CN1724003A - Health-care food with blood-sugar decreasing function, and its prepn. method - Google Patents

Abstract

A hypoglycemic health-care food for the patients of diabetes, weakness, polyuria, etc is prepared from ginkgo leaf, mulberry leaf and pumpkin through extracting their active components and mixing them with other additives.

Description

A kind of health product and preparation method with function of blood sugar reduction

Technical field:

The present invention relates to field of health care products, be specifically related to a kind of health product and preparation method with function of blood sugar reduction.

Background technology:

Diabetes are a kind of commonly encountered diseases, frequently-occurring disease, can betide any age bracket, its number of patients is along with the change of the raising of living standards of the people, the aging of population, life style and improving of diagnostic techniques and increase sharply, the whole world has diabetic more than 100,000,000, the China recent years sickness rate also has the trend of increasing, according to May nineteen ninety-five statistics, Beijing area onset diabetes rate increases to 4% by 0.7%-1.0% in 1978.In general, the city sickness rate is higher than the rural area, and China's diabetics sum has reached more than 2,500 ten thousand at present.Diabetes have become the third-largest non-infective disease after relaying cardiovascular diseases of developed country and the tumor, have become the worldwide public health problem of serious threat human health, therefore, prevent that actively hyperglycemia has crucial meaning.

Summary of the invention:

Technical problem to be solved by this invention is to utilize Chinese medical theory and modern medical theory to provide a kind of obvious results novel auxiliary hyperglycemic health product.

Health-caring product capable of reducing blood sugar disclosed by the invention is the oral formulations of being made by the active ingredient that mainly contains Folium Ginkgo, Folium Mori, Fructus Cucurbitae moschatae extract and other adjuvants.

The percentage composition that wherein said each main active accounts for the active ingredient gross weight is Folium Ginkgo 18～48%, Folium Mori 48～76%, Fructus Cucurbitae moschatae extract 2～8%.

Fructus Cucurbitae moschatae extract of the present invention be commercially available be raw material with the Fructus Cucurbitae moschatae, behind water extract-alcohol precipitation, purification, obtain, contain the extract of squash polyoses 40-60%; Described other adjuvants comprise various nutrients, food additive and pharmaceutic adjuvant etc.Described oral formulations is various medically acceptable peroral dosage forms, comprises soft capsule, hard capsule, granule, oral liquid etc.Wherein nutrient, food additive comprise perilla oil, soybean phospholipid etc., and pharmaceutic adjuvant is the various adjuvants of preparation oral formulations commonly used.

Another technical problem to be solved by this invention is to disclose the preparation method of above-mentioned health-caring product capable of reducing blood sugar.

The preparation method of health-caring product capable of reducing blood sugar disclosed by the invention comprises the following steps:

1, Folium Ginkgo, the Folium Mori of recipe quantity are cleaned, chopped up, water and/or soak with ethanol post-heating reflux, extract;

2, extracting liquid filtering, concentrate, spray drying gets xeraphium;

3, fully mix with above-mentioned xeraphium after Fructus Cucurbitae moschatae extract sieves;

4, make various oral formulations with conventional method, comprise soft capsule, hard capsule, granule, oral liquid etc.

5, be not less than 1379mg/100g with total flavones total amount in the spectrophotometer detection preparation in rutin, be not less than 1216.7mg/100mg with glucose meter with crude polysaccharides content in the spectrophotometer detection preparation.

Folium Ginkgo is a Ginkgoaceae plant Ginkgo biloba leaves in the main active ingredient prescription of the present invention, Folium Ginkgo extract (EGb) main component is flavonoid and bilobalide, experimental result shows, EGb both can reduce the blood glucose of normal rat, can reduce the hyperglycemia of alloxan diabetes rats again, and rising serum I ns content that can be to a certain degree.Studies have shown that more in recent years Radical Metabolism has participated in the generation and the evolution of diabetes, diabetes rat serum in the experiment, liver, MDA content significantly improves in the tissues such as brain, show take place that tangible lipid peroxidation sends out in the diabetes rat body should, give MDA content decline in the above-mentioned tissue in EGb treatment back, EGb has improved Radical Metabolism, reduced the attack of the unsaturated fatty acid residue of radical pair lipoprotein in tissue and the blood, alleviated level of lipid peroxidation, thereby lowered the destruction that free radical is risen in the generation of diabetes and evolution, the diabetes pathological condition improved.

Folium Mori are the leaves of Moraceae Morus plant Mulberry Morus alba.L in the present invention's prescription, the medicinal head of Folium Mori is stated from Shennong's Herbal, Folium Mori bitter but sweet flavor, cold, so sweet beneficial blood, thus cold removing heat from blood, sweet cold being harmonious, so the therapeutic method to keep the adverse QI flowing downwards and tonifying YIN, again can cough-relieving, the merit of tonification is arranged, be the key medicine of traditional Chinese medical science heat-clearing and toxic substances removing.In Folium Mori, extract polysaccharides of Folium Mori (TPM), cause diabetic mice ip administration (50 to alloxan, 100,200mg/kg), the result shows that TPM100mg/kg is in administration 4, behind the 6h, the rate of descent of blood glucose is respectively (64.9+18.1) % and (78.2+11.2) %, and the hypoglycemic activity (P＜0.01) of highly significant is arranged; TMP is 50, during 200mg/kg, behind the administration 6h, the rate of descent of blood glucose is respectively (52.4-16.5) % and (46.4-21.5) % (P＜0.05), the obvious functions of blood sugar effect is arranged, and TPM also can improve the anti-sugar amount of diabetic mice, increases liver glycogen and reduces glucose.And insulin content in the raising normal rat blood plasma.The mechanism of the hypoglycemic activity of TPM may be by promoting the B cell excreting insulin to play a role.Report that again the powder of Folium Mori boiling water extraction gets the 0.4g/mL immersion, causes diabetes rat ig with the 2mL/d immersion to alloxan, observe 30d and measure blood sugar level that the result shows that blood glucose value is reduced to (10.82 ± 3.32) mmol/L by (18.99 ± 4.28) mmol/L.There were significant differences (t=2.45, P＜0.05).The immersion of expression Folium Mori has obvious hypoglycemic activity to experimental diabetic rats.

