CN111973717A

CN111973717A - A composition containing fructus Perillae and semen Cassiae for reducing weight, and its preparation method

Info

Publication number: CN111973717A
Application number: CN202010885141.1A
Authority: CN
Inventors: 王鸿雁
Original assignee: Xi'an Royal Healthcare Products Co ltd
Current assignee: Xi'an Royal Healthcare Products Co ltd
Priority date: 2020-08-28
Filing date: 2020-08-28
Publication date: 2020-11-24

Abstract

The invention relates to a perilla seed and cassia seed composition with a weight-losing effect and a preparation method thereof, wherein the composition comprises the following raw material components in parts by weight: 800 parts of perilla fruit, 500 parts of cassia seed, 100 parts of angelica dahurica, 200 parts of prepared fleece-flower root, 200 parts of kelp and 50-90 parts of coix seed. The composition is prepared according to the weight-reducing theory of traditional Chinese medicine and modern medicine, the principle proportion is reasonable, the preparation method is scientific, and animal and human body test food tests prove that the composition has relatively obvious weight-reducing and health-care effects. The weight-reducing tea is a pure natural weight-reducing product, has no toxic or side effect after being eaten for a long time, does not cause organ burden, has a good market application prospect, and is suitable for popularization and utilization.

Description

A composition containing fructus Perillae and semen Cassiae for reducing weight, and its preparation method

Technical Field

The invention belongs to the technical field of health care products, and particularly relates to a perilla seed and cassia seed composition with a weight-losing effect and a preparation method thereof.

Background

According to the world health organization, about 2.5 million adults worldwide suffer from obesity, and at least 5 million others are overweight. The world health organization has announced obesity as the largest global adult chronic disease. The incidence of obesity has increased significantly in developed countries, with the highest prevalence of obesity in the united states, with 35% of the population being identified as obese. At least 9700 million americans, the number has been increasing continuously since 1960 for overweight or obesity, and the trend has not slowed down. In europe, the united kingdom is one of the highest increasing rates of obesity, 18%. Immediately next to france and germany, a total of over 2.5 billion people worldwide suffer from obesity. Furthermore, obesity is associated with mortality and morbidity, which can cause death of 30000 people each year in the united states alone.

With the improvement of the living standard of modern people, obesity is considered to be a problem in developed countries, and the problem is more and more prominent in developing countries. Obesity is the biggest obstacle to achieve body beauty, brings great inconvenience to life and work of people, enables people to lose normal body beauty, is easy to cause a series of related diseases, such as coronary heart disease, diabetes, hypertension, atherosclerosis, reduction of body immune function and the like, and is also an inducing factor of cardiovascular and cerebrovascular diseases and the like. Is harmful to health and has shortened life. Obesity has a morbidity of about 10% -15% in cities in China, and tends to increase and become young year by year. The main reasons for this phenomenon are the altered dietary structure, increased caloric intake, especially too much fat, salt and sugar intake, reduced physical activity, increased sitting, reduced walking, and accelerated urbanization.

Control of body fat is currently one of the most interesting issues for medical care. The control of body fat by drugs is a subject of great attention, but the use of chemically synthesized lipid-lowering drugs such as fenfluramine has been found to have serious side effects, which limits their use. The natural Chinese herbal medicines are applied to achieve the aims of losing weight and controlling body fat, which is a common choice at present. The Chinese herbal medicine health food for losing weight in China also has a certain market, but no famous brand is known, the market is relatively dispersed, and the weight-losing effect is still to be further improved.

Disclosure of Invention

The composition contains a plurality of effective components including total anthraquinones, volatile oils, fatty oils and the like, and has obvious weight-losing effect proved by experiments.

The second purpose of the invention is to provide a preparation method of a capsule containing the composition.

In order to achieve the purpose, the invention adopts the following technical scheme:

a perilla seed and cassia seed composition with a weight-losing effect comprises the following raw material components in parts by weight: 800 parts of perilla fruit, 500 parts of cassia seed, 100 parts of angelica dahurica, 200 parts of prepared fleece-flower root, 200 parts of kelp and 50-90 parts of coix seed.

Preferably, the composition of perilla seed and cassia seed with the weight-reducing effect comprises the following raw materials in parts by weight: 600 parts of perilla fruit, 375 parts of cassia seed, 225 parts of angelica dahurica, 150 parts of prepared fleece-flower root, 150 parts of kelp and 75 parts of coix seed.

In order to facilitate understanding of the present invention, the raw materials and the drug effects of the present invention will be further described below.

The fructus Perillae is dried mature fruit of Perilla frutescens (L.) Britt. of Labiatae. Pungent and warm in flavor, enter lung meridian. Perilla seed, fructus Perillae lowers qi and reduces phlegm, moistens dryness and smoothes intestines, and helps large intestine to conduct. The perilla seeds contain rich grease, and the oil content is about 35-50%. The main components of the fatty oil are linolenic acid, linoleic acid, oleic acid, palmitic acid, stearic acid, arachidic acid and the like, wherein the content of alpha-linolenic acid is high and can reach 84.5 percent. Perilla oil rich in alpha-linolenic acid has effects of changing fatty acid of rat brain and liver, and reducing blood lipid. After the perilla oil is used for intragastric administration and the high-fat model quail duck is taken after 14 days, the serum Total Cholesterol (TC) and Triglyceride (TG) are obviously reduced by measuring the infrawinged arterial blood.

The semen Cassiae is dried mature seed of Cassia obtusifolia L. or Cassia tora L. of Leguminosae. It is sweet, bitter, salty and slightly cold in property, and enters liver and large intestine meridians. Cassia seed, semen Cassiae has the effects of clearing liver fire, tonifying kidney yang, clearing heat, improving eyesight, moistening intestines and relaxing bowels. Mainly contains anthralin substances such as chrysophanol, emodin, aloe-emodin, rhein, cassia seed element, aurantio-obtusin and cassia element, naphthopyrrolones substances such as cassia glycoside, cassia ketone, cassia lactone, rubrofusarin and norrubrofusarin, and also contains sterol, fatty acid, saccharide, protein and trace elements necessary for human body. Anthraquinone substances contained in the cassia seeds are main effective components of the cassia seeds for reducing blood fat. In addition, the research on the lipid-lowering effect of the cassia seed extract shows that the lipid-lowering effect of the cassia seed water extract is better than that of other solvent extracts.

Radix Angelicae Dahuricae is dried root of Angelica dahurica (Fisch. ex Hoffm.) Benth.et hook.f. or Angelica dahurica (Fisch. ex Hoffm.) Benth.et hook.f. var. fortmosia (Boiss.) Shann et Yuan of Umbelliferae. Pungent and warm in flavor, enter stomach, large intestine and lung meridians. Radix Angelicae Dahuricae has effects of dispelling pathogenic wind, removing dampness, dredging channels, regulating qi-flowing and relieving stagnation. Pungent flavor can ascend and disperse, warm and smooth qi movement, harmonize intestines and stomach, and relieve distension and fullness in abdomen. The main components of radix Angelicae Dahuricae are volatile oil and coumarin. The coumarins include oxypeucedanin, imperatorin, isoimperatorin, alloimperatorin, byak-angelicin, isobergapten, and saxifragin. And daucosterol, and trace elements necessary for human body such as sodium, magnesium, iron, calcium, phosphorus, copper, zinc, manganese, nickel, cobalt, chromium, molybdenum, etc.

