CN104324278A - Production method of antiobesity drug and antiobesity granules - Google Patents

Production method of antiobesity drug and antiobesity granules Download PDF

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Publication number
CN104324278A
CN104324278A CN201410630384.5A CN201410630384A CN104324278A CN 104324278 A CN104324278 A CN 104324278A CN 201410630384 A CN201410630384 A CN 201410630384A CN 104324278 A CN104324278 A CN 104324278A
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powder
extract
mixed
antiobesity
appetrol
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牛犇
丁洁
梁宁
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GANSU COMMERCIAL TECHNOLOGY RESEARCH INSTITUTE
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GANSU COMMERCIAL TECHNOLOGY RESEARCH INSTITUTE
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/282—Artemisia, e.g. wormwood or sagebrush
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/42—Cucurbitaceae (Cucumber family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/482—Cassia, e.g. golden shower tree
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484—Glycyrrhiza (licorice)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/734—Crataegus (hawthorn)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815—Lycium (desert-thorn)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8962—Allium, e.g. garden onion, leek, garlic or chives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A61K36/8994—Coix (Job's tears)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
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    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

The invention provides a production method of an antiobesity drug and antiobesity granules. The antiobesity drug consists of Artemisia argyi, hawthorns, semen cassiae, coix seeds, wolfberry, oriental wormwood, onions, cucumbers and liquorice. The antiobesity granules are prepared by adopting the following steps of mixing and pulping the onions and the cucumbers, extracting, filtering, concentrating, drying and grinding to obtain extraction powder; mixing and grinding the residual components and then adding into water, carrying out reflux extraction twice, filtering, mixing two supernates, concentrating at reduced pressure, carrying out spray drying on the concentrated solution to obtain a mixed extract after drying; mixing the extraction powder with the dried mixed extract to obtain an another mixed extraction powder; and mixing amylodextrin, water and the mixed extraction powder, pressing cakes, pelleting, and drying to obtain the antiobesity granules. The antiobesity drug is prepared by compounding raw materials which are in homology of medicine and food according to a certain proportion, can take a weight-losing effect through promoting blood circulation to remove blood stasis and reducing triglyceride, blood sugar, beta lipoprotein and the like in the blood, and can treat obesity.

Description

The production method of a kind of appetrol and fat-reducing powder
Technical field
The invention belongs to pharmaceutical technology sectors, relating to a kind of medicine for losing weight mainly utilizing the natural plants of integration of edible and medicinal herbs to make, being specifically related to a kind of appetrol; The invention still further relates to a kind of production method these appetrol being made electuary.
Background technology
China at present population of being obese reaches 3.25 hundred million people, and amplification exceedes the U.S., Britain and Australia.This numeral also may double in future for 20 years.From the angle of modern medicine, obesity has at least following " misfortune point ".The first, cause figure heavy, inconvenient activity, mental maladjustment; The second, clothing, food, lodging and transportion--basic necessities of life cost increases; 3rd, bring all fatefulue diseases, even cause premature death.Wherein, fat maximum harm to cause a series of serious complication, and such as hypertension, diabetes, blood fat disorder, coronary heart disease, malignant tumor etc., these diseases are all the primary killers of human health.
The medicine of the problems such as appetrol refer to the medicine with antiobesity action, and be that solution is multiple fat because eating, sitting is got fat, fat-reducing constipation of going on a diet, and edema type is fat, and fatty is fat.Its major function accelerates metabolism, promotes and burn fat rate, suppresses body fat, stops the oil content in body absorption food, and the clean intestinal of toxin expelling removes stool etc.But appetrol are not health product, as medicine, it has certain side effect and untoward reaction, for a long time edible appetrol, and the gastrointestinal function of human body can be made disorderly, and dyspepsia appears in the lighter, and severe one may cause a series of gastrointestinal disease.Appetrol of a great variety, the appetrol wherein made with Chinese medicine are also a lot, as: patent " the natural weight-reducing medicine " (patent No. 02138853.9, notification number CN1211109C, day for announcing 2005.07.20), patent application " a kind of appetrol and preparation method thereof " (application number 98107214.3, publication number CN1231900A, publication date 1999.10.20) and patent " a kind of appetrol " (patent No. 201110164650.6, notification number CN102228548B, day for announcing 2012.07.11) etc. all disclose the appetrol made with pure Chinese medicine.But Chinese medicine is also medicine, and long-term taking still can have side effects to human body.
Summary of the invention
The object of this invention is to provide a kind of natural fat-reducing medicine obesity to good curative effect, adopt the plant of integration of edible and medicinal herbs to make, alleviate the side effect that long-term taking produces human body to greatest extent.
