CN103316106A - Danshan fat reducing granules and preparation method thereof - Google Patents
Danshan fat reducing granules and preparation method thereof Download PDFInfo
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Abstract
The invention relates to Danshan fat reducing granules and a preparation method thereof. The Danshan fat reducing granules is prepared by three kinds of traditional Chinese medicines of red sage root, fried cassia seed and haw in a mass proportion of 4:3:2. The preparation method comprises the following steps of: (1) weighting Danshan fat reducing granule medicinal material decoction pieces of twice of a prescription amount, adding water with weight ten times of that of the medicinal materials, boiling and extracting three times and 1h per time; (2) after the step (1), filtrating with 100-300-mesh filter cloth, to obtain filtrate; (3) condensing the filtrate by pressure reduction at 50-70 DEG C, and drying by pressure reduction to obtain dried paste powder; (4) mixing the obtained dried paste powder and medicinal dextrin in a mass proportion of 1:1, pelletizing by using ethanol as an adhesive, drying at 50-70 DEG C, straightening granules, and packaging, to obtain the Danshan fat reducing granules. Yield of the Danshan fat reducing granules by the method can reach 96%, and the method can be used for industrialization production. The Danshan fat reducing granules can be used as a medicine for treating a non-alcoholic fatty liver disease.
Description
Technical field
The present invention relates to the preparation technique of traditional Chinese medicine technical field, be specifically related to the Dan Shan fat granule and preparation method thereof that disappears.
Background technology
Liver is to play metabolic vitals in the human body, and it all plays an important role to the absorption of lipid, digestion, conversion, synthetic, decomposition etc., and can make the fat in the body keep dynamic equilibrium.Think at present in the ordinary course of things, the content of intrahepatic fat account for liver heavy 5%, be phospholipid more than 60 percent wherein, triglyceride accounts for 1% in addition, cholesterol then accounts for 0.5%, it is the main component that consists of cell membrane and other organelle films
[1]On the histology, when hepatic parenchymal fattyization degree reaches more than 30%, or storing up of fat reaches 5% when above of liver weight in wet base in the hepatocyte, just can be referred to as fatty liver.Along with the sickness rate of fatty liver and day by day increasing of recall rate, it has become a kind of hidden danger of multiple, common serious harm human body health, so also more and more cause people's attention
[2,3]Have clinical research to show, the sickness rate of China's fatty liver is between 5.2% to 11.3%.The area that studies confirm that economically developed is arranged, and also there is trend less than normal at the age of morbidity, and its sickness rate is also higher
[4]
Although in Chinese medicine, there is not " fatty liver " this name of disease, but by its clinical manifestation and symptom, great majority are attributable to the disease categories such as " hypochondriac pain ", " stasis of liver-Q and liver-blood ", " fullness and oppression sensation in the epigastrium due to accumulation of phlegm ", " expectorant is turbid ", " gathering ", " feeling of fullness ", think that fatty liver is stored up with stagnated phlegm and kidney spleen virtual loss is relevant.The fat heavy sensation of the body that the physician in ancient times mentions in described phlegm syndrome, breast side of body feeling of fullness, indigestion and loss of appetite lack of appetite, dizzy wind syndrome of head, the syndrome that extremity asthenia, seven emotions depression etc., these symptoms all show with the Patients with Fatty Liver in modern times mostly has its similarity [5].Therefore its etiology and pathogenesis is generally thought because of eating and drinking without temperance more, is had a liking for the delicious food savoury or be addicted to drinking alcohol so that the taste hepato-biliary function is disorderly, irritability stasis, the congestion internal resistance, damp and hot fumigation, expectorant is turbid cementing and cause formation fatty liver disease.
Modern study thinks that the risk factor of fatty liver has high protein diet, high fat, is addicted to drink, just before going to bed snack, hypersomnia, drowsiness and obesity or diabetes, fatty liver family history etc. are arranged; And regular labor intensity and work rhythm, often participating in physical training or physical work and low alcohol consumption is the key factor of protection fatty liver.Adjusting thus and keeping on a diet is an important method for the treatment of non-alcoholic fatty liver disease, also is the effective measures of Control and prevention non-alcoholic fatty liver disease.And in current medical science, Western medicine not especially targetedly specific medicament non-alcoholic fatty liver disease is treated, but advocate dietary adjustments, add the means such as sharp movement to lose weight and fat reducing, thereby reach the purpose for the treatment of and prevention non-alcoholic fatty liver disease.Yet general because modern people's rhythm of life is accelerated, diet irregular, can't or the less reason such as motion exercise of being engaged in if having time, people have often abandoned base therapy for non-alcoholic fatty liver disease.And the fat of disappearing is arranged in Chinese medicine, and blood fat reducing, the important medicine such as prevent that cholesterol from depositing in liver is such as Fructus Crataegi, Radix Polygoni Multiflori, Semen Cassiae, Rhizoma Alismatis etc.This paper used Chinese medicine that the patient is treated exactly, observed patient's state of an illness situation in clinical treatment, drew Chinese medicine at this on the one hand really effectively.
Along with the raising of people's living standard, the relatively lagging behind of the change of dietary structure, life style and prevention and health care measure, non-alcohol fatty liver (NAFLD) patient is increasing.Except non-alcohol fatty liver refers to due to ethanol and other clear and definite damage liver factors, the clinical pathology syndrome take diffusivity hepatocyte Macrovesicular steatosis as principal character, mainly comprise simple fatty liver, fat hepatitis (NASH), three kinds of histological type of fatty cirrhosis.And fat hepatitis (NASH) is the important step that causes non-alcoholic fatty liver sclerosis and related complication, block this link, can change the prognosis of non-alcohol fatty liver, therefore carry out the research of non-alcoholic stellato-hepatitis clinical treatment significant.
