CN109316490B - Pharmaceutical composition with weight-losing effect, preparation and application of pharmaceutical composition - Google Patents
Pharmaceutical composition with weight-losing effect, preparation and application of pharmaceutical composition Download PDFInfo
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- CN109316490B CN109316490B CN201811420283.XA CN201811420283A CN109316490B CN 109316490 B CN109316490 B CN 109316490B CN 201811420283 A CN201811420283 A CN 201811420283A CN 109316490 B CN109316490 B CN 109316490B
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Classifications
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- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
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Abstract
The invention discloses a pharmaceutical composition with a weight-losing effect, a preparation and application thereof. The pharmaceutical composition comprises the following components: 30-70 parts of sucrose sulfate aluminum, 20-60 parts of enteric polymer and 5-10 parts of nano silicon oxide. The pharmaceutical composition preparation comprises the pharmaceutical composition and auxiliary materials, wherein the auxiliary materials are selected from carriers, diluents or flavoring agents of medicines or foods, and the preparation is used for preparing powder, granules, capsules or tablets. The weight-losing tea is simple in formula, synergistically reduces gastrointestinal absorption to achieve the purpose of losing weight, can be used for losing weight of obese people, controlling diet of patients with diabetes, hyperglycemia and hyperlipidemia, losing weight of healthy people and the like, and is suitable for people of all ages to take.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to a pharmaceutical composition with a weight-losing effect, a preparation and application thereof.
Background
Obesity is a physiological condition caused by excessive accumulation of body fat, especially triglycerides, and is a phenomenon in which a certain amount of body weight is significantly overweight and a fat layer is too thick. With the improvement of living standard of people, the obese people are continuously enlarged, and the physical and psychological health of people is seriously influenced. Obesity is one of the risk factors for hyperglycemia and diabetes (especially type 2 diabetes) and is also a major factor in the induction of hyperlipidemia. In addition, with the increase of life pressure, fierce work competition, propaganda of media advertisement and improvement of aesthetic requirements, people do not pay attention to the internal maintenance of individuals any more, and have urgent needs for improving external images, and have higher promises for good external images of both self and other people.
Under the various conditions, a weight-losing market with huge potential is developed in China. At present, the types of weight-reducing products popular in the market of China are many, and the weight-reducing products are mainly divided into the following categories: the weight-losing medicines, weight-losing health products, weight management foods, weight-losing instruments, weight-losing external products and the like are various, and the medicines and the health products are mainly used. The medicine mainly contains sibutramine, orlistat and other components, such as cericne, trametes and the like, and the weight-losing purpose is achieved mainly through ways of reducing appetite, enhancing satiety, inhibiting food absorption of gastrointestinal tracts, promoting energy consumption, increasing metabolism and the like. Research shows that more than 270 health foods with weight-reducing function exist in the currently approved health foods, some of the health foods are not on the market or are eliminated in a strong market competition in the near future, and the number of health-care and weight-reducing products which are actually sold is relatively small. The weight management food mainly exists in the form of meal replacement products, but the food can really reduce energy intake and ensure less and fewer products with nutritional requirements, and the meal replacement food is often poor in taste and difficult for consumers to insist on taking for a long time. Thus, obese patients, diabetes, hyperglycemia, hyperlipidemia, and other people in need of dietary control need a safe and healthy product that effectively reduces food absorption and thereby achieves weight control.
Disclosure of Invention
In order to solve the problems in the background art, the invention provides a pharmaceutical composition with a weight-losing effect, a preparation and an application thereof, which can realize weight control by reducing the absorption of food in the gastrointestinal tract or avoid the absorption of specific food components so as to meet the requirements of obese patients, diabetes patients, hyperglycemia patients, hyperlipidemia patients and other people needing diet control.
The technical scheme adopted by the invention is as follows:
a pharmaceutical composition with weight reducing effect
The pharmaceutical composition comprises the following components: 30-70 parts of sucrose sulfate aluminum, 20-60 parts of enteric polymer and 5-10 parts of nano silicon oxide.