Another object of the present invention is to provide a kind of by the production method making electuary of above-mentioned appetrol.
For achieving the above object, the technical solution adopted in the present invention is: a kind of appetrol, by weight, be made up of Radix Artemisia ordosicae 1 ~ 30 part, Fructus Crataegi 0.5 ~ 3 part, Semen Cassiae 1 ~ 5 part, Semen Coicis 1 ~ 20 part, Fructus Lycii 1 ~ 10 part, Herba Artemisiae Scopariae 1 ~ 20 part, Bulbus Allii Cepae 1 ~ 30 part, Fructus Cucumidis sativi 1 ~ 20 part and 0.5 ~ 5 part, Radix Glycyrrhizae.
Another technical scheme of the present invention is: a kind of production method above-mentioned appetrol being made fat-reducing powder, specifically carries out according to the following steps:
Step 1: after got Bulbus Allii Cepae and Fructus Cucumidis sativi mixing making beating, extraction, filtration, concentrating under reduced pressure, air-dry rear pulverizing, obtains extract powder;
By got Radix Artemisia ordosicae, Fructus Crataegi, Semen Cassiae, Semen Coicis, Fructus Lycii, Herba Artemisiae Scopariae and Radix Glycyrrhizae co-grinding, make medicated powder, this medicated powder is added to the water, heat while stirring, reflux, extract, 45 ~ 60 minutes at the temperature of 85 ~ 95 DEG C, filters, and obtains first time supernatant; Then under identical temperature and time, carry out second time reflux, extract, filter, obtain second time supernatant;
Step 2: after first time supernatant is mixed with second time supernatant, heat while stirring, concentrating under reduced pressure, obtain concentrated solution;
Step 3: concentrated solution spraying dry under the condition of inlet temperature 120 DEG C ~ 180 DEG C, leaving air temp 70 DEG C ~ 90 DEG C, obtains dry rear mixed extract;
Step 4: by mixed extract mix homogeneously after the extract powder in step 1 and the drying in step 3, obtain mixed extraction powder;
Step 5: 1 ~ 4 ︰ 1.5 ︰ 5.5 ~ 7.5 in mass ratio, gets amylodextrin, water and mixed extraction powder respectively, after being uniformly mixed, is pressed into the block that particle diameter is 3 ~ 6cm, cause granularity 20 ~ 30 object granule; Drying, obtains the particulate matter that moisture content is less than 6%, is appetrol electuary.
Appetrol of the present invention adopt the raw material of integration of edible and medicinal herbs, carry out compatibility by a certain percentage and form, and are played the effect of fat-reducing by blood circulation promoting and blood stasis dispelling, triglyceride, blood glucose and the beta Lipoprotein etc. reduced in blood, can treatment of obesity.
Detailed description of the invention
Below in conjunction with detailed description of the invention, the present invention will be further described.
Appetrol of the present invention, by weight, are made up of Radix Artemisia ordosicae 1 ~ 30 part, Fructus Crataegi 0.5 ~ 3 part, Semen Cassiae 1 ~ 5 part, Semen Coicis 1 ~ 20 part, Fructus Lycii 1 ~ 10 part, Herba Artemisiae Scopariae 1 ~ 20 part, Bulbus Allii Cepae 1 ~ 30 part, Fructus Cucumidis sativi 1 ~ 20 part and 0.5 ~ 5 part, Radix Glycyrrhizae.
The function of each component in appetrol of the present invention:
1) Radix Artemisia ordosicae: perennial catananche, major function is the effect of blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, is Main Ingredients and Appearance.
2) Fructus Crataegi: the fruit of perennial deciduous tree, major function is blood fat reducing, falls serum total cholesterol, falls the effects such as beta Lipoprotein, is Main Ingredients and Appearance.
3) Semen Cassiae: the dry mature seed of annual leguminous herbaceous plant, major function is the effects such as purging liver-fire, yin nourishing improving eyesight, hypertension and hyperlipemia, is Main Ingredients and Appearance.
4) Bulbus Allii Cepae: perennial liliaceous plant, major function is triglyceride in blood pressure lowering, blood fat reducing, reduction blood, reduces the effect such as blood glucose, antithrombotic, is Main Ingredients and Appearance.
5) Semen Coicis: 1 year or perennial grass mellow fruit, mainly plays heat clearing away, eliminating dampness by diuresis, detumescence effect, is secondary composition.
6) Fructus Lycii: being the perennial shrub mellow fruit of Solanaceae Lycium, major function is the kidney invigorating and essence nourishing, nourishing the liver to improve visual acuity, nourishing the lung to arrest cough, soreness of the waist and knees, have a dizzy spell, the many tear of blurred vision, cough due to consumptive disease, quench one's thirst, pass out semen, is secondary composition.
