CN1730083A - Yuanhe tablet and process for preparing the same - Google Patents
Yuanhe tablet and process for preparing the same Download PDFInfo
- Publication number
- CN1730083A CN1730083A CN 200510088874 CN200510088874A CN1730083A CN 1730083 A CN1730083 A CN 1730083A CN 200510088874 CN200510088874 CN 200510088874 CN 200510088874 A CN200510088874 A CN 200510088874A CN 1730083 A CN1730083 A CN 1730083A
- Authority
- CN
- China
- Prior art keywords
- test
- tablet
- yuanhe
- flood
- sheet
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Abstract
The invention discloses a tablet for regulating blood sugar, which is prepared from rhizoma dioscoreae, mulberry leaf, germinated barley as raw materials. Its preparing process comprises the steps of disintegrating, extracting by ethanol backflow, reclaiming ethanol, obtaining thick grease through decompression and concentration, atomizing and granulating, granulating, tabletting, finally coating the films.
Description
Affiliated technical field
The present invention is to be primary raw material with medicine, food dual purpose plant RHIIZOMA DIOSCOREAE frOm Henan of China, Folium Mori, Fructus Hordei Germinatus (parched), through developing new type of health (function) food with blood sugar regulation effect.For the Chinese bush cherry sheet falls in a flood day board, the health ministry approval was flood day board Yuanhe tablet when this product was declared.
Background technology
Diabetes are because the normal excreting insulin of beta Cell of islet, cause insulin to be enough to relatively or anything but and target tissue reduces the sensitivity of insulin, cause a series of metabolism disorders such as sugar, fat, protein, water, electrolyte, hepatic glycogen and muscle glycogen can not be synthesized, a kind of whole body chronic progressive disease that blood glucose, glucose in urine rising and carbohydrate tolerance reduce occurs.Its typical clinical symptom is polydipsia, polyphagia, polyuria, lose weight and fatigue and weak etc., i.e. " three-many-one-little " disease.The traditional Chinese medical science claims that diabetes are diabetes, and the damage of lung, stomach, kidney is the basis, sick position of this disease, and the metabolism disorder of water liquid is its material base, thinks that " more than three " are caused by " three types of diabetes " (polydipsia disappears on being, polyphagia disappears in being, polyuria be diabetes due to kidney-deficiency).
At present, generally acknowledge that both at home and abroad effective oral chemosynthesis hypoglycemic drug has sulphur urea and biguanide two big classes.Sulfonylurea drugs such as glyburide, minidiab, diamicron and gliquidone etc. mainly are by stimulating insulin secretion and strengthening tissue to insulin sensitivity and blood sugar lowering.This class medicine can not stimulate insulin synthetic, and very poor person is invalid to the beta Cell of islet function; Also be unsuitable for the insulin non-insulin dependent diabetes merge severe infections, ketoacidosis, hyperosmolar coma, with patients such as hepatic and kidney function obstacles.Its untoward reaction or toxic and side effects have: functional gastrointestinal disorder (as inappetence, feel sick, vomiting, upper abdomen distension etc.), skin allergy, hypoglycemia, to such an extent as to headache, dizzy, drowsiness, blood system change etc.The mechanism of action of biguanides hypoglycemic drug such as phenformin and metformin awaits further research, thinks it may is that it acts on the carbohydrate metabolism process at present, promotes the picked-up utilization of tissue to sugar.This class medicine side effect of digestive tract such as anorexia, nausea,vomiting,diarrhea are arranged and lose weight, become thin, side effect (" modern pharmacology "/Tang Guang chief editor) such as lactic acidosis.
The Chinese medicine preparation that is used for the treatment of diabetes (blood sugar lowering) often uses QI invigorating, QI invigorating class Chinese crude drugs such as Radix Ginseng, Radix Ginseng Rubra, the Radix Astragali as quench one's thirst clever sheet, SHENSHI JIANGTANG JIAONANG etc., not only valency is expensive, take the scorching of generation for a long time, the diabetes that the hepatic and renal YIN deficiency is caused are not favourable.Part is treated the Chinese patent medicine of diabetes such as diabetes pill etc., has referred and synthesized western medicine composition, and its untoward reaction or toxic and side effects still exist, and not only can not effect a radical cure diabetes, and some clinical symptoms also can not get basic improvement.
Summary of the invention
Modern study is thought, the cause of disease of diabetes (diabetes) mainly by gene, drug induced injury, overfatigue, diet is not normal and factor such as psychentonia, cause beta Cell of islet damage, insulin secretion relatively or absolute not enough, and body tissue is to the sensitivity decline of insulin, and causing metabolism disorders such as sugar, fat, protein, the multiple organ dysfunction clinical pathology syndrome of hyperglycemia and " three-many-one-little " symptom appears.
The present invention according to the requirement of " be food be again medicine " and the traditional Chinese medical science to diabetes and lung, spleen (stomach), liver, the understanding of the relation of each visceral organ injury of kidney, and the pathological characteristic of " deficiency of both QI and YIN; venation block causes quenching one's thirst ", through analysis and research meticulously, adopt targetedly and have strengthening the spleen and nourishing the stomach, lung benefiting promotes the production of body fluid, the medicine of nourishing the liver and kidney, the food dual purpose plant Fructus Hordei Germinatus (parched), RHIIZOMA DIOSCOREAE frOm Henan of China, Folium Mori, be developed into can regulate hyperglycemia population on, in, following three warmers, strengthen the beta Cell of islet activity, promote insulin secretion, have the health food " Yuanhe tablet " that significantly downgrades the blood glucose effect.
One, prescription and method for making
1. formulating
The present invention follows following three principles and carries out formulating: (1) by the deficiency of YIN, the theory of Chinese medical science of scorching causing " three types of diabetes " and method of treatment principle thereof, in conjunction with the argumentation of modern medicine to diabetes, carries out scientific composition according to diabetes system; (2) selected the blood sugar regulation function for use according to " be food be again the kind list of medicine " of health ministry promulgation, and the vegetable drug raw material that has no side effect, to guarantee that human body is not produced any acute, subacute or chronic hazard; (3) Yan Zhi health food Yuanhe tablet truly has the syndrome that obvious, the stable effect of adjusting function of human body, particularly blood sugar regulation effect and prevention cause because of blood sugar increasing.Through analysis and research meticulously, comprehensive comparison and experiment screening, determine that finally prescription is as follows:
RHIIZOMA DIOSCOREAE frOm Henan of China 300g～1200g Folium Mori 400g～1600g wheat is fried bud 300g～1200g
Make 1000 every 0.5g
2. efficiency analysis
Rhizoma Dioscoreae is sweet, flat in the side, returns spleen, lung, kidney channel; " main damaging the spleen and stomach tonify deficiency is thin, removes the cold and heat pathogen, invigorating the spleen and replenishing QI power, longue meat, obey normal hearing and eyesight for a long time, not hungry the prolonging life of making light of one's life by commiting suicide " (Shennong's Herbal); Have the spleen reinforcing nourishing the stomach, the function of the lung benefiting that promotes the production of body fluid, reinforcing the kindey to control nocturnal emission, can treat the frequent micturition that deficiency of both QI and YIN causes, the disease that deficiency-heat is quenched one's thirst.Modern medicine study shows that immunity of Rhizoma Dioscoreae pair cell and humoral immune function have stronger facilitation, and contained Chinese yam polysaccharide has tangible blood sugar lowering, glucose in urine effect (" modern Chinese medicine voluminous dictionary "/chief editors such as Song Li people).Fructus Hordei Germinatus (parched) is sweet, flat, returns spleen, stomach warp; " spleen reinforcing insufficiency of stomach, wide taste are smash thin parching to brown color, and the face of getting is used it " (" medicine origin "); Owing to have spleen invigorating, appetizing, food digesting action, can treat fullness in the epigastrium and abdomen interior-heat, eating accumulation, promote body metabolism and alimentation, the disease that loses weight of prevention hyperglycemia population.Modern medicine study finds that amylase and vitamin B that Fructus Hordei Germinatus (parched) is contained have digestion-aid effect, and its preparation has hypoglycemic activity (" Chinese materia medica "/Yan Zhenghua chief editor).Folium Mori are sweet, bitter, cold, return lung, Liver Channel; " be hands, the bright medicine of foot sun, juice is fried in shallow oil Dai Ming, can only quench one's thirst " (Compendium of Material Medica); Owing to have the function of dispelling wind and heat pathogens, clearing away lung-heat and moistening for dryness, liver heat removing and eyesight improving, be used for the treatment of that dry mouth and tougue, polydipsia are quenched one's thirst, blurring of vision.Modern medicine study confirms, Folium Mori can be treated chyluria (" modern Chinese medicine voluminous dictionary "/chief editors such as Song Li people), the ecdysterone that it is contained, claim the decortication sterone can promote that glucose changes glycogen into again, diabetes, hyperglycemia animal are all had hypoglycemic activity (" conventional Chinese medicine composition and pharmacology handbook/Huang Taikang edits).Above-mentioned three flavor medical material compatibilities use, can improve body immunity, regulate body function, particularly have remarkable blood sugar regulation effect, to " three types of diabetes " of diabetes (on disappear polydipsia, in disappear polyphagia, diabetes due to kidney-deficiency polyuria), lose weight and fatigue and weak improves significantly.
