CN103006835B - Pharmaceutical composition with effects of reducing blood fat and relaxing bowels and preparation method thereof - Google Patents
Pharmaceutical composition with effects of reducing blood fat and relaxing bowels and preparation method thereof Download PDFInfo
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention belongs to the field of medicines and in particular relates to a pharmaceutical composition with effects of reducing blood fat and relaxing the bowels and a preparation method thereof. The invention aims at provides a brandnew pharmaceutical composition used for reducing blood fat and relaxing the bowels. The pharmaceutical composition is prepared from the following raw materials by weight: 1-3 parts of semen cassiae, 2-6 parts of prepared polygonum multiflorum, 2-6 parts of hawthorn and 1-5 parts of white fungus. When the pharmaceutical composition provided by the invention is used for reducing blood fat and relaxing the bowels with definite effect, and stable and controllable curative effect.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to pharmaceutical composition with blood fat reducing and relieving constipation effect and preparation method thereof.
Background technology
Hyperlipemia is a kind of common disease, is caused by Human Lipid Metabolism imbalance.Clinical Laboratory is that serum cholesterol (TC) or triglyceride (TG), low density lipoprotein, LDL (beta lipoprotein) are too high; High density lipoprotein (alpha-lipoprotein) be tending towards decline or lower than normal value.Hyperlipemia easily brings out the cardiovascular disease such as coronary heart disease, apoplexy, hypertension, also may cause cholelithiasis, pancreatitis, cause the disease such as male sexual disorder, senile dementia.Common hypolipidemic is based on Chinese medicine (as Radix et Rhizoma Rhei (processed), Fructus Aurantii) or extract (as total flavonoid, total saponins class), bread and cheese concentrate and emerging polypeptide protein class.Product forms mostly is capsule and teas.In existing health-care food for assisting blood fat lowering, material used mostly is Folium Ginkgo (functional component: total flavones), Herb Gynostemmae Pentaphylli (functional component: gypenoside), Oleum Bulbus Allii, Radix Oenotherae erythrosepalae oil, lecithin, soybean phospholipid, Oleum Hippophae, propolis, lovastatin etc. some of them imported product many employings gamma-Linolenic acid, dietary fiber, linoleic acid, chitosan, bathypelagic fish oil, Fructus Tritici aestivi wet goods.
Constipation is a kind of common sympton, refer to times of defecation reduce and (or) feces drying be difficult to resolve, general more than two days without defecation, point out there is constipation.According to statistics, China's constipation patient number is more than 30%, and women is more than 4 times of male, and along with the increase at age, its sickness rate is also in rising trend.The medicine of common treatment constipation can be divided three classes: 1. drug class: with lactulose, glycerin for representative, be generally used for the constipation patient of moderate or severe, Clinical practice is more, and share is up to 94.6%.But dosage form is single, only there are solution, tablet etc.; 2. with the product that " toxin expelling ", " skin care " are demand: as PAIDU YANGYAN JIAONANG (Yunnan interwined dragon sea of clouds Pharmaceutical), Aole Paidu capsule (Guangzhou one product hall), compound Aloe capsule (Linxi, Hebei pharmaceutical factory), YIN nourishing intestine-moisturizing oral liquid (Beijing Daheng is raw pharmacy doubly), green source of students Chang Runcha (Beijing Australia Te Shule health product development corporation, Ltd.) etc.3. dietary fiber class: as many in U.S. etc.
The present invention is for providing a kind of pharmaceutical composition with blood fat reducing and relieving constipation effect completely newly.
Summary of the invention
Technical problem solved by the invention is to provide a kind of brand-new pharmaceutical composition for blood fat reducing and relieving constipation.
Pharmaceutical composition of the present invention be with Semen Cassiae, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Tremella for crude drug, reach the object of blood fat reducing and relieving constipation.
