CN1105557A - Method for preparation of weight-loosing medicine and its products - Google Patents

Method for preparation of weight-loosing medicine and its products Download PDF

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CN1105557A
CN1105557A CN 94116739 CN94116739A CN1105557A CN 1105557 A CN1105557 A CN 1105557A CN 94116739 CN94116739 CN 94116739 CN 94116739 A CN94116739 A CN 94116739A CN 1105557 A CN1105557 A CN 1105557A
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medicine
lipidase
hawthorn
radix
weight
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吴宏伟
苏柏青
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Abstract

The present invention relates to a method for preparation of weghit-reducing medicine and its product. Said invention uses such processes of salting out, dialysis and centrifugal separation at 2-10 deg.C to extract crataegolic lipase and crataegolic acid from fresh haw juice, and uses baipingzi (a Chinese medicinal herb), turmeria, fresh fleece-flower root, cassia seed, alisma orientale, wolfberry bark, giant knotweed rhizome, red sage root, fresh rehmannia root, oriental wormwood, fresh rhubarb, magnolia bark, immature bitter orange, scrophularia root, atractylodes rhizome, stevia rebaudiana, wolfberry fruit, Chinese angelica root, batryticated silkworm, chrysanthemum flower and fresh liquorice as raw materials to extract their effective medicines, and uses crataegolic lipase as medicine core, and other medicines as coating layer, and respectively uses beeswax, shellac and enteric cupsule as enteric coating to make them into pill, tablet and capsule.

Description

Method for preparation of weight-loosing medicine and its products
The present invention relates to a kind of manufacture method and product that cures mainly the appetrol of simple obesity.
Along with improving constantly of people's living standard, obese people is on the increase, and it is attractive in appearance that obesity not only influences human body, and can also cause diseases such as diabetes, fatty liver, coronary heart disease, cerebral arteriosclerosis, hyperlipidemia, and human body health is brought threat.Therefore fat-reducing is the people's common concern and the problem of being eager to solve, and the thing followed then is miscellaneous weight reduction product, method and medicine etc.Also a lot of about the slimming medicine kind, can be divided into medicine for external use and oral medicine substantially, external type liniments such as medicine for external use such as home-made clean scholar's slimming cream, long-standing pearl fat-reducing essence have certain curative effect to local athero place, but scope of application limitation, can not reach deep fat tissue in the body, omentum majus, mesentery and lipogenesis position are not had effect.Existing oral medicine is mostly based on appetite suppressant,, be representative with the fenfluramine, for example by 5-hydroxy tryptamine appetite-suppressing maincenter from American-European amphetamine in vogue of the sixties, reduce the body taking the photograph of food asked and realize losing weight, simultaneously all right blood sugar lowering, the fat-reducing application of principle is stifled, its side effect is anorexia, drowsiness, weak, xerostomia, addiction is arranged, and body weight easily recurs original position after the drug withdrawal, and curative effect is not consolidated, and drug dependence is strong.Chinese patent discloses " a kind of preparation method of body building and weight reducing medicine " this medicine for No. 90109713 and has produced satiety with vegetable protein and the fibrous matter that human body is difficult for reception and digestion, thereby reach few food, appetite-suppressing, with the dynamic property medicine of enema and suppositories row cathartic thing as reduction fat, this medicine is the stifled medicine that combines that rushes down, in stifled, utilization is rushed down and is reached the purpose of subduing body and system's fat, though certain fat-reducing effect is arranged, but body fat three big synthesis systems and hormonal system are not had regulating action, do not have the principle therapeutic purposes.
The object of the present invention is to provide a kind of manufacture method and product of appetrol, making the prescription of this medicine and production technology make every effort to the reason that adipose cell forms from human body starts with, each system and metabolic pathway to lipogenesis are adjusted, make overweight people's lipid metabolism reach new balance, from outward appearance to inner essence, from one to the other treated, remarkable with guarantee effect, curative effect is lasting.