The non-alcohol fatty liver sickness rate increases gradually at present, and at the ill adult 20-30% that accounted for of western countries, domestic population accounts for 10-24%, accounts for 57.5-74% in obese people, and wherein fat hepatitis accounts for 30-50%.Approximately have 15% patient to be developed to liver cirrhosis if NAFLD further develops, 3% advances to final liver failure.NAFLD has become one of common chronic hepatopathy of the world and even China at present, the serious harm people's is healthy, become medical problem and the social problem of global concern, the study on prevention of actively developing fatty liver has very important medical science and social value.
Therapeutically, doctor trained in Western medicine mainly uses oral western medicine to be the master clinically at present: as the protection hepatocyte, to anti peroxidation of lipid silymarin, enhance hepatocyte lipid metabolism, Essentiale N/Essentiale Forte N), ursodesoxycholic acid, euglycemic agent etc. stablize the essential phospholipid (trade name: of liver plasma membrane.But do not have its definite curative effect of enough data show, and price is high.Utilization about blood lipid-lowering medicine is still disputable, because many hypolipidemics can impel blood fat more to concentrate on liver and carry out metabolism, may promote on the contrary lipid accumulating in liver, and further damage liver function.In fact there is no so far blood lipid-lowering medicine and the intrahepatic fat deposition is had itself the positive evidence that alleviates effect.And most of lipid lowerers have liver toxicity, therefore blood lipid-lowering medicine needs prudent the use in the treatment of NAFLD.
The traditional Chinese medical science is thought surfeit delicious food savoury, or disorder of emotion, or weakness due to chronic disease, causes the liver failing to maintain the normal flow of QI, dysfunction of the spleen in transportation, deficiency of the kidney, causes the pathological factors such as damp, expectorant are turbid, blood stasis and deposits due to the liver.The primary disease deficiency in origin and excess in superficiality, disease located in liver, closely related with spleen, kidney internal organs functional disorder.Opinion is controlled by dialectical executing such as hypochondriac pain, long-pending disease, jaundice, stasis of liver-Q and liver-blood.Chinese medicine truly has certain curative effect clinically because of it, and cheap, without obvious toxic-side effects, has certain advantage aspect the control NAFLD, thereby by the extensive approval of many doctors and society.Chinese medicine is the effective method of control non-alcohol fatty liver.
Dan Shan of the present invention disappears fat granule side on the basis of differentiation of tcm, dialectically combine with differential diagnosis of diseases, with reference to Chinese medicine meridian distribution of property and flavor and modern pharmacological research, for the pathogeny of fatty liver-wet, expectorant, the stasis of blood, heat, adopt dispersing the stagnated live-QI to relieve the stagnation of QI, dampness removing the turbid descending and select medicine formulated.Made by Radix Salviae Miltiorrhizae, Semen Cassiae (parched), Fructus Crataegi three flavor Chinese medicines.We cure the disease card for stopping syndrome of stagnation of liver qi and blood stasis in the non-alcoholic fatty liver disease turbid damp.The rule for the treatment of is the dampness removing the turbid descending, dispersing the stagnated live-QI to relieve the stagnation of QI.Make a concrete analysis of as follows:
Radix Salviae Miltiorrhizae: property is bitter, be slightly cold, GUIXIN, pericardium, Liver Channel, and function is invigorated blood circulation, and is monarch drug." book on Chinese herbal medicine justice ": " Radix Salviae Miltiorrhizae specially enters blood system, and its merit is promoting flow of QI and blood, interior reaches internal organs and blood stasis dispelling stagnates, and disappears and little lame broken------therefore gather ".Semen Cassiae: property is sweet, bitter, salty, be slightly cold, and returns liver, large intestine channel, and its main effect is liver heat removing and eyesight improving, loosening bowel to relieve constipation, is ministerial drug.Fructus Crataegi: property is sour, sweet, tepor, returns spleen, stomach, Liver Channel, and merit is arrogated to oneself the blood circulation promoting and blood stasis dispelling eliminate indigestion and helped digestion, and is adjuvant.Radix Salviae Miltiorrhizae and Fructus Crataegi compatibility merit invigorate blood circulation, blood stasis dispelling, circulation of qi promoting.The Zhou Xuehai of the Qing Dynasty thinks that liver and gall gasification imbalance is to cause the stagnation of QI, blood stasis, the solidifying key of expectorant, the capable then blood of gas, and stagnation of QI blood also stagnates, and the stagnation of QI causes blood stasis." Records of Tradition Chinese and Western Medicine in Combination ": " property is flat for Fructus Crataegi, sweet little acid of flavor, and the red flesh-coloured Huang of skin is therefore be apt to change into blood system the key medicine of congestion.If help it with sweet medicine, Removing Blood Stasis and do not hinder fresh blood, dissipating depression of QI gas and do not hinder healthy energy, particularly peace is also for its property." hawthorn digesting eliminate indigestion, dissipating blood stasis are capable stagnates, the outstanding kind greasy meat that disappears is long-pending, the Semen Cassiae liver heat removing and eyesight improving, and loosening bowel to relieve constipation, the lubricious intestinal stasis relieving of two medicines shares, and nourishes blood stasis dispelling with executing, and the liver heat removing stomach function regulating is parallel, curing hyperlipemia etc.