The human experiment experiment confirm that carries out through Xiyuan Hospital, Chinese Medicine Academy of China, Yuanhe tablet truly have and significantly downgrade the blood glucose effect.
3. preparation technology
Fructus Hordei Germinatus (parched) is divided into two parts, and a copy of it is pulverized and is 100～160 purpose fine powders, and is standby; RHIIZOMA DIOSCOREAE frOm Henan of China, Folium Mori are with 60%～80% alcohol reflux secondary, measured 60%～80% alcohol reflux 2～3 hours with 5～7 times for the first time, measured 60%～80% alcohol reflux 2～3 hours with 3～5 times for the second time, the leaching backflow, reclaim ethanol, concentrating under reduced pressure becomes thick paste (relative density is 1.25～1.30,50 ℃ of surveys).Medicinal residues after Fructus Hordei Germinatus (parched) and RHIIZOMA DIOSCOREAE frOm Henan of China, the Folium Mori alcohol extraction decocted 1～2 hour with 3～5 times of water gagings, and leaching decocting liquid, concentrating under reduced pressure become thick paste (relative density is 1.25～1.30,50 ℃ of surveys).With two kinds of thick paste mix homogeneously, be bed material with the Fructus Hordei Germinatus (parched) fine powder, mist projection granulating, granulate adds 1% lubricant tabletting, the bag film-coat, blister is promptly.
Yuanhe tablet preparation technology flow chart is seen Figure of description.
In order to investigate preparation technology and product quality, under the condition of 37 ℃～40 ℃ of temperature, relative humidity 75%, Yuanhe tablet has been carried out continuous trimestral insulation experiment (stability experiment).Whole physicochemical datas of repeated detection, microbiological data and effective component data all change not quite in the experiment, and all within prescribed limit, illustrate that preparation technology is reasonable, feasible, constant product quality, reliable.
Two, safety testing
According to " toxicological evaluation of food safety procedure and method " (15193-94), with a flood day board Yuanhe tablet one-level Kunming mouse acute oral toxicity test, bone marrow polychromatic erythrocyte micronucleus test and sperm malformation test have been carried out, to Salmonella typhimurium mutagenic action test (Salmonella reversion test).Experimental result is as follows:
1. draw female, buck LD by acute oral toxicity test
50All greater than 21500mg/kgBW, conclusion is that Yuanhe tablet belongs to nontoxic level (seeing " acute oral toxicity test report ");
2. bone marrow polychromatic erythrocyte micronucleus test result is negative, does not see the damaging action (see " PCEMNR micronucleus test report ") of Yuanhe tablet to bone marrow cell chromosome;
3. sperm malformation test result is negative, does not see the damaging action (see " mouse sperm deformity test report ") of Yuanhe tablet to the male mice sexual cell;
4.Ames result of the test is negative, shows that Yuanhe tablet does not have mutagenic action (seeing " Salmonella reversion test report ").
Above-mentioned test shows, Yuanhe tablet belongs to nontoxic level, and the gene of experimental animal are not had influence, takes safety, can life-time service.
Three, health care test
The effective component of Yuanhe tablet has total flavones (7.0～10.0mg/g) and total Saponin (1.8～3.5mg/g); Ecdysterone in the total flavones can promote that conversion of glucose is a glycogen, has significantly to downgrade the blood glucose effect; Saponin can improve body immunity, and resisting fatigue is improved the fatigue and weak disease that hyperglycemia causes.The amylase of Yuanhe tablet and vitamin B etc. can enhance metabolism, facilitating digestion, improve the diabetes that causes interior-heat to produce because of food stagnation.The polysaccharose substance of Yuanhe tablet also downgrades the blood glucose effect.Therefrom the medical science viewpoint is seen, Yuanhe tablet energy YIN nourishing and the production of body fluid promoting, and liver and kidney tonifying, thus regulate function of human body, downgrade blood glucose, improve " three-many-one-little " symptom that hyperglycemia causes.From the auxiliary adjustment blood glucose effect testing result of mice, Yuanhe tablet does not have influence to the fasting glucose and the carbohydrate tolerance of normal mouse, and fasting glucose and the carbohydrate tolerance of hyperglycemia mice had regulating action; Learn check by statistics, the Yuanhe tablet test group is compared with model control group, and difference has significance or highly significant (seeing " Chinese bush cherry sheet auxiliary adjustment blood glucose effect examining report falls in a flood day board ").
Beijing Disease Prevention and Control Centre, Xiyuan Hospital, Chinese Medicine Academy of China carry out one month by a definite date human experiment experiment confirm with flood day board Yuanhe tablet (test is called flood day board with name and falls the Chinese bush cherry sheet), Yuanhe tablet has the effect that more significantly reduces fasting glucose, its fasting blood sugar decline 0.99mmol/L, post-prandial glycemia decline 0.35mmol/L, total effective rate 70% (wherein obvious effective rate 10%); Matched group (taking sulphanylureas, biguanides or sulphur urea+biguanides antidiabetic drug etc.) fasting glucose and post-prandial glycemia descend not obvious, and total effective rate has only 30%, and do not have produce effects (seeing " Chinese bush cherry sheet human experiment visual report falls in a flood day board ").
Yuanhe tablet has a better role to cardinal symptoms such as hyperglycemia examination trencherman's polyphagia, polydipsia, polyuria, fatigue and weaks; And be better than the matched group of edible chemosynthesis antidiabetic drug.Behind the test-meal Yuanhe tablet, every clinical examination index such as hemoglobin, erythrocyte, leukocyte, total serum protein, albumin, glutamic oxaloacetic transaminase, GOT, glutamate pyruvate transaminase, creatinine, carbamide and routine urinalysis illustrate that all in normal range this product has no adverse effects to examination the healthy of trencherman.
Four, main feature
The Yuanhe tablet product is health care (function) food of health ministry approval, and authentication code is No. the 0242nd, hygienic food and health number (2001).This product has the health care of blood sugar regulation, is suitable for the higher crowd of blood glucose, and its main feature is as follows:
1. scientific formulation is reasonable, has advance
The analysis that this prescription is selected the medical material effective ingredient according to traditional Chinese medical science diabetes " three types of diabetes " theory and method of treatment, modern medicine for use to the argumentation and the plan of hyperglycemia, according to the origin cause of formation of hyperglycemia, pathological characteristic and " three-many-one-little " symptom of multiple organ injury, drug of choice targetedly, food dual purpose plant are raw material, make the Yuanhe tablet preparation.From theory of Chinese medical science, the active ingredient of Folium Mori, Fructus Hordei Germinatus (parched), RHIIZOMA DIOSCOREAE frOm Henan of China can be nursed one's health the upper, middle and lower three warmers of human body respectively in the prescription, promptly nurses one's health internal organs such as lung, taste, liver, kidney; The composition of prescription has not only met theory of Chinese medical science but also has used the related activity composition (and having stipulated the effective component index) of each plant amedica, has played the blood glucose effect that downgrades; This is this scientific formulation reasonability, advanced place.
2. preparation technology can guarantee the content and activity of plurality of enzymes, has novelty
The amylase and the vitamin B of raw medicinal material Fructus Hordei Germinatus (parched) have digestion-aid effect, and its preparation has hypoglycemic activity.Fructus Hordei Germinatus (parched) tradition usage is a decocting in water, but loses the active function of enzyme easily.For this reason, this technology is divided into two parts with Fructus Hordei Germinatus (parched), and the RHIIZOMA DIOSCOREAE frOm Henan of China of a Fructus Hordei Germinatus (parched) and alcohol extraction, Folium Mori medicinal residues are together carried with decocting in water, with aid digestion.Another part Fructus Hordei Germinatus (parched) is ground into fine powder, participates in mist projection granulating, tabletting directly, and the content of guaranteeing its active ingredient is beneficial to blood sugar regulation with active.In addition, the Fructus Hordei Germinatus (parched) fine powder is participated in pelletize, tabletting directly, has also substituted the figuration effect of starch, dextrin, and the supplementary product consumption of no effect effect in the Yuanhe tablet greatly reduced.Therefore, this preparation technology has novelty aspect two of the original activity that guarantees various enzymes and preparations shaping technologies.
3. health care is definite, has the particularly significantly blood sugar regulation effect of the function of human body of adjusting
The effective component of Yuanhe tablet have total Saponin (1.8～3.5mg/g), total flavones (7.0～10.0mg/g), in addition, also contain amylase, transform carbohydrase, plurality of enzymes and polysaccharose substances such as catalyzing enzyme; These active ingredients can be regulated function of human body, and enhancing immunity significantly downgrade blood glucose, so health care is definite.Because the effective component of Yuanhe tablet and content are determined, help the quality control of product, make it have stable health care (function) effect; Show that by animal experiment and human experiment Yuanhe tablet truly has significant blood sugar regulation effect and improves the clinical symptoms effect; Human experiment shows that also the blood glucose effect that downgrades of Yuanhe tablet also is better than sulphur urea, biguanides blood sugar lowering; Confirmed the significance of Yuanhe tablet product health-care effect.