Particularly, the crude drug weight proportion of pharmaceutical composition of the present invention is as follows:
Semen Cassiae 1-3 part, Radix Polygoni Multiflori Preparata 2-6, Fructus Crataegi 2-6 part, Tremella 1-5 part.
Sum up through prolonged application, pharmaceutical composition crude drug preferred weight proportioning of the present invention is as follows: Semen Cassiae 1.8 parts, Radix Polygoni Multiflori Preparata 4 parts, Fructus Crataegi 4 parts, 2.7 parts, Tremella.
The pharmaceutical composition curative effect be made up of above-mentioned consumption proportion relation is more stable, controlled.
For the ease of application, on the basis of crude drug, pharmaceutically acceptable adjuvant can be added and makes conventional oral formulations.As common dosage forms such as powder, capsule, tablet, granule, oral liquids.For the application characteristic of medicine of the present invention, additionally provide the preparation method of this pharmaceutical composition.As:
Method one: each crude drug is ground into fine powder, mixing powder;
Method two: each crude drug is ground into fine powder, encapsulated capsule;
Method three: each crude drug is ground into fine powder, tabletting tablet;
Method four: after each crude drug water boiling and extraction, concentrated extracting solution makes granule, granule;
Method five: after each crude drug water boiling and extraction, concentrated extracting solution makes granule, encapsulated capsule;
Method six: after each crude drug water boiling and extraction, concentrated extracting solution makes granule, tabletting tablet;
Method seven: after each crude drug water boiling and extraction, make oral liquid.
Application said method all can realize the object of medicine blood fat reducing of the present invention and relieving constipation, but because of the convenience of application and the easy of preparation, inventor is made into capsule more and uses.
To sum up, applying pharmaceutical composition provided by the invention has clear and definite effect for blood fat reducing and relieving constipation, stable curative effect, controlled.
Detailed description of the invention
The detailed description of the invention of form by the following examples, is described in further detail foregoing of the present invention again, illustrates but does not limit the present invention.
The present invention is that weight proportion is as follows with Semen Cassiae, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Tremella for crude drug for having the pharmaceutical composition of blood fat reducing and relieving constipation effect:
Semen Cassiae 1-3 part, Radix Polygoni Multiflori Preparata 2-6, Fructus Crataegi 2-6 part, Tremella 1-5 part.
Inventor finds through clinical practice and pharmacological effect test, adjusts the consumption of crude drug, all can realize the object of blood fat reducing and relieving constipation within the scope of above-mentioned weight proportion.
Through protracted experience optimal value be: Semen Cassiae 1.8 parts, Radix Polygoni Multiflori Preparata 4 parts, Fructus Crataegi 4 parts, 2.7 parts, Tremella.
For the ease of application, on the basis of crude drug, pharmaceutically acceptable adjuvant can be added and makes conventional oral formulations.As common dosage forms such as powder, capsule, tablet, granule, oral liquids.
Medicine of the present invention each serving consumption by crude drug about 0.8g, every day three times.
Pharmaceutical composition of the present invention is primary raw material with Tremella, main containing polysaccharide, gum components in Tremella, because Tremella needs soak for a long time and boil stewing, not easily extracts processing, constrains and apply widely.The optimization of preparation process, formulation are key technologies of the present invention.
Be below the preparation method screening process of pharmaceutical composition of the present invention:
Medicine of the present invention adopts general extraction process by water at the crude drug of compositions, and trial test shows that yield is higher, day dose large, be not easy to take; Adopt conjunction to carry aqueous extraction-alcohol precipitation technology, polysaccharide can be removed; After another tremella polysaccharide decocts, solution denseness is higher, is unfavorable for filtering, concentrated, dry, and not only containing tremella polysaccharide in Tremella, protein, aminoacid etc., therefore consider Tremella individual processing.
One, the independent Research on processing technology of Tremella
(1) technical study pulverized by Tremella
Main containing polysaccharide, gum components in Tremella.After finding in test that Tremella decocts, colloid is very thick, is not easy drying.Consider to pulverize separately, the receipts powder rate that Tremella is pulverized separately is investigated in table 1.