We are comprised of Radix Salviae Miltiorrhizae, Semen Cassiae (parched), Fructus Crataegi three herbal medicines, have the effect of soothing liver and strengthening spleen, activating blood and eliminatng dampness, are used for the Primary Care of non-alcoholic fatty liver disease and hyperlipidemia.
Summary of the invention
The object of the invention is intended on the basis of differentiation of tcm, dialectically combine with differential diagnosis of diseases, with reference to Chinese medicine meridian distribution of property and flavor and modern pharmacological research, for the pathogeny of fatty liver---wet, expectorant, the stasis of blood, heat, adopt dispersing the stagnated live-QI to relieve the stagnation of QI, dampness removing the turbid descending and select the formulated Dan Shan of the medicine fat granule that disappears.
Another object of the present invention provides the preparation method of this granule, and the method is made the Dan Shan fat granule that disappears by steps such as water boiling and extraction, concentrating under reduced pressure, drying under reduced pressure, granulations.
To achieve these goals, the technical measures of the present invention's employing are as follows:
A kind of Dan Shan fat granule that disappears is made by the mass ratio compatibility of 4:3:2 by Radix Salviae Miltiorrhizae, Semen Cassiae (parched) and Fructus Crataegi three flavor Chinese medicines.
Described Dan Shan disappears and also contains the pharmaceutic adjuvant dextrin in the fat granule, and Radix Salviae Miltiorrhizae, Semen Cassiae (parched) and Fructus Crataegi three flavor Chinese medicines are 1:1 by dried cream powder and the adjuvant dextrin mass ratio of water boiling and extraction, concentrating under reduced pressure, drying under reduced pressure gained.
The disappear preparation method of fat granule of Dan Shan of the present invention, its step is as follows successively:
(1) take by weighing 2 times of recipe quantity Dan Shan fat granule pharmaceutical decocting piece that disappears, add 10 times of quality water of medical material, decoct and extract 3 times, each 1h, the described Dan Shan fat granule pharmaceutical decocting piece that disappears is Radix Salviae Miltiorrhizae, Semen Cassiae (parched) and Fructus Crataegi, Radix Salviae Miltiorrhizae, Semen Cassiae (parched), Fructus Crataegi mass ratio 4:3:2;
(2) after step had been carried out, 300-500 order filter-cloth filtering got filtrate;
(3) filtrate is carried out concentrating under reduced pressure, and thickening temperature is 50-70 ℃, the drying under reduced pressure powder that gets dry extract;
(4) the gained dried cream powder is mixed by the 1:1 mass ratio with medicinal dextrin, granulate as binding agent with ethanol, 50-70 ℃ of drying, granulate, packing, i.e. the De Dan mountain fat granule that disappears.
In the preparation method of the present invention, testing used Semen Cassiae is Semen Cassiae (parched), smashs rear use to pieces, and Fructus Crataegi is Fructus Crataegi.
In the preparation method of the present invention, after pharmaceutical decocting piece adds water, soak the heart, decoct again.
Filter cloth is 400 orders in the preparation method step of the present invention (2).
In the preparation method step of the present invention (3), thickening temperature is 60 ℃, concentrating under reduced pressure.
In the preparation method step of the present invention (4), the ethanol volumetric concentration is 70%.
In the preparation method step of the present invention (4), the baking temperature of granule is 60 ℃.
In the preparation method of the present invention, take by weighing 2 times of recipe quantity Dan Shan fat granule pharmaceutical decocting piece (Radix Salviae Miltiorrhizae, Fructus Crataegi are pharmaceutical decocting piece, and Semen Cassiae (parched) is smashed rear use to pieces) that disappears, adopt orthogonal experiment to carry out water boiling and extraction, 300-500 order filter-cloth filtering gets filtrate; Take dried cream rate, tanshinone ⅡA, salvianolic acid B, Determination of chrysophanol as evaluation index, adopt analytic hierarchy process (AHP) to determine best decocting process; Carry out decocting by best decocting process and boil, 300-500 order filter-cloth filtering gets filtrate;
The Dan Shan that utilizes above-mentioned preparation method the to obtain fat granule yield that disappears reaches 96%, can carry out industrialized great production.
The Dan Shan that said method the prepares fat granule that disappears can be used for treating the medicine of the effect such as non-alcoholic fatty liver disease.
Compare with existing decoction, advantage of the present invention and effect are:
The present invention is prepared into granule with traditional decoction, and is easy to carry, and stable in properties is convenient to storage, meets the requirement of modernization of industry of Chinese materia medica.The method is simple, and used solvent is water, has followed traditional water boiling and extraction technique, has reduced production cost, has saved the energy.With the method gained Dan Shan fat granule that disappears non-alcoholic fatty liver disease had good therapeutical effect.
