CN105919096B

CN105919096B - Health food composition, preparation and application thereof

Info

Publication number: CN105919096B
Application number: CN201610318193.4A
Authority: CN
Inventors: 董霞荣
Original assignee: Tibet Hai Rong Tang Guo Health Industry Co ltd
Current assignee: Tibet Hai Rong Tang Guo Health Industry Co ltd
Priority date: 2016-05-16
Filing date: 2016-05-16
Publication date: 2020-05-22
Anticipated expiration: 2036-05-16
Also published as: CN105919096A

Abstract

The invention belongs to the technical field of traditional Chinese medicines or health-care foods, and particularly relates to a health-care food composition, a preparation and application thereof. The composition comprises: sea-buckthorn, mulberry leaf, rhodiola root, astragalus root, curcuma and emblic leafflower fruit. Pharmacodynamic studies show that the composition has good effects of invigorating qi, reducing blood sugar and the like.

Description

Health food composition, preparation and application thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines or health-care foods, and particularly relates to a health-care food composition, a preparation and application thereof.

Background

Diabetes is a chronic progressive disease of the whole body. Because islet cells do not normally secrete insulin, a relative or absolute deficiency of insulin, and a decrease in the sensitivity of the target cell to insulin, leads to a disturbance in the metabolism of sugar, protein, fat, water, and electrolytes, rendering hepatic and muscle glycogen non-synthetic. The clinical manifestations are blood sugar rise, urine glucose positive and sugar tolerance decrease, and typical symptoms are 'more than three and one less', namely polydipsia, diuresis, polyphagia and weight loss; diabetes is a common and frequent endocrine dysbolism disease in clinic, has the characteristics of difficult radical treatment, multiple complications, high morbidity, high mortality and high disability rate, and seriously threatens human health. Hyperglycemia can endanger the organs of the whole body of a human body, cause the human cerebral vascular atherosclerosis to cause hypertension and hyperlipidemia, and cause myocardial infarction, cerebral infarction and cerebral hemorrhage in severe cases; renal failure can also be caused by the three-level vascular lesion of the kidney, and proteinuria appears clinically; can also cause damage to the nervous system, the appearance of hyperalgesia or disappearance; limited limb movement, myasthenia, constipation, impotence, and bone paresis; blurred vision and blindness in severe cases can be caused by retinopathy; hyperglycemia can cause vascular and small vascular lesions to cause diabetic foot, foot ulcer, gangrene and even amputation.

Diabetes is called as diabetes in traditional Chinese medicine, the classic Chinese medical books Huangdi' are called as "diabetes", "consumptive", "pulmonary disease", "diaphragm disease", "Xiaozhong" and the like according to different pathogenesis and principal symptoms respectively, and the ancient medical books explain the book Bian Wen Ji Shi word disease Shu Xie Xian (the book of explanation of the book of explanation): "Xiao and want to drink electricity". Explanation of ancient disease states: ".. to quench thirst and thus obtain water. "diabetes is named, polyuria is characterized by: "the person drinks one bucket of water and urinates one bucket of water every day. The "jin ban" Zhong Jing Zhang of the Han Dynasty is loaded with: "desire to drink more than once", "desire to drink water, dry mouth and dry tongue". ", in turn: "food-eliminating diet, hard stools and frequent urination". ", Li Gao" lan Shi Mi Zai "(lan Shi Mi Zang) says diabetes: dry mouth and tongue, frequent urination, dry stool and induration. "also say" can eat but thin "these notes are similar to the symptoms of diabetes. So doctors of all generations always refer to diabetes as diabetes.

Along with the improvement of the living standard of people in China, the dietary structure of people is changed greatly, the long-term unreasonable diet ensures that the insulin in the body is secreted more for a long time, the sensitivity of target cells of the insulin to the insulin is gradually reduced, thereby generating hyperglycemia, the incidence rate of diabetes is improved, at present, most of the medicines for treating diabetes are mainly used for stimulating the insulin to generate the insulin, the sensitivity of the target cells of the insulin to the insulin is not fundamentally improved, once the medicine is stopped for a period of time, the blood sugar is rebounded again, simultaneously, the stimulation to the insulin by long-term administration ensures that the insulin is in a long-term nervous working state, the function of the insulin is exhausted, the diabetes patient finally has to help to reduce the blood sugar by means of the insulin in vitro, and the partial or all functions of the insulin are further lost, meanwhile, due to repeated rebound of blood sugar, the viscosity of blood is still increased, the microcirculation of the blood is disturbed, and finally, complications in the aspects of heart, brain, kidney, skin nerve and the like still occur.