7) Herba Artemisiae Scopariae: perennial herb or fruticuli, major function is clearing away heat-damp and promoting diuresis, blood pressure lowering, diuresis, is secondary composition.
8) Fructus Cucumidis sativi: annually climb up by holding on to the herbal fruit of shape, major function is heat extraction, diuretic, detoxify, control the dry effect such as yearningly, is secondary composition.
9) Radix Glycyrrhizae: the root of perennial herb, mainly plays heat-clearing and toxic substances removing, carbuncle sore tumefacting virus, cushion toxicity, strong, coordinating the actions of various ingredients in a prescription effect, is secondary composition.
Heredity, living habit, environment, Endocrine and metabolism etc. are all cause fat factor, and the food that high heat is enriched, takes in obesity and living substance has some relations.Radix Artemisia ordosicae in these appetrol, Fructus Crataegi and Bulbus Allii Cepae are monarch, mainly play triglyceride in blood circulation promoting and blood stasis dispelling, blood fat reducing, reduction blood; Semen Cassiae, Fructus Cucumidis sativi and Herba Artemisiae Scopariae are minister, play purging liver-fire, clearing away heat-damp and promoting diuresis, diuretic diuresis; Semen Coicis and Fructus Lycii are assistant, play yin nourishing, nourishing blood to promote the production of body fluid, and collaborative monarch drug and ministerial drug increase the effect of effect; Radix Glycyrrhizae plays mediation said components, separates the effect of mild toxicity Synergistic, for making.
Appetrol of the present invention mainly adopt the raw material of integration of edible and medicinal herbs, compatibility forms by a certain percentage, is played the effect of fat-reducing by blood circulation promoting and blood stasis dispelling, triglyceride, blood glucose and the beta Lipoprotein etc. reduced in blood, can treatment of obesity, to obesity, there is good curative effect, and can complete obesity controlling disease.Period in a medicine will eat the low food of some heats and coordinate fat-reducing, reaches the certain curative effect phase to settle out, and can play obesity action.
Radix Artemisia ordosicae in appetrol of the present invention, Semen Cassiae, Herba Artemisiae Scopariae and Radix Glycyrrhizae are Chinese medicinal components, although Radix Artemisia ordosicae is not at the row of integration of edible and medicinal herbs 87 kinds of medical materials 27 kinds of functional classification tables, but the tender leaf tender shoots grown before a large amount of edible Radix Artemisia ordosicae Dragon Boat Festival among the people, even lays in 1 year for beating the Radix Artemisia ordosicae tender leaf tender sprouts of glutinous rice cake.Therefore, only have Semen Cassiae, Herba Artemisiae Scopariae and Radix Glycyrrhizae to be real Chinese medicine in these appetrol, and amount used is relative to less whole prescription, is approximately 21% ~ 31%;
Fructus Crataegi, Semen Coicis, Fructus Lycii, Bulbus Allii Cepae and Fructus Cucumidis sativi are the fruit that eats of people or vegetable, and in appetrol of the present invention, consumption accounts for 69 ~ 79% of raw materials used total amount.As can be seen here, these appetrol mainly adopt the raw material of integration of edible and medicinal herbs.
The maximum difference of integration of edible and medicinal herbs composition and Chinese medicine ingredients is: be medicine three points of poison, no matter Chinese medicine or Western medicine, always long-term taking has certain harm to human body, and is that the appetrol long-term taking that primary raw material is made can not form potential harm to human body with food materials.
In order to people's above-mentioned appetrol easy to use, present invention also offers a kind of production method these appetrol being made electuary, specifically carry out according to the following steps:
Step 1: by weight, gets Radix Artemisia ordosicae 1 ~ 30 part, Fructus Crataegi 0.5 ~ 3 part, Semen Cassiae 1 ~ 5 part, Semen Coicis 1 ~ 20 part, Fructus Lycii 1 ~ 10 part, Herba Artemisiae Scopariae 1 ~ 20 part, Bulbus Allii Cepae 1 ~ 30 part, Fructus Cucumidis sativi 1 ~ 20 part and 0.5 ~ 5 part, Radix Glycyrrhizae respectively;
By got Bulbus Allii Cepae and Fructus Cucumidis sativi mixing making beating, at the temperature of 35 ~ 45 DEG C, extraction 45 ~ 60 minutes is stirred with the medical ethanol of mass fraction 95%, filter, paste is evaporated under negative pressure between 0.003 ~ 0.007MPa, stop concentrated, release concentrate in pallet, air-dry at the temperature of 35 ~ 45 DEG C, dry thing is through pulverizing to obtain extract powder;
By got Radix Artemisia ordosicae, Fructus Crataegi, Semen Cassiae, Semen Coicis, Fructus Lycii, Herba Artemisiae Scopariae and Radix Glycyrrhizae co-grinding, make medicated powder, this medicated powder is added to the water, heat while stirring, reflux, extract, 45 ~ 60 minutes at the temperature of 85 ~ 95 DEG C, filters, and obtains first time supernatant; Then under identical temperature and time, carry out second time reflux, extract, filter, obtain second time supernatant;
Because Bulbus Allii Cepae and Fructus Cucumidis sativi are fresh food materials, moisture accounts for mass fraction more than 90%, and fresh active constituent content is high.And Radix Artemisia ordosicae, Fructus Crataegi, Semen Cassiae, Semen Coicis, Fructus Lycii, Herba Artemisiae Scopariae and Radix Glycyrrhizae are dry product, so will process respectively.