Description of drawings
Fig. 1 is the Dan Shan fat granule preparing process flow chart that disappears
Fig. 2 is the hygroscopicity curve (dried cream powder, dried cream powder+soluble starch, dried cream powder+dextrin, dried cream powder+microcrystalline Cellulose, dried cream powder+lactose) of different auxiliary material
The Dan Shan shown in Figure 1 fat granule preparing process flow process that disappears is, Dan Shan disappears after fat granule pharmaceutical decocting piece (Radix Salviae Miltiorrhizae, Fructus Crataegi are pharmaceutical decocting piece, and Semen Cassiae (parched) is smashed to pieces) adds 10 times of water of quality of medicinal material, soaks the heart, decocts again.Then filter-cloth filtering gets filtrate; 60 ℃ of concentrating under reduced pressure of filtrate, drying under reduced pressure powder that gets dry extract; The gained dried cream powder mixes by the 1:1 mass ratio with dextrin, granulates 50-70 ℃ of drying, granulate, packing, i.e. the De Dan mountain fat granule that disappears as binding agent with ethanol.
The specific embodiment
Further set forth the inventive method below in conjunction with specific embodiment.
The Radix Salviae Miltiorrhizae that uses in the inventive method is available from Henan, lot number: 2011100111; Semen Cassiae is available from Hubei, lot number: 120801; Fructus Crataegi is available from Shandong, lot number: 201210001.After testing, the above-mentioned three flavor prepared slices of Chinese crude drugs all meet " the regulation under each kind item of Chinese pharmacopoeia (2010 editions an one).
Embodiment 1
The disappear extraction process of fat granule of Dan Shan
1, the Dan Shan fat granule extraction process by water that disappears, step is as follows:
(1) takes by weighing in proportion 2 times of recipe quantity medical materials, add quantitative water by orthogonal test factor level table, soak the heart.The factor level table sees Table 1.
(2) after the immersion, decoct by the corresponding tested number of orthogonal test table, filter, get filtrate.
(3) measure respectively the content of tanshinone ⅡA in the filtrate, lithospermic acid B, chrysophanol, measure simultaneously dried cream yield.
(4) take dried cream rate, tanshinone ⅡA, salvianolic acid B, Determination of chrysophanol as evaluation index, adopt analytic hierarchy process (AHP) to determine best decocting process.EXPERIMENTAL DESIGN and the results are shown in Table 2.
The table 1 Dan Shan fat granule water extraction process orthogonal test factor level table that disappears
The table 2 Dan Shan fat granule water extraction process orthogonal experiment plan that disappears is taken into account the result
The weight coefficient that adopts analytic hierarchy process (AHP) to obtain dried cream rate, tanshinone ⅡA, salvianolic acid B, chrysophanol is respectively: W
1=41.34%, W
2=10.04%, W
3=22.21%, W
4=26.41%.Carry out comprehensive grading with this weight coefficient, comprehensive grading the results are shown in Table 3, and the results of analysis of variance sees Table 4.
Table 3 analytic hierarchy process (AHP) calculates the Dan Shan fat granule extraction process by water result that disappears
Annotate: J=J1/J1max * W
1* 100+J2/J2max * W
2* 100+J3/J3max * W
3* 100+J4/J4max * W
4* 100
Table 4 comprehensive grading the results of analysis of variance
Annotate: * F0.05(2,2)=19.00, * * F0.01(2,2)=99.00
Range analysis is the result show: each factor disappears the impact of fat granule water boiling and extraction comprehensive grading sequentially for D to Dan Shan〉A〉B.The results of analysis of variance shows: factor D has utmost point significance impact (impact sequentially is D3〉D2〉D1) to comprehensive grading, and factor A has significance impact (impact sequentially is A3〉A2〉A1) to comprehensive grading, and factor B affects without significance comprehensive grading.Consider energy savings, analysis-by-synthesis determines that the Dan Shan fat granule water boiling and extraction optimum condition that disappears is A3B1D3, and namely best decocting process decocts and extracts 3 times for adding 10 times of water of quality of medicinal material, each 1h.
2, demonstration test
Get the Dan Shan 2 times of recipe quantity pharmaceutical decocting pieces of fat granule that disappear, totally 3 parts, carry out demonstration test according to preferred extraction process, namely add 10 times of quality water of medical material, decoct and extract 3 times, each 1h.Result of the test sees Table 5.
The table 5 Dan Shan three crowdes of demonstration test results of fat granule extraction process by water that disappear
Demonstration test result shows: determined best extraction process by water is reliable and stable, can be used as the disappear extracting method of fat granule of Dan Shan.The disappear extraction process by water of fat granule of Gu Dan mountain is defined as: pharmaceutical decocting piece adds 10 times of quality water loggings and soaks the heart (30min), decocts 3 times, each 1h.
Embodiment 2
The disappear screening of fat granulated pharmaceutical adjuvant of Dan Shan
The screening step of pharmaceutic adjuvant is as follows:
(1) carry out decocting by best decocting process and boil, 400 order filter-cloth filterings get filtrate.
(2) filtrate is carried out concentrating under reduced pressure, and thickening temperature is 60 ℃, the drying under reduced pressure powder that gets dry extract.
(3) investigate respectively dried cream powder and the hydroscopicity of different pharmaceutic adjuvants by the 1:1 mixing, the results are shown in Table 6 and Fig. 2.
The hygroscopicity experimental result of table 6 different auxiliary material
Annotate: moisture absorption percentage rate (%)=(medicated powder weight after the moisture absorption-moisture absorption prodrug grain weight amount)/moisture absorption prodrug grain weight amount X100%
Conclusion: above adjuvant all can improve the disappear hygroscopicity of fat granule dried cream powder of Dan Shan, but its influence degree is different, considers to select dextrin to carry out next step screening as single adjuvant.