The objective of the invention is to realize as follows successively:
1, the extraction of hawthorn lipidase and Crataegolic acid complex
A. the fresh Fructus Crataegi that will remove impurity and clean is pulverized, enucleation, defibrination are filtered, fresh Fructus Crataegi juice;
B. Fructus Crataegi juice is cooled to 2-10 ℃, adding ammonium sulfate to its concentration is 30%, and transferring pH value is that 6-7 stirs evenly, and saltouts;
C. filter after waiting to saltout fully, add 10 times (weight) water dissolution in the precipitate, dialyse then through ion-exchange treatment, through repeatedly change water precipitation fully after centrifugalize get hawthorn lipidase;
D. in the mother solution after filtering through saltouing, add this mother solution and weigh 60% ammonium sulfate, saltout as stated above and dialyse, and carry out centrifugalize and get hawthorn lipidase;
The e.d operation is saltoutd, and in the mother solution after the filtration, adds the ammonium sulfate of this mother solution weight 80%, repeat again to saltout, and dialysis, centrifugal separation processes gets hawthorn lipidase;
F. carry out lyophilization after the hawthorn lipidase merging with last 3 acquisitions and get dry powder;
G. the mother solution that the e operation is obtained carries out desalination, and repeatedly water is changed in dialysis, and keeps level balance, gets the Crataegolic acid complex, and the Crataegolic acid complex is concentrated into sticky shape or will further dries pulverize;
2, the extraction of other drug
A. take by weighing SEMEN CARTHAMI 9-20 part by weight, Rhizoma Curcumae Longae 3-15 part, Radix Polygoni Multiflori 6-15 part, Semen Cassiae 9-20 part, Rhizoma Alismatis 6-15 part, Cortex Lycii 9-20 part, Rhizoma Polygoni Cuspidati 9-20 part, Radix Salviae Miltiorrhizae 9-20 part, Radix Rehmanniae 9-20 part, Herba Artemisiae Scopariae 9-20 part, Radix Et Rhizoma Rhei 3-30 part, Cortex Magnoliae Officinalis 3-15 part, Fructus Aurantii Immaturus 3-15 part, Radix Scrophulariae 9-20 part, Rhizoma Atractylodis 3-15 part, Folium Stevlae Rebaudianae 9-20 part, Fructus Lycii 6-20 part, Radix Angelicae Sinensis 5-15 part, Bombyx Batryticatus 5-15 part, Flos Chrysanthemi 9-20 part, Radix Glycyrrhizae 2-15 part was with 50 ℃ of hot-water soaks 24 hours, be fried boiling with high heat then 1 hour, back slow fire boiling 2 hours, decoct secondary altogether, remove gruffs, merge the secondary medicinal liquid;
B. medicinal liquid is concentrated into that proportion is 1.14-1.21 in the time of 50 ℃, add ethanol content after being cooled to 20 ℃ and reach 65-75%(content) stir, left standstill 24 hours, extraction supernatant decompression recycling ethanol is ground into powder after the drying with thick paste to there not being the alcohol flavor under 80 ℃ of temperature;
3, in the hawthorn lipidase grain weight: the ratio of other drug extract grain weight=1: 2, with the hawthorn lipidase is that medicated core and other drug extract are covering, add 0.1 times of Crataegolic acid complex of its weight medicine juice, 1 times of Crataegolic acid complex powder, 0.1 times of implant in the medicated core, successively respectively with Cera Flava, Lac, enteric coated capsule as general ball core, label, the capsule core made of enteric coating, weigh the covering that 0.1 times of Crataegolic acid complex medicine juice, 1 times of Crataegolic acid powder, 0.1 times of implant pack medicated core by the covering medicine respectively in the covering medicine then and make pill or sheet medicine or capsule.
The present invention is the prescription of a large-scale synthesis treatment simple obesity, its mechanism of action is to catch the main cause of becoming fat, by adjusting human endocrine system and lipogenesis system, fully guarantee the activity of lipolytic enzyme, impel the organism metabolism amount to increase, decompose the superabundant fats that each fat depot is piled up, human body energy metabolism and substance metabolism are urged in the negative balance state, thereby reach the elimination excess energy, decompose superabundant fats and reach the fat-reducing purpose, mainly adjust and definite prescription with three approach.
1, adjusted from main three big route of synthesis of fatty tissue.
Body fat has three source: A, from the fat in the food; B, derive from the synthetic endogenous triglyceride of liver; C, adipose cell itself and with saccharide or aminoacid synthetic glycerine three esters.Hawthorn lipidase and the Crataegolic acid complex of one of main effective ingredient for from Fructus Crataegi natural juice, purifying in the medicine of the present invention, hawthorn lipidase plays catalytic decomposition and consumption to the fat that above three kinds of approach form, and the function specificity is strong, the Crataegolic acid complex can improve the activity of proteolytic enzyme, to internal body protein decomposition and inversion is each seed amino acid, rise to activate facilitation, and Fructus Crataegi and Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae Longae, SEMEN CARTHAMI are with strengthening substance metabolism, blood circulation, steatolysis conversion and energy volatilization process.The two all has blood fat reducing, cholesterol reducing effect Radix Salviae Miltiorrhizae, Rhizoma Curcumae Longae, but Radix Salviae Miltiorrhizae blood sugar lowering also contains unsaturated fatty acid, linoleic acid, phosphide, vitamin, sterols composition in the SEMEN CARTHAMI, obesity is had prevention and therapeutical effect.
2, from the internal organs of fat pathogenesis location and body substance metabolism and body fluid metabolic regulated.