Step 2: the first time supernatant in step 1 is sent in concentration tank with second time supernatant, heats while stirring, carry out concentrating under reduced pressure at the temperature of 65 ~ 85 DEG C, obtain concentrated solution;
Step 3: the concentrated solution in step 2 is carried out spraying dry under the condition of inlet temperature 120 DEG C ~ 180 DEG C, leaving air temp 70 DEG C ~ 90 DEG C, obtains moisture content and is not more than mixed extract after the drying of 6%;
Step 4: by mixed extract mix homogeneously after the extract powder in step 1 and the drying in step 3, obtain mixed extraction powder;
Step 5: 1 ~ 4 ︰ 1.5 ︰ 5.5 ~ 7.5 in mass ratio, get amylodextrin, water and mixed extraction powder respectively, 30 ~ 60 minutes are uniformly mixed in mixing and blending machine, then be pressed into the block that particle diameter is 3 ~ 6cm in the mixing cuber of 0.001 ~ 0.005MPa at pressure, join in the swing comminutor of sway velocity 15 ~ 20 beats/min and cause granularity 20 ~ 30 object granule; This granule is placed in boiling type drying machine, and at the temperature of 45 DEG C, drying 60 minutes, obtains the particulate matter that moisture content is less than 6%, obtains appetrol electuary.
Can be packed by particulate matter in the step 5 of drying on packer, packing specification is 10 grams/bag, and then every 10 bags are packaged as a bag, obtains natural fat-reducing medicine electuary bag.
The function of appetrol electuary of the present invention and curing mainly: there is blood circulation promoting and blood stasis dispelling, clearing away heat-damp and promoting diuresis, blood pressure lowering, diuretic diuresis, the triglyceride reduced in blood, reduce blood glucose, antithrombotic.
Usage and consumption: be grown up 2 times/day, 10g/time, within 2 weeks, be a course for the treatment of.
According to clinical course for the treatment of, according to new Chinese medicine toxicologic study technical requirement, with 3 month long term toxicity tests of appetrol electuary of the present invention to rat:
1. animal: Wistar rat 120, SPF level, male and female dual-purpose, body weight 65 ~ 85g; SYXK(is sweet for the animal facility quality certification) 2004 ~ 006, SCXK(is sweet for the Quality of Experimental Animals quality certification) 2004 ~ 007, provided by Gansu Chinese of Traditional Chinese Medicine's Experimental Animal Center.
2. divide into groups: Wistar rat is divided into the administration of appetrol electuary heavy dose of group, middle dosage group, small dose group and matched group at random by sex body weight, often organizes 30.Heavy dose of group dosage 14.3g/(kg.d) (100 times of clinical administration amount), middle dosage group dosage 7.1g/(kg.d) (50 times of clinical administration amount), small dose group dosage 3.5g/(kg.d) (25 times of clinical administration amount).
3. administration: by appetrol electuary feeding to high dose group, middle dosage group and low dose group, dosage is respectively 14.3g/kg.d, 7.1g/kg.d, 3.5g/kg.d, and administration volume is 10mL/kg; Vacancy matched group gavages isopyknic distilled water.
Timing gavage 2 times/d, administration 6d/ week.In the 14th week, respectively group was random puts to death 6 rats, and within the 27th week, respectively group is random puts to death 14 rats, remainings 10 rat drug withdrawals 4 weeks, watches convalescent period situation, and in drug withdrawal the 4th execution at weekend.Each group of rat is weighed weekly 1 time, according to body weight change situation adjustment dosage.Every day timed drug administrations.
4. the test period: 3 months, be about 8 times of clinical course for the treatment of (2 weeks).
5. inspection item:
1) general inspection: observe three administration group rat outward appearances sign (hair, eye, ear, mouth, nasal discharge etc.), behavioral activity, feces character, body weight change, ingest and death condition etc.General activity no abnormality seen, body weight change compares no significant difference with matched group.
