CN101732698B - Traditional Chinese medicine preparation with effect of lowering blood sugar, preparation method and application thereof - Google Patents
Traditional Chinese medicine preparation with effect of lowering blood sugar, preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine preparation with the effect of lowering blood sugar, which comprises the following raw materials in parts by weight: 0.5-60 parts of malus hupehensis extract, 1-95 parts of peptide powder and 2-70 parts of oligosaccharide. The preparation method comprises the following steps: (1) preparing the malus hupehensis extract: taking the dry tree leaves of malus hupehensis, taking ethanol as a solvent, refluxing, extracting, concentrating the extract, standing below 1-4 DEG C, centrifugalizing, removing a precipitate and concentrating supernatant liquid for later use; (2) mixing: adding the peptide powder into water, mixing evenly, regulating the sugar degree, heating, then adding the malus hupehensis extract and the oligosaccharide, mixing evenly, sterilizing and drying to obtain fine powder. The traditional Chinese medicine preparation has burnt odor in smell, is sweet and bitter in taste, has obvious curative effect and good effect of lowering sugar when being used as a medicine for lowering the blood sugar, can obviously improve the clinical symptoms of mouth dryness, throat dryness, polydipsia, frequent micturition with large quantity, myasthenia of limbs, dizziness and the like and has the functions of nourishing yin, tonifying the kidney, supplementing qi, promoting the production of the body fluid and the like.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation and preparation method thereof and application with effect of lowering blood sugar.
Background technology
Diabetes, the traditional Chinese medical science is claimed diabetes, is a kind of or a series of clinical syndromes that relative deficiency caused absolute because of insulin in the body, be a kind of common, multiple, follow lifelong disease.Its sickness rate has the trend that increases year by year, has been classified as the third-largest disease after cardiovascular disease and tumor in developed country.Present diabetes are the multiple chronic complicating diseases that on arteriosclerosis and microangiopathies basis, produces to the human health risk maximum, like diabetic cardiopathy, diabetic acromelic gangrene, diabetic cerebrovascular, diabetic nephropathy, diabetic retinopathy and neuropathy etc.Duo 10～25 times because of diabetes cause blind person than common people, diabetic retinopathy has become one of four big main blinding diseases at present; Diabetic gangrene and amputee are Duoed 20 times than common people; Diabetes are high 2～3 times than non-diabetic person cardiovascular system sickness rate and case fatality rate; Diabetes cause renal failure to Duo 17 times than nephropathy.In a word, diabetes and chronic complicating diseases thereof are very serious to the harm of human health, have caused the great attention of whole world medical circle.
Hubei Chinese flowering crabapple (Malus hupehensis) has another name called Begonia aptera Bl., Folium Mali Hupehensis, Folium hydrangeae strigosae fruit, Mount Taishan Caulis et folium euphorbiae milii, is the rosaceous plant Malus, and its leaves Chang Zuowei Folium Camelliae sinensis is quoted, and the history in existing more than 400 year is rare expelling summer-heat herbal tea in midsummer.There is document to show, contains chemical constituents such as a large amount of phenols, flavonoid in the Hubei Chinese flowering crabapple leaf, many-sided effect such as anti-inflammation, anoxia enduring, resisting fatigue, blood sugar lowering, blood fat reducing.
The peptide class be protein behind hydrolysis, the low peptide mixture that obtains (soybean peptide, wheat peptide etc.).Its essential amino acids content is abundant and be easy to digestion and absorption, and research shows that the peptide class has blood fat reducing, regulates effects such as immunity of organism effect, blood pressure lowering, resisting fatigue, blood sugar lowering.The peptide apoplexy due to endogenous wind contains alpha-glucosidase inhibitor, when it uses with carbohydrate and saccharide, can not receive the influence of amount of insulin secretion, suppresses the rising of blood glucose.
Oligosaccharide is the general name of soluble oligosaccharide; Soybean oligo saccharide, Fructus Hordei Germinatus oligose, oligofructose etc. are arranged; It has blood pressure lowering, blood fat reducing, the effect of adjusting immunity of organism, promotes calcareous absorption, promotes bacillus bifidus propagation; Enliven intestinal movement, improve intestinal microbial population, regulate sugared metabolism, make islet function obtain replying, bring into play hypoglycemic effect.
It is raw material with the Hubei Chinese flowering crabapple leaf that Chinese patent CN101233887 discloses a kind of, add multiple Chinese herbal medicine such as Folium Pini, Radix Glycyrrhizae, Fructus Momordicae process have heat-clearing and toxic substances removing, the health-care cold tea of effects such as promoting the production of body fluid to quench thirst, blood fat-reducing blood pressure-decreasing.This patent is that compound recipe that Hubei Chinese flowering crabapple and other medical material are formed extracts and gets, and fails the effect of remarkable Hubei Chinese flowering crabapple.Chinese patent CN101199301 discloses Hubei Chinese flowering crabapple brick tea, teabag, has concentrated the method for preparing of sifting tea and Hubei Chinese flowering crabapple pigment; And disclose the application of Hubei Chinese flowering crabapple tea in blood sugar lowering, blood fat reducing, but this patent does not relate to the extraction of Hubei Chinese flowering crabapple and the pharmacodynamic action that has with oligosaccharide, plant peptide drug combination.The beverage that Chinese patent CN1351839 discloses the decocte with water of a kind of Hubei Chinese flowering crabapple leaf, sterilized and process, the hypoglycemic drug effect that does not relate to Hubei Chinese flowering crabapple is learned active.Chinese patent CN101011096 discloses a kind of tea that makes with sterilizations such as Hubei Chinese flowering crabapple leaf, fruit and Radix Glycyrrhizae, Folium Mori pulverizing, does not relate to the extraction and the drug effect of Hubei Chinese flowering crabapple.Above-mentioned four patents all do not relate to the effect of compound recipe in treating diabetes of Hubei Chinese flowering crabapple and soybean oligo saccharide, soybean peptide composition.