Prepared fleece flower root is sweet, astringent and slightly warm in nature, and enters liver and kidney meridians. Prepared fleece flower root has the advantages of nourishing liver and kidney, benefiting essence and blood, warming slightly, not drying, tonifying but not greasy. The polygonum multiflorum contains three types of effective components: stilbene glycoside compounds, anthraquinone compounds, polymeric procyanidine and phospholipid. Stilbene glycoside compounds are water soluble components with significant pharmacological activity, and recently, the polygonum multiflorum contains a plurality of rhapontin derivatives, such as diphenylethenoid glycoside 2, 3,5, 4' -tetrahydroxystyrene-2-0-beta-D-glucoside, and has significant lipid-lowering effect, and the content is up to 1.2%. The content of anthraquinone compounds in Polygoni Multiflori radix is up to 1.1%, and the anthraquinone compounds exist in the form of glycoside, mainly including emodin, chrysophanol and glucose glycoside of rhein, and in addition, various anthraquinone substances such as physcion, chrysophanol anthrone, etc. Fatty Acid Synthase (FAS) is recently reported as a potential target site for the treatment of obesity, but currently, few FAS inhibitors are known. The determination shows that the traditional Chinese medicine polygonum multiflorum extract has strong reversible inhibition of fast binding and irreversible inhibition of slow binding on FAS. The polygonum multiflorum extract has a strong inhibition effect on FAS, and the inhibition capability of the polygonum multiflorum extract is obviously stronger than that of the known inhibitors. The polygonum multiflorum can be combined with cholesterol in vitro to reduce the absorption of the cholesterol from rabbit intestines, and the anthracene compound contained in the polygonum multiflorum can promote the intestinal tract to propel movement, inhibit the reabsorption of the cholesterol in the intestines and promote the metabolism of the cholesterol. The stilbene compound contained in the polygonum multiflorum can also obviously reduce the total cholesterol level in the blood of rats. When the polygonum multiflorum extract is orally fed to rats, the food intake of the rats and the weight of the rats can be obviously reduced, the liver FAS activity of the rats in an experimental group is lower than that of a control group at the end of an experiment, and the weight of the rats is obviously reduced by clinically using the compound polygonum multiflorum extract.

The thallus laminariae is dried thallus of Laminaria japonica Aresch of Laminariaceae or Ecklonia kurome okam of Alariaceae. Salty and cold in flavor, it enters liver, stomach and kidney meridians. Kun Bu softens hardness and dissipates nodulation, induces diuresis to alleviate edema. Thallus laminariae contains polysaccharide, amino acids, alginic acid, crude protein, dibenzo dioxide compounds, potassium, iodine, etc., and thallus laminariae is fed for 15 days continuously for 1g/D to significantly reduce cholesterol (TC), beta-lipoprotein (beta-LP) and Triglyceride (TG) levels of rabbits with experimental hyperlipoproteinemia induced by cholesterol crystallization and lard, and simultaneously increase the levels of high density lipoprotein-cholesterol (HDL-D) and its subclass-2 (HDL 2-C).

The Coicis semen is dried mature kernel of Coix lacryma-jobi L.var ma-yuen (Roman.) Stapf of Gramineae. Pungent, bitter and warm. It enters lung, stomach and large intestine meridians. Yi ren is bland in nature and sweet in nature to excrete dampness and benefit the spleen. It can eliminate spleen dampness, tonify spleen, nourish stomach, eliminate arthralgia and check diarrhea. The coix seed contains protein 16.2%, fat 4.65%, carbohydrate 79.17%, vitamin B1, coixol, coixenol, etc. Analysis of the coix seed oil shows that: the fatty acid of the coix seed oil is mainly oleic acid and linoleic acid, and is one of the effective components of coix seeds.

Traditional Chinese medicine research shows that obesity is mostly caused by spleen-kidney yang deficiency, spleen-stomach dysfunction, qi activity disorder, overeating fat, sweet and thick taste and excessive lipid intake, and the two cause each other (inside and outside), so that dysfunction in transportation and transformation is caused, normal metabolism of food essence is influenced, phlegm dampness and blood stasis are bred, lipid deposition is caused, and obesity is formed. In addition, accumulation of phlegm-dampness can transform into heat over a long period of time, and stagnation of heat can also generate dampness, thereby forming damp-heat type obesity with accumulation of phlegm-dampness-heat. In the composition, the perilla seed is rich in oil, can moisten dryness and smooth intestines, and can lower lung qi, lower qi and reduce phlegm. The cassia seed has the effects of clearing heat, improving eyesight, moistening intestines, relaxing bowels, and nourishing liver and kidney: the prepared fleece flower root has the functions of replenishing essence and blood, tonifying liver and kidney, and tonifying but not greasy, and both contain anthraquinone substances with efficacy components (functions of reducing fat and losing weight). Coix seed, semen Coicis, has the effects of invigorating spleen, eliminating dampness, relieving arthralgia, relieving diarrhea, softening hardness and dissipating stagnation of thallus laminariae, and inducing diuresis to alleviate edema. Bai Zhi can dredge the meridian and regulate qi to relieve its stagnation. The traditional Chinese medicine composition is combined for use, and has the effects of reducing qi and reducing phlegm, tonifying liver and kidney, invigorating spleen and excreting dampness, and inducing diuresis to alleviate edema, so that the blood fat is reduced, the weight is reduced, and the effect of losing weight is better achieved.

Modern medical research shows that obesity refers to a multifactorial chronic metabolic disease in which the intake of heat in a human body is larger than the consumption of heat, fat accumulation and/or distribution abnormality in the body are caused, and the weight is increased. Genetic factors, high calorie, high fat diet, and low physical activity are the main causes of obesity. Fat tissue is increased in obese people, the volume of fat cells is increased, and hyperlipidemia is often accompanied. The number of human adipocytes is essentially determined in nature. The main mechanism of treating obesity is to regulate metabolism, promote lipolysis, increase the utilization rate of sugar in blood, prevent the conversion of redundant sugar into fat and reduce the volume of fat cells. The composition of the invention is proved to contain more total anthraquinone components through inspection, wherein, the anthraquinone glucoside can reduce the absorption of cholesterol in intestinal tracts, increase the excretion, reduce the serum cholesterol level through feedback regulation of the metabolism of low-density lipoprotein, and delay and control the formation of atherosclerotic plaques.

The perilla seed and cassia seed composition with the weight-reducing effect can be added with auxiliary components and prepared into various dosage forms suitable for medicinal use according to the conventional technology of pharmaceutical science, wherein the dosage forms include but are not limited to capsules, tablets, powder and granules. Preferably, the preparation is a capsule, and the capsule has a shielding effect compared with other preparation, has high bioavailability, can be quickly absorbed in the stomach and intestine, can cover bad smell, prevent the preparation from being oxidized and absorbing moisture, is convenient to carry, can be stored and taken, can solve the influence of moisture and oxygen in the air on the medicinal ingredients, and can better improve and control the stability of the preparation.