Powder rate of receiving (crossing 60 mesh sieves) pulverized separately by table 1 Tremella
Result: it is lower that powder rate received by Tremella, is unfavorable for that patient takes.
(2) Tremella digesting technoloy research:
Adopt digesting technoloy through preliminary experiment, make colloid degeneration, be beneficial to pulverizing, the receipts powder rate of Tremella can be increased.Therefore inventor has carried out single factor exploration to Tremella digesting technoloy influence factor, filters out both best digestion times by investigating polyoses content.The different digestion time polyoses content of Tremella is in table 2
The different digestion time polyoses content of table 2 Tremella
Conclusion: along with the yield of the prolongation tremella polysaccharide of digestion time raises, after 2 hours, change is little.Therefore determine that the best digestion time of Tremella is 2 hours.
(3) investigation of Tremella baking temperature, time
Gum components water content in Tremella is large, is not easy drying, the high easily variable color of temperature, gelatinizing; Temperature is oversize for low drying time, is unfavorable for commercial production.The different baking temperature drying effect of Tremella is investigated for index with appearance luster, drying time, the results are shown in Table 3
Drying time of Tremella and outward appearance under the different baking temperature of table 3
Conclusion: as seen from the above table, along with temperature raises below 60 DEG C, Tremella moisture content reduces, but the time is longer; 100 DEG C are short with drying time, but easily variable color.From reducing drying time, energy savings angle is considered, Binding experiment result is optimum drying temperature with 70 DEG C.
The assay method of Tremella moisture: according to " Chinese Pharmacopoeia 2005 version annex XD first method measures, and take moisture content as index, investigates, the results are shown in Table 4 to the carrying out of 70 DEG C of Tremella drying times.
The investigation of 70 DEG C, table 4 dry Tremella time
Conclusion: along with the increase of drying time, in Tremella, water content reduces, but extends drying time, can increase expending of the energy, in conjunction with the moisture content requirement under " Chinese Pharmacopoeia " version in 2000 annex capsule item, the drying condition of Tremella is defined as 70 DEG C of dryings 11.0 hours by us.
(4) the different digestion time of Tremella is pulverized and is received the investigation of powder rate
The different digestion time of table 5 Tremella pulverizes powder rate of receiving (crossing 80 mesh sieves)
﹡ note: Tremella fructification base portion is hard, not easily shatters.Before steaming and decocting, remove sporophore base portion and residual impurities, be conducive to improving flour extraction.
Conclusion: the yield that the prolongation Tremella along with digestion time is pulverized raises.Therefore determine that the best digestion time of Tremella is that 2 hours effects are better.
(5) hygroscopicity of Tremella powder is investigated (test method according to critical relative humidity)
The hygroscopicity of table 6 Tremella is investigated
The critical relative value of Tremella steaming and decocting comminuted powder is comparatively large, and moisture absorption meets the requirements.
Brief summary: draw according to above experimental result, the independent steaming and decocting of Tremella is pulverized and can ensure Tremella uniformity in the formulation in receipts powder rate, hygroscopicity, therefore the independent steaming and decocting of Tremella is pulverized.
Tremella steams, drying, disintegrating process, yield: get the Tremella except sporophore base portion and residual impurities, steam 2 hours, in 70 DEG C of dryings 11.0 hours, pulverize and get final product.Average yield through three batches of its Tremella powder of lab scale is the average yield of 96.6%, three batches of its Tremella powder of pilot scale is 92.1%.
Two, Semen Cassiae, Radix Polygoni Multiflori, Fructus Crataegi Research on processing technology
Above-mentioned three taste raw materials adopt traditional water decoction technique, and through Pharmacodynamics screening, safety, effect are better.Consider that enterprise produces actual, inventor adopts general extraction process by water, with Determination of chrysophanol in functional component for index, adopts orthogonal experiment to investigate extraction process by water influence factor (amount of water, decoction number of times, decocting time).
