CN103284146B - L-carnitine tea polyphenol tablet and preparation method thereof - Google Patents
L-carnitine tea polyphenol tablet and preparation method thereof Download PDFInfo
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Abstract
The invention relates to an L-carnitine tea polyphenol tablet. The L-carnitine tea polyphenol tablet has a stable weight-losing effect, does not have toxin and side effect and is used for solving the problems in the conventional weight-losing medicines that Western medicines have untoward effects and relatively large accompanying side effects; and after the weight is lost by utilizing traditional Chinese medicines, the rebounding easily occurs, and the action effect is not durable. The L-carnitine tea polyphenol tablet is prepared from the following components in parts by weight: 405-495 parts of L-carnitine tartrate, 90-110 parts of lotus leaf extractives, 45-55 parts of tea polyphenol, 338.4-413.6 parts of microcrystalline cellulose, 112.5-137.5 parts of cross-linking povidone, 75.6-92.4 parts of Copovidone, 6.75-8.25 parts of silicon dioxide, 6.75-8.25 parts of magnesium stearate and 18-22 parts of film coating agents. The invention further relates to a preparation method of the L-carnitine tea polyphenol tablet. According to the L-carnitine tea polyphenol tablet, the advantages of the Western medicines and the traditional Chinese medicines are combined; and the L-carnitine tea polyphenol tablet is widely suitable for use by congenital and postnatal obese people.
Description
Technical field
The present invention relates to and a kind ofly there is stable curative effect on obesity and the compound functional health product had no side effect, particularly a kind of L-carnitine tea polyphenol tablet and preparation method thereof.
Background technology
Worldwide, fat number raises just with surprising rapidity, has now become the global major hidden danger affecting public health.Because it is difficult to cure completely, people are defined as a kind of chronic disease and are studied.
Obesity is whole body endocrine metabolism type disease, and it, to cause of disease element more complicated, comprises the reciprocations such as heredity, environment, life style, the increase of body fat cell or adipocyte is increased, causes fat excessively to accumulate the morbid state formed.Fat not only affect people figure, image and daily routines; also can threaten healthy; it not only can cause known " obesity " such as gall stone, diabetes, hyperlipidemic conditions, cardiovascular and cerebrovascular obstacle, angina pectoris miocardial infarctions, also easily brings out kinds cancer, cholecystitis, respiratory disease etc. more than 30 and plants complication.
Fat-reducing medicine popular is at present divided into the large class of Western medicine and Chinese medicine two, the chemicals that its Chinese and Western medicine is is representative with such as sibutramine or Orlistat, although there is significant fat-reducing effect fast, the bad reaction that chemicals is intrinsic and adjoint side effect larger; The advantage that bad reaction is few although traditional Chinese medicine capable of reducing weight has, side effect is little, the problems such as its existence easily rebounds after producing effects, action effect is not lasting.
Summary of the invention
The technical problem to be solved in the present invention is the above-mentioned defect how overcoming prior art, provides a kind of and has no side effects and L-carnitine tea polyphenol tablet stablizing fat-reducing effect and preparation method thereof.
For solving the problems of the technologies described above, this L-carnitine tea polyphenol tablet, is characterized in that: active ingredient is prepared by shown weight portion by following supplementary material:
Design like this, L-carnitine-L-tartrate, Tea Polyphenols, Lotus Leafextract three kinds is utilized to have the composition of stable lasting fat-reducing effect, be equipped with the multiple auxiliary materials such as the microcrystalline cellulose of no side effects, PVPP, copolyvidone, silica, dolomol, consolidate the drug effect of active ingredient, control bounce-back.Make it on the basis having no adverse reaction and have no side effect, have and stablize and lasting fat-reducing effect.
As optimization, film coating agent is prepared by shown weight portion by following supplementary material:
Hydroxypropyl methylcellulose: 12.6 ~ 15.4 talcum powder: 3.6 ~ 4.4
Glyceryl triacetate: 1.8 ~ 2.2.
Design like this, because L-carnitine-L-tartrate, Tea Polyphenols, Lotus Leafextract three kinds of compositions all have stronger moisture absorption, external application dressing becomes damp and rotten to prevent product.