4. belong to nontoxic level product, be suitable for taking for a long time
Animal acute toxicity test, bone marrow polychromatic erythrocyte micronucleus test, sperm malformation test and Salmonella reversion test through Beijing Sanitary and Antiepidemic Station show that Yuanhe tablet does not also have mutagenic action to bone marrow cell chromosome and sexual cell not damaged, belong to nontoxic level product.Human experiment experiment through Beijing Disease Prevention and Control Centre, Xiyuan Hospital, Chinese Medicine Academy of China shows, Yuanhe tablet not only has significantly blood sugar regulation effect, and in the test-meal process, do not observe allergy and other untoward reaction, therefore the blood safety index is suitable for hyperglycemia population and takes for a long time all in normal range.
Toxicity section of Beijing Sanitary and Antiepidemic Station
(95) amount is recognized (capital) word (ZO220) number survey report
Sample number into spectrum: (2000) poison 055 check numbering: (2000) malicious S027
The sample title: Chinese bush cherry sheet sample character falls in a flood day board: pale brown color chips agent
Client: Beijing flood day power pharmaceutcal corporation, Ltd
Censorship quantity: 2000g sample lot number: 991123
Accept the date: detect date: 2000.6. to 2000.11. in May, 2000
Inspection item: 1. acute oral toxicity test: 2. PCEMNR micronucleus test: 3. mouse sperm deformity test:
4.Ames test
Detect foundation: " toxicological evaluation of food safety procedure and method " (15193-94)
Assay:
1. female, the buck LD of chmice acute per os toxicity test
50All, belong to nontoxic level greater than 21500mg/kgBW.
2. PCEMNR micronucleus test result is negative
3. the mouse sperm deformity result of the test is negative
4.Ames result of the test is negative
(following blank)
The acute oral toxicity test report
One, experiment purpose: detect and tried acute oral toxicity effect and the intensity of thing to mice
Two, material and method:
1. sample source: Beijing flood day power pharmaceutcal corporation, Ltd
2. tried thing: title: the Chinese bush cherry sheet falls in a flood day board
Character: pale brown color chips agent recommended amounts: the 4.5g/ day for human beings
3. sample pre-treatments: with distilled water by design dosage preparation desired concn
4. experimental animal: one grade of Kunming mouse, 40, female, male half and half, body weight 18-21 gram is provided by Military Medical Science Institute's Experimental Animal Center, the animal quality certification number: the moving word of doctor 01-3023 number
5. experimental animal feeding environment: room temperature: 22-24 ℃, relative humidity: 48-50%RH, group's cage is raised 5/cage.
Feed resource: pull together feed corporation,Ltd's feedstuff quality certification number of Beijing section Australia: the capital is moving is betrothed to (2000) No. 015
6. test method: (horn method)
The laboratory animal quarantine was selected 40 of healthy adult mices after 3 days, body weight 18-21 gram, female, hero half and half, dosage design is female to be 2150,4640,10000,21500mg/kgBW, malely is 2150,4640,10000,21500mg/kgBW, irritates stomach by the 0.2ml/10gBW per os and is tried thing.Irritate the preceding animal overnight fasting of stomach, freely drink water.Give normal diet after irritating stomach, observed for two weeks, record poisoning symptom and death condition.
Three, result of the test:
1. experimental session animal dead situation:
| Dosage (mg/kgBW) | Sex | Number of animals only) | Dead animal number (only) | Mortality rate (%) |
| 2150 | Male and female | 5 5 | 0 0 | 0 0 |
| 4640 | Male and female | 5 5 | 0 0 | 0 0 |
| 10000 | Male and female | 5 5 | 0 0 | 0 0 |
| 21500 | Male and female | 5 5 | 0 0 | 0 0 |
2. in 14 days observation period, the animal subject no abnormality seen reacts and is dead.
Female mice per os LD
50Greater than 21500mg/kgBW
Male mice per os LD
50Greater than 21500mg/kgBW
Four, conclusion:
Judge that according to acute toxicity grading criteria among " toxicological evaluation of food safety procedure and method " 15193.3-94 a flood day board falls the Chinese bush cherry sheet and belongs to nontoxic level.
The report of PCEMNR micronucleus test
One, experiment purpose: detect and tried the influence that thing forms the PCEMNR micronucleus, estimate genetoxic in the body that is tried thing.
Two, material and method:
1. sample source: Beijing flood day power pharmaceutcal corporation, Ltd
2. tried thing: title: the Chinese bush cherry sheet falls in a flood day board
Character: pale brown color chips agent recommended amounts: the 4.5g/ day for human beings
3. sample pre-treatments: with distilled water by design dosage preparation desired concn
4. experimental animal: 50 of one grade of Kunming mouses, female, male half and half, body weight 25-30g,
Provide the animal quality certification number by Military Medical Science Institute's Experimental Animal Center: the moving word of doctor 01-3023 number
5. experimental animal feeding environment: room temperature: 22 ℃, relative humidity: 60%RH, group's cage is raised 5/cage.
Feed resource: pull together feed corporation,Ltd's feedstuff quality certification number of Beijing section Australia: the capital is moving is betrothed to (2000) No. 015
6. test method:
Select 50 healthy mices for use, be divided into five groups at random, every group female, male each 5, establish three dosage groups altogether, the dosage design is respectively 5375,10750, the 21500mg/kg body weight, and other establishes negative control and positive controls, and positive group gives cyclophosphamide 40mg/kgBW.Tried the equal per os of thing and positive thing and irritate stomach, adopt 30 hours dose regimens, promptly twice dosing interval is 24 hours, after the last administration 6 hours, routine was got breastbone film-making, fixing, dyeing, under oily mirror every animal is observed 1000 polychromatic erythrocytes, calculate micronuclear rates, carry out statistical analysis.
Three, result of the test:
| Dosage (mg/kgBW) | Sex | Number of animals (only) | Have a liking for polychromatocyte number (individual) | Micronucleus cell number (individual)/animal is arranged | Micronuclear rates (‰) P value |
| Negative control | Male and female | 5 5 | 5×1000 5×1000 | 1.8±1.09 1.8±0.84 | 1.8 1.8 |
| Low agent heavy (5375) | Male and female | 5 5 | 5×1000 5×1000 | 2.2±1.30 1.4±1.52 | 2.2 1.4 |
| Middle dosage (10750) | Male and female | 5 5 | 5×1000 5×1000 | 1.8±0.84 0.8±0.84 | 1.8 0.8 |
| High dose (21500) | Male and female | 5 5 | 5×1000 5×1000 | 1.4±0.89 1.0±0.71 | 1.4 1.0 |
| Positive control | Male and female | 5 5 | 5×1000 5×1000 | 48.8±16.31 45.4±13.11 | 48.8 0.000 45.4 0.000 |
As seen from the table, each dosage group micronuclei in mice rate all in range of normal value, compare with negative control group by positive controls, and difference has utmost point significance (P＜0.01).The animal sensitivity is described, test is reliable.
Four, brief summary:
According to PCEMNR micronucleus test standard determination among " toxicological evaluation of food safety procedure and method " 15193.5-94, a flood day board falls the Chinese bush cherry sheet in being subjected to the amount of reagent scope, does not show the damaging action to bone marrow cell chromosome.
The mouse sperm deformity test report
Experiment purpose: detect and tried the genetoxic of thing to male sex-cell.
Two, material and method:
1. sample source: Beijing flood day power pharmaceutcal corporation, Ltd
2. tried thing: title: the Chinese bush cherry sheet falls in a flood day board
Character: pale brown color chips agent recommended amounts: the 4.5g/ day for human beings
3. sample pre-treatments: with distilled water by design dosage preparation desired concn
4. experimental animal: 25 of one grade of Kunming mouses, male, body weight 30-35g,
Provide the animal quality certification number by Military Medical Science Institute's Experimental Animal Center: the moving word of doctor 01-3023 number
5. experimental animal feeding environment: room temperature: 22-24 ℃, relative humidity: 52-60%RH, group's cage is raised 5/cage.
Feed resource: pull together feed corporation,Ltd's feedstuff quality certification number of Beijing section Australia: the capital is moving is betrothed to (2000) No. 015
6. test method:
Select 25 healthy mices for use, be divided into five groups at random, 5 every group, establish three dosage groups altogether, dosage design is respectively 5375,10750, the 21500mg/kg body weight, and other establishes negative control and positive controls, and positive group lumbar injection gives cyclophosphamide 40mg/kgBW.Experimental group and negative control group are all irritated stomach by the 0.2ml/kgBW per os, and negative control group gives distilled water.Continuous 5 days, in giving the 35th day after being tried thing to put to death mice first, get epididymis film-making, fixing, dyeing, under oily mirror,, calculate the sperm deformity incidence rate to 1000 sperms of every animal counting, adopt X 2 test to add up.
