CN103463414B - Pharmaceutical composition for treating fatty liver and application thereof - Google Patents

Pharmaceutical composition for treating fatty liver and application thereof Download PDF

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CN103463414B
CN103463414B CN201310408229.4A CN201310408229A CN103463414B CN 103463414 B CN103463414 B CN 103463414B CN 201310408229 A CN201310408229 A CN 201310408229A CN 103463414 B CN103463414 B CN 103463414B
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parts
pharmaceutical composition
fatty liver
kilograms
radix
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CN103463414A (en
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闫美兴
武刚毅
刘峙
李小纪
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Qingdao Municipal Hospital
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Qingdao Municipal Hospital
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Abstract

The invention relates to a pharmaceutical composition for treating fatty liver and an application thereof. The pharmaceutical composition is prepared from the following traditional Chinese medicine materials in parts by weight: 50-80 parts of orange peel, 20-30 parts of fructus aurantii, 10-18 parts of lilies, 8-15 parts of dried rehamnnia roots, 7-12 parts of allium macrostemon, 10-16 parts of polygonum cuspidatum, 7-12 parts of scrophularia ningpoensis, 15-22 parts of radix ophiopogonis, 15-22 parts of mulberry leaves, and 30-40 parts of mulberry branches. The pharmaceutical composition disclosed by the invention has a remarkable effect for lowering transaminase level that represents hepatitis change, and also can be used for relieving fat deposition degree of fatty liver, which is possibly realized by lowering serum triglyceride and cholesterol level.

Description

A kind of pharmaceutical composition and application thereof for the treatment of fatty liver
Technical field
The invention belongs to technical field of Chinese medicine, be specifically related to a kind of pharmaceutical composition and application thereof for the treatment of fatty liver.
Background technology
Along with the raising of people's living standard, the change etc. of dietary structure, the sickness rate of non-alcoholic fatty liver disease is more and more higher.Non-alcohol fatty liver is a kind of clinical common chronic hepatic diseases slowly, and this disease may increase with proinflammatory cytokines, Anomalous lipid metablism, atherosclerosis, hypertension, type 2 diabetes mellitus, metabolism syndrome etc. are closely related.Insulin resistant, heat particularly fat intake are too much the key factors of non-alcohol fatty liver.And at present to non-alcoholic fatty liver disease, still lack effective remedy measures.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition for the treatment of fatty liver.Pharmaceutical composition of the present invention has reducing effect significantly to the transaminase level representing inflammation change, and can alleviate Fatty Liver Fatty deposition degree, it can realize by reduction serum triglycerides and cholesterol levels simultaneously.
The object of the present invention is achieved like this:
Treat a pharmaceutical composition for fatty liver, be prepared from by the Chinese crude drug of following weight portion: Pericarpium Citri Reticulatae 50-80 part, Fructus Aurantii 20-30 part, Bulbus Lilii 10-18 part, Radix Rehmanniae 8-15 part, Bulbus Allii Macrostemonis 7-12 part, Rhizoma Polygoni Cuspidati 10-16 part, Radix Scrophulariae 7-12 part, Radix Ophiopogonis 15-22 part, Folium Mori 15-22 part, Ramulus Mori 30-40 part.
Preferably, the pharmaceutical composition of above-mentioned treatment fatty liver, is prepared from by the Chinese crude drug of following weight portion: Pericarpium Citri Reticulatae 60-70 part, Fructus Aurantii 23-27 part, Bulbus Lilii 12-15 part, Radix Rehmanniae 10-13 part, Bulbus Allii Macrostemonis 8-10 part, Rhizoma Polygoni Cuspidati 12-14 part, Radix Scrophulariae 8-10 part, Radix Ophiopogonis 18-20 part, Folium Mori 18-20 part, Ramulus Mori 34-37 part.