As optimization, the formula of every 1000 these L-carnitine tea polyphenol tablet is:
The preparation method of this L-carnitine tea polyphenol tablet comprises the following steps:
1) mix:
L-carnitine-L-tartrate, Lotus Leafextract, Tea Polyphenols, microcrystalline cellulose, copolyvidone, PVPP, silica, dolomol are added in mixer by aforesaid formula ratio and mixes 20-30 minute;
2) compressing tablet:
Carry out compressing tablet with tablet press machine, sheet is heavily 1.2g/ sheet;
3) dressing:
(1) syrup preparation
1. in pot with slurry, add the purified water calculated by aforesaid formula ratio;
2. start stirring, each for film coating agent constituent is added in pot with slurry, stir 30-45 minute;
(2) plain coating tablets
Sent in coating pan by plain sheet, adjust the distance between spray gun and sheet bed, spray gun is positioned at coating pan middle, adjusts atomizing pressure 0.4 ~ 0.7Mpa; Plain sheet preheating is adjusted EAT 71 DEG C ~ 82 DEG C, temperature of outgoing air 40 DEG C ~ 46 DEG C, sheet bed tempertaure 39 DEG C ~ 41 DEG C after 5 ~ 10 minutes, dressing is carried out by film forming rotating speed 2 ~ 3.5 revs/min in early stage, after dressing to unilateral basic film forming, solid colour, be that film forming later stage rotating speed 3 ~ 5 revs/min is until sprayed syrup by adjustment of rotational speed, syrup has sprayed the heating of rear closedown air intake, be cooled to discharging after sheet bed tempertaure 28 DEG C ~ 32 DEG C, i.e. obtained L-carnitine tea polyphenol tablet.
L-carnitine tea polyphenol tablet of the present invention is the fat-reducing medication that Chinese and Western combines, with Chinese medicine burn fat, Western medicine reduces body fat and hoards for mechanism, provide unique coating components and technique, this L-carnitine tea polyphenol tablet is made to have onset speed fast, the advantages such as lasts for a long time, does not rebound, and have no side effect, and overcome the defect that the traditional Chinese medicine slimming medicine moisture absorption easily lost efficacy, be widely used in genotype congenital obesity person and the overweight people that causes due to the consequent effects such as environment, life style uses.
Accompanying drawing explanation
Below in conjunction with accompanying drawing, L-carnitine tea polyphenol tablet of the present invention is described further:
Fig. 1 is this L-carnitine tea polyphenol tablet preparation method flow process.
Note: be 100,000 grades of clean areas in dotted line in Fig. 1.
Detailed description of the invention
Embodiment one: as shown in Figure 1, this L-carnitine tea polyphenol tablet is preparation method comprise the steps,
(1) following component is taken according to shown quality:
Wherein Hydroxypropyl methylcellulose, talcum powder, glyceryl triacetate are film coating agent component.
Preparation method comprises the following steps:
1) mix:
L-carnitine-L-tartrate, Lotus Leafextract, Tea Polyphenols, microcrystalline cellulose, copolyvidone, PVPP, silica, dolomol are added in mixer by the formula ratio described in claim 1 or 3 and mixes 20-30 minute;
2) compressing tablet:
Carry out compressing tablet with tablet press machine, sheet is heavily 1.2g/ sheet;
3) dressing:
(1) syrup preparation
1. in pot with slurry, add the purified water calculated by the formula ratio described in Claims 2 or 3;
2. start stirring, each for film coating agent constituent is added in pot with slurry, stir 30-45 minute;
(2) plain coating tablets
Sent in coating pan by plain sheet, adjust the distance between spray gun and sheet bed, spray gun is positioned at coating pan middle, adjusts atomizing pressure 0.4 ~ 0.7Mpa; Plain sheet preheating is adjusted EAT 71 DEG C ~ 82 DEG C, temperature of outgoing air 40 DEG C ~ 46 DEG C, sheet bed tempertaure 39 DEG C ~ 41 DEG C after 5 ~ 10 minutes, dressing is carried out by film forming rotating speed 2 ~ 3.5 revs/min in early stage, after dressing to unilateral basic film forming, solid colour, be that film forming later stage rotating speed 3 ~ 5 revs/min is until sprayed syrup by adjustment of rotational speed, syrup has sprayed the heating of rear closedown air intake, be cooled to discharging after sheet bed tempertaure 28 DEG C ~ 32 DEG C, i.e. obtained L-carnitine tea polyphenol tablet A.
Embodiment two: as shown in Figure 1, takes following component according to shown quality,
According to preparation method described in embodiment one, i.e. obtained L-carnitine tea polyphenol tablet B.