In addition, Fructus Cucurbitae moschatae is the fruit of cucurbitaceous plant Cucurbit moschata Duch, its nutritional labeling is comprehensive and unique, the traditional Chinese medical science is thought Fructus Cucurbitae moschatae sweet in the mouth, warm in nature, have the function of invigorating the spleen and replenishing QI, the lung moistening benefit heart, can prevent multiple disease, studies show that in recent years, Fructus Cucurbitae moschatae has multiple food therapy health effect, especially extremely people's the attention as preventing the specific nutrition health food of diabetes.Squash polyoses is a blended polysaccharide.The analysis showed that, contain D mannitol, D xylose, D galactose in the squash polyoses, and rich in proteins, aminoacid and copper content slightly rises, and the prompting squash polyoses is that the form with glycoprotein exists, and copper is in stable chela and state in this macromolecular structure.Alloxan is can selectively acting downright bad because of irreversible denaturation in the pancreatic beta cell of animal, thereby generation artificial diabetes, experimental result confirms, squash polyoses can reduce the fasting blood sugar of alloxan diabetes rats, and it is multiple normal that animal subject general activity situation becomes, this shows the squash polyoses symptom of control of diabetes effectively, and may reach the effect of blood sugar lowering because of promoting secretion of insulin.This shows the effect that the squash polyoses in the Fructus Cucurbitae moschatae extract has remarkable reduction alloxan diabetes rats blood glucose and recovers its muscle power.

In sum, health product compatibility of the present invention is succinct, with " Folium Ginkgo " is monarch drug, is that minister is assisted it with " Folium Mori ", and assistant is with " Fructus Cucurbitae moschatae extract ", meet Chinese medical theory, resultant force is attacked blood sugar lowering, and the medicine of respectively distinguishing the flavor of respectively has characteristics, and specific aim is very strong again, be foundation with modern pharmacology and clinical research all, its preparation can reach the health care of auxiliary hyperglycemic.

Carry out the toxicological evaluation test with health-caring product capable of reducing blood sugar of the present invention (Fructus Pruni spirit tablet sugar likes to protect soft capsule), the result shows health product safety non-toxic of the present invention:

1, acute oral toxicity test: the acute oral LD of SD rat and Kunming mouse ₅₀All, declare the genus non-toxic type greater than 15g/kg.bw.

2. genetic toxicity test: Salmonella reversion test, PCEMNR micronucleus test and three genetic toxicity test results of mouse sperm deformity test are all negative, show the no mutagenic action of this inspection product.

3. 30 days feeding trials of rat: in 30 days feeding trials of rat (maximum dose level is 100 times of human body recommended intake), tried the ANOMALOUS VARIATIONS that thing does not cause every important indicators such as rat holistic health, biochemical functions and organ-tissue morphology, maximum no-effect dose is greater than 2.5g/kg.bw (human body recommended intake 100 times) according to a preliminary estimate.

Carry out the functional evaluation test with health-caring product capable of reducing blood sugar of the present invention (Fructus Pruni spirit tablet sugar likes to protect soft capsule):

1, animal experiment

Fructus Pruni spirit tablet sugar likes to protect soft capsule, the human body recommended dose is 3g/60kg every day, basic, normal, high three dosage groups are established in experiment, be equivalent to 5,10,30 times of human body recommended dose respectively, per os gave sample 30 days continuously, and experimental result shows: area under phase blood sugar content and blood glucose curve when sample can obviously reduce in the carbohydrate tolerance test of hyperglycemia model mice 2 hours.Illustrate that Fructus Pruni spirit tablet sugar love guarantor soft capsule has auxiliary hyperglycemic function to mice.

2, human feeding trial

100 routine experimenters are selected in test altogether, adopt the double blind control method, 100 routine type ii diabetes patients are divided into matched group and test-meal group at random by the kind of taking medicine, blood glucose, blood lipid level etc., wherein test-meal group 50 examples, matched group 50 examples, edible respectively Fructus Pruni spirit tablet sugar likes to protect soft capsule and placebo, every day 3 times, each 2, viewing duration is adhered to diet control, and former treatment Rezulin species mediating recipe amount is constant.After one month, the result shows: Fructus Pruni spirit tablet sugar likes to protect soft capsule has the improvement effect to clinical symptoms such as the thirsty polydipsia of diabetes, polyorexia, fatigue and weakness, polyurias, symptom integral obviously reduces, its total effective rate is 66.00% (matched group is 24.00%), can reduce fasting glucose, post-prandial glycemia and glucose in urine (P＜0.01, P＜0.05, P＜0.01), and can cholesterol reducing, triglyceride (P＜0.05).Test-meal front and back hemogram and the every detection index of hepatic and renal function do not have obviously change all in normal range, illustrate that Fructus Pruni spirit tablet sugar love guarantor soft capsule is to the healthy no obvious damage of experimenter.This shows that Fructus Pruni spirit tablet sugar likes to protect soft capsule the auxiliary hyperglycemic effect.