Motherland's medical science is thought to obesity, the many deficiency and excesss of obesity are held concurrently mutually, the deficiency in origin and excess in superficiality basic fixed position is that liver,spleen,kidney three is dirty, it mostly is the deficiency of vital energy, its mark mostly is phlegm-damp and blood stasis, the spleen kidney with digest and assimilate, endocrine dysfunction and vegetative nerve regulating and water-electrolyte metabolism etc. are relevant, are the important steps of general metabolism.But Rhizoma Alismatis diuretic in this medicine composition and clearing away damp-heat, the deficiency of nourishing YIN, hypoglycemic, effectively fat to water-sodium retention, Radix Polygoni Multiflori can reduce fat at intrahepatic deposition, suppresses fat and takes place, alleviate route of synthesis in the fatty liver, Semen Cassiae energy liver heat removing stomach reinforcing, clearing away heat to improve acuity of vision, same with Herba Artemisiae Scopariae with strengthening sharp liver effect, Radix Rehmanniae clearing away heat and cooling blood, YIN nourishing and the production of body fluid promoting, contained catalpol has hypoglycemic activity, the Rhizoma Polygoni Cuspidati analgesic therapy of invigorating blood circulation, clearing away heat-damp and promoting diuresis, preventing phlegm from forming and stopping coughing, fertile people's excessive phlegm, how wet fertile people is, Radix Et Rhizoma Rhei can removing the relative excess warm and relieving constipation is secret, and expectorant is real, spleen is suffered from a deficiency of the kidney lose, phlegm-damp resistance network is effective, the Cortex Lycii blood fat reducing, blood sugar lowering, and clearind deficient heat, the Fructus Lycii nourishing essence-blood, the contained Folium Stevlae Rebaudianae B of Folium Stevlae Rebaudianae, C, D, E etc. are beneficial to fat-reducing, make medicament not sour not puckery, the Rhizoma Atractylodis regulating QI to relieve pain, scorching cold expelling, the hypoglycemic function of gallbladder promoting, Fructus Aurantii Immaturus, Cortex Magnoliae Officinalis is reduced phlegm, eliminating stagnation, but Radix Scrophulariae blood sugar lowering.
3, regulated from lipid is unjust
The Rhizoma Zingiberis Recens pupa can participate in lipid metabolism, contained Rhizoma Zingiberis rhzomorph, protein, vitamin A 1, B 2, the multiple material deficiency that can replenish the overweight people such as D, thereby it is unjust to correct lipid, Flos Chrysanthemi and other 20 Herba indigoferae Pseudotinctoriae share, play altogether that turbid wet dissipation is eliminated the phlegm, changes in heat clearing away, the effect of the invigorate blood circulation logical stasis of blood, lowering blood-fat and reducing weight and strengthening vital QI to eliminate pathogenic factors, Radix Glycyrrhizae is in order to coordinating the actions of various ingredients in a prescription, relax drug toxicity, heat-clearing and toxic substances removing, the spleen reinforcing of reducing phlegm.
More than filling a prescription, there have the master to have to be auxilliary, and having disappears benefit, and existing merger synergism has auxilliary mutually main attack function again.Wherein, with hawthorn lipidase, Crataegolic acid complex, SEMEN CARTHAMI, Radix Salviae Miltiorrhizae, Rhizoma Curcumae Longae etc. serves as to suppress fat to deposit in vivo, alleviate lipogenesis speed, quicken the fat acid decomposition atomization, be the metabolism that increases body, make the evaporable main attack medicine of power conversion, be aided with consumer product dredge stasis, damp eliminating is reduced phlegm, key spleen and tonifying kidney, soothing liver-QI for relieving depression, the metabolic medicine of adjustment, Radix Et Rhizoma Rhei, Radix Polygoni Multiflori, Fructus Aurantii Immaturus, Mangnolia officinalis, Herba Artemisiae Scopariae, Radix Scrophulariae, Cortex Lycii etc. are arranged, obesity is regulated; Assistant is corrected the unjust medicine of lipid content to regulate nerve and hormonal system, and Rhizoma Zingiberis Recens pupa, Fructus Lycii, Folium Stevlae Rebaudianae, Flos Chrysanthemi etc. are arranged, and obesity is adjusted.
Hawthorn lipidase of one of main component of the present invention and Crataegolic acid complex, hawthorn lipidase is easily destroyed in hot environment, therefore carry out being lower than under 10 ℃ the temperature when from Fructus Crataegi natural juice, purifying, generally more suitable 2-10 ℃ of temperature, extract mainly method of hawthorn lipidase and Crataegolic acid complex in the Fructus Crataegi by saltouing and dialysing, these active ingredients are separated, in order to keep the hawthorn lipidase activity, must be under freezing conditions dry, can reach about 80% with enzyme content in the hawthorn lipidase powder of the method extraction, ash is below 20%, mainly contain Crataegolic acid in the Crataegolic acid complex, also contain some malic acids, oleanolic acid, ascorbic acid, Quercetin, vitamin B 2, B 6Deng.