The invention also provides a preparation method of the perilla seed and cassia seed composition capsule with the weight-losing effect, which comprises the following steps:

(1) cleaning fructus Perillae, semen Cassiae, radix Angelicae Dahuricae, radix Polygoni Multiflori Preparata, thallus laminariae, and Coicis semen;

(2) sterilizing Coicis semen, pulverizing, and sieving to obtain Coicis semen fine powder; preferably, the sterilization is microwave sterilization, and the sieving is 8-12 mesh sieving. Considering that the major functional components in coix seed, namely coixenolide and coixenolide, are easy to open and hydrolyze in water and are easy to lose by heating in alcohol, the method of pulverizing into fine powder and directly using as medicine is selected;

(3) placing radix Angelicae Dahuricae and radix Polygoni Multiflori Preparata in an extraction tank, adding ethanol, and reflux-extracting to obtain ethanol extractive solution and ethanol extractive residue; sequentially filtering and concentrating the alcohol extract to obtain a first clear paste; preferably, the mass concentration of the ethanol is 70-80%, and the temperature for reflux extraction is 80 ℃; said concentrating is carried out to a relative density of 1.30-1.32 at 60 ℃; carrying out reflux extraction for 2 times, wherein the material-liquid ratio of the first extraction is 1g:8mL, and the extraction time is 1.5-2.5 h; the ratio of the material to the liquid in the second extraction is 1g to 6mL, and the extraction time is 0.5-1.5 h. The coumarins such as imperatorin and angelica sinensis contained in the angelica dahurica and the active ingredients such as lecithin contained in the prepared polygonum multiflorum are completely extracted in alcohol, so that the two components are extracted by alcohol;

(4) putting perilla seeds, cassia seeds, kelp and the alcohol extraction residues obtained in the step (3) into an extraction tank, adding water for decoction and extraction to obtain water extract, and concentrating to obtain second clear paste; preferably, the temperature for adding water for extraction is 100 ℃; said concentrating is carried out to a relative density of 1.30-1.32 at 60 ℃; extracting with water for 2 times, wherein the ratio of the material to the liquid in the first extraction is 1g to 10mL, and the extraction time is 1.5-2.5 h; the ratio of the material to the liquid in the second extraction is 1g to 8mL, and the extraction time is 0.5-1.5 h. The water extraction of the perilla seeds, the cassia seeds and the kelp can extract more effective components of total anthraquinone, so the water extraction method is adopted for the components, and in addition, the further water extraction of the dregs of the decoction after the alcohol extraction in the step (3) can extract more components, so the weight-losing effect of the invention is further improved;

(5) mixing the fine powder of semen Coicis, the first fluid extract, and the second fluid extract, drying, pulverizing, and making into capsule to obtain the final product.

The invention has the beneficial effects that:

1. the perilla seed and cassia seed composition with the weight-losing effect contains various effective components including total anthraquinones, volatile oil, fatty oil and the like, and experiments prove that the composition has an obvious weight-losing effect. (a) The results of animal experiments show that: the weight gain of animals in each dose group is lower than that of the obesity model group, and the differences of the high and medium dose groups and the obesity model group are significant (P is less than 0.01 and P is less than 0.05); the body fat/body weight ratio of each dose group is lower than that of the obesity model group, and the body fat/body weight ratio of the high dose group and the medium dose group has significant difference (P is less than 0.01, P is less than 0.05) compared with that of the obesity model group; compared with the obesity model group, the food intake of animals in each dose group is not significant (P is more than 0.05); (b) the human body test food test result shows that: compared with a control group, the body fat content of a test group is obviously reduced (P is less than 0.05) before and after the test, the subcutaneous fat is prevented from being in four points, the thicknesses of subcutaneous fat beside the right umbilicus, the anterior superior iliac spine and the right deltoid muscle are obviously reduced, the waist image and the hip circumference are reduced, the difference is significant (P is less than 0.05) through statistical treatment, and the exercise endurance is not reduced; before and after the test, the red blood cells, the white blood cells, the hemoglobin, the glutamic-pyruvic transaminase, the glutamic-oxalacetic transaminase, the urea nitrogen, the creatinine and the blood uric acid of the tested person have no significant change (P is more than 0.05), and are in a normal range; urine ketone bodies, urine protein, urine glucose, urine cholangiogen, urine red blood cells and urine occult blood are all negative; the feces are normal; before the test, the chest X-ray, the electrocardiogram and the abdominal B-ultrasonic of the testee are all normal. Before and after the trial group experiment, no abnormality is found in spirit, sleep, diet, stool and urine, etc. In conclusion, the composition has a remarkable weight-losing effect, does not cause the change of food intake in the weight-losing process, and has no influence on the health of human bodies.

2. The perilla seed and cassia seed composition with the weight-losing effect is prepared by compounding 6 components which are homologous in medicine and food, is not added with any chemical synthesis substance, belongs to a pure natural weight-losing product, obviously reduces the burden of the liver compared with the traditional chemical weight-losing medicine, does not cause stomach discomfort in the process of taking, and is suitable for long-term taking.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be described in detail below. It is to be understood that the described embodiments are merely a few embodiments of the invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the examples given herein without any inventive step, are within the scope of the present invention. In the following examples, 1 part by weight represents 1 g.

Example 1

The embodiment provides a perilla seed and cassia seed composition capsule with a weight-losing effect, which comprises the following raw material components in parts by weight: 600 parts of perilla fruit, 375 parts of cassia seed, 225 parts of angelica dahurica, 150 parts of prepared fleece-flower root, 150 parts of kelp and 75 parts of coix seed.

The preparation method of the perilla seed and cassia seed composition capsule with the weight-losing effect comprises the following steps:

(1) selecting fructus Perillae, semen Cassiae, radix Angelicae Dahuricae, radix Polygoni Multiflori Preparata, thallus laminariae, and Coicis semen, and selecting the materials according to the requirement of the first part of pharmacopoeia of people's republic of China;

(2) sterilizing Coicis semen in microwave sterilizer (KMS-2000A) for 1 hr, pulverizing in universal pulverizer (GFSJ-16 type), and sieving with 10 mesh sieve to obtain Coicis semen fine powder;

(3) placing radix angelicae and radix polygoni multiflori preparata in a multifunctional extraction tank, adding 75% ethanol for reflux extraction for 2 times, wherein the material-liquid ratio of the first extraction is 1g:8mL, the extraction time is 2 hours, the material-liquid ratio of the second extraction is 1g:6mL, the extraction time is 1 hour, the extraction temperature is 80 ℃, filtering by using a stainless steel filter screen (with the specification of 100 meshes), merging ethanol extract, placing the ethanol extract in a DNLQ500 reduced pressure concentration tank for reduced pressure recovery of ethanol (the temperature is 60 ℃, the vacuum degree is 0.08MPa), continuously concentrating the solution to the relative density of 1.30-1.32 (60 ℃), obtaining a first clear paste, and storing the ethanol extract residues in another container for later use;