(1) investigation of medical material water absorption rate
Vegetable drug all has the ability of absorption solvent in various degree, and the large young pathbreaker absorbing solvent amount affects the effect of extraction.Therefore, the investigation of water absorption rate has been carried out to medical material.
Get total medical material 60g by prescription, each four parts, weight is W
0, add 10 times of water gagings respectively, observe every half an hour and once soak into mood condition, until medical material all soaks into, leach whole unabsorbed water liquid, medicinal residues are weighed, and are W
1, by formulae discovery water absorption rate.The results are shown in Table 7.
Table 7 medical material water absorption rate investigates result
Conclusion: the water absorption rate of this product medical material is about 170%, therefore add 1.7 times of water gagings when first time extracts.
(2) orthogonal test Study on extraction
Through By consulting literatures data and trial test, determine to select: the influence factor that amount of water, decoction number of times, decocting time three are maximum, respectively get three levels, by L9(3
4) carry out orthogonal test, take Determination of chrysophanol as index (owing to not buying emodin reference substance during craft screening, so be only index composition with chrysophanol), screening optimum extraction condition, concrete outcome in table 8, table 9, table 10.
Table 8 Semen Cassiaes etc. extract orthogonal experiment factor level table
Test method: depend on bright grade three taste medical material in prescription ratio, get 100g medical material by orthogonal by prescription, decoct with water filtration by designing requirement, filtrate reduced in volume, to 100ml, gets 20ml for subsequent use.
Evaluation index: under this condition, in test sample, the separating degree of chrysophanol is high, theoretical cam curve >5000, and peak shape is good, and specificity is good.Therefore select chrysophanol as inspection target.
(3) chrysophanol assay method (according to " under Chinese Pharmacopoeia 2005 version Semen Cassiae subitem, annex VI D)
Chromatographic column condition: KromasiL C
18(4.6 × 250mm, 7 μm); Determined wavelength: 254nm; Mobile phase: methanol-0.1% phosphoric acid (85:15); Flow velocity: 1.0ml/min; Column temperature: room temperature; Sensitivity: 0.05AUFS
The preparation of reference substance solution: precision takes chrysophanol standard substance 5.0mg, adds dissolve with methanol and is settled to 50.0ml, shake up, accurate this solution of absorption 0.25ml respectively, 2.5ml, 5ml, 7.5ml, 15ml puts in 10ml volumetric flask, standardize solution, and obtaining concentration is 0.15,0.075, the reference substance solution of 0.05,0.025,0.0025mg/ml.
The drafting of standard curve: be that 254nm place measures at wavelength by HPLC method, take peak area as vertical coordinate, concentration is abscissa, carries out rectilinear regression, calculating regression equation is Y=20862606.27X-10035.35612r=0.9999, and chrysophanol is good in 0.025 ~ 1.5 μ g internal linear relation.
The preparation of need testing solution: extracting sample solution 20ml, put in 50ml round-bottomed flask, add 2.5mol/L sulfuric acid solution 10ml, supersound process 5 minutes, add chloroform 10ml again, reflux 1 hour, let cool, in dislocation separatory funnel, with a small amount of chloroform container, be incorporated in separatory funnel, divide and get chloroform layer, acid solution chloroform extraction 2 times, each about 8ml, combined chloroform liquid, with anhydrous sodium sulfate dehydration, in chloroform solution dislocation 100ml conical flask, fling to chloroform, residue precision adds methanol 10ml, weighed weight, ultrasonic dissolution, after letting cool, weighed weight again, the weight of less loss is supplied with methanol, shake up, filter, get subsequent filtrate and get final product.
Algoscopy gets need testing solution, and sample size 10 μ L, measures by method under chromatographic condition item, the results are shown in Table 9.The results of analysis of variance is in table 10.