Summary of the invention
To above-mentioned prior art; The present invention processes Chinese medicine compound according to a certain percentage with Hubei Chinese flowering crabapple extract, plant peptide and the material that three kinds of oligosaccharide have different blood sugar lowering mechanism; Obtained to have the Chinese medicine preparation of remarkable hypoglycemic activity, the present invention also provides its preparation method.
A kind of Chinese medicine preparation with effect of lowering blood sugar comprises the raw material of following weight portion: 0.5～60 part of Hubei Chinese flowering crabapple extract, 1～95 part in peptide powder, 2～70 parts of oligosaccharide.
Preferably, be to process: 5～95 parts of Hubei Chinese flowering crabapple extracts, 1～80 part in peptide powder, 5～90 parts of oligosaccharide by the raw material of following weight portion.
Said peptide powder comprises plant peptide powder such as soy peptide powder, wheat peptide powder, also comprise have blood pressure lowering, blood fat reducing, the glycometabolic animal peptide of conciliation and microbial polypeptide, preferred soy peptide powder.
Said oligosaccharide comprises soybean oligo saccharide, Fructus Hordei Germinatus oligose, oligofructose and has the propagation probiotics, reconciles metabolic other oligosaccharide of blood glucose, preferred soybean oligo saccharide.
Said plant peptide, oligosaccharide are already present product in the prior art, and national standard is arranged.Product that the applicant uses is the applicant and produces voluntarily.
Said Chinese medicine preparation also can comprise acceptable additive on pharmaceutic adjuvant or the food, and the consumption of pharmaceutic adjuvant or additive has no special requirements and limits, and conventional the interpolation gets final product.
Said preparation can be mixed and made in capsule (comprising soft capsule), tablet, powder, granule, oral liquid, medicated wine, pill, pellet, mixture, the tincture any one for medically acceptable adjuvant and take preferred particulates agent, capsule, tablet.Also comprise and process various forms of food and health product.
A kind of method for preparing with Chinese medicine preparation of effect of lowering blood sugar may further comprise the steps:
1) preparation Hubei Chinese flowering crabapple extract: getting the Hubei Chinese flowering crabapple dried leaf, is solvent with 0～95% ethanol (refer to volume parts, when getting " 0 ", be pure water), refluxes 1～8 time; Reclaim ethanol, and extracting solution is concentrated into 10～20Bx, and (unit is Bo Likesi scale: Brixsale, writes a Chinese character in simplified form BX, i.e. pol; Percetage by weight with pure sucrose solution is represented ratio), under 1～4 ℃, leave standstill 24～36h, centrifugal; Remove deposition, with supernatant concentration to 20～40Bx, subsequent use;
2) mix: the peptide powder is added in the entry, mixing, the adjusting pol is 15～20Bx, is heated to 70～80 ℃; Add Hubei Chinese flowering crabapple extract and oligosaccharide then, mixing makes pol at 15～25Bx; Utilize the antibacterial of flash distillation unit, utilize spray drying tower dry then, get fine powder after the drying, be Chinese medicine preparation with effect of lowering blood sugar; Or: the Hubei Chinese flowering crabapple extract is utilized the antibacterial of flash distillation unit, utilize the spray drying tower drying after, add peptide powder and oligosaccharide again, mixing is the Chinese medicine preparation with effect of lowering blood sugar.
Said method for preparing is further comprising the steps of: 3) granulate; 4) molding; 5) packing.This three step is the routine techniques operation, repeats no more.
In the said step 1), during reflux, extract,, each extraction time is 1～5h, preferred 2～3h; Each solvent amount that adds is 4～10 times of the shared volume of Hubei Chinese flowering crabapple dried leaf, preferred 6～8 times.
Said step 2) in, sterilization temperature is 135～150 ℃, and when dry, EAT is 170～190 ℃, and leaving air temp is 85～95 ℃.
Chinese medicine preparation of the present invention can be used as hypoglycemic drug and uses.
Chinese medicine preparation abnormal smells from the patient burnt odor of the present invention; Sweet in the mouth, hardship; When using as hypoglycemic drug, curative effect is obvious, hypoglycemic effect good, can significantly improve clinical symptoms such as diabetics dryness of the mouth and throat, excessive thirst polydipsia, urinary micturition, myasthenia of limbs, the vertigo; And have functions such as enriching yin and nourishing kidney, supplementing QI for promoting the production of body fluid, be applicable to the treatment of type ii diabetes and the generation of complication prevention.