(4) putting perilla seeds, cassia seeds, kelp and the alcohol extraction residues obtained in the step (3) into an extraction tank, adding water, decocting and extracting for 2 times, wherein the material-liquid ratio of the first extraction is 1g to 10mL, the extraction time is 2 hours, the material-liquid ratio of the second extraction is 1g to 8mL, the extraction time is 1 hour, the extraction temperature is 100 ℃, and the extracting solution is put into a DNLQ500 reduced pressure concentration tank (the temperature is 80 ℃, the vacuum degree is 0.08MPa) and concentrated to the relative density of 1.30-1.32 (60 ℃) to obtain a second clear paste;

(5) mixing Coicis semen fine powder, the first fluid extract, and the second fluid extract, and drying in a low temperature vacuum drying oven (65 deg.C, vacuum degree of 0.06MPa) to obtain dry extract; putting the dry paste into a GFSJ-16 type universal pulverizer to be pulverized, sieving the pulverized dry paste by a sieve of 80 meshes, putting the pulverized dry paste into a CFM-1500A type full-automatic capsule filling machine to be filled into No. 0 capsules, wherein each capsule is 0.3g, the packaging material is a medicinal hollow capsule, and 0 is the perilla seed and cassia seed composition capsule with the weight-reducing function. Polishing the filled capsule in a (HPJ-II) capsule polishing machine. Randomly sampling 1% of the polished capsules in each batch, and testing to obtain capsules containing 150mg of total anthraquinone per 100g of the perilla seed and cassia seed composition capsules with weight reducing effect.

Example 2

The embodiment provides a perilla seed and cassia seed composition with a weight-reducing effect, which comprises the following raw material components in parts by weight: 400 parts of perilla fruit, 500 parts of cassia seed, 100 parts of angelica dahurica, 200 parts of prepared fleece-flower root, 100 parts of kelp and 90 parts of coix seed.

(2) sterilizing Coicis semen in microwave sterilizer (KMS-2000A) for 1 hr, pulverizing in universal pulverizer (GFSJ-16 type), and sieving with 8 mesh sieve to obtain Coicis semen fine powder;

(3) putting radix angelicae and radix polygoni multiflori preparata into a multifunctional extraction tank, adding 70% ethanol for reflux extraction for 2 times, wherein the material-liquid ratio of the first extraction is 1g:8mL, the extraction time is 1.5 hours, the material-liquid ratio of the second extraction is 1g:6mL, the extraction time is 0.5 hours, the extraction temperature is 80 ℃, filtering by a stainless steel filter screen (specification 100 meshes), merging the ethanol extract, putting the ethanol extract into a DNLQ500 reduced pressure concentration tank, recovering ethanol under reduced pressure (temperature 60 ℃, vacuum degree 0.08MPa), continuously concentrating the solution to the relative density of 1.30-1.32 (60 ℃), obtaining a first clear paste, and preserving the ethanol extract residues in another container for later use;

(4) putting perilla seeds, cassia seeds, kelp and the alcohol extraction residues obtained in the step (3) into an extraction tank, adding water, decocting and extracting for 2 times, wherein the material-liquid ratio of the first extraction is 1g to 10mL, the extraction time is 2.5 hours, the material-liquid ratio of the second extraction is 1g to 8mL, the extraction time is 1.5 hours, the extraction temperature is 100 ℃, putting the extracting solution into a DNLQ500 reduced pressure concentration tank (the temperature is 80 ℃, the vacuum degree is 0.08MPa), and concentrating the extracting solution to the relative density of 1.30-1.32 (60 ℃) to obtain a second clear paste;

(5) mixing Coicis semen fine powder, the first fluid extract, and the second fluid extract, and drying in a low temperature vacuum drying oven (65 deg.C, vacuum degree of 0.06MPa) to obtain dry extract; putting the dry paste into a GFSJ-16 type universal pulverizer to be pulverized, sieving the pulverized dry paste by a sieve of 80 meshes, putting the pulverized dry paste into a CFM-1500A type full-automatic capsule filling machine to be filled into No. 0 capsules, wherein each capsule is 0.3g, and the packaging material is a medicinal hollow capsule, thus obtaining the perilla seed and cassia seed composition capsule with the weight-reducing function.

Example 3

The embodiment provides a perilla seed and cassia seed composition with a weight-reducing effect, which comprises the following raw material components in parts by weight: 800 parts of perilla fruit, 200 parts of cassia seed, 300 parts of angelica dahurica, 100 parts of prepared fleece-flower root, 200 parts of kelp and 50 parts of coix seed.

(2) sterilizing Coicis semen in microwave sterilizer (KMS-2000A) for 1 hr, pulverizing in universal pulverizer (GFSJ-16 type), and sieving with 12 mesh sieve to obtain Coicis semen fine powder;

(3) putting radix angelicae and radix polygoni multiflori preparata into a multifunctional extraction tank, adding 80% ethanol for reflux extraction for 2 times, wherein the material-liquid ratio of the first extraction is 1g:8mL, the extraction time is 2.5 hours, the material-liquid ratio of the second extraction is 1g:6mL, the extraction time is 1.5 hours, the extraction temperature is 80 ℃, filtering by a stainless steel filter screen (specification 100 meshes), merging the ethanol extract, putting the ethanol extract into a DNLQ500 reduced pressure concentration tank, recovering ethanol under reduced pressure (temperature 60 ℃, vacuum degree 0.08MPa), continuously concentrating the solution to the relative density of 1.30-1.32 (60 ℃), obtaining a first clear paste, and preserving the ethanol extract residues in another container for later use;

(4) putting perilla seeds, cassia seeds, kelp and the alcohol extraction residues obtained in the step (3) into an extraction tank, adding water, decocting and extracting for 2 times, wherein the material-liquid ratio of the first extraction is 1g to 10mL, the extraction time is 1.5 hours, the material-liquid ratio of the second extraction is 1g to 8mL, the extraction time is 0.5 hours, the extraction temperature is 100 ℃, and the extracting solution is put into a DNLQ500 reduced pressure concentration tank (the temperature is 80 ℃, the vacuum degree is 0.08MPa) and concentrated to the relative density of 1.30-1.32 (60 ℃) to obtain a second clear paste;

Examples of the experiments

Safety toxicology test

1. Sample (I)

The capsule of the invention in the example 1 has the content of tan powder, the recommended dosage of 1.8 g/person/day for human body, and each dosage concentration is prepared by distilled water.

2. Laboratory animal

Secondary SD rats and Kunming mice (SCXK (military) -2002-005) provided by the fourth university of military medical science laboratory animal center were selected. Animals of the corresponding sex and weight were selected according to the needs of the test. The animal house quality certificate number is: the medical character No. 08-32, the temperature is 21-23 ℃, and the humidity is 45-50%. The feed and padding are provided by the experimental animal center of the fourth military medical university.

3. Acute oral toxicity test in mice

20 rats with half of male and female body weight of 186-213 g. The test was performed overnight for 16 hours before fasting, and the sample was administered to rats by gavage three times (4 hours apart) at a dose of 15.0g/kg · bw (corresponding to 500 times the recommended dose for human) according to the maximum tolerated dose method, and at a gavage capacity of 1.5ml/100g · bw. The animals were then observed for performance for 14 consecutive days.