Three, result of the test: observing sperm count is: 1000/ animal
| Dosage (mg/kgBW) | Number of animals (only) | The teratocyte number | Distortion sperm count (individual) | Aberration rate (%) | |||||
| Unsetting | Fructus Musae | Fat head | The end of reel | Wugou | Two tails | ||||
| (10750) high (21500) positive control in the negative control low (5375) | 5 5 5 5 5 | 72 70 59 62 200 | 19 17 9 17 53 | 33 25 30 24 102 | 1 0 1 1 1 | 7 8 9 3 20 | 1 1 1 0 5 | 133 121 109 107 381 | 2.66 2.42 2.18 2.14 7.62 |
By table as seen, each dosage group mouse sperm deformity rate all belongs to range of normal value, and positive controls is compared with negative control group, difference tool utmost point significance (P＜0.01).The animal sensitivity is described, test is reliable.
Four, brief summary:
Judge according to mice sperm malformation test evaluation criterion among " toxicological evaluation of food safety procedure and method " 15193.7-94, a flood day board falls the Chinese bush cherry sheet in being subjected to the amount of reagent scope, do not see the damaging action to the male mice sexual cell, this tests negative result.
The Salmonella reversion test report
One, experiment purpose: detection is tried thing whether Salmonella typhimurium is had mutagenic action.
Two, material and method:
1. sample source: Beijing flood day power pharmaceutcal corporation, Ltd
2. tried thing: Chinese bush cherry sheet character falls in a flood day board: pale brown color chips agent
3. sample pre-treatments: sample thief 2g is dissolved in the 40ml distilled water, after waiting to dissolve, uses filter paper filtering, gets filtrate 30ml
Cross post by XAD-2 resin, the filter rate is the 2ml/ branch, and reuse 30ml acetone eluting is collected eluent
Can use.
4. test strain: select for use Salmonella typhimurium TA97, the TA98, TA100, the TA102 that obtain from Ames Lab to be this
The test strain of test.
5. test method:
Undertaken by the method that Ames proposes.Employing is mixed method and is put the examination method, adds or does not add external activation system (S9 mixed liquor) respectively and tested trying thing in two kinds of methods.Establish 5 dosage groups altogether, dosage design is respectively 0.001,0.005,0.05,0.5, the 5mg/ ware, other establishes negative control (beaming back change certainly), tried thing solvent control group, (specific positive thing is selected in the requirement that adds or do not add external activation system-S9 by different strains for positive thing solvent control group and positive controls, the concrete title and the dosage of positive thing see Table), each dosage is made three plates, and test repeats once.
Three, result of the test:
Table 1.1 a flood day board falls Chinese bush cherry sheet Salmonella reversion test and mixes method result ()
Table 1.2 a flood day board falls Chinese bush cherry sheet Salmonella reversion test and mixes method result (two)
Chinese bush cherry sheet Salmonella reversion test point examination method result falls in table 2 a flood day board
Four, brief summary:
Result of the test shows that flood day board falls the Chinese bush cherry sheet Salmonella reversion test method of mixing and is negative findings with some examination method under the situation that has or do not have external activation system (S-9) to exist.
Table 1.1 a flood day board falls Chinese bush cherry sheet Salmonella reversion test and mixes method result (return and become clump count) ()
| Test strain | Dosage (mg/ ware) | From beaming back change | Tried the thing solvent control | Positive thing solvent control | Positive control | |||||||||||||
| 0.001 | 0.005 | 0.05 | 0.5 | 5 | ||||||||||||||
| -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
| TA97 | 116.0 ±23.6 | 134.7 ±29.1 | 130.0 ±38.3 | 136.3 ±27.8 | 138.7 ±30.0 | 149.3 ±21.9 | 122.0 ±12.0 | 146.7 ± 25.3 | 141.3 ±32.4 | 138.7 ±29.3 | 140.7 ±33.0 | 145.3 ±21.2 | 144.0 ±26.9 | 146.7 ±11.0 | - | - | 536.0 ± 144.4 | 687.3 ± 49.4 |
| TA98 | 25.3± 6.8 | 24.0± 2.6 | 28.0± 2.6 | 36.0± 6.0 | 37.3 3.1 | 33.0± 8.9 | 31.7± 6.6 | 33.7± 8.5 | 26.3± 2.1 | 25.3± 3.5 | 30.7 ± 8.3 | 33.3 ± 11.0 | 31.3± 7.4 | 35.7± 5.9 | - | - | 933.3± 61.1 | 2076.7 ± 384.2 |
| TA100 | 100.7 ±15.1 | 127.0 ±33.9 | 124.0 ±18.0 | 113.3 ±30.7 | 153.3 ±35.8 | 128.3 ±23.5 | 133.3 ±21.2 | 103.3 ±12.8 | 124.0 ±32.9 | 149.3 ±30.0 | 136.0 ±24.9 | 142.7 ±34.9 | 109.4 ±24.4 | 126.7 ±12.9 | - | - | 593.3± 172.1 | 866.7 151.4 |
| TA102 | 268.7 ±29.3 | 273.8 ±27.2 | 248.0 ±46.9 | 268.7 ±34.2 | 239.3 ±44.1 | 248.7 ±31.9 | 163.3 ±33.5 | 222.0 ±45.8 | 266.3 ±71.6 | 289.3 ±32.3 | 237.3 ±45.5 | 282.7 ±25.7 | 235.3 ±37.8 | 250.0 ±59.4 | - | 288.0 ±12.0 | 1120.0 ±280.0 | 866.7± 133.2 |
Table 1.2 a flood day board falls Chinese bush cherry sheet Salmonella reversion test and mixes method result (return and become clump count) (two)
| Test strain | Dosage (mg/ ware) | From beaming back change | Tried the thing solvent control | Positive thing solvent control | Positive control | |||||||||||||
| 0.001 | 0.005 | 0.05 | 0.5 | 5 | ||||||||||||||
| -S9 | +S9 | -S9 | ±S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
| TA97 | 164.0 ±38.2 | 112.7 ±35.2 | 139.6 ±28.2 | 150.0 ±30.3 | 120.7 ±19.4 | 126.0 ±22.3 | 125.0 ±27.6 | 126.0 ±19.1 | 138.0 ±14.0 | 130.7 ±12.9 | 118.7 ±21.4 | 161.3 ±28.1 | 138.7 ±14.7 | 123.3 ±21.9 | - | - | 536.0± 144.4 | 687.3± 49.4 |
| TA98 | 30.7± 7.0 | 29.7± 2.1 | 27.7± 2.5 | 28.3± 3.1 | 37.3± 2.5 | 33.0± 7.9 | 32.3± 5.2 | 34.7± 5.0 | 34.3± 6.0 | 36.0± 6.2 | 31.0± 3.0 | 30.7± 4.7 | 35.7± 6.0 | 36.3± 4.5 | - | - | 933.3± 61.1 | 2076.7 ±384.2 |
| TA100 | 138.7 ±28.4 | 142.0 ±34.7 | 127.3 ±34.2 | 142.7 ±24.4 | 130.7 ±36.5 | 144.0 ±18.3 | 121.3 ±15.0 | 126.7 ±24.0 | 135.3 ±23.2 | 129.3 ±20.5 | 131.3 ±9.2 | 133.3 ±32.1 | 126.0 ±19.1 | 133.3 ±30.6 | - | - | 593.3± 172.1 | 866.7± 150.4 |
| TA102 | 292.7 ±24.8 | 289.3 ±32.5 | 266.0 ±23.1 | 268.0 ±31.7 | 258.0 ±19.7 | 286.0 ±34.1 | 304.0 ±38.2 | 291.3 ±9.5 | 270.0 ±31.7 | 276.7 ±34.1 | 285.3 ±19.4 | 273.3 ±13.6 | 259.3 ±45.4 | 266.7 ±27.7 | - | 292.0 ±9.2 | 1120.0 ±280.0 | 866.7± 133.2 |
Chinese bush cherry sheet Salmonella reversion test point examination method result falls in a table .2 flood day board
| Test strain | Dosage (mg/ ware) | From beaming back change | Tried the thing solvent control | Positive thing solvent control | Positive control | |||||||||||||
| 0.001 | 0.005 | 0.05 | 0.5 | 5 | ||||||||||||||
| -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
| TA97 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | + | + |
| TA98 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | + | + |
| TA00 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | + | + |
| TA02 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | + | + |
Annotate: it is fenaminosulf (50 μ g/ ware) that 1.TA97, TA98, TA102 do not add the positive thing that S9 selects for use.
2.TA100 not adding the positive thing that S9 selects for use is sodium azide (1.5 μ g/-ware).
3.TA97, to add the positive thing that S9 selects for use be 2-aminofluorene (5 μ g/ ware) for TA98, TA100.