The specific embodiment
The present invention is further described with experiment below in conjunction with embodiment:
1 one kinds of tablet method for makings of embodiment with blood sugar reducing function, step is following:
(1) preparation of Hubei Chinese flowering crabapple extract: get Hubei Chinese flowering crabapple dried leaf 5kg, add 25kg concentration 30% edible ethanol,, reflux, extract.Merge extractive liquid, 4 times reclaims ethanol.Extracting solution is concentrated into 20Bx, and concentrated solution leaves standstill 24h under 4 ℃, centrifugal, and reconcentration is subsequent use to 40Bx.
(2) preparation process thereof: in jar, add water 20kg, 40 ℃ of heating systems, the soybean oligo saccharide of adding 10kg soy peptide powder, 5kg concentration 58%; Abundant stirring and evenly mixing; Add the above-mentioned Hubei Chinese flowering crabapple extract of 2kg again, be warming up to 80 ℃ of antibacterials 30 minutes behind the mixing, dry with band drier.Pulverize the cooling back, and fine powder adopts the compound plastic bag packing, is stored in the stainless steel cask.
(3) granulate: take by weighing above-mentioned fine powder 6kg, add magnesium stearate 50g, silica 1 5g mixed 20 minutes in the three-dimensional mixer of packing into, emitted, and granulated, and put into the stainless steel cask of cleaning with cover with the plastic bag splendid attire.
(4) molding: tabletting prepares the tablet of 0.2g/ sheet.
(5) packing: adopt packaging of aluminium foil bag.
Promptly obtain the tablet of this invention through above-mentioned steps.
2 one kinds of powder method for makings of embodiment with blood sugar reducing function, step is following:
(1) preparation of Hubei Chinese flowering crabapple extract: with embodiment 1.
(2) extract is dry: above-mentioned preparation liquid is utilized the antibacterial of flash distillation unit, 135 ℃ of sterilization temperatures; Adopt the pressure type drying tower to carry out spray drying then, 175 ℃ of spray tower EATs, 70 ℃ of leaving air temps; Get fine powder after the drying and pack with compound plastic bag, subsequent use.
(3) mix powder process: take by weighing above-mentioned fine powder 2kg, add soy peptide powder 6kg, dextrinosan powder 4kg mixed 20 minutes in the three-dimensional mixer of packing into, emitted, and the composite plastic packing of aluminizing is adopted in metering.
Promptly obtain the powder of this invention through above-mentioned steps.
Embodiment 3
Take by weighing the fine powder 2kg that embodiment 2 steps (2) obtain, add dextrinosan powder 8kg, do not add the soybean peptide powder, mixed 20 minutes in the three-dimensional mixer of packing into, emit, the composite plastic packing of aluminizing is adopted in metering.
Embodiment 4
Take by weighing the fine powder 2kg that embodiment 2 steps (2) obtain, add soy peptide powder 8kg, do not add oligomeric Icing Sugar, mixed 20 minutes in the three-dimensional mixer of packing into, emit, the composite plastic packing of aluminizing is adopted in metering.
5 one kinds of unguentum method for makings of embodiment with blood sugar reducing function, step is following:
(1) preparation of Hubei Chinese flowering crabapple extract: get Hubei Chinese flowering crabapple dried leaf 5kg, add 25kg concentration 30% edible ethanol,, reflux, extract.Merge extractive liquid, 4 times reclaims ethanol.Extracting solution is concentrated into 20Bx, subsequent use.
(2) unguentum method for making: get above-mentioned preparation liquid 2kg and put into vacuum concentration pot, add 0.5kg wheat peptide powder and 0.2kg oligofructose again, suction, 75 ± 5 ℃ of heating-up temperatures of control, vacuum concentration is during to 65BX, and hot filling seals, and is unguentum of the present invention.
6 one kinds of powder method for makings of embodiment with blood sugar reducing function, step is following:
(1) preparation of Hubei Chinese flowering crabapple extract: get Hubei Chinese flowering crabapple dried leaf 5kg, add 25kg concentration 90% edible ethanol, reflux, extract, 4 times.Merge extractive liquid, reclaims ethanol.Extracting solution is concentrated into 10Bx, and concentrated solution leaves standstill 36h under 4 ℃, centrifugal, and reconcentration is subsequent use to 20Bx.
(2) extract is dry: above-mentioned preparation liquid is utilized the antibacterial of flash distillation unit, 150 ℃ of sterilization temperatures; Adopt the pressure type drying tower to carry out spray drying then, 190 ℃ of spray tower EATs, 95 ℃ of leaving air temps; Get fine powder after the drying and pack with compound plastic bag, subsequent use.
(3) mix powder process: take by weighing above-mentioned fine powder 0.5kg, add soy peptide powder 1kg, dextrinosan powder 2kg mixed 20 minutes in the three-dimensional mixer of packing into, emitted, and the composite plastic packing of aluminizing is adopted in metering.
7 one kinds of powder method for makings of embodiment with blood sugar reducing function, step is following:
(1) preparation of Hubei Chinese flowering crabapple extract: get Hubei Chinese flowering crabapple dried leaf 5kg, add 25kg concentration 60% edible ethanol, reflux, extract, 8 times.Merge extractive liquid, reclaims ethanol.Extracting solution is concentrated into 20Bx, and concentrated solution leaves standstill 30h under 1 ℃, centrifugal, and reconcentration is subsequent use to 40Bx.