Further preferably, the pharmaceutical composition of above-mentioned treatment fatty liver, is prepared from by the traditional Chinese medicinal material raw materials of following weight portion: Pericarpium Citri Reticulatae 65 parts, Fructus Aurantii 25 parts, Bulbus Lilii 14 parts, 12 parts, the Radix Rehmanniae, Bulbus Allii Macrostemonis 10 parts, Rhizoma Polygoni Cuspidati 13 parts, Radix Scrophulariae 9 parts, Radix Ophiopogonis 18 parts, 20 parts, Folium Mori, Ramulus Mori 36 parts.
Again further preferably, the pharmaceutical composition of above-mentioned treatment fatty liver is granule.
Shown by a large amount of animal experiment, pharmaceutical composition of the present invention has therapeutical effect significantly to fatty liver, is especially applicable to treatment non-alcoholic fatty liver disease.Therefore, another object of the present invention is to provide a kind of pharmaceutical applications, that is: the application of aforementioned pharmaceutical compositions in the medicine of preparation treatment fatty liver.The application of preferred aforementioned pharmaceutical compositions in the medicine of preparation treatment non-alcoholic fatty liver disease.
Above-mentioned each Chinese crude drug is prepared into the preparation method of compound preparation of the present invention, comprises the steps:
The first step, prepare clear paste powder:
1) get the raw materials ready: take the above-mentioned Chinese crude drug cleaned up by recipe quantity, for subsequent use;
2) decoct: decoct with water, first decocts 8 times that every tank adds water as medical material total amount, and keep 3 hours after ebuillition of heated, extracting solution enters settling tank through 200 order metre filter; Second decocts the water heating extraction adding medical material amount 4 times, and protect and boil 3 hours, extracting solution enters settling tank through 200 order metre filter;
3) precipitate: extracting solution precipitation 24 ~ 36 hours in settling tank, extract supernatant through 200 order metre filter in triple effect evaporator, precipitate is by offal treatment;
4) concentrated: to be 1.00 ~ 1.10(40 DEG C of mensuration when supernatant is concentrated into relative density in triple effect evaporator) time, by rare clear paste in 200 order metre filter suction vacuum decompressioning and concentrating tanks, concentrating and being mixed to relative density is 1.30 ~ 1.32(90 DEG C of mensuration) time go out cream, to in storage cream bucket, for subsequent use;
5) dry: wherein vacuum :-0.1MPa, temperature: 78 ~ 82 DEG C, 20 ~ 24 hours drying times;
6) powder is beaten: smashing fineness 80 mesh sieve, obtains clear paste powder;
Second step, according to clear paste powder: dextrin is that the weight ratio of 1:1 ~ 3 takes clear paste powder, dextrin and appropriate 55% ethanol, and wherein 55% ethanol refers to that volumetric concentration is the ethanol water of 55%;
3rd step, drops in trough type mixing machine by clear paste powder and dextrin, stirs 20 minutes, slowly adds 55% ethanol while stirring, to making soft material, granulates with 12 order stainless steel sifts, and 65 ~ 75 DEG C of dryings 2 hours, take out, cool and obtain described granule.
According to Chinese medicine Historical Data Data About, the pharmacologically active of above-mentioned Ten Herbs material is as follows:
Pericarpium Citri Reticulatae: there is regulating qi-flowing for strengthening spleen, in tune, dampness, the effect of reducing phlegm.Cure mainly distension and fullness in the abdomen or pain, the dyspepsia of stagnation of QI in spleen and stomach.Abdominal distention uncomfortable in chest in turbid damp resistance, indigestion and loss of appetite loose stool.Phlegm-damp stops up the cough and asthma of lung.Select the dry mature skin for rutaceae orange and variety thereof.
Fructus Aurantii: regulating the flow of QI to ease the stomach, the stagnant relieving distension of row.For the breast side of body stagnation of QI, distension pain, accumulation of food in the stomach and intes tine due to indigestion, stops in phlegm retention; Gastroptosis, proctoptosis, sub-official's prolapsus.Select the dry immature fruit of rutaceae Citrus aurantium Linn. Citrus aurantium L. and variety thereof.