The specific embodiment:

Embodiment 1, auxiliary hyperglycemic function animal experiment

1. sample character: sample Fructus Pruni spirit tablet sugar is liked to protect soft capsule, and content is a dark brown grease.

2. laboratory animal: Kunming kind white mice, body weight 24～28 grams, female, provide by Chinese Academy of Sciences's Shanghai Experimental Animal Center.

3. dosage design: this product human body recommended dose is 3g/60kg every day, basic, normal, high three dosage groups are established in this experiment, be respectively 0.25,0.5,1.5g/kg, be equivalent to 5,10,30 times of human body recommended dose respectively, other establishes 2% sucrose fatty acid ester blank group and hyperglycemia model group.

4. sample treatment: sample thief 0.25,0.5,1.5g, add sucrose fatty acid ester respectively to 20ml, be the test liquid of basic, normal, high three dosage groups.

5. give the sample approach: irritate stomach, irritate gastric capacity 0.4ml/20g body weight.

6. reagent and instrument:

Alloxan (Alloxan), Sigma company with the normal saline preparation, carries out tail vein injection by the 40mg/kg body weight, injection capacity 0.15ml/25g.

Glucose is irritated stomach by the 2.0/kg body weight.

Blood sugar monitoring instrument (Johson ﹠ Johnson)

7. experimental technique:

7.1 intact animal's model:

Screening fasting glucose (FBC) fasting 24 hours, 40 of the mices in 3～5mmol/L scope are divided into four groups at random by blood sugar level, 10 every group, are respectively each dosage group of sample and normal control group.

7.2 zoic model with hyperglycemia:

Get 60 strict fasting of mice 24 hours, tail vein injection alloxan 40mg/kg.bw, fasting 16 hours again after 72 hours, 40 of the mices of screening FBG＞10mmol/L, be divided into four groups at random by blood sugar level, be respectively three agent groups and hyperglycemia model matched group.

7.3 the mensuration of hyperglycemia model animal carbohydrate tolerance (GT):

According to dosage design above two kinds of animal models (mice) are fed 30 days continuously after, give glucose 2.0g/kg.bw and irritate stomach, measure blood glucose value respectively in 0,0.5,2.0 hour 3 phase.

8. result:

8.1 sample is to the influence of the weight of animals

Sample is to the influence of normal the weight of animals

Group	Number of animals (only)	Body weight (gram)
						At the beginning of the experiment	In the experiment	Experiment eventually
	Blank	10	25.3±1.2	30.4±1.9					33.6±1.6
1.5g/kg					10	26.3±1.2	30.7±1.2	34.4±1.1

As seen from the above table, sample does not have obvious influence to normal the weight of animals.

Sample is to the influence of hyperglycemia model the weight of animals

Group	Number of animals (only)	Body weight (gram)
						At the beginning of the experiment	In the experiment	Experiment eventually
	Hyperglycemia model	10	23.3±1.0	24.2±0.9					27.1±0.9
0.25g/kg					10	23.3±0.8	24.7±0.7	26.9±2.0
	0.5g/kg	10	23.5±1.6	25.4±1.1					26.4±1.4
1.5g/kg					10	22.9±1.1	25.2±1.1	25.1±1.7

As seen from the above table, sample does not have obvious influence to the hyperglycemia model the weight of animals

8.2 influence to normal animal blood glucose:

Sample is to the influence of intact animal's fasting glucose (X ± SD)

Group	Number of animals (only)	Blood glucose (mmol/L)
							At the beginning of the experiment	After the experiment	Blood glucose decline percentage rate
Blank	10	4.05±0.8	3.90±0.6	1.83±15.21
					1.5g/kg	10	4.02±0.6	3.82±0.6	4.40±13.27

As seen from the above table, each dosage group of sample is compared difference that there are no significant with the blank group.

8.3 influence to zoic model with hyperglycemia blood glucose:

Sample is to the influence of zoic model with hyperglycemia fasting glucose (X ± SD)

Group	Number of animals (only)	Blood glucose (mmol/L)
						At the beginning of the experiment	After the experiment	Blood glucose decline percentage rate
	Hyperglycemia model	10	20.2±5.5	20.1±5.4					0.13±2.46
0.25g/kg					10	18.9±5.2	18.7±5.3	1.20±6.03
	0.5g/kg	10	19.9±5.3	19.4±4.9					1.54±5.76
1.5g/kg					10	18.8±5.3	18.7±4.9	0.51±4.53

As seen from the above table, each dosage group of sample is compared with the hyperglycemia model group, all indifference opposite sex difference.