Embodiment three: as shown in Figure 1, the formula that this L-carnitine tea polyphenol tablet is every 1000 is:
Wherein Hydroxypropyl methylcellulose, talcum powder, glyceryl triacetate are film coating agent component.
According to preparation method described in embodiment one, i.e. obtained i.e. obtained L-carnitine tea polyphenol tablet C.
Weight losing function human feeding trial:
1 materials and methods
1.1 sample; Placebo consistent with L-carnitine tea polyphenol tablet A in L-carnitine tea polyphenol tablet A and packaging, outward appearance, color and luster and mouthfeel, human oral's RD is every day 2 times, each 2.
1.2 study subjects: experimenter's male or female, Simple Obesity, through health check-up, without dysfunctions such as the obvious heart, liver, courage, kidneys.
1.2.1 experimenter's choice criteria: adult BMI >=30, or total fat percentage reaches male >25%, the volunteer of female >30%.
1.2.2 exclusion standard:
1.2.2.1 merge intentionally, liver, the serious disease such as kidney and hemopoietic system, mental patient.
1.2.2.2 take the article relevant with tested function in a short time, have influence on the judgement person to result.
1.2.2.3 not by the edible tested material of regulation, effect or data not umbra sound effect or security judgement person cannot be judged.
1.3 test methods: will inclusive criteria be met and ensure the volunteer of compatibility test, being divided into test-meal group and control group at random.Test-meal group and control group take by RD the sample that producer provides, continuous 45 days.Duration of test does not change original eating habit, normal diet.Test-meal test is carried out by an ancient small-mouthed wine vessel method.
1.4 key instruments: Sebum thickness measurer, body composition analysis instrument, cycle ergometer.
2. observation index: indices starts in test-meal experiment and terminates each test once.
2.1 safety observations:
2.1.1 ordinary circumstance: spirit, sleep, diet, stool and urine, blood pressure, heart rate etc.
2.1.2 Blood routine examination: red blood cell count(RBC), hemoglobin, white blood cell count(WBC).
2.1.3 routine urinalysis (comprising urine ketoboidies) and stool routine examination.
2.1.4 Biochemical Indexes: albumin (ALB), total protein (TP), glutamic-oxalacetic transaminease (AST), glutamic-pyruvic transaminase (ALT), urea nitrogen (BUN), creatinine (Cr), uric acid (UA), blood sugar (GLU), triglycerides (TG), T-CHOL (CHOL) etc.
2.1.5 Abdominal B type ultrasonography, electrocardiogram, x-ray fluoroscopy of chest.
2.1.6 exercise tolerance test: exercise tolerance method of testing is cycle ergometer test
Before and after test-meal, experimenter is with identical motion scheme power cycle test, recorded heart rate, and applies the maximal oxygen uptake (L/ divides) of each experimenter of nomography indirect determination of Astrand and Ryhming.
2.1.7 other bad reaction is observed.
2.2 dietary factors and motion conditions are observed.
2.3 efficiency index
2.3.1 body weight and height: emptying stool and urine before measuring, takes off one's shoes, and the timing of resurveying of test-meal forebody-afterbody is all worn same clothes and measured in same scale.
2.3.2 bioelectrical impedance analysis: measure human body body fat rate.
2.3.3 girth diameter measures:
2.3.3.1 waistline: the abdomen girth of flat navel.
2.3.3.2 hip circumference: with the girth of both sides greater trochanter of femur level.
2.3.4 stratum corneum lipids measures: measurement site:
2.3.4.1 mid-point outside right deltoid muscle lower edge arm.
2.3.4.2 right angulus inferior scapulae.
2.3.4.3 the other 3cm of right navel.
2.3.4.4 right anterior superior spine.
2.4 experimental data statistics: carry out statistical analysis with INSTAT software.
3. result
Double-blind study observation end is made known: take No. 2 persons for placebo, taking No. 1 person is L-carnitine tea polyphenol tablet A.
3.1 ordinary circumstances: initial trial crowd test-meal group 52 example, control group 52 example.Before and after test-meal test, experimenter's spirit, sleep, diet, stool and urine situation no abnormality seen.Control group: male/female is 14/38, the age is 45.46 ± 10.33 years old: test-meal group: male/female is 14/38, and the age is 46.33 ± 10.81 years old.