Bulbus Lilii: nourishing YIN and moistening the lung, clearing away heart-fire for tranquillization.For deficiency of YIN chronic cough, sputum mixed with blood, fidgets due to deficiency is palpitated with fear, insomnia and dreamful sleep, absentminded.There is nourishing YIN and moistening the lung cough-relieving effect, for the cough caused by dryness-heat of deficiency of lung-YIN.The present invention selects the dry meat scale leaf of liliaceous plant tiger lily Lilium lancifolium Thunb., Bulbus Lilii Lilium brownii F.E.Brown var.viridulum Baker or Bulbus lilii concoloris Bulbus Lilii (Lilium tenuifolium) Lilium pumilum DC..
The Radix Rehmanniae: clearing away heat and cooling blood, yin nourishing, promotes the production of body fluid.For calentura crimson tongue excessive thirst, yin asthenia generating intrinsic heat, hectic fever due to YIN-deficiency consumptive fever, interior-heat is quenched one's thirst, and spits blood, and epistaxis sends out speckle dermexanthesis.Be selected from the dried root of Scrophulariaceae herbaceos perennial Radix Rehmanniae Rehmannia glutinosa Libosch..
Bulbus Allii Macrostemonis: the dry bulb selecting liliaceous plant Allium macrostemon Allium macrostemon Bge., summer, Qiu Erji excavate, and clean, removing fibrous root, steam thoroughly or put in boiling water and scald thoroughly, dry.There is activating YANG and eliminating stagnation, effect of circulation of qi promoting intestinal stasis relieving.For thoracic obstruction pain, phlegm retention cough with asthma is heavy after letting out dysentery.
Rhizoma Polygoni Cuspidati: heat-clearing and toxic substances removing, promoting the function of the gallbladder to alleviate jaundice, expelling wind and removing dampness, dissipating blood stasis analgesic therapy, relieving cough and resolving phlegm.For arthralgia, jaundice due to damp-heat, amenorrhea , WEIJIA, cough with copious phlegm, burn due to hot liquid or fire, injury from falling down, carbuncle sore tumefacting virus.Select dry rhizome and the root of Polygonaceae Polygonaceae plant polygonum cuspidatum Polygonum cuspidatum Sieb.et Zucc..
Radix Scrophulariae: clearing away heat and cooling blood, eliminating fire and detoxication, YIN nourishing.Cure mainly pathogenic warmth to join the army, cave in pericardium, maculae caused by violent heat pathogen, and consumption of YIN caused by febrile disease, crimson tongue excessive thirst, Tianjin hinder constipation, hectic fever due to YIN-deficiency chronic cough, conjunctival congestion, pharyngalgia, scrofula, diphtheria, carbuncle sore tumefacting virus.Be selected from the dry root of dicotyledon Scrophulariaceae Scrophulariaceae Radix Scrophulariae Scrophularia ningpoensisHemsl..
Radix Ophiopogonis: YIN nourishing and the production of body fluid promoting, lung moistening clears away heart-fire.For dryness of the lung dry cough, deficiency of YIN consumptive disease is coughed, sore throat pharyngalgia, and Tianjin wound is thirsty, and interior-heat is quenched one's thirst, vexed insomnia, dryness of the intestine constipation.Be selected from Liliaceae Ophiopogon plant Ophiopogon Radix Ophiopogonis Japonicus(Thunb.) dried root of Ker-Gawl..
Folium Mori: there is dispelling wind and heat pathogens, clearing away lung-heat and moistening for dryness, suppressing liver-YANG, liver heat removing and eyesight improving, effect of cooling blood for hemostasis.Select the dried leaves of Moraceae Moraceae plant Mulberry Morus alba L..
Ramulus Mori: wind-damp dispelling, sharp joint, row aqueous vapor.Control anemofrigid-damp arthralgia, spasm of the limbs, beriberi edema, human body pruritus due to wind pathogen.Select the dry twig of moraceae plants Mulberry Morus alba L..
Pharmaceutical composition of the present invention has reducing effect significantly to the transaminase level representing inflammation change, and can alleviate Fatty Liver Fatty deposition degree, it can realize by reduction serum triglycerides and cholesterol levels simultaneously.