8.4 influence to the zoic model with hyperglycemia carbohydrate tolerance:

Sample is to the influence of zoic model with hyperglycemia carbohydrate tolerance (X ± SD)

Group	Number of animals (only)	Blood glucose (mmol/L)
							0 hour	0.5 hour	2 hours
Hyperglycemia model	10	21.1±4.4	23.8±4.1	20.6±3.8
					0.25g/kg	10	19.0±5.5	22.7±3.4	18.2±4.8
0.5g/kg	10	20.0±5.2	23.1±4.0	19.2±4.1
					1.5g/kg	10	16.9±4.6	22.0±4.4	14.6±2.4 *

^*(through variance analysis) compared with the hyperglycemia model group in P＜0.05

As seen from the above table, the phase blood sugar content is compared with the hyperglycemia model group during 2 hours of sample 1.5g/kg treated animal, and significant difference is arranged.

Sample is to the influence of area under the zoic model with hyperglycemia carbohydrate tolerance test blood glucose curve (X ± SD)

Group	Number of animals (only)	Area under the blood glucose curve
			Hyperglycemia model	10	43.65±6.92
0.25g/kg	10	39.96±8.53
			0.5g/kg	10	41.53±8.23
1.5g/kg	10	35.33±4.93 *

^*(through variance analysis) compared with the hyperglycemia model group in P＜0.05

As seen from the above table, area is compared with the hyperglycemia model group under the blood glucose curve of sample 1.5g/kg treated animal, and significant difference is arranged.

9. conclusion: per os gives mice sample Fructus Pruni spirit tablet sugar continuously and likes to protect soft capsule after 30 days, has auxiliary hyperglycemic function.

Embodiment 2, auxiliary hyperglycemic function human feeding trial

1. materials and methods:

1.1 sample

Fructus Pruni spirit tablet sugar likes to protect soft capsule to be provided by Xingling Sci. ﹠ Tech. Pharmaceutical Co., Ltd., Shanghai for No. 1, No. 2, the two is in full accord on packing, outward appearance, color and luster and mouthfeel, one of them is that Fructus Pruni spirit tablet sugar is liked to protect soft capsule, and another is a placebo, and recommended intake was 3 gram/days.

1.2 the experimenter selects

1.2.1 standard of including in: the diabetes diagnosis standard of formulating by international diabetes association in 1997, selection state of an illness after diet control or oral antidiabetic drug treatment is more stable, do not need to change types of drugs and dosage, only take the adult type ii diabetes patient of maintenance dose.Patient meets above-mentioned condition and voluntary participation and guarantee that cooperation person all can include test in.

1.2.2 exclusion standard: type i diabetes (insulin-dependent) patient; Noncooperationist's (referring to diet control person in accordance with regulations); Complication such as severe cardiac, liver, kidney are arranged through B ultrasonic, Chest X-rays and Electrocardioscopy, serious gastroenteropathy, or be associated with other serious primary disease, the psychotic; Diabetes ketosis, ketoacidosis and the infected were arranged in nearly one month; Take glucocorticoid and often use other to influence the pharmacohistory person of blood glucose.

1.3 EXPERIMENTAL DESIGN and grouping

The double blind random grouping is adopted in this test, between group and self two kinds of control design.According to above-mentioned Standard Selection 100 routine type ii diabetes patients, by blood glucose, blood lipid level, sex, age, the course of disease, the kind of taking medicine (sulphanylureas, two croak class, glycosidase and drug combination) random packet balancedly, matched group 50 examples wherein, test-meal group 50 examples.

1.4 test method

Before the test each experimenter is pressed sex, age, different labor intensity, ideal body weight, stipulate corresponding diet with reference to original living habit, each group of duration of test is adhered to diet control, and the former medicament categories mediating recipe amount of using is constant.The test-meal group is taken Fructus Pruni spirit tablet sugar and is liked guarantor's soft capsule, and matched group is taken placebo, every day 3 times, each 2, observes continuously 30 days.

1.5 observation index

1.5.1 effect is observed: each tests once every index when on-test and end.

1.5.1.1 observation of symptoms: detailed medical history-taking, understand patient's diet situation, medicining condition, activity, observe main clinic symptoms such as thirsty polydipsia, polyuria, polyorexia, fatigue and weakness, add up integrated value by mild symptoms multiple integral (serious symptom 3 minutes, middle disease 2 minutes, light disease 1 minute) before and after test-meal, and improve (each doing well,improving is effectively more than 1 minute) with regard to its cardinal symptom, the improvement rate observes the symptoms.

1.5.1.2 blood sugar detection: the steamed bread that the unification of test-meal thing is refined into for 100g, survey on an empty stomach and 2 hours after the meal blood glucose.

1.5.1.3 urinary glucose determination: urina sanguinis is qualitative on an empty stomach, by-, ± ,+, ++, +++, ++ ++ long-pending 0,0.5,1,2,3,4 minute respectively, statistics integrated value before and after test-meal.

1.5.1.4 lipid determination: T-CHOL (TC), triglyceride (TG), high density lipoprotein (HDL-C).

1.5.2 safety is observed

1.5.2.1 hemogram: red blood cell count(RBC) (RBC), hemoglobin (Hb), numeration of leukocyte (WBC).

1.5.2.2 hepatic and renal function: glutamic oxaloacetic transaminase, GOT (AST), glutamate pyruvate transaminase (ALT), total serum protein (TP), albumin (ALB), blood urea nitrogen (BUN), creatinine (Cr).