Embodiment 3
The disappear screening of fat granule supplementary product consumption of Dan Shan
The Dan Shan fat granule preparing process that disappears is as follows:
(1) carry out decocting by best decocting process and boil, 400 order filter-cloth filterings get filtrate;
(2) filtrate is carried out concentrating under reduced pressure, and thickening temperature is 60 ℃, the drying under reduced pressure powder that gets dry extract;
(3) the gained dried cream powder is mixed by different proportion with dextrin, granulate as binding agent with volumetric concentration 60% ethanol, 60 ℃ of dryings, granulate, the De Dan mountain fat granule that disappears the results are shown in Table 7.
Table 7 dextrin consumption is investigated the result
The result shows: consider from the difficulty or ease of granulating and character and the yield of granule, disappear fat granule dried cream powder and dextrin of Dan Shan is comparatively reasonable in 1:1 ratio mixing granulation.
Embodiment 4
The disappear screening of fat particle binders of Dan Shan
The Dan Shan fat granule preparing process that disappears is as follows:
(1) carry out decocting by best decocting process and boil, 400 order filter-cloth filterings get filtrate;
(2) filtrate is carried out concentrating under reduced pressure, and thickening temperature is 60 ℃, the drying under reduced pressure powder that gets dry extract;
(3) the gained dried cream powder is mixed by 1:1 with dextrin, granulate as binding agent with the ethanol of different volumes concentration, 60 ℃ of dryings, granulate, the De Dan mountain fat granule that disappears the results are shown in Table 8.
The investigation result of table 8 concentration of alcohol
Experimental result shows: consider from the difficulty or ease of granulating, character and the yield of granule, select 70% alcohol granulation more reasonable.
Embodiment 5
The Dan Shan three batches of checkings of fat granule preparing process that disappear
The Dan Shan fat granule preparing process that disappears is as follows:
(1) carry out decocting by best decocting process and boil, 400 order filter-cloth filterings get filtrate;
(2) filtrate is carried out concentrating under reduced pressure, and thickening temperature is 60 ℃, the drying under reduced pressure powder that gets dry extract;
(3) the gained dried cream powder is mixed by 1:1 with dextrin, granulate as binding agent with 70% ethanol, 60 ℃ of dryings, granulate, the De Dan mountain fat granule that disappears the results are shown in Table 9.
The table 9 Dan Shan three batches of the results of fat granule formation technology lab scale that disappear
The result shows, this moulding process good stability, and method is reliable, can be used as the disappear moulding process of fat granule preparation of Dan Shan.
Embodiment 6
The Dan Shan fat granule acute toxicity test that disappears
Experiment purpose
1.LD
50After mensuration observation tested material once gives animal, the toxic reaction that produces and death condition.
2.MTD mensuration does not measure LD when tested material toxicity is lower
50The time, can do once or maximum tolerance determination on the one, also can reflect the toxicity situation of tested material.
Experiment material
1. laboratory animal and breeding observing environmental condition
Cleaning level kunming mice, 20, body weight 19-21 gram, male and female half and half are provided by Wuhan University's Experimental Animal Center.
Experimental animal feeding is in plastics are raised box, and beverage is the pure Mus pellet of full price, is provided by Wuhan University's Experimental Animal Center, drinks water to be the cleaning tap water.
Laboratory temperature is 19-21 ℃, and relative humidity is 40-60%.
2. medicine and preparation
The Dan Shan fat granule extractum that disappears, every 1ml contain compound recipe raw medicinal herbs 1.5 grams, are provided by Hubei Province institute of traditional Chinese medicine hepatopathy institute.
3. experimental technique and result
LD
50Measure
Method: get 20 of white mice, male and female half and half, body weight 19-21 gram, fasting is 16 hours before the administration, can't help water, with the Dan Shan fat granule extractum 150g.kg that disappears
-1Gavage 1 time is observed reaction of animals situation, poisoning symptom and death condition at once, Continuous Observation 7 days.
The result: the mice ordinary circumstance is good after the administration, has no untoward reaction, Continuous Observation 7 days, animal activity freely, hair color is smooth, the drinking-water of ingesting, feces are all without unusual, LD is estimated in none death of mice
50Can't measure.
Embodiment 7
The disappear clinical research of fat granule of Dan Shan
Data and method
1 clinical data
1.1 physical data
Observe case from Hubei Province institute of traditional Chinese medicine in December, 2009-2011 year December the medical patient of LC, be non-alcoholic fatty liver disease, together totally 56 examples.Adopt the randomized in the statistics that the patient is divided into 2 groups: treatment group 30 examples, male's 18 examples wherein, women's 12 examples, 22～60 years old age on average was 45.16 ± 7.28 years old, the course of disease 2～10 years; Matched group 26 examples, male's 14 examples, women's 12 examples, 21～59 years old age on average was 43.34 ± 8.57 years old, the course of disease 1～9 year (seeing Table 10).Two groups of patients all have in various degree epigastric discomfort, abdominal part distension, be off one's feed or the symptom such as uncomfortable liver area, and its general data indifference opposite sex has comparability.
Table 10 liang group patient physical data relatively
Annotate: two groups of patient's physical data are the indifference opposite sex (P〉0.05) relatively.
1.2 diagnosis and criterion of therapeutical effect
1.2.1 diagnostic criteria
This diagnostic criteria is reference " non-alcoholic fatty liver disease diagnostic criteria (draft) "
[6]Drafting of standard: each person among 1-5 item described below or the 6th and the 7th is just diagnosable to be non-alcoholic fatty liver disease when clinical manifestation possesses.