2) hematological examination: the numeration of erythrocyte, hemoglobin, platelet, platelet, red cell volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration (MCHC), reticulocyte, clotting time.Three dosage group successive administrations 3 months and drug withdrawal 14 days, rat blood index and clotting time compare all without significant difference with matched group.
3) blood biochemical analysis inspection: glutamate pyruvate transaminase ALT, alkaline phosphatase, glutamic oxaloacetic transaminase, GOT AST, blood urea nitrogen BUN, creatinine Cre, total protein TP, albumin A LB, glucose GLU, total bilirubin T-BIL, creatine kinase CK, chlorine CL, potassium K, sodium Na.Three dosage group successive administrations 3 months and drug withdrawal 14 days, rat blood biochemical indexes compares all without significant difference with matched group.
4) organ coefficient: put to death rat by each group and carry out Systematic anatomy, by complete taking-ups of internal organs such as the heart, liver, spleen, lung, kidney, brain, testis, epididymis, uterus, ovary, thymus, adrenal gland, weigh and calculate organ coefficient.Three dosage group successive administrations 3 months and drug withdrawal 14 days, Rats Organs and Tissues coefficient and the equal nonsignificance of matched group comparing difference.
5) histopathological examination: the heart of administration group rat, liver, spleen, lung, kidney, brain, adrenal gland, thymus, Stomach duodenum, ileum, colon, testis, epididymis, prostate, ovary, breastbone, mesenteric lymph node, pancreas, optic nerve, uterus, bladder, spinal cord, thyroid, hypophysis, fallopian tube, mammary gland, sciatic nerve, thyroid, parathyroid gland, salivary gland, trachea, the organs and tissues pathological examination such as esophagus and skin have no drug-induced abnormal change.
Reversibility or delay Toxicity Observation after drug withdrawal: continue normal feed after the drug withdrawal of each group residue rat and put to death after 14 days, carry out the Indexs measure such as hematology, blood biochemical analysis, histopathology.Three above-mentioned observation index of administration group rat compare without significant difference with matched group; Heavy dose of group rat above-mentioned organs and tissues pathological examination has no drug-induced delay toxicity damage.Experimental result prompting is under this experiment condition, and this medicine uses by clinical prescribed dose and has no obvious toxic reaction.
The high, medium and low dosage group of appetrol electuary of the present invention, dosage is respectively 14.3g/kg.d, 7.1g/kg.d, 3.5g/kg.d, and to rat continuous 3 months gastric infusions, each group activities in rats is normal, and body weight growth compares no significant difference with matched group; Hematological indices, blood biochemical analysis index, organ index compares no significant difference with Matrix controls group; The organs and tissues pathological examinations such as heavy dose of group rat heart, liver, spleen, lung, kidney, brain, adrenal gland, thymus, Stomach duodenum, ileum, colon, testis, epididymis, prostate, ovary, breastbone, mesenteric lymph node, pancreas, optic nerve, uterus, bladder, spinal cord, thyroid, hypophysis, fallopian tube, mammary gland, sciatic nerve, thyroid, parathyroid gland, salivary gland, trachea, esophagus have no drug-induced abnormal change.Drug withdrawal 14 days, each administration group activities in rats is normal, and body weight change compares no significant difference with matched group; Hematological indices, blood biochemical analysis index and organ index compare with matched group, difference nonsignificance; The above-mentioned organs and tissues pathological examination of heavy dose of group rat is showed no medicine and causes delay toxicity damage.
Long term toxicity test result is pointed out: the animal safety consumption of appetrol electuary of the present invention is 100 times of 14.3g/kg.d(clinical administration amount); This appetrol electuary, under this experiment condition, does not find obvious toxic reaction within the scope of clinical prescribed dose.
clinical practice: get above-mentioned natural fat-reducing medicine electuary, be packaged into the bag of Different Weight: 15 grams/bag, 10 grams/bag, 5 grams/bag.Volunteer 20 people/group, 10 male 10 female/groups (age at 30 ~ 40 years old, body weight: man 180 ~ 200 jin, female 160 ~ 180 jin), totally 4 groups, wherein 1 group of experimental group in contrast, only gives Jerusalem artichoke powder placebo.
Oral test is carried out to above-mentioned 4 groups of personnel: through 2 times/day, within continuous 30 days, try out, result shows: take 5 grams/bag dosage group, the phenomenon that significantly not lose weight after having 15 people to take 25 is continuously paid a return visit in 20 people when 30 days, just there is obvious hunger sensation, (have in 5 people 2 ages 30 ~ 40 years old women continuous use after 15 days body weight there is no bright change, just forget continuous use, just hope and taken once, can not remember and just do not take, 3 male's medications are not obviously felt for 10 days afterwards, and just abandon taking, therefore this 5 people does not have referential).