Conclusion: obtained by variance analysis, what have the greatest impact is decoct number of times, and be secondly decocting time, affecting minimum is amount of water.Obtaining optimum extraction process is: A
3b
3c
2.
Comprehensive analysis: little with decoction 1.5 hours acquired results diversityes because decocting 1.0 hours, therefore select 1.0 hours as the time decocted, amount of water affects without significance extraction ratio, therefore chooses low-level, i.e. 6 times of water gagings.Consider that extraction time is to actual production efficiency, has a significant impact, therefore determine that optimum extraction process is, add 6 times of water gagings, extract 3 times, each 1 hour.
Table 9 orthogonal and result
The analysis of variance table of table 10 Extract Technology of Active Ingredients From Cassia
Note: * P<0.05F(2,2)
0.05=19
(3) demonstration test
According to Orthogonal experiment results, verify three times, the results are shown in Table 11.
Table 11 demonstration test result
Conclusion: demonstration test result shows with orthogonal experiments basically identical, illustrates that extracting factor is stablized, has repeatability.
Three, impurity removal process research
1, extraction process by water receives cream rate
Get 100g medical material by prescription, decoct with water filtration on request, filtrate reduced in volume, to 100ml, is got 25ml and is put the dry evaporating dish (W weighed
1) in, water-bath volatilizes solvent, to be placed in drying baker dry 3 hours, take out, be placed on exsiccator cooling, weigh (W
2), calculate and receive cream rate.
Receive cream rate=(W
2-W
1)/25 × 100%
Table 12 is received cream rate and is investigated result table
2, alcohol precipitation process conditional filtering
Consider that former technique is extracted, receive cream rate too high, 40g*20%+6.6=14.6g; Be unfavorable for molding, therefore consider to adopt alcohol precipitation process, to receive cream rate and chrysophanol for index, investigate alcohol precipitation process, impurity-eliminating effect is in table 13.
Table 13 impurity removal process investigates result table
Conclusion: extracting solution is through cold preservation, and after precipitate with ethanol, it receives cream rate obvious decline, and loss of effective components is less, therefore combined effect is best, selects 60% ethanol remove impurity.
Four, concentrated and drying process is studied
1, concentrated
Because in this product, effective ingredient is soluble in water, therefore extracted by water extraction, obtain decocting liquid.Boiling point again because of water is higher, can shorten required time by concentrating under reduced pressure; Another chrysophanol composition is by thermally labile, and concentrating under reduced pressure can prevent effective ingredient for a long time by heat damage, and prevents gelatinizing, therefore adopts concentrating under reduced pressure at laboratory.In actual production, in conjunction with plant experiment border working condition, therefore adopt current pharmaceutical factory to produce the most frequently used triple effect concentrator to concentrate, screen concentration technology condition and investigate, the results are shown in Table 14.
The investigation of table 14 concentration technology
Conclusion: as seen from the above table, optimum condition is: temperature 70 C, and vacuum is 0.08 ~ 0.1MPa.
2, dry
The 1. atmosphere pressure desiccation 2. boulton process 3. drying means such as spraying dry is often adopted in Chinese Traditional Medicine.Wherein atmosphere pressure desiccation, required drying time is long, uneven drying, and needs after drying to pulverize again, and production process is numerous and diverse, and product quality is more restive; It is fast that spray drying method has rate of drying, and material heated time is short, and does not need in dry run to add adjuvant, and production process is simple, and product quality controllability is strong, is applicable to the advantages such as the large production of industry.But temperature is higher, chrysophanol easily destroys.Adopt vacuum drying to reduce drying time, the principal element affecting drying under reduced pressure has: clear paste relative density, temperature and vacuum.Must investigate these factors.
2.1 clear paste relative densities
By clear paste relative density (60 DEG C of surveys) respectively furnishing 1.12,1.20,1.28,1.32 carry out drying under reduced pressure (temperature: 60 ~ 70 DEG C, vacuum: 0.08 ~ 0.1) observed 24 hours material situations, be the results are shown in Table 15.