4.TA102 adding the positive thing that S9 selects for use is 1,8-dihydroxyanthraquinone (50 μ g/ ware), and positive thing solvent is a dimethyl sulfoxide.
5. being tried the thing solvent control is acetone.
Toxicity section of Beijing Sanitary and Antiepidemic Station
(95) amount is recognized (capital) word (Z0220) number survey report
Sample number into spectrum: (2000) poison 055 check numbering: (2000) malicious S027
The sample title: Chinese bush cherry sheet sample character falls in a flood day board: pale brown color chips agent
Client: Beijing flood day power pharmaceutcal corporation, Ltd
Censorship quantity: 4500g sample lot number: 991123
Accept the date: detected date: 2000.7. to 2000.9. on May 11st, 2000
Inspection item: the effect of auxiliary adjustment blood glucose detects
Detect foundation: " the health food function assessment assessment process and the method for inspection "
Assay:
This sample does not have influence to the fasting glucose and the carbohydrate tolerance of normal mouse, and the fasting glucose and the carbohydrate tolerance of alloxan induced hyperglycemia mice had regulating action.
(following blank)
This survey report only is responsible for submitted sample
Chinese bush cherry sheet auxiliary adjustment blood glucose effect examining report falls in a flood day board
One, test objective: understand and tried thing to the fasting glucose of normal mouse and alloxan induced hyperglycemia mice and the influence of carbohydrate tolerance
Two, material and method:
1. tried thing: character is fallen the Chinese bush cherry sheet, in a flood day board: pale brown color chips agent.
Day for human beings recommended amounts: 4.5g, i.e. 75mg/kgBW.
Sample source: Beijing flood day power pharmaceutcal corporation, Ltd
2. laboratory animal: Kunming mouse, 96, female, body weight 25-30g,
Provide by Military Medical Science Institute's Experimental Animal Center
The quality certification number: the moving word of doctor 01-3023 number
3. dosage design: the dosage that is tried basic, normal, high three dosage groups of thing is respectively: 75mg/kgBW, 750mg/kgBW and 2250mg/kgBW (be respectively day for human beings recommended amounts 1 times, 10 times and 30 times); With distilled water with diluted sample to desired concn, irritating the stomach amount is 0.1ml/10gBW.
4. key instrument: like the Kang Quan blood glucose monitoring system
5. test method:
5.1 select 48 of healthy adult female mices, fasting 5 hours, freely drink water, get tail blood and survey fasting blood sugar, be divided into four groups at random according to blood sugar level, be negative control group and three dosage groups being tried thing, regularly irritate stomach once (negative control group gives solvent---distilled water) every day, successive administration 28 days, fasting was 5 hours in the 29th day, freely drank water, after getting tail blood survey fasting glucose, irritate stomach and give 20% glucose solution (0.1ml/10gBW),, observe and tried thing the fasting glucose of normal mouse and the influence of carbohydrate tolerance respectively at measuring blood glucose value once more to 0.5h and 2h behind the glucose.
5.2 select the healthy adult female mice, after the fasting 24 hours, give lumbar injection alloxan (100mg/kgBW), in injection back fasting in the 7th day 5 hours, freely drink water, measure fasting blood sugar, select fasting glucose greater than 48 of the mices of 10mmol/L, be divided into four groups at random according to blood sugar level, i.e. hyperglycemia model matched group and tried three dosage groups of thing, administering mode and blood sugar detection program are with 5.1.Observation is tried the influence of thing to fasting glucose, post-prandial glycemia and the carbohydrate tolerance of alloxan induced hyperglycemia mice.
5.3 date processing: result of the test adopts SPSS 8.0 software processes (variance analysis), and data are with the formal representation of X ± S.
Three, result of the test
1. the influence of Chinese bush cherry sheet to the normal mouse body weight falls in a flood day board.(seeing Table 1)
The influence of Chinese bush cherry sheet to the normal mouse body weight falls in table 1 flood day board
| Group | Initial body weight body weight in mid-term finishes body weight | |||||
| Number of animals (only) | Body weight (g) | Number of animals (only) | Body weight (g) | Number of animals (only) | Body weight (g) | |
| Dosage high dose in the negative control low dosage | 12 12 12 12 | 26.7±1.1 26.7±1.2 26.6±1.2 26.6±0.4 | 12 12 12 12 | 33.1±1.2 34.1±2.3 34.8±2.1 34.7±2.5 | 12 12 12 12 | 39.4±1.7 38.2±2.8 38.7±2.8 38.8±2.9 |
By the listed result of table 1 as seen, duration of test, the difference of statistical significance does not appear having in each body weight of organizing laboratory animal, points out this sample that the normal mouse body weight is not had influence.
2. the influence of Chinese bush cherry sheet to the normal mouse fasting glucose falls in a flood day board.(seeing Table 2)
The influence of Chinese bush cherry sheet to the normal mouse fasting glucose falls in table 2 flood day board
| Group | Dosage (mg/kgBW) | Number of animals (only) | Fasting blood sugar (mmol/L) | ||
| Before the test | After the test | The P value | |||
| Dosage high dose in the negative control low dosage | - 75 750 2250 | 12 12 12 12 | 6.91±1.19 6.91±1.16 6.97±1.24 7.04±1.21 | 7.53±0.93 7.28±0.99 7.36±1.07 7.03±1.34 | - 0.578 0.697 0.269 |
By the listed result of table 2 as seen, the fasting blood sugar of each treated animal does not all have the difference of tool statistical significance before and after the test, points out this sample that the normal mouse fasting glucose is not had influence.
3. the influence of Chinese bush cherry sheet to the normal mouse post-prandial glycemia falls in a flood day board.(seeing Table 3)
The influence of Chinese bush cherry sheet to the normal mouse post-prandial glycemia falls in table 3 flood day board
| Group | Dosage (mg/kgBW) | Number of animals (only) | Glucose (g/kgBW) | Blood glucose value (mmol/L) | ||
| 0h | 0.5h | 2h | ||||
| Dosage high dose in the negative control low dosage | - 75 750 2250 | 12 12 12 12 | 2.0 2.0 2.0 2.0 | 7.53±0.93 7.28±0.99 7.36±1.07 7.03±1.34 | 12.76±1.56 12.79±1.40 12.92±1.78 12.78±1.15 | 10.49±1.25 10.61±1.32 10.32±1.83 10.07±1.51 |
By the listed result of table 3 as seen, each blood glucose value of organizing experimental animal is each time point there are no significant difference after giving glucose, points out this sample that the post-prandial glycemia of normal mouse is not had influence.
4. the influence of Chinese bush cherry sheet to the normal mouse carbohydrate tolerance falls in a flood day board.(seeing Table 4)
The influence of Chinese bush cherry sheet to the normal mouse carbohydrate tolerance falls in table 4 flood day board
| Group | Dosage (mg/kgBW) | Number of animals (only) | Blood sugar increasing and reduction amplitude (mmol/L) | |||
| 0.5h-0h | The P value | 0.5h-2h | The P value | |||
| Dosage high dose in the negative control low dosage | - 75 750 2250 | 12 12 12 12 | 5.22±1.70 5.51±1.48 5.57±1.09 5.75±0.58 | - 0.592 0.519 0.323 | 2.27±0.57 2.18±0.68 2.61±0.86 2.71±1.17 | - 0.812 0.331 0.210 |
By the listed result of table 4 as seen, each organizes the reduction amplitude of the rising amplitude of experimental animal 0.5 hour blood glucose after giving glucose and 2 hours blood glucose there are no significant difference, points out this sample that the carbohydrate tolerance of normal mouse is not had influence.
5. the influence of Chinese bush cherry sheet to hyperglycemia mice fasting glucose falls in a flood day board.(seeing Table 5)
The influence of Chinese bush cherry sheet to hyperglycemia mice fasting glucose falls in table 5 flood day board
| Group | Dosage (mg/kgBW) | Number of animals (only) | Fasting blood sugar (mmol/L) | ||
| Before the test | After the test | The P value | |||
| Dosage high dose in the model contrast low dosage | - 75 750 2250 | 12 12 12 12 | 11.93±1.44 11.91±1.53 11.87±1.52 11.87±1.52 | 12.45±1.96 12.40±1.7 11.08±1.10* 10.07±0.95** | - 0.936 0.031 0.000 |
Annotate: compare with model control group: * P＜0.05; * P＜0.01
By the listed result of table 5 as seen, each treated animal fasting blood sugar there was no significant difference before the test, and after the test, the fasting glucose of middle and high dosage treated animal is starkly lower than model control group, learn check by statistics, difference has significance or highly significant, points out this sample can reduce the fasting glucose of alloxan induced hyperglycemia mice.