Detailed description of the invention
Be below specific embodiments of the invention, technical scheme of the present invention is done to describing further, but protection scope of the present invention be not limited to these embodiments.Every do not deviate from the present invention's design change or equivalent substituting include within protection scope of the present invention.
The preparation of embodiment 1 Chinese medicine granules
Crude drug prescription: Pericarpium Citri Reticulatae 65 kilograms, Fructus Aurantii 25 kilograms, Bulbus Lilii 14 kilograms, 12 kilograms, the Radix Rehmanniae, Bulbus Allii Macrostemonis 10 kilograms, Rhizoma Polygoni Cuspidati 13 kilograms, Radix Scrophulariae 9 kilograms, Radix Ophiopogonis 18 kilograms, 20 kilograms, Folium Mori, Ramulus Mori 36 kilograms.
Preparation method:
The first step, prepare clear paste powder:
1) get the raw materials ready: take the above-mentioned Chinese crude drug cleaned up by recipe quantity, for subsequent use;
2) decoct: decoct with water, first decocts 8 times that every tank adds water as medical material total amount, and keep 3 hours after ebuillition of heated, extracting solution enters settling tank through 200 order metre filter; Second decocts the water heating extraction adding medical material amount 4 times, and protect and boil 3 hours, extracting solution enters settling tank through 200 order metre filter;
3) precipitate: in settling tank, extracting solution precipitates 24 hours, extract supernatant through 200 order metre filter in triple effect evaporator, precipitate is by offal treatment;
4) concentrated: to be 1.10(40 DEG C of mensuration when supernatant is concentrated into relative density in triple effect evaporator) time, by rare clear paste in 200 order metre filter suction vacuum decompressioning and concentrating tanks, concentrating and being mixed to relative density is 1.30 ~ 1.32(90 DEG C of mensuration) time go out cream, to in storage cream bucket, for subsequent use;
5) dry: wherein vacuum :-0.1MPa, temperature: 78 ~ 82 DEG C, 20 hours drying times;
6) powder is beaten: smashing fineness 80 mesh sieve, obtains clear paste powder;
Second step, according to clear paste powder: dextrin is that the weight ratio of 1:2 takes clear paste powder, dextrin and appropriate 55% ethanol, and wherein 55% ethanol refers to that volumetric concentration is the ethanol water of 55%;
3rd step, drops in trough type mixing machine by clear paste powder and dextrin, stirs 20 minutes, slowly adds 55% ethanol while stirring, to making soft material, granulates with 12 order stainless steel sifts, and 70 DEG C of dryings 2 hours, take out, cool and obtain described granule.
The preparation of embodiment 2 Chinese medicine granules
Crude drug prescription: Pericarpium Citri Reticulatae 80 kilograms, Fructus Aurantii 25 kilograms, Bulbus Lilii 10 kilograms, 10 kilograms, the Radix Rehmanniae, Bulbus Allii Macrostemonis 12 kilograms, Rhizoma Polygoni Cuspidati 16 kilograms, Radix Scrophulariae 12 kilograms, Radix Ophiopogonis 15 kilograms, 15 kilograms, Folium Mori, Ramulus Mori 30 kilograms.