4. Genotoxicity test

(1) Micronucleus test for mouse bone marrow cells

The weight of 50 mice is 25-30 g, the mice are randomly divided into 5 groups, each group comprises 10 mice, and the mice are female and male. The samples were divided into 3 dose groups of 6.27g/kg · bw, 3.14g/kg · bw, and 1.57g/kg · bw, and a negative control group (distilled water) and a positive control group (cyclophosphamide 40mg/kg · bw) were also included. The test object is administrated by oral gavage twice at an interval of 24 hours at a gavage capacity of 0.2ml/10g · bw, the animal is killed by dislocation of cervical vertebra 6 hours after the test object is administrated for the second time, the femoral bone marrow is taken for flaking, and the prescription test is carried out on the result after microscopic examination.

(2) Mouse teratospermia test

Male mice, 25-32 g in weight, were randomly divided into 5 groups of 5 animals each. The samples were divided into 3 dose groups of 6.27g/kg · bw, 3.14g/kg · bw, and 1.57g/kg · bw, and a negative control group (distilled water) and a positive control group (cyclophosphamide 40mg/kg · bw) were also included. The test substance was orally administered once a day for 5 consecutive days in a gavage capacity of 0.2ml/10g · bw. On the 35 th day after the test object is given for the first time, the cervical vertebra is dislocated to kill the animal, the epididymis on the two sides of the animal is taken to be filmed, and the result is subjected to chi fang inspection after microscopic examination.

(3) Contaminant mutagenicity detection (Ames test)

Strain: ames test standard strain was introduced by the disease prevention and control center of Henan province in 5 months in 2003. The strain identification is carried out by the laboratory according to the method of national standard GB15193.4-2003, 5 strains have good characteristics, and are stored in a liquid nitrogen tank for later use.

Liver S-9 was provided by the disease prevention and control center of Henan province in 2003, and the activity of the test results was good by testing positive control substances, and the test results were stored in a liquid nitrogen tank for later use. The test dosage of the mixed solution of the liver S-9 is 0.5 ml/dish.

The method comprises designing tested substance into five dosage groups of 8 ug/dish, 40 ug/dish, 200 ug/dish, 1000 ug/dish and 5000 ug/dish, adding natural back-changing control group, solvent control group (distilled water) and positive control group, and performing plate doping method Ames test on the sample with Ames test standard strains TA97, TA98, TA100 and TA102 with or without liver S-9 mixed solution. Three parallel dishes of each strain are made for each dose, each dish is added with 0.1ml of bacteria and the whole test is repeated twice. The test article was recorded as a colony which was more than twice as many as the colony of the solvent control group and was positive if it had a dose-response relationship.

5. Rat 30-day feeding test

80 SD rats with the body weight of 76-88 g are divided into 4 groups according to the body weight semi-randomly, wherein each group comprises 20 animals, and the female and male animals are half of each other. The test subjects were in 3 dose groups of 3.0g/kg · bw (corresponding to 100 times the recommended dose for human body), 15g/kg · bw and 0.75g/kg · bw, respectively. The gavage volume was 1.0ml/100g · bw, and the test substance (solvent control group with equal volume of distilled water) was gavage once a day for 30 consecutive days. Animals had free access to food and water, general performance of the animals was observed and recorded daily, body weight and food intake were weighed weekly, and food utilization was calculated. At the end of the test, the eye is pulled out to draw blood, and biochemical indexes (glutamic oxaloacetic transaminase, glutamic-pyruvic transaminase, urea nitrogen, total protein, albumin, total cholesterol, creatinine, triglyceride and blood sugar) of serum are measured by an American AG II type full-automatic biochemical analyzer. Hematological parameters (hemoglobin, red blood cell count, white blood cell count, differential white blood cell count, etc.) were determined using a full-automatic, Swedish AC-900+ -producing cytometer. Then, the experimental animals are killed after cervical vertebra removal and are roughly dissected, whether the abnormal condition exists or not is observed, visceral organs such as liver, kidney, spleen, stomach and intestine, testis and the like are taken and weighed, and the liver, kidney, spleen, stomach and intestine and testis (ovary) of the animals in the solvent control group and the animals in the high-dose group are fixed for histopathological examination. The data of the test results are subjected to variance analysis.

6. Experimental unit: disease prevention control center of Shaanxi province

7. Experiment summary

(1) Oral acute toxicity test in rats

No obvious toxic manifestation and death of the animals are found in the experimental observation period. As can be seen, the maximum acute oral tolerance dose (MTD) of the sample to male and female rats is more than 15.0 g/kg-bw, and the dose of the sample is 500 times of the recommended dose to human body.

(2) Genotoxicity test

(ii) micronucleus test of mouse bone marrow cells

The micronucleus rates of the male and female rat positive control groups are obviously higher than those of the negative control group, and the differences are highly significant (P is less than 0.01); the micronucleus rate of each dose group of the test object has no significance (P is more than 0.05) compared with that of a negative control group. That is, the sample is negative in the micronucleus test result of mouse bone marrow cells in the test dose range of 1.57 g/kg-bw to 6.27 g/kg-bw.

② mouse sperm malformation test

The sperm aberration rate of the positive control group mouse is obviously higher than that of the negative control group mouse, and the difference is highly significant (P is less than 0.01); the sperm aberration rate of mice in each dose group of the test object has no significance compared with that of a negative control group (P is more than 0.05). That is, the sample was negative in mouse teratospermia test result in a test dose range of 1.57 g/kg-bw to 6.27 g/kg-bw.

③ detection of mutagenicity of pollutants (Ames test)

The number of the bacterial strain retrogradation colonies in each dose group does not exceed twice of that of the solvent control group, and the number of the positive control group exceeds more than twice of that of the solvent control group. The Ames test is a negative result, which indicates that the sample has no mutagenesis effect within the range of 8 ug/dish to 5000 ug/dish of the test dose.

(3) Rat 30-day feeding test

No obvious toxic effect expression is found in rats in the observation period.

Influence on rat body weight

The body weight of the female and male mice in each period of each dose group has no significance compared with the body weight of the solvent control group (P is more than 0.05).

② influence on rat food utilization

Compared with the solvent control group, the total food utilization rate of each dose group of the female rat and the male rat has no significance (P is more than 0.05).

Influence on rat blood routine

Compared with the solvent control group, the conventional indexes of the blood of each dose group of the test object have no significance (P is more than 0.05).

Influence on biochemical index of rat

The biochemical indexes of each dose group of the tested substance and each solvent control group are within the normal reference value range of the laboratory, and no obvious pathological significance change is seen.

Pathology examination

a. Gross anatomical observation:

gross anatomy of each group of animals was tested without obvious abnormalities.

b. Effect on rat visceral weight and visceral/body ratio:

compared with the solvent control group, the results of the organ weight and the organ/body ratio of each dose group of the test object have no significance (P is more than 0.05).

c. Histopathological examination:

since no obvious lesion was observed in general examination of each major organ, only the high dose group and the solvent control group were selected for histopathological examination. It can be seen that in the high dose group, individual animals exhibited lobular hepatocyte swelling, vacuolation and granulosis; in the high dose group and the solvent control group, individual animals have renal tubular vacuolation and swelling of the renal cortex; individual animals in the solvent control group showed infiltration of gastrointestinal inflammatory cells. No obvious toxic change is observed in the organs of the female and male rats in the high-dose group.