Research and development of a novel health food with the function of reducing blood sugar have important significance for diabetics.

Disclosure of Invention

Based on the reasons, the applicant invents a novel health food composition through years of clinical research, based on the theory of traditional Chinese medicine and combined with the modern medical research, and the composition comprises the following raw materials: sea-buckthorn, mulberry leaf, rhodiola root, astragalus root, curcuma and emblic leafflower fruit. Pharmacodynamic studies show that the composition has good effects of invigorating qi, reducing blood sugar and the like.

The seabuckthorn and the mulberry leaf are combined to be used as monarch drugs in the formula; rhodiola rosea and astragalus are used together as ministerial drugs to assist sea buckthorn and mulberry leaf to enhance the efficacy. Rhizoma Curcumae Longae and fructus Phyllanthi are added. The ingredients are combined to play the effects of reinforcing qi and reducing blood sugar.

The invention is realized by the following technical scheme.

A nutraceutical composition comprising: sea-buckthorn, mulberry leaf, rhodiola root, astragalus root, curcuma and emblic leafflower fruit.

Wherein: 5-10 parts of sea-buckthorn, 3-8 parts of mulberry leaf, 4-12 parts of rhodiola rosea, 3-5 parts of astragalus membranaceus, 1-5 parts of turmeric and 4-8 parts of emblic leafflower fruit.

The health food composition is applied to the blood sugar reducing food.

The health food composition is applied to qi tonifying foods.

The oral preparation prepared from the composition.

The composition is prepared into tablets or capsules.

The oral liquid is prepared from the composition.

Detailed Description

Test example 1 toxicological test

And (3) test groups: 80g of sea-buckthorn, 60g of mulberry leaf, 80g of rhodiola rosea, 40g of astragalus, 30g of turmeric and 60g of emblic leafflower fruit.

The preparation method comprises the following steps: taking the above raw materials, adding 3000ml of 60% ethanol, extracting for 2 hours, filtering to obtain an extract A, adding 2500ml of 45% ethanol into residues, extracting for 2 hours, filtering to obtain an extract B, adding 2000ml of water into residues, extracting for 1.5 hours, filtering to obtain an extract C, combining the extract A and the extract B, recovering ethanol to the full, combining the extract C, concentrating and drying to obtain the extract.

1. Mouse LD50 assay

60 healthy mice with half male and female body weight of 18-22g were randomly divided into 6 groups of 10 mice each. The corresponding concentration is prepared according to the dosages of 0.4g/kg, 0.8g/kg, 1.6g/kg, 3.2g/kg, 6.4g/kg and 12.8g/kg (respectively equivalent to 6.25 times, 12.5 times, 25 times, 50 times, 100 times and 200 times of the dosage of the adult), the dosage of each time is 0.25ml/10g, and all animals are subjected to intragastric administration once a day for 7 days continuously. The animal activity, diet, stool, hair color and posture are observed during the administration period without any abnormality. On day 7, all animals were sacrificed and dissected, and no abnormality was observed in the observation of each important organ and tissue. The LD50 of the composition is far more than 12.8g/kg (which is equivalent to 200 times of the dosage of the composition for adults) for mice.

2. Determination of maximum tolerance of mouse

20 healthy mice are taken, half of the mice are male and female, and the weight of the mice is 18-22 g. Dissolving the extract with distilled water, dissolving in 50% water, and performing gavage administration of 0.7ml each time after fasting for 12 hr for 7 days, 2 times daily. The observation of animal activity, diet, stool and urine is normal, and no abnormality is found in the observation of each important organ and tissue after the sacrifice of the anatomical animal. The maximum tolerance of the granules to mice is 36g/kg (equivalent to 562.5 times of the dosage for adults).

3. Long term toxicity test

80 healthy rats with weight of 90-110g and half of male and female are randomly divided into four groups, namely high, medium and low dose groups of composition extract and normal control groups, wherein each group comprises 20 rats. The composition is prepared by respectively intragastrically irrigating 3g/kg.1.5g/kg, 0.75g/kg of the composition extract suspension and equal dose of physiological saline, 3ml/100g each time, 1 time per day, weighing 1 time per 2 weeks to adjust the dosage, continuously administering for 12 weeks, and then killing No. 1-10 animals to take blood, and measuring blood routine, liver function and kidney function. Dissecting after blood sampling, and observing the shape of the main viscera by naked eyes; and taking out and weighing in turn. Calculating and recording the dirty body ratio; taking out the bladder, and taking urine from the bladder for routine urine examination; the main organs were fixed with 10% formaldehyde solution and sectioned for histological examination. After the remaining groups of animals No. 11-20 were observed for two weeks, the experimental data were obtained using the same procedure and method as described above. Results show that the blood and urine routine and the liver and kidney functions of all animals are in a normal range, and no significant difference exists between groups; the morphology of each major organ was observed with naked eyes without abnormality. Histology examination of the cells for normal morphological structure without pathological changes; the visceral body ratio was not significantly different among the groups.