1.5.2.3 other: Abdominal B type ultrasonography, electrocardiogram, X line fluoroscopy of chest (only pretest inspection is once).

1.6 test data statistics

(X ± SD) expression self relatively uses paired t-test before and after the test-meal to the result, relatively uses t check in groups, percentage rate X between group with means standard deviation ²Check.

1.7 clinical observation effect criterion:

Effectively: fundamental symptoms obviously improves, and fasting glucose is tested preceding decline＞10% or the preceding decline＞20% of test of 2h blood glucose after the meal.

Invalid: fundamental symptoms does not have obvious improvement, and fasting glucose is tested preceding decline＜10% or the preceding decline＜20% of test of 2h blood glucose after the meal.

2. result:

Double-blind method is observed and is finished to make known: take No. 1 person and like to protect soft capsule for the Fructus Pruni spirit tablet, take No. 2 persons and be placebo.

2.1 physical data: hemogram, hepatic and renal function, Chest X-rays, electrocardiogram, B ultrasonic etc. check that the experimenter is all in normal range before the test, the grouping situation sees Table 1, the preceding two groups of equal no significant differences of patient age, the course of disease, blood glucose, blood lipid level and medicining condition of test-meal have comparability.

Data relatively as table 1 test-meal was last

Project	Matched group	The test-meal group
			The example number	50	50
Man/woman	34/16	32/18
			Age (year)	53.66±8.37	53.36±8.82
The course of disease (year)	4.78±3.89	3.88±3.19
			Fasting glucose (mmol/L)	8.03±1.47	8.50±1.24
2h blood glucose (mmol/L) after the meal	11.67±2.58	12.27±2.94
			Cholesterol (mmol/L)	4.79±0.55	4.98±0.58
Not medication	0	0

Sulphanylureas	6	5
			Biguanides	4	6
Glycosidase	12	10
			Drug combination	28	29
Other	0	0

2.2 effect is observed

2.2.1 observation of symptoms:

Show that by table 2,3 take and tried thing one month, clinical symptoms such as the thirsty polydipsia of test-meal group, polyorexia, fatigue and weakness, polyuria have clear improvement, apparent in view reduction before symptom integral and the test-meal, difference has highly significant (P＜0.01); Compare with matched group, difference also has highly significant (P＜0.01).

Table 2 clinical symptoms integration statistics (X ± SD)

Group	Example number (n)	Before the test-meal	After the test-meal
				Matched group	50	3.36±1.88	3.38±2.01
The test-meal group	50	4.06±2.07	2.16±1.97 *#

Annotate: ^*With comparison P＜0.01 before the test-meal, # and matched group be P＜0.01 relatively

Table 3 clinical symptoms is improved situation

Symptom	Matched group (n=50)			Test-meal group (n=50)			Improvement rate (%)
									The example number	Effectively	Invalid	The example number	Effectively	Invalid	Matched group	The test-meal group
	Thirsty polydipsia	36	8	28	34	27	7	22.22									79.41
Polyorexia									17	3	14	21	15	6	18.65	71.43
	Fatigue and weakness	46	12	34	47	38	9	26.09									80.85
Polyuria									33	9	24	32	23	9	27.27	71.88

2.2.2 clinical observation:

Show that by table 4 take and tried thing one month, test-meal group clinical observation total effective rate is 66.00%, with matched group (24.00%) comparing difference significance (P＜0.01) is arranged.

Table 4 clinical observation effect relatively

Group

Example number (n)

Effectively

Invalid

Total effective rate %

Matched group	50	12	38	24.00
					The test-meal group	50	33	17	66.00#

Annotate: # and matched group compare＜0.01

2.2.3 fasting glucose

Shown that by table 5 self relatively compares before fasting glucose and the test-meal after the test-meal of test-meal group, difference has highly significant (P＜0.01); The preceding comparing difference of fasting glucose and test-meal does not have significance after the matched group test-meal.Compare between group, fasting glucose no significant difference before two groups of test-meals, test-meal group fasting glucose, blood glucose fall and matched group compare after the test-meal, and difference has significance (P＜0.05), its decline percentage rate and matched group compare, and difference also has highly significant (P＜0.01).Illustrate that Fructus Pruni spirit tablet sugar love guarantor soft capsule has the effect of the fasting glucose of reduction.

Fasting glucose variation before and after table 5 test-meal (mmol/L, X ± SD)

Group	The example number	Before the test-meal	After the test-meal	The blood glucose fall	Decline percentage rate (%)
						Matched group	50	8.03±1.47	7.97±1.42	0.08±1.01	0.79±12.39
The test-meal group	50	8.50±1.24	7.44±1.06 *#	1.06±0.92U	11.83±10.51 ##

Annotate: ^*With comparison P＜0.01 before the test-meal, # and matched group be P＜0.05 relatively, and ## and matched group be P＜0.01 relatively.

2.2.4 2h blood glucose after the meal

Show by table 6,2h blood glucose and the preceding comparison of test-meal after the meal after the test-meal of test-meal group, difference has highly significant (P＜0.01), compares with matched group, and difference also has significance (P＜0.05); And 2h blood glucose after the meal after the matched group test-meal does not have significance with comparing difference before the test-meal.Test-meal group 2h blood glucose after the meal descends and the fall percentage rate, and compares difference highly significant (P＜0.01) is arranged.Illustrate that Fructus Pruni spirit tablet sugar likes to protect soft capsule and have and reduce 2h blood glucose effect after the meal.