(1) patient has obesity, and diabetes or hyperlipemia etc. are the trouble factor easily;
(2) viral hepatitis, Wilson disease, drug-induced liver disease, autoimmune liver disease and total parenteral nutrition etc. except;
(3) without history of drinking history or drink amount to the ethanol amount weekly＜40g;
(4) except the protopathy clinical manifestation, dull pain in liver, the symptom such as weak can appear, can accompany hepatosplenomegaly;
(5) serum transaminase can raise, and take ALT as main, can increase with ferritin, GGT and uric acid etc.;
(6) the imaging diagnosis foundation is arranged;
(7) liver histological has typical case's performance.
1.2.2 tcm diagnosis standard
With reference to " national Chinese medicine management board Eleventh Five-Year Plan Pivot Subjects liver addiction diagnosis and treatment scheme "
(1) stagnation of liver-QI with deficiency of the spleen, the stagnation of phlegm-damp card: distending pain over the hypochondrium, heaviness sensation over the head and body, weak, breast gastral cavity painful abdominal mass is vexed, inappetence, glutinous feeling in the mouth without thirst, the loose stool is not well, white and greasy fur, stringy and rolling pulse.
(2) stagnation of phlegm blood stasis, damp-stagnancy heat-transformation card: distending pain over the hypochondrium, indigestion and loss of appetite nauseating, dry mouth with bitter taste, anorexia is greasy, abdominal distention, yellowish fur, stringy and rolling pulse.
(3) damp-stagnancy blood stasis, deficiecny of liver-YIN card: uncomfortable liver area, side of body rib dull pain, dry mouth and throat, dysphoria with smothery sensation in the heart, two dryness and uneasy feeling of the eye have a dizzy spell, and purplish tongue has ecchymosis petechia, greasy fur on tongue, stringy,thready and rapid pulse.
1.2.3 exclusion standard
The patient that (1), history of drinking history is arranged;
(2), get rid of the specific hepatic disease that viral hepatitis, drug-induced liver disease, total parenteral nutrition, hepatolenticular degeneration etc. can cause fatty liver.
(3), other serious pathological changes person is arranged
1.2.4 criterion of therapeutical effect
With reference to " new Chinese medicine guideline of clinical investigations "
[7]
Recovery from illness: symptom, sign disappear, and laboratory and imaging examination are normal;
Produce effects: symptom, sign obviously alleviate, and liver function is normal, and rate and blood-lipid decreased reaches following each person: TCH decline＞20%, TG and descends＞30%, and imaging examination liver form and essence are obviously improved;
Effectively: symptom, sign alleviate, and liver function takes a turn for the better, and rate and blood-lipid decreased reaches following each person: TCH decline 〉=10%, TG and descends 〉=20%, and imaging examination liver form and essence are improved relatively;
Invalid: as not reach above standard person.
1.2.5B super Inspection graduation criterion:
Non-alcoholic fatty liver disease can be divided into these two kinds of diffuse fatty liver and focal fatty livers, and the former is comparatively common.This research is according to the traveling of blood vessel in the attenuation of echo in the liver parenchyma and the liver, and non-alcoholic fatty liver disease is divided into three degree:
(1) severe: liver form size is dwindled within normal range or slightly, the edge contour of liver shows unclear, the margo anterior hepatis rust, liver parenchyma is cloud and changes, luminous point is intensive in the liver increases slightly, liver parenchyma back court echo is obviously decayed, and liver parenchyma front court echo obviously strengthens, and liver inner tubular structure texture display is unclear.
(2) moderate: liver size, form increase within normal range or slightly, and it is still clear that the Glisson's capsule border shows, luminous point is intensive in the liver, the echo attenuation of liver parenchyma back court, and liver parenchyma front court Echoenhance, the traveling of liver inner tubular structure is fuzzy, attenuates, and shows unintelligible.
(3) slight: the liver morphosis is in normal range, and luminous point is thin and intensive in the liver, is evenly distributed, and the echo attenuation of liver parenchyma back court is not obvious, and liver parenchyma front court echo diffusivity strengthens, and the liver inner tubular structure is clear.
2 Therapeutic Method
Treatment group gives Dan Shan fat granule (the Radix Salviae Miltiorrhizae 20g that disappears, Semen Cassiae 15g, Fructus Crataegi 10g), divide sooner or later empty stomach decoction being taken warmly, the matched group patient uses liver-protecting tablet (Radix Bupleuri, Radix Isatidis, Semen phaseoli radiati, Pulvis Fellis Suis, Herba Artemisiae Scopariae, Fructus Schisandrae Chinensis, Heilongjiang Kuihua Yaoye Co.Ltd Co., Ltd produces) oral, every day 3 times, each 4.Two groups of patients equal 3 months were 1 course for the treatment of.
In addition, two groups of patients adjusting that will be careful in one's diet in the treatment non-alcoholic fatty liver disease take low fat, less salt, light diet as main, is eaten vegetable more, moderate exercise, and forbid drinking, greasy product avoid pungent food.The clinical manifestation of non-alcoholic fatty liver disease is various to differ, and some patients only have tired sense, and therefore most of patient is difficult to discover slight subjective symptoms because build is fat.
3 observation index
Observing time is for before treating and after finishing 1 course for the treatment of.
Observation index is clinical symptoms, liver function, blood fat and ultrasound diagnosis result.