(2) extract is dry: above-mentioned preparation liquid is utilized the antibacterial of flash distillation unit, 140 ℃ of sterilization temperatures; Adopt the pressure type drying tower to carry out spray drying then, 170 ℃ of spray tower EATs, 85 ℃ of leaving air temps; Get fine powder after the drying and pack with compound plastic bag, subsequent use.
(3) mix powder process: take by weighing above-mentioned fine powder 6kg, add microbial polypeptide powder 9.5kg, oligofructose 7kg mixed 20 minutes in the three-dimensional mixer of packing into, emitted, and the composite plastic packing of aluminizing is adopted in metering.
8 one kinds of powder method for makings of embodiment with blood sugar reducing function, step is following:
(1) preparation of Hubei Chinese flowering crabapple extract: get Hubei Chinese flowering crabapple dried leaf 5kg, add 25kg concentration 45% edible ethanol, reflux, extract, 2 times.Merge extractive liquid, reclaims ethanol.Extracting solution is concentrated into 15Bx, and concentrated solution leaves standstill 33h under 2 ℃, centrifugal, and reconcentration is subsequent use to 30Bx.
(2) extract is dry: above-mentioned preparation liquid is utilized the antibacterial of flash distillation unit, 145 ℃ of sterilization temperatures; Adopt the pressure type drying tower to carry out spray drying then, 175 ℃ of spray tower EATs, 88 ℃ of leaving air temps; Get fine powder after the drying and pack with compound plastic bag, subsequent use.
(3) mix powder process: take by weighing above-mentioned fine powder 3kg, add animal peptide powder 4.5kg, oligofructose 3.5kg mixed 20 minutes in the three-dimensional mixer of packing into, emitted, and the composite plastic packing of aluminizing is adopted in metering.
9 one kinds of powder method for makings of embodiment with blood sugar reducing function, step is following:
(1) preparation of Hubei Chinese flowering crabapple extract: get Hubei Chinese flowering crabapple dried leaf 5kg, add 25kg concentration 20% edible ethanol, reflux, extract, 6 times.Merge extractive liquid, reclaims ethanol.Extracting solution is concentrated into 13Bx, and concentrated solution leaves standstill 28h under 3 ℃, centrifugal, and reconcentration is subsequent use to 28Bx.
(2) extract is dry: above-mentioned preparation liquid is utilized the antibacterial of flash distillation unit, 150 ℃ of sterilization temperatures; Adopt the pressure type drying tower to carry out spray drying then, 180 ℃ of spray tower EATs, 90 ℃ of leaving air temps; Get fine powder after the drying and pack with compound plastic bag, subsequent use.
(3) mix powder process: take by weighing above-mentioned fine powder 5kg, add soy peptide powder 10kg, soybean oligo saccharide 10kg mixed 20 minutes in the three-dimensional mixer of packing into, emitted, and the composite plastic packing of aluminizing is adopted in metering.
10 1 kinds of powder method for makings of embodiment with blood sugar reducing function, step is following:
(1) preparation of Hubei Chinese flowering crabapple extract: get Hubei Chinese flowering crabapple dried leaf 5kg, add 25kg concentration 10% edible ethanol, reflux, extract, 1 time.Merge extractive liquid, reclaims ethanol.Extracting solution is concentrated into 10Bx, and concentrated solution leaves standstill 36h under 4 ℃, centrifugal, and reconcentration is subsequent use to 40Bx.
(2) extract is dry: above-mentioned preparation liquid is utilized the antibacterial of flash distillation unit, 135 ℃ of sterilization temperatures; Adopt the pressure type drying tower to carry out spray drying then, 185 ℃ of spray tower EATs, 92 ℃ of leaving air temps; Get fine powder after the drying and pack with compound plastic bag, subsequent use.
(3) mix powder process: take by weighing above-mentioned fine powder 10kg, add soy peptide powder 5kg, Oligomeric maltose 5kg mixed 20 minutes in the three-dimensional mixer of packing into, emitted, and the composite plastic packing of aluminizing is adopted in metering.
11 1 kinds of powder method for makings of embodiment with blood sugar reducing function, step is following:
(1) preparation of Hubei Chinese flowering crabapple extract: get Hubei Chinese flowering crabapple dried leaf 5kg, add 25kg water, reflux, extract, 7 times.Merge extractive liquid, reclaims ethanol.Extracting solution is concentrated into 15Bx, and concentrated solution leaves standstill 30h under 4 ℃, centrifugal, and reconcentration is subsequent use to 40Bx.
(2) extract is dry: above-mentioned preparation liquid is utilized the antibacterial of flash distillation unit, 142 ℃ of sterilization temperatures; Adopt the pressure type drying tower to carry out spray drying then, 190 ℃ of spray tower EATs, 90 ℃ of leaving air temps; Get fine powder after the drying and pack with compound plastic bag, subsequent use.
(3) mix powder process: take by weighing above-mentioned fine powder 3kg, add soy peptide powder 4kg, oligofructose 2kg mixed 20 minutes in the three-dimensional mixer of packing into, emitted, and the composite plastic packing of aluminizing is adopted in metering.
12 1 kinds of powder method for makings of embodiment with blood sugar reducing function
Prescription is: Hubei Chinese flowering crabapple extract 5kg, soy peptide powder 80kg, soybean oligo saccharide 5kg; All the other are with embodiment 2.