2h changes of blood glucose (mmol/L, X ± SD) after the meal before and after table 6 test-meal

Group	The example number	Before the test-meal	After the test-meal	Difference	Decline percentage rate (%)
						Matched group	50	11.67±2.58	11.38±2.47	0.30±1.14	2.18±10.51
The test-meal group	50	12.27±2.94	10.44±2.10 *#	1.81±1.96 ##	12.77±14.98 ##

Annotate: ^*With comparison P＜0.01 before the test-meal, # and matched group be P＜0.05 relatively, and ## and matched group be P＜0.01 relatively.

2.2.5 glucose in urine

Show by table 7, after the test-meal before glucose in urine and the test-meal relatively, difference has highly significant (P＜0.01), and glucose in urine and the preceding comparing difference of test-meal do not have significance after the matched group test-meal; Test-meal group glucose in urine reduces difference and the matched group comparing difference has significance (P＜0.05).Illustrate that Fructus Pruni spirit tablet sugar love guarantor soft capsule has the effect of the glucose in urine of reduction.

The variation of glucose in urine before and after table 7 test-meal (integrated value, X ± SD)

Group	The example number	Before the test-meal	After the test-meal	Difference
					Matched group	50	0.14±0.42	0.14±0.35	0.00±0.27
The test-meal group	50	0.21±0.39	0.064±0.17 *	0.15±0.31 #

Annotate: ^*Compare P＜0.05 with comparison P＜0.01 # and matched group before the test-meal

2.2.6 blood fat

By table 8 demonstration, the preceding comparing difference of cholesterol, triglyceride and test-meal has significance (P＜0.05) after the test-meal of test-meal group, with the matched group comparing difference significance (P＜0.050) is arranged also, and Fructus Pruni spirit tablet sugar love guarantor soft capsule energy cholesterol reducing, triglyceride are described.

Blood Lipid before and after table 8 test-meal (mmol/L, X ± SD)

Project	Matched group (n=50)		Test-meal group (n=50)
					Before the test-meal	After the test-meal	Before the test-meal	After the test-meal
	Cholesterol (TC)	4.79±0.55	4.97±0.54	4.98±0.58					4.70±0.51 *#
Triglyceride (TG)					1.80±1.71	1.94±1.59	1.98±2.06	1.72±10.5 *#
	High density lipoprotein (HDL-C)	1.48±0.26	1.41±0.29	1.44±0.28					1.47±0.24

Annotate: ^*Compare P＜0.05 with comparison p＜0.05 # and matched group before the test-meal

2.3 safety inspection

By table 9,10 as seen, edible tried thing one month, two groups of hemogram and the every detection index of hepatic and renal function be all in normal range, illustrate that the Fructus Pruni spirit tablet likes that guarantor's soft capsule does not have obvious damage to body health.

The variation of hemogram before and after table 9 test-meal

Project	Matched group (n=50)		Test-meal group (n=50)
					Before the test-meal	After the test-meal	Before the test-meal	After the test-meal
	Erythrocyte (* 10 12/L)	4.31±0.55	4.65±0.43	4.40±0.52					4.42±0.37
Leukocyte (* 10 9/L)					5.63±1.39	6.22±1.30	5.44±1.33	5.58±0.86
	Hemoglobin	125.32±15.63	133.58±13.39	126.20±17.38					127.74±12.39

(g/L)

The variation of liver, renal function before and after table 10 test-meal (X ± SD)

Project	Matched group (n=50)		Test-meal group (n=50)
					Before the test-meal	After the test-meal	Before the test-meal	After the test-meal
	Total serum protein (g/L)	72.35±2.00	72.92±1.66	72.20±1.93					72.37±1.44
Serum albumin (g/L)					43.32±1.62	43.41±1.51	43.24±1.59	43.07±1.58
	Glutamate pyruvate transaminase (μ/L)	22.50±6.11	23.86±8.18	21.90±6.79					21.50±6.86
Glutamic oxaloacetic transaminase, GOT (μ/L)					20.26±5.08	22.52±7.91	20.40±4.58	19.60±7.02
	Blood urea nitrogen (mmol/L)	4.35±0.65	4.45±0.64	4.44±0.68					4.46±0.61
Creatinine (umol/L)					83.20±11.22	76.96±10.84	81.99±10.88	78.56±12.58

3. brief summary:

Adopt the double blind control method, 100 routine type ii diabetes patients are divided into matched group and test-meal group, wherein test-meal group 50 examples at random by the kind of taking medicine, blood glucose, blood lipid level etc., matched group 50 examples, edible respectively Fructus Pruni spirit tablet sugar likes to protect soft capsule and placebo, every day 3 times, each 2.Observe and adhere to diet control therebetween, former treatment Rezulin species mediating recipe amount is constant.After one month, the result shows: Fructus Pruni spirit tablet sugar likes to protect soft capsule has the improvement effect to clinical symptoms such as the thirsty polydipsia of diabetes, polyorexia, fatigue and weakness, polyurias, symptom integral obviously reduces, its total effective rate is 66.00% (matched group is 24.0%), can reduce fasting glucose, post-prandial glycemia and glucose in urine (P＜0.01, P＜0.05, P＜0.01), and can cholesterol reducing, triglyceride (P＜0.05).Test-meal front and back hemogram and the every detection index of hepatic and renal function do not have obviously change all in normal range, illustrate that Fructus Pruni spirit tablet sugar love guarantor soft capsule is to the healthy no obvious damage of experimenter.This shows that Fructus Pruni spirit tablet sugar likes to protect soft capsule the auxiliary hyperglycemic effect.