4 statistical procedures
This problem adopts SPSSl3.0 statistics software to carry out data statistics Epidemiological Analysis and processing, uses X 2 test, and setting the α value is 0.05, and statistical significance is arranged when P＜0.05.To above-mentioned two groups before and after the treatment of totally 56 routine nonalcoholic fatty liver diseases clinical efficacy total effective rate, liver function index, blood lipids index and ultrasound diagnosis result compare and add up, thereby draw the statistics conclusion.
The result
1 liang of group patient clinical curative effect total effective rate compares (seeing Table 11)
Table 11 liang group NAFLD patient clinical curative effect total effective rate relatively
Annotate: compare total effective rate before and after two groups of patient treatments and be improved, P＜0.05 is compared in P＜0.01 between group.
Through the t check, treatment group and matched group total effective rate have significant difference.
Liver function index compares (seeing Table 12) before and after 2 liang of group patient treatments
Changes of liver function relatively before and after the table 12 liang group NAFLD patient treatment
Annotate: relatively front with the treatment of this group, P＜0.01; With comparison after the treatment of control group, P＞0.05.
Through the t check, treatment group and matched group liver function are from there being significant difference.
Blood lipids index compares (seeing Table 13) before and after 3 liang of group patient treatments
Blood Lipid relatively before and after the table 13 liang group NAFLD patient treatment
Annotate: compare P＜0.01 before and after the treatment group treatment; Compare P＜0.05 before and after the treatment of control group.
Through the t check, treatment group and matched group blood fat have significant difference.
The B ultrasonic size scale is than (seeing Table 14) before and after 4 liang of group patient treatments
The B ultrasonic size scale before and after the table 14 liang group NAFLD patient treatment
Annotate: compare P＜0.01 before and after the treatment group treatment; Compare P＞0.05 before and after the treatment of control group
Through the t check, treatment group and matched group B ultrasonic result have significant difference.
The Dan Shan fat granule modern pharmacological research that disappears
Blood fat reducing is the key for the treatment of non-alcoholic fatty liver disease.And blood fat is to change living precise and tiny material for water paddy, its absorb with fail cloth and in vivo metabolism all to depend on the liver synergism, wherein the department of the catharsis of the strong fortune of spleen, liver and kidney turns into the most important, therefore focus on liver,spleen,kidney when treating.Use respectively clinically the method for depressed liver-energy dispersing and QI regulating, invigorating spleen to remove dampness, blood circulation promoting and blood stasis dispelling, reinforcing the kidney and supporting YANG according to the state of an illness, make the liver,spleen,kidney function normal, make that lipid turns to essence and blood in the blood, defeated cloth whole body.Modern pharmacological research shows many Chinese herbal medicine to blood fat reducing, promotes that lipid metabolism has certain effect in the liver.Fructus Crataegi can reduce cholesterol and the triglyceride in the serum.Radix Salviae Miltiorrhizae can promote fat in liver oxidation and reduce fat content.In addition, Semen Cassiae, Rhizoma Chuanxiong, Rhizoma Polygonati, giant knotweed rhizome tablet, Fructus Lycii, Pollen Typhae, Rhizoma Wenyujin Concisum, Flos Carthami, Folium Ginkgo, Hirudo etc. all have effect for reducing blood fat, therefore can select according to different pattern of syndrome when treatment, and curative effect all can.In sum, the genesis of non-alcoholic fatty liver disease and liver controlling conveyance and dispersion, the function that The spleen has the function to transport and transform nutrients are closely related, and expectorant, wet, the stasis of blood are its Etiological pathogenesis, thereby blood circulation promoting and blood stasis dispelling, dampness removingization is turbid to be its main method for the treatment of, therefore receive comparatively satisfied curative effect with the Dan Shan fat granule plus-minus treatment that disappears.
To the treatment of non-alcoholic fatty liver disease, preferably mainly carry out from dispelling several aspects such as the cause of disease, adjustment diet, appropriate exercise, Drug therapy according to sick Chinese traditional treatment fatty liver.Dan Shan disappears, and the fat granule is entirely square to be comprised of Radix Salviae Miltiorrhizae, Fructus Crataegi, Semen Cassiae, has the spleen invigorating soothing liver-QI, and the effect of activating blood and eliminatng dampness is used for the Primary Care of non-alcoholic fatty liver disease and hyperlipemia.Full side share giving consideration to both the incidental and fundamental, altogether the merit of long memorial liver spleen, activating blood and eliminatng dampness.The confirmation of modern Chinese medicine pharmacological research, Radix Salviae Miltiorrhizae can make aorta atheromatous plaque formation area obviously reduce serum total cholesterol, triglyceride, all decreases to some degree.The blood fat that Radix Salviae Miltiorrhizae can suppress the high lipid diet rabbit rises.Find that by research danshensu can also suppress the synthetic of cell endogenous cholesterol.Fructus Crataegi does medicinal with fruit, slightly warm in nature, and sour in the mouth is sweet, enters spleen, stomach, Liver Channel, and the function of promoting digestion and invigorating the stomach, activating blood circulation to dissipate blood stasis, convergence dysentery relieving is arranged.To the long-pending phlegm retention of meat, feeling of fullness acid regurgitation, dysentery hemorrhoidal hamorrhage, lumbago hernia, puerperal after-pains, lochiorrhea, children's's breast food stagnate etc., all effective in cure.Appetite-stimulating indigestion-relieving, change stagnant removing food stagnancy, promoting blood circulation to remove blood stasis, the circulation of qi promoting of reducing phlegm.Be used for carnivorous stagnate long-pending, lump in the abdomen, abdominal distention feeling of fullness, stasis blocking stomachache, phlegm retention, have loose bowels, discharging fresh blood stool etc.Clinical research confirmation, Fructus Crataegi can significantly reduce serum cholesterol and triglyceride.The loose effect that reduction serum total cholesterol and triglyceride are arranged of Semen Cassiae; Also have and reduce triglyceride and the effect that suppresses platelet aggregation in the rats'liver. also there is report to point out, Semen Cassiae on the mice serum total cholesterol level of hypercholesterolemia without impact, but can increase Serum High-Density Lipoprotein-Cholesterol content, namely obviously improve the distribution situation of body inner cholesterol, finally be transported to liver for cholesterol and do to process at last very favourable.