Medicine of the present invention is in order to give full play to the activity of hawthorn lipidase, and prolongs drug effect medicine is made stomach, the intestinal two parts two facies pattern medicines that absorb of disintegrate respectively.Hawthorn lipidase is easily destroyed in high temperature or gastric sour environment, easily lose activity, and its pharmaceutical properties is the strongest in alkaline environment, drug effect can be fully played, and enzyme is the most active, and effectiveness is single-minded, pharmaceutical science ground is divided into enteric part and gastric solubleness part, enteric partly is a medicated core, with hawthorn lipidase respectively with Cera Flava, Lac, enteric coated capsule as general ball core, label and the capsule core made of enteric coating, be that covering is wrapped medicated core then with the other drug extract.This medicine has guaranteed hawthorn lipidase safety after making as stated above as much as possible by stomach, arrives disintegrate after the intestinal, whole small intestinals are absorbed the drug and accurately brings into play the drug effect of hawthorn lipidase.
It is as follows to carry out the animal experiment situation with medicine of the present invention:
1, materials and methods: experiment provides by Harbin Medical University pharmacological evaluation chamber with 30 of purebred New Zealand white rabbit of female 3 monthly ages, and body weight all is selected in 1.80-2.00kg, is divided into 3 groups at random, 10 every group.
2, dosage and medication: by the clinical common dose of adult (the per kilogram of body weight dosage conversion factor table (1) by animal and human body converts), medication is for gavaging.
A, treatment group: take medicine 0.35mg/ kilogram of the present invention, every day 3 times, eat and took in preceding 15 minutes.
B, comparable group: clothes amfepramone sheet 0.20mg/ kilogram, every day 2 times, eat and took in preceding 30 minutes.
C, observation group: clothes Pulvis Radix Et Rhizoma Rhei 0.24mg/ kilogram, every day 2 times, eat and took in back 20 minutes.
3, medication and observing time: above 3 groups are 30 days.
4, Experimental Evaluation method:
1. 30 days body weight decline 10-16g are produce effects, and decline 6-12g is that effectively decline 3-5g is invalid.
2. all the other observe medicines to the mental status of rabbit, reaction, activity, hair, just time, the sensitivity of appetite etc.
Observed result sees Table 1.
Table 1
Other performance of group quantity produce effects enabledisable total effective rate
10 361 90% movable feeds of treatment group are normal, and just inferior slightly many, hair color is bright and clean
10 172 80% of comparable group are movable few, and lack of appetite is cracked between the teeth and slept, and hair color is dark
10 nothings 64 60% of observation group are just inferior many, half congealed rare, and movable few, hair color is dark
Above zoopery shows that three kinds of medicines are all effective to the treatment of obesity, but the produce effects of medicine of the present invention and total effective rate are the highest, and does not have abnormal phenomena after taking medicine of the present invention, and the effect of this medicine obviously is better than the amfepramone sheet.
Medicine clinical trial situation of the present invention is as follows:
Treat adiposis patient 5500 examples altogether from year May in March, 1988 to 1994 with medicine of the present invention.
In order further to investigate drug effect stochastic sampling 80 examples of this medicine, be divided into two groups and compare test.
1, case is selected
Treatment group (A group) is totally 40 examples, wherein male 20 examples, woman's 20 examples, the range of age 25-52 year, 37.3 years old mean age, matched group (B group) is totally 40 examples, wherein male 29 examples, women 11 examples, the range of age 16-47 year, 26.6 years old mean age, there was no significant difference<P〉0.05 between two groups of mean aves>, fat 20 examples of treatment group mild or moderate, average overweight 10-20%, fat 10 examples of moderate, average overweight 30-40%, fat 10 examples of severe are average overweight more than 50 jin, matched group is slight, moderate, severe fat each 15,10,15 examples, two groups of overweight situation no significant differences<P〉0.05>.
In the treatment group, companion's Patients with Fatty Liver 2 examples, hyperlipemia 5 examples, arteriosclerosis 10 examples, diabetes 2 examples, matched group is respectively 2,4,9,2 examples in proper order by treatment group disease, between two groups with the disease no significant difference,<P〉0.05 〉.
Above patient all belongs to simple obesity.
2, dosage and method: A group use capsule of the present invention, every 35mg, each 1, taking medicine before meal usefulness, the B group is used the amfepramone sheet, every 20mg, each 1, every day secondary, taking medicine before meal usefulness.
3, observation index and efficacy evaluation method:
1. one the course of treatment weight loss 2-3kg be produce effects, decline 1.5-2kg is effectively, decline 0-1kg is invalid.