Embodiment 3,

Folium Ginkgo 8kg

Folium Mori 20kg

Fructus Cucurbitae moschatae extract 1.2kg (containing squash polyoses 60%)

Perilla oil 5.55kg

Cera Flava 0.3kg

Soybean phospholipid 0.3kg

1, Chinese medicine extraction: silk is cleaned, is cut into to Folium Ginkgo, Folium Mori through identifying check, weigh, and drop in the multi-function extractor, add 70% ethanol of 12 times of amounts, soaks after 1 hour heating decoction 1 hour, residue adds 10 times of water gagings and extracted 1 hour with method, merges extracted twice liquid;

2, tubular-bowl centrifuge: be used for high speed centrifugation (8000 rev/mins);

3, spray drying: medicinal liquid carries out spray drying, and its parameter is: moisture≤3.5% of 18000 rev/mins of rotating speeds, 185 ℃ of inlet temperature, 85 ℃ of leaving air temps, powder delivery gets dry powder 2.65kg;

4, mix:, get mixed powder with above-mentioned spray drying powder and as Fructus Cucurbitae moschatae extract (prior mistake 200 mesh sieves) mix homogeneously;

5, mixing: mix and powerful the stirring with the substrate (being the adjuvant of liposoluble constituent) of soft capsule, get suspended matter (content);

6, sterilization treatment: said mixture carries out microwave sterilizating and handles microwave frequency 2450MHz, sterilization time 5min;

7, compacting: the mensuration that the xeraphium that sterilization is good carries out functional component content, physics and chemistry, microorganism, meet behind the quality standard under 100,000 grades condition, above-mentioned content is pressed into soft capsule;

8, drying: the soft capsule that is shaped is carried out drying (≤60 ℃), get finished product, every 0.5g, testing result: total flavones 1393mg/100g, crude polysaccharides 1302.8mg/100g.

Total flavones is measured in embodiment 4, the preparation

(1) rutin standard reference material solution: precision takes by weighing at the control substance of Rutin 15.0mg of 105 ℃ of drying under reduced pressure to constant weight, adds dissolve with methanol and is settled to 100mL, is made into 150 μ g/mL rutin standard solution.

(2) accurate absorption standard rutin standard solution 0.0,0.50,1.00,2.00,3.00,4.00mL are equivalent to rutin 0,75,150,300,450,600 μ g and move in the 10mL scale color comparison tube, respectively add 30% ethanol to 5ml, respectively add 5%NaNO ₂Solution 0.3ml shakes up and places 5min, respectively adds 10%Al (NO ₃) ₃Solution 0.3ml shakes up, and places 6min again, adds 1.0mol/LNaOH solution 2ml, be settled to scale with 30% ethanol, shake up and place 10-20min, at 510nm wavelength place, make blank with zero pipe solution and measure absorbance respectively, concentration is returned the drawing standard curve with absorbance.

(3) preparation of need testing solution

Take by weighing 1.0g sample (embodiment 3 methods make content), pack tightly with filter paper, place boiling flask, add 50-100mL70% ethanol, after the infiltration, the 2h that refluxes under 80 ℃ of water-baths extracts substantially to flavone compound fully.After the crude extract cooling, decompress filter, and wash filtering residue, merging filtrate with a small amount of 25% alcoholic solution.50 ℃ of following distilling under reduced pressure, remove ethanol wherein, solution is in flask does not have the alcohol flavor.Pour out solution in the flask, and divide the washing flask 3 times, behind the sucking filtration, filtrate is poured in the separatory funnel, divide with the 75mL chloroform to extract defat 3 times with 30mL hot water, treat complete layering after, collect each time lower aqueous solution and be settled to 50mL.

Take by weighing 1-2g through pretreated polyamide powder, wet method dress post is used water saturation.Draw the aqueous solution 1-2mL after the above-mentioned defat, slowly splash in the post along chromatographic column, place certain hour, liquid to be measured is by after the abundant absorption, and with 70% ethanol or methanol-eluted fractions, flow velocity is 1.0mL/min, and is colourless substantially to effluent, generally collects 10mL and gets final product.Above-mentioned eluate promptly can be used for after with the eluant standardize solution measuring.

(4) sample determination

The accurate sample extracting solution 1.00ml that draws carries out the mensuration of absorbance in the 510nm place by standard curve preparation manipulation step in the 10ml color comparison tube.

(5) calculate

$X=\frac{m1\×V2}{m\×V2\×106}\×100=1393\mathrm{mg}/100g$

In the formula: content of total flavone in the X----sample (in rutin), mg/100g;

M1----establishing criteria opisometer is calculated flavones content in the test solution, μ g;

The quality of m----sample, g;

The volume that V1----liquid branch to be measured is got, mL;

The cumulative volume of V2----liquid to be measured, mL.