6. the influence of Chinese bush cherry sheet to hyperglycemia mice post-prandial glycemia falls in a flood day board.(seeing Table 6)
The influence of Chinese bush cherry sheet to hyperglycemia mice post-prandial glycemia falls in table 6 flood day board
| Group | Dosage (mg/BW) | Number of animals (only) | Glucose (g/kgBW) | Blood glucose value (mmol/L) | ||
| 0h | 0.5h | 2h | ||||
| Dosage high dose in the model contrast low dosage | - 75 750 2250 | 12 12 12 12 | 2.0 2.0 2.0 2.0 | 12.45±1.96 12.40±1.77 11.08±1.10* 10.07±0.9** | 19.18±2.66 17.88±2.11 14.66±1.49** 13.52±1.2** | 15.62±1.89 13.67±1.54** 11.62±1.20** 10.52±0.96** |
Annotate: compare with model control group: * P＜0.05; * P＜0.01
By the listed result of table 6 as seen, compare with model control group, middle and high dosage group gives that the blood glucose value of each time point obviously reduces behind the glucose, learns check by statistics, and difference has significance or highly significant; And low dose group gives behind the glucose 2 hours blood glucose value and also is starkly lower than model control group, and through check, difference has highly significant.
7. the influence of Chinese bush cherry sheet to hyperglycemia mice carbohydrate tolerance falls in a flood day board.(seeing Table 7)
The influence of Chinese bush cherry sheet to hyperglycemia mice carbohydrate tolerance falls in table 7 flood day board
| Group | Dosage (mg/kgBW) | Number of animals (only) | Blood sugar increasing and reduction amplitude (mmol/L) | |||
| 0.5h-0h | The P value | 0.5h-2h | The P value | |||
| Dosage high dose in the model contrast low dosage | - 75 750 2250 | 12 12 12 12 | 6.73±0.92 5.48±1.67* 3.57±1.28** 3.44±0.85** | - 0.016 0.000 0.000 | 3.56±1.61 4.22±1.44 3.03±1.36 3.00±0.77 | - 0.233 0.340 0.310 |
Annotate: compare with model control group: *, p＜0.05; *, p＜0.01
By the listed result of table 7 as seen, compare with model control group, tried each dosage group of thing give glucose after 0.5 hour the rising amplitude of blood glucose obviously reduce, learn check by statistics, difference has significance or highly significant, points out this sample that the carbohydrate tolerance reduction of alloxan induced hyperglycemia mice is had regulating action.
Four, conclusion
Evaluation criterion according to auxiliary adjustment blood glucose effect (animal experiment) in " the health food function assessment assessment process and the method for inspection " is judged, this sample does not all have influence to the fasting glucose and the carbohydrate tolerance of normal mouse, and the fasting glucose and the carbohydrate tolerance of alloxan induced hyperglycemia mice had regulating action.
Beijing Disease Prevention and Control Centre
Beijing Municipal Center for Disease prevention and Control
Xiyuan Hospital, Chinese Medicine Academy of China
Xiyuan Hospital of China Academy of Traditional Chinese Medicine
Survey report
CERTIFICATE OF ASSAY
Sample number into spectrum: 2000 poison 055
Inspection product numbering: 2000 malicious S027
Censorship unit: Beijing flood day power pharmaceutcal corporation, Ltd
Production unit: Beijing flood day power pharmaceutcal corporation, Ltd
Date of manufacture: on November 23rd, 1999
Inspection product title: the Chinese bush cherry sheet falls in a flood day board
Sample size: I II sheet, * 30 * 540 bottles of each 0.5 grams
Test item: blood sugar lowering effect human experiment experiment
Date received: on December 10th, 2000
Reporting date: February 2 calendar year 2001
Test basis: " the health food function assessment assessment process and the method for inspection "
Result and judgement:
Adopt counter point between double blinding self and group, 60 routine hyperglycemia examination trenchermans be divided into test-meal group and matched group at random, every group 30 example, viewing duration is former take the hypoglycemic medicine kind and dosage constant, the test-meal group adds a food flood day board and falls the Chinese bush cherry sheet, matched group is with the food placebo tablet.After one month, its result shows that the effect that the Chinese bush cherry sheet has blood sugar lowering falls in a flood day board, the fasting glucose 0.99 ± 1.91mmol/L that descends, the post-prandial glycemia 0.35 ± 2.42mml/L that descends, produce effects 3 examples wherein, effective 18 examples, total effective rate 70.00%; Matched group fasting glucose, post-prandial glycemia descend not obvious, wherein effective 9 examples, and there were significant differences for 30.00%, two group of contrast of total effective rate.Every clinical examination index such as hemoglobin, erythrocyte, leukocyte, total serum protein, albumin, glutamic oxaloacetic transaminase, GOT, glutamate pyruvate transaminase, carbamide, creatinine and routine urinalysis illustrate that all in normal range a flood day board falls the Chinese bush cherry sheet to the healthy no tangible harmful effect of examination trencherman before and after the test-meal.
This survey report only is responsible for submitted sample
" the Chinese bush cherry sheet falls in a flood day board " human experiment visual report
1. materials and methods:
1.1. sample: the Chinese bush cherry sheet falls in flood day board I number, II sheet, be orange colour, both outward appearance tastes are basic identical, all provided by Beijing flood day power pharmaceutcal corporation, Ltd.
1.2. the experimenter selects:
1.2.1. 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, fasting glucose 〉=7.8mmol/L (140mg/dl) or 2h blood glucose 〉=11.1mmol/L (200mg/dl) after the meal; Also can select the hyperglycemia population of 7.8mmol/L 〉=fasting glucose 〉=6.7mmol/L (120mg/dl) or 11.1mmol/L (200mg/dl) 〉=after the meal 2h blood glucose 〉=7.8mmol/L.
1.2.2. the complication of main organs such as the experimenter is not in the mood for, liver, kidney, hepatic and renal function is good, and nothing is taken glucocorticoid and other influences the blood glucose pharmacohistory.
1.2.3. eliminator's standard:
1.2.3.1.I diabetes mellitus type.
1.2.3.2. the age is under-18s or over-65s person, gestation or women breast-feeding their children.
1.2.3.3. complication such as severe cardiac, liver, kidney are arranged, or are associated with other serious primary disease, the psychotic.
1.2.3.4. the noncooperationist can't judge the infull person of curative effect or data.
1.3. test-meal method: 60 routine experimenters, be divided into two groups at random, former take the hypoglycemic medicine kind and dosage constant, the test-meal group adds a food flood day board and falls the Chinese bush cherry sheet, every day 3 times, each 3.Matched group is taken placebo, requires the examination trencherman to adhere to diet control for a long time, by different labor intensity and build feed.Each group adopts the own control design, is control design between group between two groups.
1.4. instrument and reagent: F-820 type blood counting instrument, ten analysers of MIDIRON urine (Germany produces), Olympus automatic clinical chemistry analyzer model AU600 (Japan produces), the biochemical reagents box is all provided by middle living company.
2. observation index:
Each was tested once when every index began and finishes in the test-meal experiment, and test-meal added on the 15th day surveys fasting glucose once.
2.1. effect observation:
2.1.1. observation of symptoms:
Detailed medical history-taking is understood patient's diet situation, and activity is observed main clinic symptoms: polyphagia, polydipsia, polyuria, soreness of the waist and knees, fatigue and weak etc.Before and after test-meal, add up integrated value by symptom weight (serious symptom 3 minutes, moderate 2 minutes, light disease 1 minute), and improve (2 fens produce effects of each doing well,improving are improved 1 and are divided into effectively), observation doing well,improving rate with regard to its cardinal symptom.
2.1.2. fasting glucose and 2 hours after the meal blood sugar test.
2.1.3. glucose in urine urine ketoboidies detects.
2.1.4. blood fat (T-CHOL TC, triglyceride TG, HDL-C HDL-C) detects.
2.2. safety is observed:
2.2.1. hematuria routine examination:
Red blood cell count(RBC), hemoglobin, numeration of leukocyte is urinated ten mensuration.
2.2.2. biochemical indicator is measured:
Serum albumin ALB, total protein TP, darling renal function (glutamic oxaloacetic transaminase, GOT AST, glutamate pyruvate transaminase ALT, carbamide UREA, creatinine Crea).
2.2.3. Abdominal B type ultrasonography, electrocardiogram, the fluoroscopy of chest of X line.
3. effect criterion:
3.1. produce effects: fundamental symptoms disappears, and blood glucose descends 〉=30% before the treatment.
3.2. effectively: fundamental symptoms obviously improves, blood glucose descends 〉=10% before the treatment
3.3. invalid: fundamental symptoms does not have obvious improvement, and blood glucose descends and do not reach above-mentioned standard.
4. result: observe and finish double blinding and makes known: take I person for falling Chinese bush cherry sheet group, taking II person is the placebo group.
4.1. physical data:
Observe 60 examples altogether, Chinese bush cherry sheet group male 14 examples fall in a flood day board, women's 16 examples, minimum 32 years old of age, the oldest 65 years old, average 54.33 years old, average course of disease 6.47 years; Matched group male 10 examples, women's 20 examples, minimum 32 years old of age, maximum 65 years old, average 55.73 years old, average course of disease 6.95 years.