Preparation method:
The first step, prepare clear paste powder:
1) get the raw materials ready: take the above-mentioned Chinese crude drug cleaned up by recipe quantity, for subsequent use;
2) decoct: decoct with water, first decocts 8 times that every tank adds water as medical material total amount, and keep 3 hours after ebuillition of heated, extracting solution enters settling tank through 200 order metre filter; Second decocts the water heating extraction adding medical material amount 4 times, and protect and boil 3 hours, extracting solution enters settling tank through 200 order metre filter;
3) precipitate: in settling tank, extracting solution precipitates 30 hours, extract supernatant through 200 order metre filter in triple effect evaporator, precipitate is by offal treatment;
4) concentrated: to be 1.05(40 DEG C of mensuration when supernatant is concentrated into relative density in triple effect evaporator) time, by rare clear paste in 200 order metre filter suction vacuum decompressioning and concentrating tanks, concentrating and being mixed to relative density is 1.30 ~ 1.32(90 DEG C of mensuration) time go out cream, to in storage cream bucket, for subsequent use;
5) dry: wherein vacuum :-0.1MPa, temperature: 78 ~ 82 DEG C, 24 hours drying times;
6) powder is beaten: smashing fineness 80 mesh sieve, obtains clear paste powder;
Second step, according to clear paste powder: dextrin is that the weight ratio of 1:3 takes clear paste powder, dextrin and appropriate 55% ethanol, and wherein 55% ethanol refers to that volumetric concentration is the ethanol water of 55%;
3rd step, drops in trough type mixing machine by clear paste powder and dextrin, stirs 20 minutes, slowly adds 55% ethanol while stirring, to making soft material, granulates with 12 order stainless steel sifts, and 75 DEG C of dryings 2 hours, take out, cool and obtain described granule.
The preparation of embodiment 3 Chinese medicine granules
Crude drug prescription: Pericarpium Citri Reticulatae 50 kilograms, Fructus Aurantii 30 kilograms, Bulbus Lilii 18 kilograms, 15 kilograms, the Radix Rehmanniae, Bulbus Allii Macrostemonis 8 kilograms, Rhizoma Polygoni Cuspidati 10 kilograms, Radix Scrophulariae 7 kilograms, Radix Ophiopogonis 22 kilograms, 20 kilograms, Folium Mori, Ramulus Mori 40 kilograms.
Preparation method:
The first step, prepare clear paste powder:
1) get the raw materials ready: take the above-mentioned Chinese crude drug cleaned up by recipe quantity, for subsequent use;
2) decoct: decoct with water, first decocts 8 times that every tank adds water as medical material total amount, and keep 3 hours after ebuillition of heated, extracting solution enters settling tank through 200 order metre filter; Second decocts the water heating extraction adding medical material amount 4 times, and protect and boil 3 hours, extracting solution enters settling tank through 200 order metre filter;
3) precipitate: in settling tank, extracting solution precipitates 36 hours, extract supernatant through 200 order metre filter in triple effect evaporator, precipitate is by offal treatment;
4) concentrated: to be 1.10(40 DEG C of mensuration when supernatant is concentrated into relative density in triple effect evaporator) time, by rare clear paste in 200 order metre filter suction vacuum decompressioning and concentrating tanks, concentrating and being mixed to relative density is 1.30 ~ 1.32(90 DEG C of mensuration) time go out cream, to in storage cream bucket, for subsequent use;
5) dry: wherein vacuum :-0.1MPa, temperature: 78 ~ 82 DEG C, 24 hours drying times;
6) powder is beaten: smashing fineness 80 mesh sieve, obtains clear paste powder;
Second step, according to clear paste powder: dextrin is that the weight ratio of 1:2 takes clear paste powder, dextrin and appropriate 55% ethanol, and wherein 55% ethanol refers to that volumetric concentration is the ethanol water of 55%;
3rd step, drops in trough type mixing machine by clear paste powder and dextrin, stirs 20 minutes, slowly adds 55% ethanol while stirring, to making soft material, granulates with 12 order stainless steel sifts, and 75 DEG C of dryings 2 hours, take out, cool and obtain described granule.
Embodiment 4 Chinese medicine composition of the present invention is to the effect of Models of Fatty Liver rat
SD rat, male, body weight 220 ± 20g, adopts the method modeling of gavage height lipoprotein emulsion.High lipoprotein emulsion formula: Adeps Sus domestica 200g, cholesterol 100g, fructose 50g, sucrose 50g, cholate 10g, sodium glutamate 10g, propylene glycol 150ml, add a little twen-80 and stir, adding distil water is settled to 1000ml.Except rats in normal control group, the equal gavage of other rats gives high lipoprotein emulsion and continues 7 weeks.