The parts may be in the weight units commonly used in the art, such as milligrams (mg), grams (g), kilograms (kg), and the like, or may be in any other numerical weight unit.
The enteric polymer is preferably one or more of hydroxypropyl methylcellulose phthalate, acrylic resin II, acrylic resin III, Eudragit RL/RS type, NE30D, Eudragit S100, Eudragit L100 and Eudragit FS 30D.
Secondly, a preparation based on the pharmaceutical composition
Comprises the pharmaceutical composition and auxiliary materials.
The auxiliary material is selected from carriers, diluents or flavoring agents of medicines or foods, and preferably is selected from one or more of sweetening agents, souring agents, flavoring agents, filling agents, binding agents or lubricating agents.
Wherein the sweetener is selected from sucrose, glucose, lactose, sorbitol, xylitol, isomalt, crystalline fructose, mogroside, stevioside, etc.; the sour agent is selected from citric acid or malic acid, etc.; the flavoring agent is selected from natural essence such as blueberry essence, sweet orange essence, etc.; the filler is selected from powdered sugar, fruit powder, starch, dextrin, cyclodextrin, calcium sulfate dihydrate, calcium phosphate, calcium carbonate or microcrystalline cellulose. The adhesive is selected from starch, alginic acid and salts thereof, methylcellulose, sodium carboxymethylcellulose, ethylcellulose or polyvinylpyrrolidone and the like; the lubricant is selected from magnesium stearate, zinc stearate, talcum powder, sodium dodecyl sulfate, silicon dioxide and the like; the preparation is used for preparing powder, granules, capsules or tablets, and can also be other oral dosage forms which are conventionally used in the field.
Third, application of the pharmaceutical composition or preparation
Can be used for preparing diet-controlling medicines for people with obesity or diabetes, hyperglycemia, and hyperlipemia.
The invention has the beneficial effects that:
1) the inventor unexpectedly finds that the combination of the raw materials can realize excellent control effect on gastrointestinal absorption, and when the proportion of the combination is the proportion of the invention, the gastrointestinal absorption is lower and the weight control effect is better.
2) The weight-losing tea is simple in formula and wide in application, can be used for losing weight of obese people, controlling diet of patients with diabetes, hyperglycemia and hyperlipidemia, losing weight of healthy people and the like, and is suitable for people of all ages to take.
Detailed Description
The principles and features of this invention are described below in conjunction with examples which are set forth to illustrate, but are not to be construed to limit the scope of the invention.
Example 1: the weight-reducing effect of the combination of the sucrose sulfate aluminum, the enteric polymer and the nano silicon dioxide is proved.
1. Optimization of experimental animal model by obesity prevention model method
Feeding a maintenance feed to all rats under a barrier system for 7 days, and randomly dividing the rats into a blank group and a model group according to the weight after the adaptation period of 7 days is finished, wherein the blank group is the rats given the maintenance feed, and the model group is the rats given a high-calorie feed; the food intake, feed amount, food remaining amount, and body weight were recorded daily. After feeding for 2 weeks, the rats in the model group are sorted according to weight gain, obesity resistant rats with lower weight gain are eliminated, the screened rats sensitive to obesity are used as an experimental group, and the rats in the experimental group are randomly divided into a test group and a control group according to weight.