13 1 kinds of powder method for makings of embodiment with blood sugar reducing function
Prescription is: Hubei Chinese flowering crabapple extract 95kg, soy peptide powder 1kg, soybean oligo saccharide 90kg; All the other are with embodiment 2.
14 1 kinds of powder method for makings of embodiment with blood sugar reducing function
Prescription is: Hubei Chinese flowering crabapple extract 10kg, soy peptide powder 70kg, soybean oligo saccharide 20kg; All the other are with embodiment 2.
15 1 kinds of powder method for makings of embodiment with blood sugar reducing function
Prescription is: Hubei Chinese flowering crabapple extract 30kg, soy peptide powder 50kg, soybean oligo saccharide 40kg; All the other are with embodiment 2.
16 1 kinds of powder method for makings of embodiment with blood sugar reducing function
Prescription is: Hubei Chinese flowering crabapple extract 50kg, soy peptide powder 30kg, soybean oligo saccharide 60kg; All the other are with embodiment 2.
17 1 kinds of powder method for makings of embodiment with blood sugar reducing function
Prescription is: Hubei Chinese flowering crabapple extract 80kg, soy peptide powder 20kg, soybean oligo saccharide 80kg; All the other are with embodiment 2.
The preparation that makes with embodiment 1 has carried out pharmacodynamics and toxicologic study:
One, preparation of the present invention causes the influence of mice hyperglycemia to streptozotocin
1, test material
Positive drug: diabetes pill
The modeling agent: streptozotocin (STREPTOZOCIN, STZ), specification: 1g/ bottle, SIGMA Company products, lot number: 015K1279.
Test kit: blood glucose (GLU) test kit, lot number: 240711, Beijing Zhong Shengbei is controlled bio tech ltd.
2, laboratory animal
60 of Male Kunming strain mice, body weight 25 ± 1g is provided credit number by Lukang Medical Co., Ltd., Shandong's animal center: SCXK (Shandong) 20050017.
3, experimental technique and result
60 of Male Kunming strain mice, selecting 10 Mus at random is the normal control group, and all the other 50 mouse peritoneal injection streptozotocin 120mg/kg cause diabetes model, and the drug administration by injection volume is 0.5ml/25g.The isopyknic citrate buffer solution of normal control group lumbar injection.After the modeling 48 hours, 50 mices are divided into 5 groups at random by body weight, are respectively the heavy dose of group of preparation of the present invention 500mg/kg, middle dose groups 250mg/kg, small dose group 125mg/kg, model group and positive drug contrast disappear and drink ball group 2.5 balls/kg.Each dose groups animal is irritated stomach and gives corresponding medicine, irritates the long-pending 0.5ml/25g mice of body of stomach, irritates stomach every day 1 time, continuous irrigation stomach 5 days.In administration the 5th day, 2 hours gastric infusions of mice fasting, behind the medicine 1 hour, each was organized mice and plucks eyeball and get blood, measures the mice fasting glucose with full automatic biochemical apparatus.Result of the test is seen table 1.
Table 1 pair streptozotocin cause mice diabetes blood glucose influence (x ± sd, n=10)
| Group | Dosage (g/kg) | Blood glucose (mmol/L) | The P value |
| The blank group | - | 7.96±1.50 | - |
| Model control group | - | 18.21±9.07 | ＜0.01 |
| The insoral group | 100mg/kg | 14.33±8.27 | ＞0.05 |
| The Chinese medicine preparation experimental group | 500mg/kg | 10.52±2.79 | ＜0.05 |
| The Chinese medicine preparation experimental group | 250mg/kg | 10.46±3.18 | ＜0.05 |
| The Chinese medicine preparation experimental group | 125mg/kg | 13.30±4.65 | ＞0.05 |
This result of the test shows: compare with the normal control group, model group mouse blood sugar level obviously increases (P＜0.05).Heavy dose of 500mg/kg of this preparation and middle dose groups 250mg/kg explain that to the obvious blood sugar lowering level of mice streptozotocin diabetes model ability said preparation has blood sugar reducing function.
Two, preparation acute toxicity test of the present invention (maximum dosage-feeding method)
(1), test objective:
Observe the toxic reaction that animal produced after the Chinese medicine preparation administration.
(2), test material
(1) laboratory animal: SPF level Kunming mouse, 20, male and female half and half, body weight: 18-22g is provided by Lukang Medical Co., Ltd., Shandong's animal center, laboratory animal production licence number: SCXK (Shandong) 20050017.
(2) experimental animal feeding environmental condition: animal feeding in barrier environment, temperature: 20～26 ℃ (temperature difference per day≤3 ℃); Relative humidity: 40%～70%; Illumination: the 12h:12h light and shade replaces, illumination: 150～300lx; Noise :≤60dB.Laboratory animal occupancy permit: SYXK (Shandong) 20030015, issuing unit: Shandong Province science and technology bureau.
(3) feeding and management: the male and female sub-cage rearing, 5 in every cage is regularly thrown in feedstuff weekly, freely drinks water; The Mus box is changed weekly 2 times.
(4) feedstuff: pellet, credit number: SCXK (Shandong) 20040014 is provided by Shandong Province's Experimental Animal Center.