3.2 safety observations Indexs measure-
3.2.1 blood pressure, heart rate, routine urinalysis, stool routine examination, blood routine and Biochemical Indexes:
Table l, blood pressure before and after test-meal, heart rate, urine, stool, blood routine and biochemical indicator testing result (x ± s)
From table 1, before and after test-meal, indices is all in normal range (NR).
3.2.2 Abdominal B type ultrasonography, electrocardiogram, x-ray fluoroscopy of chest detect: all in normal range (NR).
3.2.3 obvious adverse reaction is had no during test-meal.-
3.2.4 the change of maximal oxygen uptake and main nutrients intake
Large oxygen uptake and main nutrients intake (x ± s) before and after table 2 test-meal
From table 2, maximal oxygen uptake and the main nutrients intake of test front and back experimenter have no significant change.-
3.2.5 the moving situation of test front and back experimenter is without significant change
3.3 advise validity observation index
3.3.1 body weight, body fat gross weight and fat percentage measure
Body weight, body fat total amount and fat percentage measurement result (x ± s) before and after table 3 test-meal
Note:
*compare P<0.05 # with before test-meal and compare P<0.05 with control group
Before test, control group and test-meal group body weight, body fat gross weight, Rate of body lipid level compare, and P value is all greater than 0.05, points out between two groups and has comparativity.After test, test-meal group experimenter comparatively tests front weight average and declines I.35kg, and body fat gross weight on average declines 1.19kg, and Rate of body lipid on average declines 1.00%.After test, body weight has no obvious change (P>0.05).Test rear test-meal group subject fat gross weight and Rate of body lipid and control group and self test front comparing difference and have conspicuousness (P<0.05).
3.3.2 subcutaneous fat thickness measuring-
Subcutaneous fat thickness measuring result (x ± s) before and after table 4 test-meal
Note:
*compare P<0.05 # with before test-meal and compare P<0.05 with control group,
After test, test-meal group experimenter comparatively tests the decline of front subcutaneous fat thickness, and wherein deltoid muscle place reduces 1.10mm, and under omoplate, place reduces 0.93mm, and other the locating of navel reduces 0.4lmm, and bone sour jujube place reduces 0.39mm.After test test-meal group experimenter's deltoid muscle place with locate under omoplate subcutaneous fat thickness compare with before test, and control group comparing difference all have conspicuousness (P<0.05), navel side place and ilium sour jujube place's subcutaneous fat thickness and control group comparing difference are without conspicuousness (P>0.05).
3.3.3 girth diameter measurement result-
Girth diameter measurement result (x ± s) before and after table 5 test-meal
Note:
*with L before test-meal comparatively P<0.05 # compare P<0.05 with control group
After test, test-meal group experimenter comparatively tests front waistline minimizing 2.34cm, and hip circumference reduces 1.07cm.Test rear test-meal group experimenter's waistline and control group and self test front comparing difference and have conspicuousness (P<0.05), after test, test-meal group experimenter hip circumference compares there was no significant difference (P>0.05) before testing with control group and self.
3.3.4 depigmentation rate: after test in 45 days, control group has l example experimenter cannot judge that effect is screened out because being interrupted to take by test product; Test-meal group has 1 routine experimenter cannot judge that effect is screened out because being interrupted to take by test product.Last efficiency test crowd is according to group 5l example, and test-meal group 51 is routine.In table 6.
| Group | Control group | Test-meal group |
| Before test-meal | 52 | 52 |
| Depigmentation number | 1 | 1 |
| Depigmentation rate | 1.92% | 1.92% |
Replace L-carnitine tea polyphenol tablet A to repeat the experiment of above-mentioned human experiment with L-carnitine tea polyphenol tablet B, L-carnitine tea polyphenol tablet C respectively, result, without essential difference, is omited.