Crude polysaccharides is measured in embodiment 5, the preparation

(1) glucose titer: accurately take by weighing 1.0000g through 98-100 ℃ of glucose (AR) that is dried to constant weight, the back that is dissolved in water is diluted to 1000ml with water, and this solution 1ml contains the 1mg glucose, with 10 times of preceding dilutions (0.1mg/ml), matching while using.

(2) precision pipettes glucose standard solution 0,0.10,0.20,0.30,0.40,0.50,0.60 mL, in the tool plug test tube that is placed in.Adding distil water is supplemented to volume 2.00mL, adds phenol solution 1.00mL again, shakes up, and adds concentrated sulphuric acid 5.00mL successively, shakes up, and puts boiling water bath 2min, takes out and puts room temperature, measures trap in wavelength 485nm place.With the sugar content is abscissa, and absorbance is a vertical coordinate, the drawing standard curve.

(3) preparation of need testing solution

Sample extraction: take by weighing sample 2.0g (embodiment 3 methods make content), place the 100mL volumetric flask, add about water 80mL, on boiling water bath, heat 2h, be cooled to mend after the room temperature and add water to scale, behind the mixing, filter, discard filtrate just, collect remaining filtrate for the precipitation polysaccharide.

Accurately draw above whole filtrate 5.00mL, place the 50mL centrifuge tube, add dehydrated alcohol 20mL, behind the mixing 5min, with the centrifugal 5min of 3000r/min, abandoning supernatant.Residue is with milliliter washing of 80% (volume fraction) alcoholic solution number, centrifugal back abandoning supernatant, repeatable operation 3-4 time.Residue is with water dissolution and be settled to 5.0mL, behind the mixing, for the precipitation glucosan.

Accurately draw above whole solution 2.00mL, place the 20mL centrifuge tube, add 100g/L sodium hydroxide solution 2.0mL, copper test solution solution 2.0mL, boil heating 2min in the boiling water bath, cooling is with the centrifugal 5min of 3000r/min, abandoning supernatant.Residue is with milliliter washing of cleaning mixture number, centrifugal back abandoning supernatant, and repeatable operation 3 times, residue dissolves with 10% (volume fraction) sulfuric acid solution 2.0mL and is transferred in the 50mL volumetric flask, and thin up is to scale, mixing.

(4) sample determination

Draw need testing solution 1.00ml, add water and be supplemented to 2.00ml, add phenol solution 1.00ml again, shake up, add concentrated sulphuric acid 5.00ml successively, shake up, put boiling water bath 2min, take out and put room temperature, measure trap in wavelength 485nm place.

(5) calculate crude polysaccharides (with glucose meter) $\mathrm{mg}/100\mathrm{ml}=\frac{m\×50}{10.00\×1.0\×1000}\×100=1302.8\mathrm{mg}/100g$

In the formula:

M---is for measuring the amount of the suitable glucose of solution, μ g.

The preparation of embodiment 6 tablets

Embodiment 3 methods make mixed powder, get mixed powder 1kg, add starch 1kg and low-substituted hydroxypropyl cellulose 0.48kg, cross 80 mesh sieves respectively, and mix homogeneously is that wetting agent is granulated with the Diluted Alcohol, and dry granulate adds magnesium stearate 20g, tabletting, every 0.25g.

The preparation of embodiment 7 oral liquids

With the dry Folium Ginkgo of 1kg, the dry Folium Mori adding of 2.5kg 30L water, soak post-heating and extracted 1 hour, residue adds 24L water and extracts merge extractive liquid, with method, add Fructus Cucurbitae moschatae extract (containing squash polyoses 40%) 0.3kg, sodium carboxymethyl cellulose 40g, glucide 5g, sodium benzoate 10g, stirring and dissolving is filtered, water is adjusted to 40L, packing, sterilization, promptly.

Claims (5)

1, a kind of health product with function of blood sugar reduction is characterized in that these health product are oral formulations of being made by the active ingredient that mainly contains Folium Ginkgo, Folium Mori, Fructus Cucurbitae moschatae extract and other adjuvants.

2, the health product with function of blood sugar reduction according to claim 1 is characterized in that the percentage composition that wherein said each main active accounts for the active ingredient gross weight is Folium Ginkgo 18～48%, Folium Mori 48～76%, Fructus Cucurbitae moschatae extract 2～8%.

3, the health product with function of blood sugar reduction according to claim 1 is characterized in that wherein said Fructus Cucurbitae moschatae extract for being raw material with the Fructus Cucurbitae moschatae, obtains behind water extract-alcohol precipitation, purification, contain the extract of squash polyoses 40-60%.

4, the health product with function of blood sugar reduction according to claim 1 is characterized in that wherein said other adjuvants comprise various nutrients, food additive and pharmaceutic adjuvant.

5, the preparation method with health product of function of blood sugar reduction according to claim 1 is characterized in that this method comprises the following steps:

1) Folium Ginkgo, the Folium Mori of recipe quantity are cleaned, chopped up, water and/or soak with ethanol post-heating reflux, extract;

2) extracting liquid filtering, concentrate, spray drying gets xeraphium;

3) fully mix with above-mentioned xeraphium after Fructus Cucurbitae moschatae extract sieves;

4) make various oral formulations with conventional method;

5) be not less than 1379mg/100g with total flavones total amount in the spectrophotometer detection preparation in rutin, be not less than 1216.7mg/100mg with glucose meter with crude polysaccharides content in the spectrophotometer detection preparation.