Take 10 grams/bag dosage group, pay a return visit when 30 days in 20 people after having 17 people to take 25 continuously and have obvious hunger sensation and phenomenon (wherein have the man of 2 people's age one's late 30s and 1 women not to take continuously, therefore this 3 people does not have referential) of losing weight.
Take 15 grams/bag dosage group, pay a return visit when 30 days in 20 people to have after having 15 people to take 25 continuously and have strong hunger sensation every day, body weight has significant decline (to have the male of 3 age one's late 30s not take continuously because feeling unbearably hungry every day in all the other 5 people, the women of 2 age one's late 30s does not take continuously because feeling unbearably hungry every day, and therefore this 5 people does not have referential).
Take Jerusalem artichoke powder placebo group: 10 grams/bag, 2 times/day, pay a return visit when 30 days in 20 people after having 11 people to take 25 continuously because of without any change (cutting out because of unchanged after wherein having 9 people to take 15).
embodiment 1
By weight, Radix Artemisia ordosicae 1 part, Fructus Crataegi 0.5 part, Semen Cassiae 1 part, Semen Coicis 1 part, Fructus Lycii 1 part, Herba Artemisiae Scopariae 1 part, Bulbus Allii Cepae 1 part, Fructus Cucumidis sativi 1 part and 0.5 part, Radix Glycyrrhizae is got respectively; By got Bulbus Allii Cepae and Fructus Cucumidis sativi mixing making beating, at 35 DEG C of temperature, extraction 60 minutes is stirred with the medical ethanol of mass fraction 95%, filter, under the negative pressure of 0.007MPa, be evaporated to paste, stop concentrated, release concentrate in pallet, air-dry at 35 DEG C of temperature, dry thing is through pulverizing to obtain extract powder; By got Radix Artemisia ordosicae, Fructus Crataegi, Semen Cassiae, Semen Coicis, Fructus Lycii, Herba Artemisiae Scopariae, Bulbus Allii Cepae, Fructus Cucumidis sativi and Radix Glycyrrhizae co-grinding, make medicated powder, this medicated powder is added to the water, heat while stirring, reflux, extract, 60 minutes at the temperature of 85 DEG C, filters, and obtains first time supernatant; Then under identical temperature and time, carry out second time reflux, extract, filter, obtain second time supernatant; Supernatant and second time supernatant will send into concentration tank for the first time, and heat while stirring, at the temperature of 65 DEG C, carry out concentrating under reduced pressure, obtain concentrated solution; By concentrated solution spraying dry under the condition of inlet temperature 120 DEG C, leaving air temp 90 DEG C, obtain moisture content and be not more than mixed extract after the drying of 6%; Mixed extract after Homogeneous phase mixing extract powder and drying, obtains mixed extraction powder; 1 ︰ 1.5 ︰ 7.5 in mass ratio, get amylodextrin, water and mixed extraction powder respectively, be uniformly mixed 30 minutes, being be pressed into the block that particle diameter is 3 ~ 6cm in the mixing cuber of 0.001MPa at pressure, is obtained particle diameter 20 ~ 30 object granule in the swing comminutor of 15 beats/min in wobble frequency; This granule is placed in boiling type drying machine, and at the temperature of 45 DEG C, drying 60 minutes, obtains the particulate matter that moisture content is less than 6%, obtains appetrol electuary.Dried particulate matter is packed by packer, and packing specification is 10 grams/bag, and then every 10 bags are packaged as a bag, obtains appetrol electuary bag.