(5) animal quarantine and adaptability are raised: the animal adaptability was raised 3 days, and observe the animal symptom every day, rejects underproof animal.
(6). key instrument: JY2001 type electronic balance, Shanghai Precision Scientific Apparatus Co., Ltd.
(3), test method
Design of 1 dosage and foundation:
The trial test result shows: it is 0.4ml/10g that mouse stomach gives the maximum administration volume of Chinese medicine preparation, the overt toxicity reaction do not occur, so adopt the maximum dosage-feeding method to carry out acute toxicity test.
2 animal identification and grouping:
The animal adaptability is divided into two groups, i.e. gastric infusion group 20g/kg and negative control group after raising at random.The male and female sub-cage rearing, 5 in every cage, animal is designated with picric acid solution respectively: head, neck, the back of the body, tail and blank.Each cage box is hung cage card sign, indicates: thematic code name, cage number, group, animal kind system, number of animals, sex, thematic director's name, administration beginning and ending time.
3. test sample preparation: taking by weighing test sample 10g, to be mixed with the test sample of 0.5g/ml subsequent use.
3. route of administration: gastric infusion.
4. administration volume: single is irritated stomach and is given 0.4ml/10g behind the mice fasting 3h.
5. experimental period: observed 14 days behind the single-dose.
6. observation index:
6.1 general observation of symptoms: observe ordinary circumstances such as animal appearance sign, behavioral activity, glandular secretion, feces character every day, recording exceptional reaction and poisoning symptom.
6.2 death condition: record animal dead number, dead animal is midway in time dissected, carry out perusal and histopathological examination, with the clear and definite cause of death.
6.3 body weight: weigh weekly once, calculate each treated animal body weight change situation, observe receiving of the influence of reagent thing to body weight gain.
7. Data Processing Method: the experimental result body weight is with (
± SD) expression of mean ± standard deviation.
(4), result of the test:
1 general observation of symptoms: after mouse stomach gave Chinese medicine preparation, its behavior, diet, outward appearance, secretions, Excreta etc. are Non Apparent Abnormality all.
2 death condition: do not see death behind the animals administer.
3 body weight change: do not see behind the animals administer and become thin that body weight gain is good, sees table 2 for details.
Table 2: Chinese medicine preparation is to acute toxicity test in mice (gastric infusion)
The influence of body weight (g, X ± SD)
(5), conclusion (of pressure testing):
Tangible toxic reaction did not appear in animal after Kunming mouse (male and female half and half) was irritated stomach 20g/kg (0.4ml/10g) administration.
The preparation that makes with embodiment 2 carries out pharmacodynamics and toxicologic study:
1, the present invention executes routine 2 preparations cause the mice hyperglycemia to streptozotocin influence
1.1 test material
Positive drug: diabetes pill
The modeling agent: streptozotocin (STREPTOZOCIN, STZ), specification: 1g/ bottle, SIGMA Company products, lot number: 015K1279.
Test kit: blood glucose (GLU) test kit, lot number: 240711, Beijing Zhong Shengbei is controlled bio tech ltd.
1.2 laboratory animal
100 of Male Kunming strain mice, body weight 25 ± 1g is provided credit number by Lukang Medical Co., Ltd., Shandong's animal center: SCXK (Shandong) 20090120.
1.3 experimental technique and result
100 of Male Kunming strain mice, selecting 20 Mus at random is the normal control group, and all the other 80 mouse peritoneal injection streptozotocin 120mg/kg cause diabetes model, and the drug administration by injection volume is 0.5ml/25g.The isopyknic citrate buffer solution of normal control group lumbar injection.After the modeling 48 hours, 80 mices are divided into 5 groups at random by body weight, are respectively the heavy dose of group of preparation of the present invention 500mg/kg, middle dose groups 250mg/kg, small dose group 125mg/kg, model group and positive drug contrast disappear and drink ball group 2.5 balls/kg.Each dose groups animal is irritated stomach and gives corresponding medicine, irritates the long-pending 0.5ml/25g mice of body of stomach, irritates stomach every day 1 time, continuous irrigation stomach 7 days.In administration the 7th day, 2 hours gastric infusions of mice fasting, behind the medicine 1 hour, each was organized mice and plucks eyeball and get blood, measures the mice fasting glucose with full automatic biochemical apparatus.Result of the test is seen table 3.
Table 3 pair streptozotocin cause mice diabetes blood glucose influence (x ± sd, n=10)
| Group | Dosage (g/kg) | Blood glucose (mmol/L) | The P value |
| The blank group | - | 7.96±1.50 | - |
| Model control group | - | 18.21±9.07 | ＜0.01 |
| The insoral group | 100mg/kg | 14.33±8.27 | ＞0.05 |
| The Chinese medicine preparation experimental group | 500mg/kg | 9.85±1.63 | ＜0.05 |
| The Chinese medicine preparation experimental group | 250mg/kg | 10.38±2.69 | ＜0.05 |
| The Chinese medicine preparation experimental group | 125mg/kg | 13.52±3.85 | ＞0.05 |
This result of the test shows: compare with the normal control group, model group mouse blood sugar level obviously increases (P＜0.05).Heavy dose of 500mg/kg of this preparation and middle dose groups 250mg/kg explain that to the obvious blood sugar lowering level of mice streptozotocin diabetes model ability said preparation has blood sugar reducing function.