2. Design of experimental groups
Dividing blank component into blank control group and blank experiment group
Blank control group (10 rats): administration maintenance feed
Blank experimental group 1(10 rats): administration maintenance feed and pharmaceutical composition 1
Blank experiment group 2(10 rats): administration of maintenance feed and control pharmaceutical composition 1
Dividing the experimental components into experimental blank group, experimental group and control group
Experimental blank group (10 rats): feeding high calorie
Test group 1(10 rats): administration of high calorie feed and pharmaceutical composition 1
Test group 2(10 rats): administration of high calorie feed and pharmaceutical composition 2
Test group 3(10 rats): administration of high calorie feed and pharmaceutical composition 3
Test group 4(10 rats): administration of high calorie feed and pharmaceutical composition 4
Test group 5(10 rats): administration of high calorie feed and pharmaceutical composition 5
Control group 1(10 rats): administration of high calorie feed, control pharmaceutical composition 1
Control group 2(10 rats): administration of high calorie feed, control pharmaceutical composition 2
Control group 3(10 rats): administration of high calorie feed, control pharmaceutical composition 3
Control group 4(10 rats): administration of high calorie feed, control pharmaceutical composition 4
Control group 5(10 rats): administration of high calorie feed, control pharmaceutical composition 5
Control group 6(10 rats): administration of high calorie feed, control pharmaceutical composition 6
The ingredients of the pharmaceutical composition are shown in table 1.
Table 1: pharmaceutical composition ingredient (%)
3. Dosing regimens
During the administration period, the feed is maintained for 3 times a day and 1 hour each time by the blank control group and the blank experiment group; all experimental groups (5 test groups, 6 control groups, 1 experimental blank) were given high-calorie feed 3 times daily for 1 hour each time. Meanwhile, different drug composition samples (60mg/kg) were gavaged half an hour before meals in the blank test group, the test group and the control group, the test sample was administered for 4 weeks, and the body weight was recorded 1 time per week.
4. Results of the experiment
4.1 the effect of each experimental group and blank group on the body weight of obese sensitive rats in each week, the results are shown in Table 2.
TABLE 2 Effect of the groups on the body weight of obesity-sensitive rats
From table 2 it can be derived:
1) the body weights of the 5 test groups at 2 weeks and 4 weeks are both greatly lower than those of the experimental blank group and the blank control group, and the statistical significance is achieved.
2) The comparison of the weight results of the test group 1 and the control group 1 shows that the sucrose sulfate aluminum has the weight control effect, the comparison of the weight results of the test group 2 and the control group 2 shows that the enteric polymer has the weight control effect, and the comparison of the weight results of the test group 3 and the control group 2 shows that the nano silicon dioxide has the weight control effect.
3) The pharmaceutical composition with the weight-losing effect can play a good role in controlling the body weight of rats whether eating normal diet or high-calorie diet.
Example 2: powder preparation
1. The raw materials comprise: 60g of sucrose sulfate aluminum, 120g of hydroxypropyl cellulose phthalate, 20g of nano silicon dioxide and 5g of Arabic gum.
2. The preparation method comprises the following steps: weighing sucrose sulfate aluminum, hydroxypropyl cellulose phthalate, nano silicon dioxide and Arabic gum according to the raw material composition formula, sieving and uniformly mixing to obtain powder.
Example 3: granules
1. The raw materials comprise: 140g of sucrose sulfate aluminum, 40g of cellulose acetate phthalate, 20g of nano silicon dioxide, 36g of lactose and 4g of mogroside.
2. The preparation method comprises the following steps:
1) respectively weighing sucrose aluminum sulfate, cellulose acetate phthalate, nanometer silicon dioxide, lactose and mogroside according to the above proportion, mixing well, and sieving.
2) Making soft material with 60% (m/v) ethanol as binder, making wet granule with a swing granulator, and drying at about 50 deg.C in oven to obtain granule.
Example 4: capsule preparation
1. The raw materials comprise: 100g of sucrose sulfate aluminum, 90g of acrylic resin II, 10g of nano silicon dioxide, 50g of microcrystalline cellulose and 2g of magnesium stearate.
2. The preparation method comprises the following steps: the sucrose sulfate aluminum, the acrylic resin II, the nano silicon dioxide, the microcrystalline cellulose and the magnesium stearate are weighed according to the proportion respectively, sieved and mixed uniformly, and prepared into capsules.