8. Test results

The test results were judged according to the "technical standards for health food testing and evaluation" (2003 of Ministry of health) as follows:

(1) acute oral toxicity test in rats: the maximum oral tolerance dose (MTD) of the sample to female and male rats is more than 15.0 g/kg-bw, and the dose of the sample is 500 times of the recommended dose of human bodies.

(2) And (3) a genotoxicity test, namely the sample is negative to the mouse bone marrow cell micronucleus test, the mouse sperm malformation test and the pollutant mutagenicity detection (Ames test), namely the genotoxicity effect is not seen.

(3) The rat is fed for 30 days, and the sample has no obvious adverse effect on the test of various related indexes of growth and development, hematology, blood biochemistry and pathology of the test rat in the test dosage range of 0.75 g/kg-bw to 3.00 g/kg-bw (the highest dosage is equivalent to 100 times of the recommended dosage of a human body).

Animal experiment for weight-reducing effect

1. Sample (I)

The sample is the capsule of the invention example 1, the content is brown powder, the recommended amount for human body is 1.8 g/person/day, and the capsule is prepared by diluting with distilled water during the test.

2. Laboratory animal

The experimental animal center of the fourth military medical university provides 50 secondary male SD rats with the weight of 144-159 g, and the basic feed and the nutritional feed (80% of the basic feed, 10% of the lard oil and 10% of the egg yolk powder) are provided by the experimental animal center of the fourth military medical university. The certificate number is SCXK (2002) -005.

3. Laboratory environment

The laboratory animal house quality certificate number is No. 08-32 of the medical letters, the room temperature is 22-24 ℃, and the relative humidity is 45-55%.

4. Test method

The samples were set to three dose groups, high dose (0.60g/kg · bw), medium dose (0.30g/kg · bw), low dose (0.15g/kg · bw), and one obesity model group and solvent control group. Each group contained 10 rats. The dosage is respectively equivalent to 20 times, 10 times and 5 times of the recommended amount of human body. The test was performed according to the obesity prevention model method: the animals of the obesity model group and each dosage group were fed with nutritional feeds at the same time, and the daily feeds were given in a metered amount, while the solvent control group was fed with an equivalent amount of basal feed. Each dose group was administered with the test substance by oral gavage, and the control group was administered with an equal volume of solvent (distilled water) once a day for 30 consecutive days. Each group weighed twice a week, and food intake, remaining food intake and food scattering were recorded, and finally food utilization was calculated. At the end of the experiment, animals were sacrificed after weighing, and the testis and perirenal fat pads of each rat were dissected and weighed. Calculating body weight, body fat/body weight ratio, total food intake, and food utilization rate. After the obesity model is successfully established, comparing the two indexes of the body weight gain and the body fat/body weight ratio of each dosage group with the obesity model group respectively, and carrying out variance analysis.

5. And (4) experimental data processing, namely performing analysis of variance (SPSS statistical software) on the experimental result.

6. Experimental unit: disease prevention control center of Shaanxi province

7. The experiment summary:

(1) obesity model building results

The weight gain and body fat/weight ratio of rats in the obesity model group are obviously higher than those of the solvent control group, and the differences are highly significant (P is less than 0.01), which indicates that the obesity model is successfully established in the experiment.

(2) Effect on weight gain in rats

The weight gain of animals in each dose group is reduced to different degrees compared with a model control group by perfusing the rats with samples of different doses for 30 days, and the differences between the high and medium dose groups and the model control group are significant (P is less than 0.01 and P is less than 0.05).

(3) Effect on body fat/body weight in rats

Compared with the obesity model group, the food intake of animals in each dose group is not significant (P is more than 0.05).

(4) Effect on body fat/body weight in rats

The wet weight of perirenal fat pad, peritesticular fat pad and body fat/body weight ratio were lower in each dose group than in the obesity model group. And the difference between the wet weight of fat around the kidney and testis and the body fat/weight ratio of the high and medium dose groups and the obesity model group is significant (P is less than 0.01 and P is less than 0.05).

8. And (4) testing results:

(1) the experiment proves that the rat obesity model is successfully established.

(2) The weight gain of animals in each dose group is lower than that of the obesity model group, and the differences of the high and medium dose groups and the obesity model group are significant (P is less than 0.01 and P is less than 0.05).

(3) The body fat/body weight ratio of each dose group is lower than that of the obesity model group, and the body fat/body weight ratio of the high dose group and the medium dose group has significant difference (P is less than 0.01, P is less than 0.05) compared with the obesity model group.

(4) Compared with the obesity model group, the food intake of animals in each dose group is not significant (P is more than 0.05).

The results show that the results of the two indexes of the weight gain and the body fat/weight ratio of the rat are positive, and the animal food intake of each dosage group is not different from that of an obesity model group, so that the sample can be judged to have the weight-reducing effect according to the evaluation standard of health food inspection and evaluation technical specifications.

Human body test eating test with fat-reducing function

1. Sample (I)

In the example 1 of the invention, the content is brown powder, and the content is packaged by hard capsules, wherein the net weight of each capsule is 0.3g, and the recommended amount for human body is as follows: the dosage of the preparation is 2 times per day and 3 capsules per time, namely 1.80g per day, which is equivalent to the recommended amount of a 60kg body weight adult of 0.03g/kg · bw.

2. Test population

According to the voluntary principle, the following standard persons are selected as subjects to participate in the human body test feeding experiment.

(1) Subject selection criteria

(ii) simple obesity.

Secondly, the adult Body Mass Index (BMI) is more than or equal to 30, the total fat percentage reaches more than 25 percent for men and more than 30 percent for women, and the actually measured body weight of children and adolescents exceeds 20 percent of the standard body weight.

And thirdly, the female can be 18-65 years old.

And fourthly, voluntarily taking part in the clinical trial and signing an informed consent.

(2) Subject exclusion criteria

(ii) those under 18 years of age or over 65 years of age.

② pregnant or lactating women who are allergic to health food.

③ patients with serious general diseases such as cardiovascular diseases, liver diseases, kidney diseases, hemopoietic system diseases and the like and psychonoses.

Fourthly, the article related to the received function is taken in a short time, and the judgment of the butt joint is influenced.

Fifthly, the tested sample is not used according to the rule, and the efficacy or the safety judgment cannot be judged if the efficacy or the data are not complete.

3. Design of experiments and grouping requirements

The method for testing the weight-reducing function specified in the technical Specification for testing and evaluating health food is carried out. 110 subjects who met the inclusion criteria were randomized to double blind control (55:55) and 55 subjects who were fed placebo as tan powder in hard capsules and were of the same appearance, color and weight as the samples, based on the subjects' body weight and body fat content. Before the test, the balance test between the groups is carried out on the test group and the control group, wherein the comparative differences of the conditions such as age, sex, diet, exercise condition and the like have no significance (P is more than 0.05), and the test group and the control group have comparability. The subjects adopt a control group and a group control group to compare the changes of indexes such as body fat weight, subcutaneous fat thickness, waist circumference, hip circumference and the like before and after the test group and after the test of the test group and the control group.