4.2. situation was relatively as two groups of observations were last:
Situation comparison as table 1. observation is last (X ± SD)
| Grouping | Example number (example) | Age (year) | Sex | The course of disease (year) | Blood glucose (mmol/L) | ||
| The man | The woman | On an empty stomach | 2 hours after the meal | ||||
| Chinese bush cherry sheet group matched group falls | 30 30 | 54.33±8.38 55.73±9.58 | 14 10 | 16 20 | 6.47±5.60 6.95±4.29 | 10.88±3.07 9.8±2.51 | 13.98±3.42 13.75±3.28 |
Table 2. examination trencherman takes the hypoglycemic medicine situation
| Grouping | The example number | Sulphanylureas | Biguanides | Sulphur urea+biguanides | Do not take |
| Chinese bush cherry sheet group matched group falls | 30 30 | l5 15 | 7 7 | 3 2 | 5 6 |
Table 1, table 2 as seen, every index no significant differences before two groups of test-meals have comparability.
4.3. blood sugar lowering effect:
4.3.1. empty stomach and post-prandial glycemia are relatively:
A fasting glucose and blood glucose comparison in 2 hours after the meal before and after the table 3. liang group test-meal (mmol/L, X ± SD)
| Grouping | Fasting glucose | 2 hours after the meal blood glucose | ||||
| Before the test-meal | After the test-meal | Difference | Before the test-meal | After the test-meal | Difference | |
| Chinese bush cherry sheet group matched group falls | 10.88±3.07 9.88±2.51 | 9.89±2.77 10.08±2.71 | -0.99±1.91** +0.20±1.62# | 13.98±3.42 13.75±3.28 | 13.63±3.59 14.31±3.80 | -0.35±2.42 0.56±2.17 |
Contrast #P＜0.05 between own control * * P＜0.01 group
After one month, the Chinese bush cherry sheet group fasting glucose 0.99mmol/L that on average descends falls, 2 hours after the meal blood glucose 0.35mmol/L that on average descends; Matched group fasting glucose and 2 hours after the meal blood glucose descend not obvious.
4.3.2. fasting glucose, glucose in urine, urine ketoboidies are relatively:
Back fasting glucose and glucose in urine urine ketoboidies changes relatively (X ± SD) in before table 4. test-meal
| Project | The example number | Before the test-meal | In the test-meal | Difference in preceding | After the test-meal | The front and back difference |
| Blood glucose (mmol/L) glucose in urine (integrated value) urine ketoboidies | 30 (30) 30 (30) 30 (30) | 10.88±3.07 (9.88±2.5) 1.97±1.81 (1.07±1.44) - (-) | 10.58±2.86 (9.68±2.61) | -0.30±2.03 (-0.19±1.63) | 9.89±2.78 (10.08±2.7) 1.57±1.63 (1.40±1.67) - (-) | -0.99±1.91** (0.20±1.62) -0.40±2.53 (0.33±1.27) |
() matched group own control * * P＜0.01
4.3.3. on an empty stomach, post-prandial glycemia is relatively:
Blood glucose comparison in 2 hours after the meal before and after the table 5. liang group test-meal (mmol/L, X ± SD)
| Grouping | The example number | Before the test-meal | After the test-meal | ||||
| Fasting glucose | 2 hours after the meal blood glucose | The post-prandial glycemia lift-off value | Fasting glucose | 2 hours after the meal blood glucose | The post-prandial glycemia lift-off value | ||
| Chinese bush cherry sheet group matched group falls | 30 30 | 10.88±3.07 9.88±2.51 | 13.98±3.42 13.75±3.28 | 3.09±2.43 3.87±1.93 | 9.89±2.77 10.08±2.71 | 13.63±3.59 14.31±3.80 | 3.74±2.26 4.23±2.31 |
4.4. effect of lowering blood sugar is relatively:
Table 6. blood glucose value effect statistics
| Grouping | Produce effects | Effectively | Invalid | Total effective rate (%) | |
| Chinese bush cherry sheet group matched group falls | Example number effect rate (%) routine number effect rate (%) | 3 10.00 0 0.00 | 18 60.00 9 30.00 | 9 30.00 21 70.00 | 21 70.00# 9 30.00 |
Through X
2Check, two groups of total effective rate significant differences, P＜0.05.
4.5. doing well,improving situation:
Table 7. cardinal symptom is improved situation
| Symptom | The example number | Produce effects | Effectively | Invalid | Improvement rate (%) |
| Polyphagia polydipsia polyuria lassitude and weak | 15 (12) 11 (12) 12 (19) 14 (26) | 1 (0) 1 (1) 2 (1) 1 (0) | 6 (6) 5 (5) 5 (7) 6 (10) | 8 (6) 5 (6) 5 (11) 7 (16) | 46.67 (50.00) 54.55 (50.00) 58.33 (42.10) 50.00 (38.46) |
() matched group
Aspect each cardinal symptom improves, fall Chinese bush cherry sheet group and all be better than matched group.
4.6. clinical symptoms integration statistics:
Table 8 clinical symptoms integration statistics (X ± SD)
| Grouping | The example number | Before the test-meal | In the test-meal | After the test-meal |
| Chinese bush cherry sheet group matched group falls | 30 30 | 23.17±20.18 34.47±16.61 | 17.93±17.18*** 24.50±13.88*** | 15.00±14.45*** 21.00±13.12*** |
Own control * * * P＜0.001
Fall Chinese bush cherry sheet group and matched group the effect that improves clinical symptoms is all arranged.
4.8. blood safety index observing:
Blood safety index variation comparison before and after table 9. test-meal (X ± SD)
| Project | Chinese bush cherry sheet group (n=30) is fallen | Matched group (n=30) | ||
| Before the test-meal | After the test-meal | Before the test-meal | After the test-meal | |
| TP(g/L) ALB(g/L) ALT(u/L) AST(u/L) UREA(mmol/L) Cre(umol/L) HGB(g/L) RBC(×1012/L) WBC(×109/L) | 73.78±4.60 46.45±2.26 26.36±22.88 24.77±11.02 6.12±1.91 79.47±11.87 152.07±17.61 5.22±0.66 6.61±1.59 | 75.18±4.13 48.46±2.18 19.79±13.73 22.37±7.39 6.08±2.03 82.46±14.55 147.73±17.99 5.26±0.55 6.70±1.55 | 76.01±4.87 45.96±2.56 23.75±19.45 26.99±7.75 6.12±1.38 82.76±12.05 143.60±13.87 5.09±±0.52 6.25±1.67 | 77.91±4.16 47.14±2.51 25.05±23.26 27.19±13.10 5.86±1.16 82.87±10.11 148.50±17.20 5.26±0.59 6.29±1.60 |
Before and after two groups of test-meals, the every index of blood testing is all in normal range.
4.9. Chest X-rays, electrocardiogram, ultrasound diagnosis: the experimenter is all in normal range.
5. sum up:
5.1. the Chinese bush cherry sheet falls in a flood day board effect that comparatively significantly reduces fasting glucose is arranged, fall the Chinese bush cherry sheet group fasting blood sugar 0.99 ± 1.91mmol/L that descends, the post-prandial glycemia 0.35 ± 2.42mmol/L that descends, produce effects 3 examples wherein, effective 18 examples, total effective rate 70.00%; Matched group fasting glucose and post-prandial glycemia descend not obvious, wherein effective 9 examples, and 30.00%, two group relatively there were significant differences for total effective rate, illustrates that a flood day board falls the Chinese bush cherry sheet certain effect of lowering blood sugar is arranged.
5.2. a flood day board falls the Chinese bush cherry sheet to cardinal symptoms such as hyperglycemia examination trencherman polyphagia, polydipsia, polyuria, fatigue and weaks, has a better role.
After 5.3. the Chinese bush cherry sheet falls in a test-meal flood day board, every inspection indexs such as hemoglobin, erythrocyte, leukocyte, total serum protein, albumin, glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, creatinine, carbamide and routine urinalysis are all in normal range, and this product is described, and the trencherman is healthy to have no adverse effects to trying.
5.4. a flood day board falls the Chinese bush cherry sheet and do not observe allergy and other untoward reaction in the test-meal process.