2. obviously not dwindle the person be produce effects in the subcutaneous fat of body surface storehouse, and slightly not dwindling the person is effectively, and no change slightly deliquescing is invalid.
More than the upper and lower abdominal part fat of 80 routine patients storehouse all have more obviously and to increase, so can be for referencial use when efficacy evaluation.
Observed result sees Table 2.
Table 2
The effective routine number of the invalid routine number of group (%) (%) produce effects example number (%) total effective rate example number (%)
A 2(5.0) 17(42.5) 21(52.5) 38(95.0)
B 6(3.8) 19(47.5) 15(39.0) 34(86.0)
P <0.01 >0.05 <0.01 <0.01
A group produce effects number is organized more than B as seen from Table 2, and invalid number A group is less than the B group, and obvious difference, and total effective rate A group is apparently higher than the B group, and there was no significant difference between two groups of effective percentage sees that from total therapeutic effect drug effect of the present invention is better than the drug effect of amfepramone.
3. side reaction situation after taking medicine: A group side reaction 2 examples, be laxativeness, need not dispose, symptom disappears with defecation.B group side reaction 8 examples, wherein nauseating, drowsiness, each 2 example of anorexia, dizzy 1 example, 1 example of suffering from diarrhoea.
4. B ultrasonic and change inspection: A group hyperlipemia, fatty liver take a turn for the better, and clinical liver pain disappears, the reduction of check blood fat index, and diabetes take a turn for the better.The B group is except that 1 routine fatty liver takes a turn for the better, and all the other 12 examples do not have big the variation.
Follow up a case by regular visits to situation such as following table 3 after above-mentioned 80 routine patients were recovered 2 years.
Follow up a case by regular visits to body weight steady change table table 3 after 2 years
The unsteady constipation menstruation of the unsteady body weight of the steady body weight of body weight is greasy ill
Group is decided the above people of number 2Kg number 5Kg and is told noses the imbalance sweet food in hospital
A 32 people 31 people 7 people 5 people 2 people 19 people 1 people
B 18 people 15 people 14 people 12 people 4 people 22 people 2 people
P P<0.01 P<0.01 P<0.01 P<0.01 P>0.05 P<0.01 P>0.05
Can find out that from last table the weight in patients stability number of taking medicine of the present invention is more than clothes amfepramone group.
Last 80 routine patients regularly show as follow-up investigation after clinical trial, individual patient is taken amfepramone and is produced addiction and toleration, need take for a long time every year, phenomenons such as that one drug withdrawal just produces headache, feels sick, appetite heightens, sleeps is bad, constipation, be because medicine source dependency causes, take medicine of the present invention and do not find this phenomenon.
The present invention has the following advantages:
1, on pharmacological action and the formulation concept, start with from the reason that the human body fatty tissue forms, synthetic by hindering, strengthen decomposing, approach such as promotion metabolism reach the fat-reducing purpose, and multiple element of additional body and nutrient substance, with the long-pending unjust phenomenon of the lipid stasis of blood of adjusting the overweight people, therefore, can make mark, can also make this, drug effect is outstanding, lasting, the efficacy of a drug is simple and honest, obvious effective rate reaches 52.5%, and total effective rate reaches more than 95%.
2, medicine method for making science is fully used physiological characteristics and is dissected the location, medicine is made stomach, intestinal two facies patterns, so disintegrate release position is accurate, brings into play the drug effect of hawthorn lipidase effectively.
3, strengthen the blood circulation process, impel each functional organ activity amount increase in the body, and it is slow to change the gastrointestinal motility ripple, and endocrine, autonomic nervous system and liver,spleen,kidney are all had corresponding regulating action.
4, this medicine is not only lost weight, and can also treat owing to fat caused other disease, and as fatty liver, coronary heart disease, hyperlipemia etc., toxic and side effects is little.
Further specify technical solution of the present invention below in conjunction with embodiment.
One, the extraction of hawthorn lipidase and Crataegolic acid
A. get fresh Fructus Crataegi mature fruit 100kg, remove impurity, clean, pulverize, enucleation, defibrination, filtration get fresh Fructus Crataegi juice.
B. Fructus Crataegi juice is cooled to 2-10 ℃, adds 176 gram (NH 4) 2SO 4(industrial), and transfer pH value to stir well to 6-7, saltout.
C. after waiting to saltout fully, filter, precipitate used water dissolution through ion-exchange treatment, dialyse with artificial filter membrane then, change water repeatedly the hawthorn lipidase precipitation take out the back fully, carry out centrifugalize with the LXT-64-01 centrifuge, get hawthorn lipidase.
D. add 214 gram (NH in the mother solution through saltouing after filtering 4) 2SO 4, stir evenly, saltout as stated above and dialyse, and centrifugalize gets hawthorn lipidase.