Table 15 clear paste relative density is screened
As can be seen from the above table, clear paste relative density is 1.28 ~ 1.32(60 DEG C of survey) time, drying under reduced pressure can obtain the good powdered extract of quality for 24 hours.Because of a little, the relative density of clear paste is defined as 1.28 ~ 1.32(60 DEG C of survey) carry out spraying dry.In addition, the problem of added adjuvant when investigating dry.It is feasible that result does not add adjuvant when showing drying under reduced pressure.
2.2 temperature, vacuum
Clear paste is carried out drying under reduced pressure respectively under different inlet temperature, vacuum, observes dry materials situation, the results are shown in Table 16.
Table 16 temperature, vacuum are screened
Conclusion: as seen from the above table, optimum condition is: temperature 70 C, and vacuum is 0.10 ~ 0.12MPa.
Consider, the process conditions of this product drying are: when clear paste being concentrated into relative density 1.28 ~ 1.32 (60 DEG C of surveys), at temperature 70 C, and vacuum is that under the condition of 0.10 ~ 0.12MPa, reduced vacuum is dry.
Comprehensive above-mentioned technical study, the oral formulations preparation technology of pharmaceutical composition of the present invention is as follows:
A, Tremella normal pressure water proof steam 1-3 hour, and dry, pulverize, powder is for subsequent use;
B, depend on pine torch, Radix Polygoni Multiflori Preparata, Fructus Crataegi decocts with water, decocting liquid filters, and is concentrated into relative density 1.10 ~ 1.15(60 DEG C), add ethanol and make alcohol content reach 50-70%, leave standstill, filter, filtrate is for subsequent use; Be concentrated into the clear paste of relative density 1.28 ~ 1.32 (60 DEG C), dry, pulverize, powder is for subsequent use;
C, blend step A and B gained powder, add pharmaceutically acceptable adjuvant and make conventional oral formulations.
The dosage form of pharmaceutical composition embody rule of the present invention is capsule, and its preferred preparation technology is as follows:
A, Tremella normal pressure water proof steam 2 hours, constant pressure and dry at 70 DEG C, pulverize, and cross 100 mesh sieves, for subsequent use;
B, depend on pine torch, Radix Polygoni Multiflori Preparata, Fructus Crataegi decocts with water three times, first time adds 8 times amount soak by water 1 hour, second time adds 6 times amount soak by water 1 hour, and third time adds 6 times amount soak by water 1 hour, collecting decoction, filter, filtrate reduced in volume is to relative density 1.10 ~ 1.15(60 DEG C), add ethanol and make alcohol content reach 60%, leave standstill 12 hours, filter, filtrate is for subsequent use; Be concentrated into the clear paste of relative density 1.28 ~ 1.32 (60 DEG C), it is for subsequent use that reduced vacuum dry, pulverize 100 mesh sieves;
C, merge above-mentioned powder, mix homogeneously, dry granulation, granulate, encapsulated, to obtain final product.
Capsule prescription of the present invention is:
Make capsule 1000 altogether, every 0.42g, three times on the one, each 2.
Following product stability test and efficacy test are all according to above-mentioned prescription and the preparation of capsule formulation optimum process.In following test, capsule of the present invention is called " Radix Polygoni Multiflori Tremella capsule ".
One, pharmaceutical composition of the present invention carries out hygiology stability test, functional component or significant component testing through Institute of Analysis of West China HSPH of Sichuan University, all meets relevant regulations; Toxicological evaluation, assert that pharmaceutical composition of the present invention is nontoxic, without aberration inducing effect.Functional component measurement result is in table 17.