4. brief summary
Experimenter eats L-carnitine tea polyphenol tablet 45 days continuously; test-meal group weight average decline 1.35kg; body fat gross weight on average declines 1.19kg; Rate of body lipid on average declines 1.00%: subcutaneous fat thickness all declines; wherein l.00nun deltoid muscle place reduces; under omoplate, place reduces 0.93mm, and the other place of navel reduces 0.4lmm, and ilium sour jujube place reduces 0.39mm; Waistline reduces 2.34cm, and hip circumference reduces 1.07cm.After the test of test-meal group, body fat gross weight, Rate of body lipid, two place's subcutaneous fat thicknesses (locating under deltoid muscle place, omoplate) and waistline and control group are tested rear and more all have significant difference (P<0.05) before self testing.After test, the other place of test-meal group experimenter navel, ilium sour jujube place's subcutaneous fat thickness are with control group comparing difference without conspicuousness (P>0.05), and self test front comparing difference without conspicuousness (P>0.05).After the test of test-meal group, body weight, hip circumference index are without marked change (P>0.05).Before and after test, test-meal group and control group experimenter every safety observations index depressed place are in normal range (NR), have no obvious adverse reaction during test-meal.Study subject exercise tolerance and appetite have no decline.According to " health food inspection and assessment technical specification " (version in 2003) evaluation criterion, prompting l-cn Ah tea polyphenol tablet has antiobesity action to human body.
The present invention includes but be not limited to above-mentioned embodiment, any product meeting these claims and describe, all falls within protection scope of the present invention.
Claims (1)
1. a L-carnitine tea polyphenol tablet, is characterized in that: formulated by shown weight ratio by following component:
Described film coating agent is formulated by shown weight ratio by following component:
Hydroxypropyl methylcellulose: 12.6 ~ 15.4 talcum powder: 3.6 ~ 4.4
Glyceryl triacetate: 1.8 ~ 2.2;
The preparation method of described L-carnitine tea polyphenol tablet comprises the following steps:
1) mix:
L-carnitine-L-tartrate, Lotus Leafextract, Tea Polyphenols, microcrystalline cellulose, copolyvidone, PVPP, silica, dolomol are added in mixer by described formula ratio and mixes 20-30 minute;
2) compressing tablet:
Carry out compressing tablet with tablet press machine, sheet is heavily 1.2g/ sheet;
3) dressing:
(1) syrup preparation
1. in pot with slurry, add the purified water calculated by described formula ratio;
2. start stirring, each for film coating agent constituent is added in pot with slurry, stir 30-45 minute;
(2) plain coating tablets
Sent in coating pan by plain sheet, adjust the distance between spray gun and sheet bed, spray gun is positioned at coating pan middle, adjusts atomizing pressure 0.4 ~ 0.7Mpa; Plain sheet preheating is adjusted EAT 71 DEG C ~ 82 DEG C, temperature of outgoing air 40 DEG C ~ 46 DEG C, sheet bed tempertaure 39 DEG C ~ 41 DEG C after 5 ~ 10 minutes, dressing is carried out by film forming rotating speed 2 ~ 3.5 revs/min in early stage, after dressing to unilateral basic film forming, solid colour, be that film forming later stage rotating speed 3 ~ 5 revs/min is until sprayed syrup by adjustment of rotational speed, syrup has sprayed the heating of rear closedown air intake, be cooled to discharging after sheet bed tempertaure 28 DEG C ~ 32 DEG C, i.e. obtained L-carnitine tea polyphenol tablet.
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| CN104188037A (en) * | 2014-09-29 | 2014-12-10 | 天津市聚星康华医药科技有限公司 | Composite L-carnitine beverage |
| CN104367563A (en) * | 2014-11-18 | 2015-02-25 | 成都医路康医学技术服务有限公司 | Tablet containing grifola frondosa and preparation method thereof |
| CN107184868A (en) * | 2017-06-03 | 2017-09-22 | 河北御芝林药业有限公司 | It is a kind of being capable of effectively lowering blood-fat and reducing weight, the Chinese medicine composition of strengthen immunity |
| CN107753477A (en) * | 2017-11-08 | 2018-03-06 | 罗昌兴 | A kind of medicine for treating obesity and preparation method thereof |
| CN108095113A (en) * | 2017-12-22 | 2018-06-01 | 成都博创必成医药技术有限公司 | A kind of composition, preparation and its application with fat reducing blood sugar reducing function |
| CN109846938A (en) * | 2019-04-03 | 2019-06-07 | 江西安顺堂生物科技有限公司 | It is a kind of containing tea polyphenols weight-reducing oil extraction, norcholesterol preparation and preparation process |
| CN111543635A (en) * | 2020-05-29 | 2020-08-18 | 江西复真药业有限公司 | Health food with weight reducing function and preparation method thereof |
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| CN102205011A (en) * | 2011-05-25 | 2011-10-05 | 遵义陆圣康源科技开发有限责任公司 | Medicinal composition with weight loss function |
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