The e.d operation is saltoutd, and in the mother solution after the filtration, adds 171 gram (NH 4) 2SO 4, repeat again to saltout, dialysis, centrifugalize gets hawthorn lipidase.
F. put into the LGJ-11 freezer dryer dry 24 hours after the hawthorn lipidase merging with last 3 acquisitions, get little yellow and slightly be cotton-shaped dried hawthorn lipidase powder 450 grams, add hydroxy methocel electrophoresis qualification result purity 80%, ash 19%, moisture content 1% with agar.
G. the mother solution with the acquisition of e operation carries out desalination, and repeatedly water is changed in dialysis, and keeps level balance, gets the Crataegolic acid complex, and the Crataegolic acid complex is concentrated into sticky shape or it is further dried the back pulverize.
Two, the extraction of other drug
Example 1
A. take by weighing SEMEN CARTHAMI, Semen Cassiae, Cortex Lycii, Rhizoma Polygoni Cuspidati, Radix Salviae Miltiorrhizae, Radix Rehmanniae, Herba Artemisiae Scopariae, Radix Scrophulariae, Folium Stevlae Rebaudianae, each 9000 gram of Flos Chrysanthemi, Rhizoma Curcumae Longae, Cortex Magnoliae Officinalis, Fructus Aurantii Immaturus, each 3000 gram of Rhizoma Atractylodis, Radix Polygoni Multiflori, each 6000 gram of Rhizoma Alismatis, Fructus Lycii 6000 grams, Radix Angelicae Sinensis, each 5000 gram of Bombyx Batryticatus, Radix Glycyrrhizae 2000 grams, Radix Et Rhizoma Rhei 3000 grams, with 50 ℃ of hot-water soaks 24 hours, fried in shallow oil with high heat then 1 hour, 2 hours at a simmer of back decocts 2 times altogether, remove medicinal residues, merge 2 times medicinal liquid.
B. medicinal liquid is concentrated into that proportion is 1.14 in the time of 50 ℃, cool to room temperature adds ethanol and stirs, and static 24 hours, extract the supernatant decompression recycling ethanol to there not being the alcohol flavor, be ground into after dry down Powdered at 80 ℃ thick paste.
Example 2
A. take by weighing SEMEN CARTHAMI, Semen Cassiae, Cortex Lycii, Rhizoma Polygoni Cuspidati, Radix Salviae Miltiorrhizae, Radix Rehmanniae, Artemisia anethoicles Mattf, Radix Scrophulariae, Folium Stevlae Rebaudianae, Flos Chrysanthemi, each 20000 gram of Fructus Lycii, Rhizoma Curcumae Longae, Radix Polygoni Multiflori, Rhizoma Alismatis, Cortex Magnoliae Officinalis, Fructus Aurantii Immaturus, Rhizoma Atractylodis, Radix Angelicae Sinensis, Bombyx Batryticatus, Radix Glycyrrhizae 15000 grams, Radix Et Rhizoma Rhei 30000 grams, medicinal liquid is concentrated into proportion is 1.2 50 ℃ the time, other are with example 1.
Example 3
A. take by weighing SEMEN CARTHAMI, Semen Cassiae, Cortex Lycii, Rhizoma Polygoni Cuspidati, Radix Salviae Miltiorrhizae, Radix Rehmanniae, Artemisia anethoicles Mattf, Radix Scrophulariae, Folium Stevlae Rebaudianae, each 15000 gram of Flos Chrysanthemi, Rhizoma Curcumae Longae, Rhizoma Alismatis, Fructus Aurantii Immaturus, Rhizoma Atractylodis, Radix Angelicae Sinensis, Bombyx Batryticatus, Radix Glycyrrhizae 9000 grams, Radix Et Rhizoma Rhei 20000 grams, Cortex Magnoliae Officinalis 10000 grams, Radix Polygoni Multiflori, each 12000 gram of Fructus Lycii, other are with example 1.
Three, the manufacturing of patent medicine
1, the manufacturing of pill
A. take by weighing hawthorn lipidase 250 gram, take off acetyl carapace ester 200 grams and starch 10 grams and mix and mix thoroughly, other gets pure Cera Flava (commercially available) 35 gram heat fused, with 1000 of the general medicated core of making Semen phaseoli radiati grain size of 25ml Crataegolic acid complex medicine juice (is 1.2 at 50 ℃ of following proportions) and medicated powder and charges mixing.
B. claim other drug powder 500 grams, take off acetyl carapace ester 300 grams and starch 20 gram mixings, it is same a) and old honey 5 gram mixings to take by weighing Crataegolic acid medicine juice 50ml(proportion again, the medicated core that will make is put into the medicine plaque then, powder limit spray medicine juice and old sweet wetting agent spread pesticides on the limit, make it bonding shaping, get final product up to the soybean grain size, every ball weighs 0.5 gram, take by weighing the 25ml yellow wine and be sprayed on the pill surface, keep soft with anti-chap.