4. Taking method, dosage and time

The experimental period of human body feeding test is 45 days, each subject takes 6 grains per day 2 times per day with 3 grains of warm boiled water, the original dietary habit and normal diet are not changed during the experimental period, and all health foods with similar functions to the product are stopped, and the taking observation time is 35 days.

5. Main instrument

Each index is tested once at the beginning and the end of the test feeding experiment, and fasting blood sugar is tested once on the 15 th day of the test feeding.

(1) Body fat content

Bioelectrical impedance apparatus (RJL-systems, BIA 101, Detroit, USA); subcutaneous fat thickness meter (six plants of automated instrumentation in the west of the river); exercise tolerance; power bicycles (Monark 818E, Varberg sweden); heart rate recorders (Sport-tester, PE3000, Fend).

(2) Measurement of other items

A red blood cell analyzer (SF-3000 produced in Japan), a urine analyzer (Youlite 3000 produced in Guilin), a full-automatic biochemical analyzer (Hitachi-7060 produced in Japan), a biochemical kit (Beijing Zhongsheng and Shanghai Kehua special for Hitachi-7060), an ultrasonic B machine (Hewlett packard apex image in America), an X-ray chest X-ray machine (HG 3200 type 800 mA produced in Shimadzu corporation in Japan), an electrocardiograph (Hewlett packard type in America), and the like are adopted.

6. Observation index

(1) Safety index

General conditions: subjects had mental status, dietary status, sleep, stool and urine, blood pressure, heart rate, etc. during the trial.

Routine blood examination: hemoglobin, red blood cell, white blood cell count; the routine of urine: urine ketone body, urine protein, urine sugar, urine red blood cell, urine occult blood, urine cholangiogen; the manure is conventional: glutamic-oxaloacetic transaminase, glutamic-pyruvic transaminase, urea nitrogen, creatinine and blood uric acid. Chest X-rays, electrocardiogram and abdominal B-ultrasound were examined once before the start of the test.

Testing the exercise endurance: the exercise endurance test method is a power bicycle test.

Before and after the test, the testee uses the same motion scheme to make a power bicycle test, and when the endurance of the testee is measured, the preset motion power is as follows: female 100 watts (equivalent to 2kg/50 rpm); male 120 watts (equivalent to 2kg/60 rpm). The 5 minute exercise heart rate was recorded using a telemetric heart rate recorder and the maximum oxygen uptake (L/min) was measured indirectly for each subject using Astrand and rxhmging nomography.

And fourthly, observing other adverse reactions: such as anorexia, diarrhea, etc.

(2) Dietary factor and exercise status observations

The subjects inquire about diet survey for three days before the test is started and finished, know about the diet condition during the test, easily put in the standard of 'Chinese resident' dietary nutrient reference intake amount '(2000 edition) provided by the national nutrient association, and divide the diet condition of all the subjects into three groups according to the conditions of the subjects' main nutrient intake amount, age, sex, exercise amount, constitution and the like: the low intake group, i.e. the intake of primary nutrients such as carbohydrates, fats, proteins, vegetables per day, reaches or falls below the average demand (EAR); the group of medium intakes, i.e. intakes of major nutrients between the average required and the highest tolerable intake (UL); the high intake group, i.e. the intake of the primary nutrient is higher than the highest tolerable intake. The effect of dietary factors on the test results was not excluded, requiring the test period to be as consistent as possible with a daily diet.

Inquiring and observing the motion conditions of the testees during the test, and dividing all the testees into three groups according to the exercise amount of the testees according to the division standard of the heat energy consumption rate of different intensity labor items proposed by the Chinese academy of nutrition: a light physical exercise group, i.e. reaching or falling below light labor intensity; middle-strength sports group. Thereby achieving medium labor intensity; the heavy physical exercise group can reach or exceed the heavy labor intensity. In order to eliminate the influence of motion factors on the experimental results, the experimental period is required to be consistent with daily motion.

(3) Index of efficacy

Weight, height, waist circumference (around the umbilicus) and hip circumference, and Body Mass Index (BMI), standard weight and overweight are calculated.

Measuring the thickness of the fat in the body and the subcutaneous fat: the body fat content was measured using a bioelectrical impedance and the skin fold thickness at four sites specified in "health food inspection and evaluation specifications" was measured using a subcutaneous and fat thickness meter.

7. Analysis of test data

Calculating the mean value and standard deviation of each index of the testee before and after the test, adopting paired t test in the test group, carrying out homogeneity test on the variance between the groups, adopting grouped t test on the homogeneity of the variance, and considering that the difference has significance when the P value is less than 0.05. The categorical variable data was examined using the X2 test.

8. Experimental unit: disease prevention control center of Shanxi province of Shanxi traditional Chinese medicine college subsidiary hospitals

9. The experiment summary:

(1) general conditions

Comparing the age and sex of the test group with the control group

105 subjects completed the trial, 53 of which in the dietary cohort were male 15, female 38; control group 52, 14 men and 38 women; the test is carried out by adopting an X2 test, and the sex constitution difference between the test group and the control group is not significant (P is more than 0.05) and is comparable. The average age of the test group is 36.26 plus or minus 9.69 years; the mean age of the control group was 35.84 ± 10.07 years; the homogeneous variance test is carried out among groups, the homogeneous variance can be proved, and the group t test is adopted, so that the age constitution difference between the test group and the control group is not significant (P is more than 0.05) and is comparable.

② comparison of dietary status of subjects during the test period

Compared with the diet status of the subjects during the test, the diet status of the two groups of subjects has no significant difference (P > 0.05) in composition and is comparable.

Third, the movement status of the tested person is compared during the test period

The exercise conditions of the subjects are compared during the test, and the two groups of exercise conditions have no significant difference in composition (P > 0.05) and are comparable.

And fourthly, the testee is normal in spirit and sleep, and has no abnormality in chest penetration, abdominal B-ultrasonic and electrocardiogram before the test.

(2) Safety observation index

The routine and biochemical index change conditions of the blood before and after the test are:

comparison of erythrocyte, leukocyte count, hemoglobin content, glutamic-pyruvic transaminase, glutamic-oxalacetic transaminase, urea nitrogen, creatinine, and blood uric acid before and after the test in 105 subjects showed no significant difference (P > 0.05), and all were in the normal range.

Second, the routine change conditions of urine and feces before and after the test:

105 subjects who were negative in urine normal examination before and after the test for urine ketone bodies, urine protein, urine glucose, erythrocytes, urinary occult blood and urinary cholangiogen; routine examination of feces shows no abnormality.

③ the change conditions of the body weight, the body fat content and the percentage body fat content before and after the test:

compared with the control group, the weight, the body fat content and the percentage of the body fat of the test group are obviously reduced, and the difference is significant (P is less than 0.05).

Fourthly, the change conditions of the subcutaneous fat thickness and the circumference diameter before and after the test:

compared with the control group, the subcutaneous fat prevention point in the test group before and after the test is obviously reduced in the subcutaneous fat prevention point, the subcutaneous fat thickness of the right periumbilical part, the right anterior superior iliac spine and the right deltoid muscle is obviously reduced, the waist image and the hip circumference are reduced, and the difference is significant (P is less than 0.05) after statistical treatment.