And (4) test conclusion: the results of acute toxicity tests show that: the mouse LD50 is far more than 12.8g/kg (equivalent to 200 times of human dose), and the maximum tolerance of the mouse reaches 36g/kg (equivalent to 562.5 times of human dose). The long-term toxicity test results suggest: has no obvious influence on the blood routine and the liver and kidney functions of the tested rat and has no damage to the viscera of the tested rat. The composition has no obvious toxic or side effect.

Pharmacological test

Test materials

Test animals: pure breed Japanese white rabbits with half female and half male, no pregnancy for female, weight of 2kg and 0.2 kg; kunming mouse, male and female half, body weight 20g and 2 g; SD rats, half male and female, 100g body weight 10 g.

Test drugs:

test 1 group: 50g of sea-buckthorn, 30g of mulberry leaf, 40g of rhodiola rosea, 30g of astragalus, 10g of turmeric and 40g of emblic leafflower fruit.

Test 2 groups: 100g of sea-buckthorn, 80g of mulberry leaf, 120g of rhodiola rosea, 50g of astragalus, 50g of turmeric and 80g of emblic leafflower fruit.

Run 3 groups: 80g of sea-buckthorn, 60g of mulberry leaf, 80g of rhodiola rosea, 40g of astragalus, 30g of turmeric and 60g of emblic leafflower fruit.

Test 1 group-test 3 group preparation methods: taking the above raw materials, adding 3000ml of 60% ethanol, extracting for 2 hours, filtering to obtain an extract A, adding 2500ml of 45% ethanol into residues, extracting for 2 hours, filtering to obtain an extract B, adding 2000ml of water into residues, extracting for 1.5 hours, filtering to obtain an extract C, combining the extract A and the extract B, recovering ethanol to the full, combining the extract C, concentrating and drying to obtain the extract.

Positive control group: the balsam pear and American ginseng soft capsules are sold in the market.

The main reagents are as follows: alloxan, manufactured by SIGMA chemical, usa; 1mg of adrenaline hydrochloride injection is contained in 1ml of each injection; a blood glucose kit; insulin-clearing radioimmunoassay kit.

The main apparatus is as follows: a model 721 spectrophotometer; the detection instrument is exempted; a common centrifuge, a three-purpose water temperature box and an automatic biochemical analyzer.

Test 1

Influence on blood sugar and serum insulin release of alloxan diabetic rabbits

68 healthy rabbits with the weight of 1.85-2.15kg and half of the male and female are selected, after fasting for 12 hours, 60 rabbits are injected with 5% alloxan physiological saline solution 120mg/kg into the ear margin, and the other 8 rabbits are not treated (normal control group). After 64h molding, all animals were fasted for another 12h, and the fasting blood was quickly removed from the heart and the fasting blood was measured by o-toluidine. 20 rabbits with higher and lower blood sugar in the molding rabbits are removed, 40 rabbits with approximate blood sugar level (blood sugar value is 14.11-20.84mmol/L) with high blood sugar are selected and randomly divided into five groups, and each group comprises 8 rabbits, which are respectively a model control group, a positive control group and a test group of the invention. Normal control group and model control group use normal saline 5 ml/kg; the positive test group uses 2.4 g/kg; test 1 to test 3 gave 1.5 g/kg. Are all prepared into suspension. The composition is administered by intragastric administration once a day for four weeks at a dose of 5ml per kg body weight. During the drug filling period, normal diet is given, and attention is paid to increase water supply. After administration for four weeks, all animals were bled from the heart after 12h of fasting, and fasting Blood Glucose (BG) and serum insulin (IRI) values were determined from the rabbits.

The results are shown in Table 1.

TABLE 1 influence of the fasting blood glucose and serum insulin levels of the tetraoxypyrimidinic diabetic rabbits

Note that P < 0.05P < 0.01 in comparison with the model control group and △ P < 0.05 in comparison with the positive pellet group.

As can be seen from Table 1, the balsam pear and American ginseng soft capsules and the composition have obvious effect of reducing the blood glucose level of diabetic rabbits. Compared with the market balsam pear and American ginseng soft capsule group, the health food composition group has better effect of reducing blood sugar.