Table 17 capsule functional component of the present invention measures
| ? | Emodin (mg/kg) | Chrysophanol (mg/kg) |
| Batch 1 | 180 | 10.1 |
| Batches 2 | 170 | 18.5 |
| Batches 3 | 142 | 11.9 |
| Meansigma methods | 164 | 13.5 |
Above-mentioned three batches of capsules in 37 DEG C, relative humidity 75% environment deposits trimestral emodin and Determination of chrysophanol rate of change between-17% ~ 19.0% and-35.1% ~ 38.6%.
Two, blood fat reducing function
1, per os Radix Polygoni Multiflori Tremella capsule (content) gavage 30 days continuously that gives male SD rat 210mg/Kg.bw, 630mg/Kg.bw, 1260mg/Kg.bw dosage (being equivalent to respectively recommend Coming-of-Age Day to take 5 times, 15 times, 30 times of recommended doses), result shows that rats in test groups body weight increases compared with high fat matched group, there was no significant difference.Test basic, normal, high dosage group TC level and compare with high fat matched group that there were significant differences, serum TG levels middle and high dosage group TC level compares with high fat matched group that there were significant differences.Experimental result shows, this product has auxiliary lipid-lowering function.
2, show through 110 examples (effective case 102 example) hypolipemic function human feeding trial result, during off-test, the physical examination result of experimenter and every safety indexes no abnormality seen, show that this product has no adverse effects to human body.Test-meal group took this product after 45 days, cholesterol and triglyceride all significantly reduce (p<0.01), cholesterol on average declines 11.00 ± 5.32%, triglyceride on average declines 16.76 ± 21.24%, High-density Lipoprotein-cholesterol is without significant change, and its total effective rate is 50.00%.Result of the test shows, Radix Polygoni Multiflori Tremella capsule has hypolipemic function to human body.
Three, relieving constipation effect
1, per os gives the Radix Polygoni Multiflori Tremella capsule (content) 7 days of Kunming mouse 210mg/Kg.bw, 420mg/Kg.bw, 840mg/Kg.bw dosage (being equivalent to respectively recommend Coming-of-Age Day to take 5 times, 10 times, 20 times of recommended doses), through the test of intestinal motility, defecation time, fecal grains, stool weight.Three dosage group small intestine contents propelling rates are all apparently higher than compound diphenoxylate model group (p<0.01), defecation time is obviously faster than compound diphenoxylate model group, and 420mg/Kg.bw, 840mg/Kg.bw dosage group defecation weight is apparently higher than model group (p<0.05).Experimental result shows, this product has bowel relaxing functions.
2, show through 120 examples (effective case 120 example) bowel relaxing functions human feeding trial result, during off-test, the physical examination result of experimenter and every safety indexes no abnormality seen, show that this product has no adverse effects to human body.Test-meal group took this product after 14 days, and test-meal group weekly defecation frequency obviously increases, and compares and more all have significant difference with matched group with before test-meal; Test-meal group integral of defecation condition and feces character integration are with before test-meal and more all have significance to reduce with matched group; Experimenter take tested material first 6 days and with 14 days test-meal periods every day cellulose family food mean intake without significant difference, with matched group more also there was no significant difference.Result of the test shows, Radix Polygoni Multiflori Tremella capsule has bowel relaxing functions to human body.
To sum up, pharmaceutical composition of the present invention finally determines that Semen Cassiae, Radix Polygoni Multiflori Preparata, Fructus Crataegi, Tremella are crude drug after screening prescription, and blood fat reducing and aperient effects the best, for the public provides a kind of selection completely newly.