2, preparation acute toxicity test of the present invention (maximum dosage-feeding method)
2.1 test objective:
Observe the toxic reaction that animal produced after the Chinese medicine preparation administration.
2.2 test material
2.2.1 laboratory animal: SPF level Kunming mouse, 20, male and female half and half, body weight: 18-22g is provided by Lukang Medical Co., Ltd., Shandong's animal center, laboratory animal production licence number: SCXK (Shandong) 20090120.
2.2.2 experimental animal feeding environmental condition: animal feeding in barrier environment, temperature: 20～26 ℃ (temperature difference per day≤3 ℃); Relative humidity: 40%～70%; Illumination: the 12h:12h light and shade replaces, illumination: 150～300lx; Noise :≤60dB.
2.2.3 feeding and management: the male and female sub-cage rearing, 5 in every cage is regularly thrown in feedstuff weekly, freely drinks water; The Mus box is changed weekly 2 times.
2.2 4 feedstuffs: pellet, credit number: SCXK (Shandong) 20040014 is provided by Shandong Province's Experimental Animal Center.
2.2.5 animal quarantine and adaptability are raised: the animal adaptability was raised 3 days, and observe the animal symptom every day, rejects underproof animal.
2.2.6 key instrument: JY2001 type electronic balance, Shanghai Precision Scientific Apparatus Co., Ltd.
2.3 test method
2.3.1 dosage design and foundation:
The trial test result shows: it is 0.4ml/10g that mouse stomach gives the maximum administration volume of Chinese medicine preparation, the overt toxicity reaction do not occur, so adopt the maximum dosage-feeding method to carry out acute toxicity test.
2.3.2 animal identification and grouping:
The animal adaptability is divided into two groups, i.e. gastric infusion group 20g/kg and negative control group after raising at random.The male and female sub-cage rearing, 5 in every cage, animal is designated with picric acid solution respectively: head, neck, the back of the body, tail and blank.Each cage box is hung cage card sign, indicates: thematic code name, cage number, group, animal kind system, number of animals, sex, thematic director's name, administration beginning and ending time.
2.3.3 test sample preparation: taking by weighing test sample 10g, to be mixed with the test sample of 0.5g/ml subsequent use.
2.3.4 route of administration: gastric infusion.
2.3.5 administration volume: single is irritated stomach and is given 0.4ml/10g behind the mice fasting 3h.
2.3.6 experimental period: observed 14 days behind the single-dose.
2.3.7 observation index:
2.3.7.1 general observation of symptoms: observe ordinary circumstances such as animal appearance sign, behavioral activity, glandular secretion, feces character every day, recording exceptional reaction and poisoning symptom.
2.3.7.2 death condition: record animal dead number, dead animal is midway in time dissected, carry out perusal and histopathological examination, with the clear and definite cause of death.
2.3.7.3 body weight: weigh weekly once, calculate each treated animal body weight change situation, observe receiving of the influence of reagent thing to body weight gain.
2.3.8 Data Processing Method: the experimental result body weight is with (
± SD) expression of mean ± standard deviation.
2.4 result of the test:
2.4.1 general observation of symptoms: after mouse stomach gave Chinese medicine preparation, its behavior, diet, outward appearance, secretions, Excreta etc. are Non Apparent Abnormality all.
2.4.2 death condition: do not see death behind the animals administer.
2.4.3 body weight change: do not see behind the animals administer and become thin that body weight gain is good, sees table 4 for details.
Table 4: Chinese medicine preparation is to acute toxicity test in mice (gastric infusion)
The influence of body weight (g, X ± SD)
2.5 conclusion (of pressure testing): tangible toxic reaction did not appear in animal after Kunming mouse (male and female half and half) was irritated stomach 20g/kg (0.4ml/10g) administration.Embodiment 1, embodiment 3, embodiment 4 pharmacology tests are relatively
1, the embodiment of the invention 1,3,4 preparations cause the influence of mice hyperglycemia to streptozotocin
1.1 test material
Positive drug: diabetes pill
The modeling agent: streptozotocin (STREPTOZOCIN, STZ), specification: 1g/ bottle, SIGMA Company products, lot number: 015K1279.
Test kit: blood glucose (GLU) test kit, lot number: 240711, Beijing Zhong Shengbei is controlled bio tech ltd.
1.2 laboratory animal
60 of Male Kunming strain mice, body weight 25 ± 1g is provided credit number by Lukang Medical Co., Ltd., Shandong's animal center: SCXK (Shandong) 20050017.