The present invention by with two groups of patients totally 56 routine nonalcoholic fatty liver diseases be divided into treatment group and matched group is treated, can see in the non-alcoholic fatty liver disease curative effect significant difference is arranged, no matter be clinical symptoms, or liver function index, blood lipids index and ultrasound diagnosis result, two groups have significant difference.In sum, carry out analysis and understanding to fatty liver by the angle of the traditional Chinese medical science, by the Dan Shan clinical observation experiment explanation Dan Shan of the fat granule fat granule that disappears that disappears non-alcoholic fatty liver disease is had good therapeutical effect.
List of references
[1] Ye Weifa, Zhong Zhenyi. contemporary liver and gall diseases therapeutics [M]. Chengdu: Sichuan science tech publishing house, 2000,2:615-625.
[2] Liu Qihua. the discussion of fatty liver ultrasonic diagnosis [J]. Chinese medical collection, 2002,5:21-22.
[3] Hu Darong. the cause of disease of fatty liver [J]. practical hepatopathy magazine, 1997,29-3O.
[4] Chen Jianguo. the Recent Research of fatty liver [J]. the Chinese medicine Leader, 2005,11(5): 83.
[5] Li Peisheng. Treatise on Febrile Diseases teaching materials (higher medical institution teaching material). Shanghai: Shanghai science tech publishing house, 1985,5:14-16.
[6] Chinese Medical Association's hepatology branch fatty liver and alcoholic liver disease group. non-alcoholic fatty liver disease diagnostic criteria [J]. Chinese Journal of Hepatology, 2003,11 (2): 71.
[7] Zheng Xiao cornel. new Chinese medicine guideline of clinical investigations (trying) [M]. Beijing: Chinese Medicine science and technology publishing house, 2002:233-237.
Claims (9)
1. Dan Shan fat granule that disappears is characterized in that: this Dan Shan fat granule that disappears is made by the mass ratio compatibility of 4:3:2 by Radix Salviae Miltiorrhizae, Semen Cassiae (parched) and Fructus Crataegi three flavor Chinese medicines.
2. a kind of Dan Shan according to claim 1 fat granule that disappears, it is characterized in that: this Dan Shan disappears and also contains the pharmaceutic adjuvant dextrin in the fat granule, and Radix Salviae Miltiorrhizae, Semen Cassiae (parched) and Fructus Crataegi three flavor Chinese medicines are 1:1 by dried cream powder and the pharmaceutic adjuvant dextrin mass ratio of water boiling and extraction, concentrating under reduced pressure, drying under reduced pressure gained.
3. the Dan Shan preparation method of fat granule that disappears is characterized in that step is as follows successively:
(1) takes by weighing 2 times of recipe quantity Dan Shan fat granule pharmaceutical decocting piece that disappears, add 10 times of water of quality of medicinal material, decoct and extract each 1 hour 3 times, the described Dan Shan fat granule pharmaceutical decocting piece that disappears is Radix Salviae Miltiorrhizae, Semen Cassiae (parched) and Fructus Crataegi, Radix Salviae Miltiorrhizae, Semen Cassiae (parched), Fructus Crataegi mass ratio 4:3:2;
(2) after step (1) has been carried out, with 300-500 order filter-cloth filtering, get filtrate;
(3) filtrate is carried out concentrating under reduced pressure, and thickening temperature is 50-70 ℃, the drying under reduced pressure powder that gets dry extract;
(4) the gained dried cream powder is mixed by the 1:1 mass ratio with medicinal dextrin, granulate as binding agent with ethanol, 50-70 ℃ of drying, granulate, packing, i.e. the De Dan mountain fat granule that disappears.
4. the Dan Shan according to claim 3 preparation method of fat granule that disappears, it is characterized in that: used Semen Cassiae is Semen Cassiae (parched), smashs rear use to pieces, Fructus Crataegi is Fructus Crataegi.
5. the Dan Shan according to claim 3 preparation method of fat granule that disappears is characterized in that: after pharmaceutical decocting piece adds water, soak the heart, decoct.
6. the Dan Shan according to claim 3 preparation method of fat granule that disappears, it is characterized in that: the filter cloth of using in the step (2) is 400 orders.
7. the Dan Shan according to claim 3 preparation method of fat granule that disappears, it is characterized in that: in the step (3), thickening temperature is 60 ℃, concentrating under reduced pressure.
8. the Dan Shan according to claim 3 preparation method of fat granule that disappears, it is characterized in that: the ethanol volumetric concentration is 70% in the step (4).
9. the Dan Shan according to claim 3 preparation method of fat granule that disappears, it is characterized in that: the baking temperature of granule is 60 ℃ in the step (4).
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