Claims (9)
1. there is the pharmaceutical composition of blood fat reducing and relieving constipation effect, it is characterized in that: the weight proportion of crude drug is as follows:
Semen Cassiae 1-3 part, Radix Polygoni Multiflori Preparata 2-6, Fructus Crataegi 2-6 part, Tremella 1-5 part;
Weighting raw materials by weight ratio, preparation process is as follows:
A, Tremella normal pressure water proof steam 1-3 hour, and dry, pulverize, powder is for subsequent use;
B, depend on pine torch, Radix Polygoni Multiflori Preparata, Fructus Crataegi decocts with water, decocting liquid filters, and being concentrated into relative density 60 DEG C time is 1.10 ~ 1.15, adds ethanol and makes alcohol content reach 50-70%, leaves standstill, and filter, filtrate is for subsequent use; Being concentrated into relative density 60 DEG C time is the clear paste of 1.28 ~ 1.32, and dry, pulverize, powder is for subsequent use;
C, blend step A and B gained powder, add pharmaceutically acceptable adjuvant and make conventional oral formulations.
2. the pharmaceutical composition with blood fat reducing and relieving constipation effect according to claim 1, is characterized in that: the weight proportion of crude drug is as follows:
Semen Cassiae 1.8 parts, Radix Polygoni Multiflori Preparata 4 parts, Fructus Crataegi 4 parts, 2.7 parts, Tremella.
3. the pharmaceutical composition with blood fat reducing and relieving constipation effect according to claim 1 and 2, is characterized in that: described oral formulations is capsule.
4. the preparation method with the pharmaceutical composition of blood fat reducing and relieving constipation effect according to claim 1, it is characterized in that: weighting raw materials by weight ratio, preparation process is as follows:
A, Tremella normal pressure water proof steam 1-3 hour, and dry, pulverize, powder is for subsequent use;
B, depend on pine torch, Radix Polygoni Multiflori Preparata, Fructus Crataegi decocts with water, decocting liquid filters, and being concentrated into relative density 60 DEG C time is 1.10 ~ 1.15, adds ethanol and makes alcohol content reach 50-70%, leaves standstill, and filter, filtrate is for subsequent use; Being concentrated into relative density 60 DEG C time is the clear paste of 1.28 ~ 1.32, and dry, pulverize, powder is for subsequent use;
C, blend step A and B gained powder, add pharmaceutically acceptable adjuvant and make conventional oral formulations.
5. the preparation method with the pharmaceutical composition of blood fat reducing and relieving constipation effect according to claim 4, is characterized in that: baking temperature described in steps A is 60-80 DEG C.
6. the preparation method with the pharmaceutical composition of blood fat reducing and relieving constipation effect according to claim 5, is characterized in that: baking temperature described in steps A is 70 DEG C.
7. the preparation method with the pharmaceutical composition of blood fat reducing and relieving constipation effect according to claim 5, is characterized in that: water proof described in steps A steams 2 hours.
8. the preparation method with the pharmaceutical composition of blood fat reducing and relieving constipation effect according to claim 5, is characterized in that: the condition decocted with water described in step B is: decoct with water 1-3 time, and amount of water 6-8 doubly.
9. the preparation method with the pharmaceutical composition of blood fat reducing and relieving constipation effect according to claim 5, is characterized in that: add ethanol in step B and make alcohol content reach 60%.
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| CN1251298A (en) * | 1998-10-21 | 2000-04-26 | 赵舜英 | Naoxinkang tea good for brain and heart and preparation method thereof |
| CN1788757A (en) * | 2005-10-18 | 2006-06-21 | 安微济人药业有限公司 | Hyperlipemia-treating Chinese traditional medicinal tablet and its preparation process |
| CN101698032A (en) * | 2008-12-09 | 2010-04-28 | 浙江天一堂集团有限公司 | Method for preparing tablets for treating hyperlipemia and prepared product |
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| CN1251298A (en) * | 1998-10-21 | 2000-04-26 | 赵舜英 | Naoxinkang tea good for brain and heart and preparation method thereof |
| CN1788757A (en) * | 2005-10-18 | 2006-06-21 | 安微济人药业有限公司 | Hyperlipemia-treating Chinese traditional medicinal tablet and its preparation process |
| CN101698032A (en) * | 2008-12-09 | 2010-04-28 | 浙江天一堂集团有限公司 | Method for preparing tablets for treating hyperlipemia and prepared product |
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