Test 2

Effect on blood glucose levels in adrenergic hyperglycemic mice

60 healthy mice with the weight of 18-22g and half of the male and female are randomly divided into 6 groups, and each group contains 10 mice, namely a normal control group, a model control group, a commercial health-care product group and a health-care composition group. The normal group and the model group were separately gavaged with 0.25ml/10g of physiological saline. The commercial health care product group uses 2.5g/kg of commercial health care products; the dosage of the health care product composition group is 1.5 g/kg. The 4 groups are respectively prepared into suspensions with different concentrations, and the suspensions are respectively folded into 0.25ml/10g volume. Each group was administered once daily by gavage for one week, 1h after the last administration, except for the normal group, the animals in the other groups were injected with adrenaline 0.2mg/kg intraperitoneally, and after 30min, blood was collected from the eye sockets of all animals, and the blood glucose concentration was measured by o-toluidine method.

The results are shown in Table 2.

TABLE 2 influence of the blood glucose levels of adrenergic hyperglycemic mice

Group of	N	Blood sugar mmol/L (X Shi SD)
			Normal control group	10	6.35±0.34**
Model control group	10	13.72±0.46
			Positive test group	10	10.72±0.58*
Test 1 group	10	8.13±0.49*△
			Test 2 groups	10	8.25 shi 0.73 x △
Test 3 groups	10	7.71 Earth 0.62X △

As shown in Table 2, the health product composition of the invention can reduce the blood sugar level of the mice with adrenergic hyperglycemia, and has better blood sugar reducing effect compared with the balsam pear and American ginseng soft capsule group sold in the market.

Preparation examples

Example 1

The health food composition comprises: 50g of sea-buckthorn, 30g of mulberry leaf, 40g of rhodiola rosea, 30g of astragalus, 10g of turmeric and 40g of emblic leafflower fruit.

The preparation method comprises the following steps: taking the raw materials, adding 3000ml of 60% ethanol, extracting for 2 hours, filtering to obtain an extracting solution A, adding 2500ml of 45% ethanol into residues, extracting for 2 hours, filtering to obtain an extracting solution B, adding 2000ml of water into the residues, extracting for 1.5 hours, filtering to obtain an extracting solution C, combining the extracting solution A and the extracting solution B, recovering ethanol to the full, combining the extracting solution C, concentrating and drying to obtain an extract;

the obtained extract can be made into tablet, capsule, granule or oral liquid according to conventional preparation method of oral preparation.

Example 2

The health food composition comprises: 100g of sea-buckthorn, 80g of mulberry leaf, 120g of rhodiola rosea, 50g of astragalus, 50g of turmeric and 80g of emblic leafflower fruit.

Example 3

The health food composition comprises: 80g of sea-buckthorn, 60g of mulberry leaf, 80g of rhodiola rosea, 40g of astragalus, 30g of turmeric and 60g of emblic leafflower fruit.

Example 4

The health food composition comprises: 55g of sea-buckthorn, 35g of mulberry leaf, 45g of rhodiola rosea, 35g of astragalus, 15g of turmeric and 45g of emblic leafflower fruit.

Example 5

The health food composition comprises: 95g of sea-buckthorn, 75g of mulberry leaf, 110g of rhodiola rosea, 45g of astragalus, 45g of turmeric and 75g of emblic leafflower fruit.

Example 6

The health food composition comprises: 75g of sea-buckthorn, 55g of mulberry leaf, 70g of rhodiola rosea, 35g of astragalus, 25g of turmeric and 55g of emblic leafflower fruit.

Example 7

The health food composition comprises: 85g of sea-buckthorn, 65g of mulberry leaf, 85g of rhodiola rosea, 45g of astragalus, 35g of turmeric and 65g of emblic leafflower fruit.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims

1. The health food composition is characterized by being prepared from the following raw materials in parts by weight: 5-10 parts of sea-buckthorn, 3-8 parts of mulberry leaf, 4-12 parts of rhodiola rosea, 3-5 parts of astragalus membranaceus, 1-5 parts of turmeric and 4-8 parts of emblic leafflower fruit.

2. Use of a health food composition according to claim 1 in the preparation of a food product for assisting in lowering blood glucose.

3. The use of a health food composition according to claim 1 in the preparation of a gas-supplementing food.

4. A health food composition as claimed in claim 1, wherein the composition is formulated for oral administration.

5. A health food composition as claimed in claim 1, wherein the composition is in the form of a tablet or capsule.

6. A health food composition in accordance with claim 1, wherein the composition is formulated as an oral liquid.