After rat adaptability raises 1 week, be divided into Normal group, model control group and Chinese drug-treated group at random, often organize 12.Except normal group, other each group in every morning 9:30 gavage height lipoprotein emulsion, dosage 10mlkg -1d -1.In addition, from gavage height lipoprotein emulsion after 10 days, gavage tested material during 14:30 every afternoon, administration 6 weeks.Tested material and the dosage of each group are as follows:
Normal group: the dextrin in aqueous solution of same volume;
Model control group: the dextrin in aqueous solution of same volume;
Chinese drug-treated group: 30gkg -1d -1clear paste powder (prepared by embodiment 1)
After last administration, pentobarbital sodium anesthetized rat, dissect, abdomen cardinal vein gets hematometry Serum ALT, AST, and detects T-CHOL, triglyceride, high density lipoprotein and low density lipoprotein, LDL.
Result of the test according to table 1 can be found out, the obvious rising compared with normal group of Models of Fatty Liver group rat blood serum ALT, AST content, rat blood serum ALT, AST content for the treatment of by Chinese herbs group has obvious decline compared with model group, has significant difference (P < 0.05) or pole significant difference (P < 0.01).
Table 1 Chinese medicine clear paste powder is on the impact of rat model liver function
Compare with model control group, *p < 0.05; Compare with model control group, *p < 0.01.
Result of the test according to table 2 can be found out, the T-CHOL of Chinese drug-treated group rat of the present invention, triglyceride, high density lipoprotein have significant difference (P < 0.05) or pole significant difference (P < 0.01) with the level of low density lipoprotein, LDL compared with fatty liver model of rats group, and this illustrates that pharmaceutical composition of the present invention has good synergism for the prevention of nonalcoholic fatty liver model rat or treatment.
Table 2 Chinese medicine clear paste powder is on the impact of rat fat
Compare with model control group, *p < 0.05; Compare with model control group, *p < 0.01.

Claims (5)

1. treat a pharmaceutical composition for fatty liver, it is characterized in that: described pharmaceutical composition is prepared from by the traditional Chinese medicinal material raw materials of following weight portion: Pericarpium Citri Reticulatae 60-70 part, Fructus Aurantii 23-27 part, Bulbus Lilii 12-15 part, Radix Rehmanniae 10-13 part, Bulbus Allii Macrostemonis 8-10 part, Rhizoma Polygoni Cuspidati 12-14 part, Radix Scrophulariae 8-10 part, Radix Ophiopogonis 18-20 part, Folium Mori 18-20 part, Ramulus Mori 34-37 part.
2. treat the pharmaceutical composition of fatty liver according to claim 1, it is characterized in that: described pharmaceutical composition is prepared from by the traditional Chinese medicinal material raw materials of following weight portion: Pericarpium Citri Reticulatae 65 parts, Fructus Aurantii 25 parts, Bulbus Lilii 14 parts, 12 parts, the Radix Rehmanniae, Bulbus Allii Macrostemonis 10 parts, Rhizoma Polygoni Cuspidati 13 parts, Radix Scrophulariae 9 parts, Radix Ophiopogonis 18 parts, 20 parts, Folium Mori, Ramulus Mori 36 parts.
3. according to claim 1 or 2, treat the pharmaceutical composition of fatty liver, it is characterized in that: described pharmaceutical composition is granule.
4. the application of pharmaceutical composition described in claim 1 or 2 in the medicine of preparation treatment fatty liver.
5. the application of pharmaceutical composition described in claim 1 or 2 in the medicine of preparation treatment non-alcoholic fatty liver disease.
CN201310408229.4A 2013-09-09 2013-09-09 Pharmaceutical composition for treating fatty liver and application thereof Expired - Fee Related CN103463414B (en)

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CN103860884A (en) * 2014-04-01 2014-06-18 范东晨 Drug for treating non-alcoholic fatty liver disease
CN104258276A (en) * 2014-09-23 2015-01-07 苏州市天灵中药饮片有限公司 Traditional Chinese medicine composition for treating non-alcoholic fatty liver disease and preparation method of traditional Chinese medicine composition

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