This medicinal method: oral each 6, morning and evening on the one secondary, warm water delivery service.
2, the manufacturing of sheet medicine
A. take by weighing hawthorn lipidase 1000 gram, Crataegolic acid complex powder 1000 grams take off acetyl carapace ester 300 grams and magnesium stearate 20 grams and put in the mixer and mix.
B. claim 240 gram Lac (medical) to be made into 30% alcoholic solution and a is mixed and made into soft material, granulate, under 30 ℃ of temperature, dry that dry granular 12 mesh sieve granulate add and are pressed into 10000 tablets of sheet medicines with multidaylight press after Pulvis Talci 100 restrains mixings by 14 order wire gauzes.
C. claim other drug powder 2000 grams, Crataegolic acid complex powder 1000 grams, take off acetyl carapace ester 300 grams and magnesium stearate 20 gram mixings; the starch slurry that claims starch 25 grams to be mixed with 5% concentration mixes with medicated powder and charges; in oscillating granulator, granulate by 14 order wire gauzes; under 40-42 ℃ of temperature, dry; dry granular is with 12 mesh sieve granulate; claim behind 100 gram Pulvis Talci and magnesium stearate, the 20 gram mixings sheet medicine skin in the bag and b then, be pressed into 10000 tablets of sheet medicines with multidaylight press.
3, capsular manufacturing
A. take by weighing hawthorn lipidase 2500 gram, take off acetyl carapace ester 2000 grams, Crataegolic acid complex powder 250 grams and the pure Semen Glycines powder 250 gram mixings of processing, cross in 10000 enteric coated capsulees of packing into behind 100 mesh sieves (gelatine capsule of crossing with the formaldehyde steam treatment).
B. take by weighing other drug powder 5000 gram, take off acetyl carapace ester 4000 grams, Crataegolic acid powder 500 grams and pure Semen phaseoli radiati powder 300 gram mixings cross behind 100 mesh sieve together with enteric coated capsule 10000 No. 0 large capsules of packing into and get final product.
The gastric solubleness of medicine of the present invention, enteric test are carried out by the following method:
1, the preparation of simulated gastric fluid: claim dilute hydrochloric acid 24ml adding distil water to 1000ml, making it pH value is 1.2-1.4.
2, the preparation of simulated intestinal fluid: take by weighing (M/5) potassium dihydrogen phosphate 250ml, sodium hydroxide (M/5) 196.7ml, adding distil water are to 1000ml, and making pH value is 7.2-7.6.
3, get 2 in ball or tablet and put in the 50ml conical flask, add the 20ml simulated gastric fluid, under 37 ± 2 ℃ of temperature, jolting was one minute in per 9 minutes, after 2 hours, only dissolved the gastric solubleness part, and the enteric part must not disintegrate.
4, ball in the taking-up 3 or the medicinal distilled water wash of sheet are 2 times, replace gastric juice with simulated intestinal fluid, and put into baffle plate, and the method by 3 is carried out, and medicine passes through screen cloth the whole disintegrates of planted agent in 1 hour.
Medicine of the present invention is tested all as stated above and is met the demands.

Claims (2)

1, a kind of manufacture method of appetrol is characterized in that successively by following operation manufacturing:
1. the extraction of hawthorn lipidase and Crataegolic acid complex
A. the fresh Fructus Crataegi that will remove impurity and clean is pulverized, enucleation, defibrination are filtered, fresh Fructus Crataegi juice;
B. Fructus Crataegi juice is cooled to 2-10 ℃, adding ammonium sulfate to its concentration is 30%, and transferring pH value is that 6-7 stirs well, and saltouts;
C. filter after waiting to saltout fully, add 10 times (weight) water dissolution through ion-exchange treatment in the precipitate, dialyse then, centrifugalize gets hawthorn lipidase after repeatedly changing water dialysis fully;
D. in the mother solution after filtering through saltouing, add this mother solution and weigh 60% ammonium sulfate, saltout as stated above and dialyse, and carry out centrifugalize and get hawthorn lipidase;
The e.d operation is saltoutd, and in the mother solution after the filtration, adds the ammonium sulfate of this mother solution weight 80%, repeat again to saltout, and dialysis, centrifugal separation processes gets the Crataegolic acid lipase;
F. carry out lyophilization after the hawthorn lipidase merging with last 3 acquisitions and get dry powder not;