1.3 experimental technique and result
60 of Male Kunming strain mice, selecting 10 Mus at random is the normal control group, and all the other 50 mouse peritoneal injection streptozotocin 120mg/kg cause diabetes model, and the drug administration by injection volume is 0.5ml/25g.The isopyknic citrate buffer solution of normal control group lumbar injection.After the modeling 48 hours, 50 mices are divided into 5 groups at random by body weight, embodiment 1,3,4 preparations of difference feeding dosage 500mg/kg, model group and positive drug contrast disappear and drink ball group 2.5 balls/kg.Each dose groups animal is irritated stomach and gives corresponding medicine, irritates the long-pending 0.5ml/25g mice of body of stomach, irritates stomach every day 1 time, continuous irrigation stomach 5 days.In administration the 5th day, 2 hours gastric infusions of mice fasting, behind the medicine 1 hour, each was organized mice and plucks eyeball and get blood, measures the mice fasting glucose with full automatic biochemical apparatus.Result of the test is seen table 5
Table 5 pair streptozotocin cause mice diabetes blood glucose influence (x ± sd, n=10)
| Group | Dosage (g/kg) | Blood glucose (mmol/L) | The P value |
| The blank group | - | 7.92±1.48 | - |
| Model control group | - | 18.15±9.03 | ＜0.01 |
| The insoral group | 100mg/kg | 14.33±8.27 | ＞0.05 |
| Embodiment 1 experimental group | 500mg/kg | 10.52±2.79 | ＜0.05 |
| Embodiment 3 experimental grouies | 500mg/kg | 13.92±3.67 | ＞0.05 |
| Embodiment 4 experimental grouies | 500mg/kg | 13.80±4.65 | ＞0.05 |
This result of the test shows: embodiment 1,3,4 preparations of feeding dosage 500mg/kg; Have only embodiment 1 preparation group mouse blood sugar level obviously to increase (P＜0.05); Be embodiment 1 preparation when dosage 500mg/kg to the obvious blood sugar lowering level of mice streptozotocin diabetes model, embodiment 3,4 preparation blood sugar reducing functions are not obvious.
Conclusion: have only Hubei Chinese flowering crabapple extract, peptide powder, oligosaccharide to work in coordination blood sugar reducing function is preferably just arranged.
Claims (6)
1. the Chinese medicine preparation with effect of lowering blood sugar is characterized in that, comprises the raw material of following weight portion: 0.5～60 part of Hubei Chinese flowering crabapple extract, 1～95 part in peptide powder, 2～70 parts of oligosaccharide;
Said Hubei Chinese flowering crabapple extract prepares through following method: getting the Hubei Chinese flowering crabapple dried leaf, is solvent with 0～95% ethanol, refluxes 1～8 time; Reclaim ethanol, and extracting solution is concentrated into 10～20Bx, under 1～4 ℃, leave standstill 24～36h; Centrifugal; Remove deposition, with supernatant concentration to 20～40Bx, subsequent use;
Said peptide powder is soy peptide powder or wheat peptide powder;
Said oligosaccharide is soybean oligo saccharide, dextrinosan or oligofructose.
2. a kind of Chinese medicine preparation with effect of lowering blood sugar according to claim 1 is characterized in that: also comprise acceptable additive on pharmaceutic adjuvant or the food; Said Chinese medicine preparation is any in capsule, tablet, powder, granule, oral liquid, medicated wine, pill, pellet, mixture, the tincture.
3. the described a kind of method for preparing with Chinese medicine preparation of effect of lowering blood sugar of claim 1 is characterized in that, may further comprise the steps:
1) preparation Hubei Chinese flowering crabapple extract: getting the Hubei Chinese flowering crabapple dried leaf, is solvent with 0～95% ethanol, refluxes 1～8 time, reclaims ethanol; And extracting solution is concentrated into 10～20Bx, and under 1～4 ℃, leave standstill 24～36h, centrifugal; Remove deposition, with supernatant concentration to 20～40Bx, subsequent use;
2) mix: the peptide powder is added in the entry, mixing, the adjusting pol is 15～20Bx, is heated to 70～80 ℃; Add Hubei Chinese flowering crabapple extract and oligosaccharide then, mixing, pol is at 15～25Bx; Utilize the antibacterial of flash distillation unit, utilize spray drying tower dry then, get fine powder after the drying, be Chinese medicine preparation with effect of lowering blood sugar; Or: the Hubei Chinese flowering crabapple extract is utilized the antibacterial of flash distillation unit, utilize the spray drying tower drying after, add peptide powder and oligosaccharide again, mixing is the Chinese medicine preparation with effect of lowering blood sugar.
4. method for preparing according to claim 3 is characterized in that, and is further comprising the steps of: 3) granulate; 4) molding; 5) packing.
5. method for preparing according to claim 3 is characterized in that: said step 2), sterilization temperature is 135～150 ℃, and when dry, EAT is 170～190 ℃, and leaving air temp is 85～95 ℃.
6. the described a kind of application of Chinese medicine preparation in preparation treatment hypoglycemic drug of claim 1 with effect of lowering blood sugar.
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| CN105031034B (en) * | 2015-07-21 | 2020-04-14 | 中国科学院西北高原生物研究所 | A blood sugar lowering composition containing fructus Lycii |
| CN106511968A (en) * | 2016-11-23 | 2017-03-22 | 武汉百思凯瑞纳米科技有限公司 | Selenium-rich oral solution with effects of reducing blood sugar, reducing blood fat and boosting immunity and preparation method thereof |
| CN109247482A (en) * | 2017-07-13 | 2019-01-22 | 上海冬泽特医食品有限公司 | Diabetic's solid beverage and preparation method thereof |
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Denomination of invention: The invention relates to a traditional Chinese medicine preparation with hypoglycemic effect and a preparation method and application thereof Effective date of registration: 20211230 Granted publication date: 20120215 Pledgee: Linyi Branch of Bank of China Ltd. Pledgor: Linyi Shansong Biological Products Co.,Ltd. Registration number: Y2021980017268 |
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