Example 5: tablet formulation
1. The raw materials comprise: 115g of sucrose sulfate aluminum, 70g of hydroxypropyl cellulose phthalate, 50g of microcrystalline cellulose, 2.5g of polyvinylpyrrolidone and 3.0g of magnesium stearate.
2. The preparation method comprises the following steps: respectively weighing sucrose sulfate aluminum, hydroxypropyl cellulose phthalate and microcrystalline cellulose according to the proportion, sieving and mixing uniformly, adding a proper amount of polyvinylpyrrolidone ethanol solution to prepare a soft material, granulating with a 16-mesh sieve, drying at 50 ℃, granulating with the 16-mesh sieve, adding magnesium stearate, mixing uniformly, and tabletting.
Example 6: the function of the medicine composition of the invention for reducing weight of human body is proved.
The product of example 4 was applied to 30 persons with symptoms of obesity, and selected subjects were selected under the following conditions: (1) the product is voluntarily accepted for testing; (2) the age is 25-60 years; (3) all had symptoms of obesity, with 16 women and 14 men.
Other weight-reducing medicines and other weight-reducing measures are required to be stopped during the use period of the product, and each person takes the product 3 times a day, 2 grains each time and half an hour before a meal. The test subjects took the product of example 4 for 30 consecutive days. The results showed that the weight loss of the subject ranged from 2.56 to 2.84kg after 30 consecutive days of administration to 30 subjects.
All documents referred to herein are incorporated by reference into this application as if each were individually incorporated by reference. Furthermore, it should be understood that various changes and modifications of the present invention can be made by those skilled in the art after reading the above teachings of the present invention, and these equivalents also fall within the scope of the present invention as defined by the appended claims.
Claims (6)
1. The pharmaceutical composition with the weight-losing effect is characterized by comprising the following components: 30-70 parts of sucrose sulfate aluminum, 20-60 parts of enteric polymer and 5-10 parts of nano silicon oxide.
2. The pharmaceutical composition with weight-reducing effect according to claim 1, wherein the enteric polymer is one or more of hypromellose phthalate, acrylic resin II, acrylic resin III, Eudragit RL/RS type, NE30D, Eudragit S100, Eudragit L100, Eudragit FS 30D.
3. A preparation based on the pharmaceutical composition of any one of claims 1-2, which comprises the pharmaceutical composition and an adjuvant.
4. The formulation according to claim 3, wherein the adjuvant is selected from the group consisting of carriers, diluents or flavoring agents for pharmaceuticals or food products.
5. The formulation of claim 3, wherein the formulation is used to make a powder, granule, capsule or tablet.
6. Use of a pharmaceutical composition according to any one of claims 1-2 or a formulation according to any one of claims 3-5 for the manufacture of a medicament for the diet control of a weight-loss person or a diabetic, hyperglycemic, or hyperlipidemic subject.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20110105223A (en) * | 2010-03-18 | 2011-09-26 | 일양약품주식회사 | Oral pharmaceutical composition for preventing or treating a gastroenteric disease comprising ilaprazole and a mixture of sucralfate and bismuth agents |
| WO2014151565A1 (en) * | 2013-03-15 | 2014-09-25 | The Brigham And Women's Hospital, Inc. | Compounds to modulate intestinal absorption of nutrients |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20110105223A (en) * | 2010-03-18 | 2011-09-26 | 일양약품주식회사 | Oral pharmaceutical composition for preventing or treating a gastroenteric disease comprising ilaprazole and a mixture of sucralfate and bismuth agents |
| WO2014151565A1 (en) * | 2013-03-15 | 2014-09-25 | The Brigham And Women's Hospital, Inc. | Compounds to modulate intestinal absorption of nutrients |
Non-Patent Citations (1)
| Title |
|---|
| 3种便秘模型的比较研究;黄小丽等;《四川动物》;20150128(第34卷第1期);全文 * |
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