15 |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100566729C (en) * | 2006-11-29 | 2009-12-09 | 李晨 | Chinese medicine for treating hepatic fibrosis |
| CN102357171A (en) * | 2011-10-26 | 2012-02-22 | 上海中医药大学 | Traditional Chinese medicine composition for preventing and curing hepatic fibrosis, and preparation method and application thereof |
| CN103519215A (en) * | 2013-10-20 | 2014-01-22 | 马光元 | Soup chicken with effect of treating cirrhosis ascites |
| CN104606647A (en) * | 2015-02-17 | 2015-05-13 | 聂玮 | Liver-soothing and depression-relieving preparation for patients with liver cirrhosis |
| CN104689053A (en) * | 2015-02-17 | 2015-06-10 | 聂玮 | Preparation for soothing liver and dispelling melancholy to treat liver cirrhosis and preparation method of preparation |
| CN104826019A (en) * | 2015-05-15 | 2015-08-12 | 青岛辰达生物科技有限公司 | Traditional Chinese medicine composition for treating hepatitis B with hepatic fibrosis |
| CN107737214A (en) * | 2017-10-27 | 2018-02-27 | 昆明市中医医院 | A kind of drug regimen for treating liver fibrosis and its preparation method and application |
| CN108619416A (en) * | 2018-07-19 | 2018-10-09 | 郑法海 | The pharmaceutical composition and preparation method thereof for the treatment of hepatic sclerosis, liver ascites and liver tumour |
| CN111991540A (en) * | 2020-10-23 | 2020-11-27 | 浙江省中医药研究院 | Traditional Chinese medicine composition for treating hepatic fibrosis and preparation method and application thereof |
| CN113855775A (en) * | 2021-11-19 | 2021-12-31 | 临澧县中医医院 | A pill for treating chronic hepatitis and its preparation method |
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2002
- 2002-12-10 CN CNB021552185A patent/CN1245173C/en not_active Expired - Fee Related
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100566729C (en) * | 2006-11-29 | 2009-12-09 | 李晨 | Chinese medicine for treating hepatic fibrosis |
| CN102357171A (en) * | 2011-10-26 | 2012-02-22 | 上海中医药大学 | Traditional Chinese medicine composition for preventing and curing hepatic fibrosis, and preparation method and application thereof |
| CN103519215A (en) * | 2013-10-20 | 2014-01-22 | 马光元 | Soup chicken with effect of treating cirrhosis ascites |
| CN103519215B (en) * | 2013-10-20 | 2015-11-18 | 马光元 | There is the soup chicken for the treatment of cirrhotic ascites effect |
| CN104606647A (en) * | 2015-02-17 | 2015-05-13 | 聂玮 | Liver-soothing and depression-relieving preparation for patients with liver cirrhosis |
| CN104689053A (en) * | 2015-02-17 | 2015-06-10 | 聂玮 | Preparation for soothing liver and dispelling melancholy to treat liver cirrhosis and preparation method of preparation |
| CN104826019A (en) * | 2015-05-15 | 2015-08-12 | 青岛辰达生物科技有限公司 | Traditional Chinese medicine composition for treating hepatitis B with hepatic fibrosis |
| CN107737214A (en) * | 2017-10-27 | 2018-02-27 | 昆明市中医医院 | A kind of drug regimen for treating liver fibrosis and its preparation method and application |
| CN108619416A (en) * | 2018-07-19 | 2018-10-09 | 郑法海 | The pharmaceutical composition and preparation method thereof for the treatment of hepatic sclerosis, liver ascites and liver tumour |
| CN111991540A (en) * | 2020-10-23 | 2020-11-27 | 浙江省中医药研究院 | Traditional Chinese medicine composition for treating hepatic fibrosis and preparation method and application thereof |
| CN113855775A (en) * | 2021-11-19 | 2021-12-31 | 临澧县中医医院 | A pill for treating chronic hepatitis and its preparation method |
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| Publication number | Publication date |
|---|---|
| CN1245173C (en) | 2006-03-15 |
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