G. the mother solution that the e operation is obtained carries out desalination, and repeatedly water is changed in dialysis, and keeps level balance, gets the Crataegolic acid complex, and the Crataegolic acid complex is concentrated into sticky shape or will further dries pulverize;
2. the extraction of other drug
A. take by weighing SEMEN CARTHAMI 9-20 part by weight, Rhizoma Curcumae Longae 3-15 part, Radix Polygoni Multiflori 6-15 part, Semen Cassiae 9-20 part, Rhizoma Alismatis 6-15 part, Cortex Lycii 9-20 part, Rhizoma Polygoni Cuspidati 9-20 part, Radix Salviae Miltiorrhizae 9-20 part, Radix Rehmanniae 9-20 part, Herba Artemisiae Scopariae 9-20 part, Radix Et Rhizoma Rhei 3-30 part, Cortex Magnoliae Officinalis 3-15 part, Fructus Aurantii Immaturus 3-15 part, Radix Scrophulariae 9-20 part, Rhizoma Atractylodis 3-15 part, Folium Stevlae Rebaudianae 9-20 part, Fructus Lycii 6-20 part, Radix Angelicae Sinensis 5-15 part, Bombyx Batryticatus 5-15 part, Flos Chrysanthemi 9-20 part, Radix Glycyrrhizae 2-15 part was with 50 ℃ of hot-water soaks 24 hours, be fried boiling with high heat then 1 hour, back slow fire boiling 2 hours, decoct secondary altogether, remove gruffs, merge the secondary medicinal liquid;
B. medicinal liquid is concentrated into that proportion is 1.14-1.21 in the time of 50 ℃, adding ethanol content after being cooled to 20 ℃ reaches 65-75% (weight) and stirs, left standstill 24 hours, extraction supernatant decompression recycling ethanol is ground into powder after the drying with thick paste to there not being the alcohol flavor under 80 ℃ of temperature;
3. in the hawthorn lipidase grain weight: the ratio of his drug extract grain weight of medicine=1: 2, with the hawthorn lipidase is that medicated core and other drug extract are covering, add 0.1 times of Crataegolic acid medicine juice of its weight, 1 times of Crataegolic acid powder, 0.1 times of implant in its core, successively respectively with Cera Flava, Lac, enteric coated capsule as general ball core, label, the capsule core made of enteric coating, weigh the covering that 0.1 times of Crataegolic acid medicine juice, 1 times of Crataegolic acid powder, 0.1 times of implant pack medicated core by the covering medicine respectively in the covering medicine then and make pill or sheet medicine or capsule.
2, a kind of appetrol made from the method for claim 1.
CN 94116739 1994-10-11 1994-10-11 Method for preparation of weight-loosing medicine and its products Pending CN1105557A (en)

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1045246C (en) * 1995-08-07 1999-09-29 吴宏伟 Fat reducing chewing gum
CN1090482C (en) * 1996-06-03 2002-09-11 杨建军 Massage oil for skin
US6582735B2 (en) * 2000-12-15 2003-06-24 Npi, Llc. Compositions and methods of use for extracts of magnoliaceae plants
WO2005048973A1 (en) * 2003-11-20 2005-06-02 Branislav Bogicevic Oral application of extract of stevia rebaudiana or its active substances for the elimination of cellulite
US7410658B2 (en) * 2004-12-22 2008-08-12 Avon Products, Inc. Use of Alisma orientale in cosmetics and compositions thereof
CN101485865B (en) * 2009-02-11 2011-06-29 白云沂 Chinese medicine fat-reducing plaster
CN101518646B (en) * 2009-04-02 2012-10-03 深圳市绿微康生物工程有限公司 Lipase-containing composition
CN114887042A (en) * 2022-05-19 2022-08-12 北京荣寿堂生物科技有限公司 Composition for defatting and losing weight, preparation method and capsule

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1045246C (en) * 1995-08-07 1999-09-29 吴宏伟 Fat reducing chewing gum
CN1090482C (en) * 1996-06-03 2002-09-11 杨建军 Massage oil for skin
US6582735B2 (en) * 2000-12-15 2003-06-24 Npi, Llc. Compositions and methods of use for extracts of magnoliaceae plants
US6814987B2 (en) 2000-12-15 2004-11-09 Npi, Llc. Compositions and methods of use for extracts of magnoliaceae plants
WO2005048973A1 (en) * 2003-11-20 2005-06-02 Branislav Bogicevic Oral application of extract of stevia rebaudiana or its active substances for the elimination of cellulite
US7410658B2 (en) * 2004-12-22 2008-08-12 Avon Products, Inc. Use of Alisma orientale in cosmetics and compositions thereof
CN101485865B (en) * 2009-02-11 2011-06-29 白云沂 Chinese medicine fat-reducing plaster
CN101518646B (en) * 2009-04-02 2012-10-03 深圳市绿微康生物工程有限公司 Lipase-containing composition
CN114887042A (en) * 2022-05-19 2022-08-12 北京荣寿堂生物科技有限公司 Composition for defatting and losing weight, preparation method and capsule

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