embodiment 2
By mass fraction, get Radix Artemisia ordosicae 15 parts, Fructus Crataegi 1.5 parts, Semen Cassiae 2.5 parts, Semen Coicis 10 parts, Fructus Lycii 5 parts, Herba Artemisiae Scopariae 10 parts, Bulbus Allii Cepae 15 parts, Fructus Cucumidis sativi 10 parts and 2.5 parts, Radix Glycyrrhizae respectively; By got Bulbus Allii Cepae and Fructus Cucumidis sativi mixing making beating, extraction is stirred 50 minutes with at medical ethanol 40 DEG C of temperature of mass fraction 95%, filter, under the negative pressure of 0.005 MPa, be evaporated to paste, stop concentrated, release concentrate in pallet, air-dry at 40 DEG C of temperature, dry thing is through pulverizing to obtain extract powder; By got Radix Artemisia ordosicae, Fructus Crataegi, Semen Cassiae, Semen Coicis, Fructus Lycii, Herba Artemisiae Scopariae and Radix Glycyrrhizae co-grinding, make medicated powder, medicated powder is added to the water, heat while stirring, at the temperature of 90 DEG C, stir extraction 50 minutes, filter, obtain first time supernatant; Then under identical temperature and time, carry out second time reflux, extract, filter, obtain second time supernatant; Supernatant and second time supernatant will send into concentration tank for the first time, and heat while stirring, at the temperature of 75 DEG C, carry out concentrating under reduced pressure, obtain concentrated solution; By concentrated solution spraying dry under the condition of inlet temperature 150 DEG C, leaving air temp 80 DEG C, obtain moisture content and be not more than mixed extract after the drying of 6%; Mixed extract after Homogeneous phase mixing extract powder and drying, obtains mixed extraction powder; 1 ︰ 1.5 ︰ 5.5 in mass ratio, get amylodextrin, water and mixed extraction powder respectively, 45 minutes are uniformly mixed in mixing and blending machine, then being be pressed into the block that particle diameter is 3 ~ 6cm in the mixing cuber of 0.003MPa at pressure, is obtained particle diameter 20 ~ 30 object granule in the swing comminutor of 18 beats/min in wobble frequency; This granule is placed in boiling type drying machine, and at the temperature of 45 DEG C, drying 60 minutes, obtains the particulate matter that moisture content is less than 6%, obtains appetrol electuary.Dried particulate matter is packed by packer, and packing specification is 10 grams/bag, and then every 10 bags are packaged as a bag, obtains natural fat-reducing medicine electuary bag.
embodiment 3
By mass fraction, get Radix Artemisia ordosicae 30 parts, Fructus Crataegi 3 parts, Semen Cassiae 5 parts, Semen Coicis 20 parts, Fructus Lycii 10 parts, Herba Artemisiae Scopariae 20 parts, Bulbus Allii Cepae 30 parts, Fructus Cucumidis sativi 20 parts and 5 parts, Radix Glycyrrhizae respectively; By got Bulbus Allii Cepae and Fructus Cucumidis sativi mixing making beating, extraction is stirred 45 minutes with under the medical ethanol temperature 45 C of mass fraction 95%, filter, under the negative pressure of 0.003 MPa, be evaporated to paste, stop concentrated, release concentrate in pallet, carry out air-dry under temperature 45 C, dry thing is through pulverizing to obtain extract powder; By got Radix Artemisia ordosicae, Fructus Crataegi, Semen Cassiae, Semen Coicis, Fructus Lycii, Herba Artemisiae Scopariae and Radix Glycyrrhizae co-grinding, make medicated powder, medicated powder is added to the water, heat while stirring, at the temperature of 95 DEG C, stir extraction 45 minutes, filter, obtain first time supernatant; Then under identical temperature and time, carry out second time reflux, extract, filter, obtain second time supernatant; Supernatant and second time supernatant will send in concentration tank for the first time, and heat while stirring, at the temperature of 85 DEG C, carry out concentrating under reduced pressure, obtain concentrated solution; Concentrated solution is carried out spraying dry under the condition of inlet temperature 180 DEG C, leaving air temp 70 DEG C, obtains moisture content and be not more than mixed extract after the drying of 6%; Mixed extract after Homogeneous phase mixing extract powder and drying, obtains mixed extraction powder; 1 ︰ 1.5 ︰ 6.5 in mass ratio, get amylodextrin, water and mixed extraction powder respectively, 60 minutes are uniformly mixed in mixing and blending machine, then be pressed into the block that particle diameter is 3 ~ 6cm in the mixing cuber of 0.005MPa at pressure, join in the swing comminutor of sway velocity 20 beats/min and cause granularity 20 ~ 30 object granule; This granule is placed in boiling type drying machine, and at the temperature of 45 DEG C, drying 60 minutes, obtains the particulate matter that moisture content is less than 6%, obtains appetrol electuary.Think dried particulate matter is packed by packer, packing specification is 10 grams/bag, and then every 10 bags are packaged as a bag, obtains appetrol electuary bag.
embodiment 4
Obtain mixed extraction powder by the method for embodiment 1,4 ︰ 1.5 ︰ 7.5, get amylodextrin, water and mixed extraction powder respectively, then obtain appetrol electuary by the method for embodiment 1 in mass ratio.
embodiment 5
Obtain mixed extraction powder by the method for embodiment 2,4 ︰ 1.5 ︰ 6.5, get amylodextrin, water and mixed extraction powder respectively, then obtain appetrol electuary by the method for embodiment 2 in mass ratio.