The change situation of the endurance of the front and back sports is tested:

compared with the control group, the exercise endurance of the test group is not obviously reduced (P is more than 0.05) by self comparison before and after the test and comparison of the test group and the control group after the test.

10. Test results

A double blind self and placebo-controlled design was used. The 110 individuals without organic diseases and admitted to standard obesity patients were randomly divided into two groups of 55 individuals, namely a test group and a control group, wherein the test group takes the sample and the control group takes placebo, 3 granules are taken at a time, 2 times a day, and the observation time is 35 days. The test result is separated from 5 cases of testers because the testers cannot insist on taking the product, wherein 2 cases of the test group are taken as a test, and 3 cases of the control group are taken as a control. The experiment was actually completed in 105 cases, 53 cases in the test group and 52 cases in the control group. Through statistics, compared with a test group before and after a test and a test group after the test and a control group, the body fat content is obviously reduced (P is less than 0.05), the subcutaneous fat thickness of the right periumbilical cord, the right anterior superior iliac spine and the right deltoid muscle is obviously reduced in the subcutaneous fat prevention four-point, the waist image and the hip circumference are reduced, the difference is significant (P is less than 0.05) through statistical treatment, and the exercise endurance is not reduced. Before and after the test, the red blood cells, the white blood cells, the hemoglobin, the glutamic-pyruvic transaminase, the glutamic-oxalacetic transaminase, the urea nitrogen, the creatinine and the blood uric acid of the tested person have no significant change (P is more than 0.05), and are in a normal range; urine ketone bodies, urine protein, urine glucose, urine cholangiogen, urine red blood cells and urine occult blood are all negative; the feces are normal; before the test, the chest X-ray, the electrocardiogram and the abdominal B-ultrasonic of the testee are all normal. Before and after the test, the group of trial food does not have abnormality in spirit, sleep, diet, stool and urine, and the like, the diet is normal during the test, the original diet habit is not changed, and the exercise condition is consistent with the daily exercise during the test. The sample has no influence on human health. According to the judgment standard of 'health food inspection and evaluation technical specification', the sample is considered to have the function of losing weight.

IV, agonist detection

1. Sample (I)

The sample is the capsule of the invention example 1, the content is tan powder, 0.3 g/granule, and the capsule is stored in a cool and dry place.

2. Detecting items

World irritants agency disabling drugs

3. Inspection unit

Analeptic detection center of national institute of sports medicine

4. The result of the detection

The sample is tested, and no stimulant, anesthetic, beta-blocker, diuretic and hormone medicine which are forbidden according to the specification of the international Oersstandards in 2005 are found.

Fifth, hygiene test, efficacy component test, stability test

1. Sample preparation: the capsules of the embodiment 1 of the invention are 0.3g per capsule and are stored at normal temperature.

2. The inspection basis is as follows: GB/T5009 food hygiene physicochemical inspection method, pharmacopeia 2000 edition, detection method for health food effective components, GB4789-2003 inspection method for food hygiene microorganisms, etc.

3. The inspection mechanism comprises: disease prevention control center of Shaanxi province

4. And (4) testing results:

(1) and (3) hygiene examination: the sample is tested according to the method specified in the national standard, and the result shows that the relevant indexes of the sample hygiene conform to the national standard.

(2) And (4) functional component inspection, namely performing a three-month heat preservation experiment on the sample at 38 +/-1 ℃ and 75% relative humidity, and prompting that the quality of the inspected index is stable through functional component project inspection.

(3) And (3) accelerated stability test: the sample is subjected to a three-month heat preservation experiment at the temperature of 38 +/-1 ℃ and the relative humidity of 75 percent, and the physicochemical and microbial detection shows that the quality of the detected index is stable.

The above description is only for the specific embodiments of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present invention, and all the changes or substitutions should be covered within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the appended claims.

Claims

1. The composition of perilla seed and cassia seed with the weight-losing effect is characterized by comprising the following raw material components in parts by weight:

800 parts of perilla fruit, 500 parts of cassia seed, 100 parts of angelica dahurica, 200 parts of prepared fleece-flower root, 200 parts of kelp and 50-90 parts of coix seed.

2. The composition of perilla seed and cassia seed with the weight-losing effect as claimed in claim 1, which is characterized by comprising the following raw material components in parts by weight:

600 parts of perilla fruit, 375 parts of cassia seed, 225 parts of angelica dahurica, 150 parts of prepared fleece-flower root, 150 parts of kelp and 75 parts of coix seed.

3. The composition of perilla seed and cassia seed with weight-reducing effect as claimed in claim 1, wherein the composition of perilla seed and cassia seed with weight-reducing effect is in the form of any one of capsule, tablet, powder and granule.

4. The preparation method of the perilla seed and cassia seed composition capsule with the weight-losing effect as claimed in claim 3 is characterized by comprising the following steps:

(2) sterilizing Coicis semen, pulverizing, and sieving to obtain Coicis semen fine powder;

(3) placing radix Angelicae Dahuricae and radix Polygoni Multiflori Preparata in an extraction tank, adding ethanol, and reflux-extracting to obtain ethanol extractive solution and ethanol extractive residue; sequentially filtering and concentrating the alcohol extract to obtain a first clear paste;

(4) putting perilla seeds, cassia seeds, kelp and the alcohol extraction residues obtained in the step (3) into an extraction tank, adding water for decoction and extraction to obtain water extract, and concentrating to obtain second clear paste;

5. The preparation method of the perilla seed and cassia seed composition capsule with the weight-losing effect according to claim 4, wherein in the step (2), the sterilization is microwave sterilization, and the sieving is 8-12 mesh sieving.

6. The method for preparing the perilla seed and cassia seed composition capsule with the weight-losing effect according to claim 4, wherein in the step (3), the mass concentration of the ethanol is 70-80%, and the temperature for performing the reflux extraction is 80 ℃; the concentration is carried out to a relative density of 1.30-1.32 at 60 ℃.

7. The method for preparing the perilla seed and cassia seed composition capsule with the weight-losing effect according to claim 4, wherein in the step (3), the reflux extraction is carried out for 2 times, the material-liquid ratio of the first extraction is 1g to 8mL, and the extraction time is 1.5-2.5 h; the ratio of the material to the liquid in the second extraction is 1g to 6mL, and the extraction time is 0.5-1.5 h.

8. The method for preparing the perilla seed and cassia seed composition capsule with the weight-losing effect according to claim 4, wherein in the step (4), the temperature for adding water for extraction is 100 ℃; the concentration is carried out to a relative density of 1.30-1.32 at 60 ℃.

9. The method for preparing the perilla seed and cassia seed composition capsule with the weight-losing effect according to claim 4, wherein in the step (4), the water is added for extraction for 2 times, the material-liquid ratio of the first extraction is 1g to 10mL, and the extraction time is 1.5-2.5 h; the ratio of the material to the liquid in the second extraction is 1g to 8mL, and the extraction time is 0.5-1.5 h.

10. The method for preparing the perilla seed and cassia seed composition capsule with the weight-losing effect as claimed in claim 4, wherein in the step (4), each 100g of the perilla seed and cassia seed composition capsule with the weight-losing effect contains not less than 150mg of total anthraquinone.