embodiment 6
Obtain mixed extraction powder by the method for embodiment 3,4 ︰ 1.5 ︰ 5.5, get amylodextrin, water and mixed extraction powder respectively, then obtain appetrol electuary by the method for embodiment 3 in mass ratio.
embodiment 7
Obtain mixed extraction powder by the method for embodiment 1,2.5 ︰ 1.5 ︰ 5.5, get amylodextrin, water and mixed extraction powder respectively, then obtain appetrol electuary by the method for embodiment 1 in mass ratio.
embodiment 8
Obtain mixed extraction powder by the method for embodiment 2,2.5 ︰ 1.5 ︰ 6.5, get amylodextrin, water and mixed extraction powder respectively, then obtain appetrol electuary by the method for embodiment 2 in mass ratio.
embodiment 9
Obtain mixed extraction powder by the method for embodiment 3,2.5 ︰ 1.5 ︰ 7.5, get amylodextrin, water and mixed extraction powder respectively, then obtain appetrol electuary by the method for embodiment 3 in mass ratio.

Claims (5)

1. appetrol, it is characterized in that, by weight, be made up of Radix Artemisia ordosicae 1 ~ 30 part, Fructus Crataegi 0.5 ~ 3 part, Semen Cassiae 1 ~ 5 part, Semen Coicis 1 ~ 20 part, Fructus Lycii 1 ~ 10 part, Herba Artemisiae Scopariae 1 ~ 20 part, Bulbus Allii Cepae 1 ~ 30 part, Fructus Cucumidis sativi 1 ~ 20 part and 0.5 ~ 5 part, Radix Glycyrrhizae.
2. appetrol described in claim 1 are made a production method for fat-reducing powder, it is characterized in that, this production method is specifically carried out according to the following steps:
Step 1: by weight, gets Radix Artemisia ordosicae 1 ~ 30 part, Fructus Crataegi 0.5 ~ 3 part, Semen Cassiae 1 ~ 5 part, Semen Coicis 1 ~ 20 part, Fructus Lycii 1 ~ 10 part, Herba Artemisiae Scopariae 1 ~ 20 part, Bulbus Allii Cepae 1 ~ 30 part, Fructus Cucumidis sativi 1 ~ 20 part and 0.5 ~ 5 part, Radix Glycyrrhizae respectively;
After got Bulbus Allii Cepae and Fructus Cucumidis sativi mixing making beating, extraction, filtration, concentrating under reduced pressure, air-dry rear pulverizing, obtains extract powder;
By got Radix Artemisia ordosicae, Fructus Crataegi, Semen Cassiae, Semen Coicis, Fructus Lycii, Herba Artemisiae Scopariae and Radix Glycyrrhizae co-grinding, make medicated powder, this medicated powder is added to the water, heat while stirring, reflux, extract, 45 ~ 60 minutes at the temperature of 85 ~ 95 DEG C, filters, and obtains first time supernatant; Then under identical temperature and time, carry out second time reflux, extract, filter, obtain second time supernatant;
Step 2: after first time supernatant is mixed with second time supernatant, heat while stirring, concentrating under reduced pressure, obtain concentrated solution;
Step 3: concentrated solution spraying dry under the condition of inlet temperature 120 DEG C ~ 180 DEG C, leaving air temp 70 DEG C ~ 90 DEG C, obtains dry rear mixed extract;
Step 4: by mixed extract mix homogeneously after the extract powder in step 1 and the drying in step 3, obtain mixed extraction powder;
Step 5: 1 ~ 4 ︰ 1.5 ︰ 5.5 ~ 7.5 in mass ratio, gets amylodextrin, water and mixed extraction powder respectively, after being uniformly mixed, is pressed into the block that particle diameter is 3 ~ 6cm, cause granularity 20 ~ 30 object granule; Drying, obtains the particulate matter that moisture content is less than 6%, is appetrol electuary.
3. the production method of fat-reducing powder according to claim 2, it is characterized in that, in described step 1, Bulbus Allii Cepae and Fructus Cucumidis sativi mixing are stirred extraction 45 ~ 60 minutes with the medical ethanol of mass fraction 95%, are filtered after pulling an oar at the temperature of 35 ~ 45 DEG C, paste is evaporated under the negative pressure of 0.003 ~ 0.007MPa, air-dry, pulverize, obtain extract powder.
4. the production method of fat-reducing powder according to claim 2, is characterized in that, in described step 2, at the temperature of 65 ~ 85 DEG C, carries out concentrating under reduced pressure.
5. the production method of fat-reducing powder according to claim 2, is characterized in that, in described step 3, after dry, the moisture content of mixed extract is not more than 6%.
CN201410630384.5A 2014-11-11 2014-11-11 Production method of antiobesity drug and antiobesity granules Pending CN104324278A (en)

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