Description of drawings
Fig. 1 Yuanhe tablet preparation technology flow chart
The specific embodiment
Embodiment 1 is by prescription, amplify the effective component (total flavones, total Saponin) of the Yuanhe tablet of production with RHIIZOMA DIOSCOREAE frOm Henan of China 600g, Folium Mori 1000g, Fructus Hordei Germinatus 400g, meet the effective component index request of health ministry approval, other performance indications of product all meet the regulation of its company standard; And has a significant blood sugar regulation effect.Its preparation technology is as follows: Fructus Hordei Germinatus (parched) is divided into two parts, and a copy of it is ground into 100 order fine powders, and is standby.RHIIZOMA DIOSCOREAE frOm Henan of China, Folium Mori are with 60% alcohol reflux secondary (with 6 times of amount ethanol, reflux, extract, 3 hours was measured alcohol reflux 2 hours with 5 times for the second time for the first time), the leaching extracting solution, reclaim ethanol, concentrating under reduced pressure becomes thick paste (relative density is 1.25～1.30,50 ℃ of surveys).Medicinal residues after Fructus Hordei Germinatus (parched) and RHIIZOMA DIOSCOREAE frOm Henan of China, the Folium Mori alcohol extraction decocted 1 hour with 5 times of water gagings, and leaching decocting liquid, concentrating under reduced pressure become thick paste (relative density is 1.25～1.30,50 ℃ of surveys).Two kinds of thick paste mix homogeneously are bed material with the Fructus Hordei Germinatus (parched) fine powder, mist projection granulating, and granulate adds 1% magnesium stearate tabletting, the bag film-coat, blister is promptly.
Embodiment 2 is by prescription, amplify the effective component (total flavones, total Saponin) of the Yuanhe tablet of production with RHIIZOMA DIOSCOREAE frOm Henan of China 1000g, Folium Mori 500g, Fructus Hordei Germinatus 500g, meet the effective component index request of health ministry approval, other performance indications of product all meet the regulation of its company standard; And has a significant blood sugar regulation effect.Its preparation technology is as follows: Fructus Hordei Germinatus (parched) is divided into two parts, and a copy of it is ground into 150 order fine powders, and is standby.RHIIZOMA DIOSCOREAE frOm Henan of China, Folium Mori are with 80% alcohol reflux secondary (with 7 times of amount ethanol, reflux, extract, 2 hours was measured alcohol reflux 3 hours with 4 times for the second time for the first time), the leaching extracting solution, reclaim ethanol, concentrating under reduced pressure becomes thick paste (relative density is 1.25～1.30,50 ℃ of surveys).Medicinal residues after Fructus Hordei Germinatus (parched) and RHIIZOMA DIOSCOREAE frOm Henan of China, the Folium Mori alcohol extraction decocted 2 hours with 4 times of water gagings, and leaching decocting liquid, concentrating under reduced pressure become thick paste (relative density is 1.25～1.30,50 ℃ of surveys).Two kinds of thick paste mix homogeneously are bed material with the Fructus Hordei Germinatus (parched) fine powder, mist projection granulating, and granulate adds 1% magnesium stearate tabletting, the bag film-coat, blister is promptly.
Claims (2)
1. health food Yuanhe tablet is characterized in that Yuanhe tablet makes 1000, every 0.5g by medicine, food dual purpose plant raw material RHIIZOMA DIOSCOREAE frOm Henan of China 300g～1200g, Folium Mori 400g～1600g, Fructus Hordei Germinatus (parched) 300g～1200g.
2. health food Yuanhe tablet is characterized in that the preparation method of Yuanhe tablet is: Fructus Hordei Germinatus (parched) is divided into two parts, and a copy of it is pulverized and is 100～160 purpose fine powders, and is standby; RHIIZOMA DIOSCOREAE frOm Henan of China, Folium Mori are with 60%～80% alcohol reflux secondary, measured 60%～80% alcohol reflux 2～3 hours with 5～7 times for the first time, measured 60%～80% alcohol reflux 2～3 hours with 3～5 times for the second time, the leaching backflow, reclaim ethanol, it is 1.25～1.30 thick paste that concentrating under reduced pressure becomes relative density; Medicinal residues after Fructus Hordei Germinatus (parched) and RHIIZOMA DIOSCOREAE frOm Henan of China, the Folium Mori alcohol extraction decocted 1～2 hour with 3～5 times of water gagings, and it is 1.25～1.30 thick paste that leaching decocting liquid, concentrating under reduced pressure become relative density; With two kinds of thick paste mix homogeneously, be bed material with the Fructus Hordei Germinatus (parched) fine powder, mist projection granulating, granulate adds 1% lubricant tabletting, the bag film-coat, blister is promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100888748A CN100428951C (en) | 2005-08-02 | 2005-08-02 | Yuanhe tablet and process for preparing the same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100888748A CN100428951C (en) | 2005-08-02 | 2005-08-02 | Yuanhe tablet and process for preparing the same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1730083A true CN1730083A (en) | 2006-02-08 |
| CN100428951C CN100428951C (en) | 2008-10-29 |
Family
ID=35962528
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100888748A Active CN100428951C (en) | 2005-08-02 | 2005-08-02 | Yuanhe tablet and process for preparing the same |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100428951C (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102742830A (en) * | 2011-04-18 | 2012-10-24 | 北京天植百桂生物技术有限公司 | Dietetic therapy product for regulating blood sugar and preparation method thereof |
| CN103859088A (en) * | 2012-12-13 | 2014-06-18 | 广州白云山中一药业有限公司 | Tea food with auxiliary hpyerglycemic efficacy and its preparation method |
| CN104905261A (en) * | 2015-05-28 | 2015-09-16 | 南京大地冷冻食品有限公司 | Intestine moistening and bowel relaxing health care food and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1325095C (en) * | 2004-10-29 | 2007-07-11 | 罗玉文 | Health caring beer with cold preventing and treating function |
-
2005
- 2005-08-02 CN CNB2005100888748A patent/CN100428951C/en active Active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102742830A (en) * | 2011-04-18 | 2012-10-24 | 北京天植百桂生物技术有限公司 | Dietetic therapy product for regulating blood sugar and preparation method thereof |
| CN102742830B (en) * | 2011-04-18 | 2014-11-26 | 北京天植百桂生物技术有限公司 | Dietetic therapy product for regulating blood sugar and preparation method thereof |
| CN103859088A (en) * | 2012-12-13 | 2014-06-18 | 广州白云山中一药业有限公司 | Tea food with auxiliary hpyerglycemic efficacy and its preparation method |
| CN104905261A (en) * | 2015-05-28 | 2015-09-16 | 南京大地冷冻食品有限公司 | Intestine moistening and bowel relaxing health care food and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100428951C (en) | 2008-10-29 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1390594A (en) | Mixture for improving blood circulation | |
| CN1712048A (en) | Chinese medicines for stomach pain due to Qi stagnation and its preparing method | |
| CN1132615C (en) | Health-care product with function of regulating blood sugar and its preparation method | |
| CN1263494C (en) | Granule for treating puerperal galactozemia and its preparation method | |
| CN1698713A (en) | Compound composition for treating arthralgia caused by wind-dampness and preparation thereof | |
| CN1075735C (en) | Compound diabetes-treating Chinese medicine preparation | |
| CN1263471C (en) | Lactogenic medicine and its preparing process and application | |
| CN1290517C (en) | Combination of propolis, preparation method and usage | |
| CN1246011C (en) | Multi-function health care food and application thereof | |
| CN1730083A (en) | Yuanhe tablet and process for preparing the same | |
| CN1294936C (en) | Medicine for treating diabetes and its preparation method | |
| CN1112439A (en) | Chinese medicine for diabetes and its preparation | |
| CN1879706A (en) | 'Shuang Huang Lian' dispersible tablet and preparation method thereof | |
| CN1290529C (en) | Medicine for treating gout, hyperuricemia and hyperlipemia and preparation method thereof | |
| CN1314418C (en) | Medicine for clearing away lung-heat, eliminating phaegn, reliveing cough and asthma and its preparing method | |
| CN1335161A (en) | Deer bone powder capsule | |
| CN1814110A (en) | Medicine for treating gynecophathy | |
| CN1733089A (en) | Medicine for treating diabetes and its complications and process for preparing the same | |
| CN1923270A (en) | Medicine for treating benign prostate hyperplasia and method of prepn. of the same | |
| CN1634496A (en) | Chinese traditional medicine composition for treating diabetes and preparation method thereof | |
| CN1726987A (en) | Combined of Chinese traditional medicine for lowering blood sugar, preparation and discrimination method | |
| CN1296080C (en) | Liver clearing blood pressure lowering capsule nd its preparation method | |
| CN1990022A (en) | Traditional Chinese medicine composition, its preparation and quality controlling means | |
| CN1698715A (en) | Heat-clearing abortion-preventing Chinese medicine and its preparation method | |
| CN100349530C (en) | Health-care food with anti-fatigue and anti-oxidation function and its prepn. method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C56 | Change in the name or address of the patentee | ||
| CP03 | Change of name, title or address |
Address after: Jinqiao Science and technology industrial base, Jinqiao Science and technology industrial base, No. 5-5, Middle Road, Zhongguancun science and Technology Park, Beijing, Tongzhou District Patentee after: Jia Hongzhang Address before: Room 1701, block B, 80 South Street, Guanganmen, Beijing, Xuanwu District Patentee before: Jia Hongzhang |
|
| EE01 | Entry into force of recordation of patent licensing contract |
Application publication date: 20060208 Assignee: Beijing Hong Tianli Pharmaceutical Co.,Ltd. Assignor: Jia Hongzhang Contract record no.: 2012990000542 Denomination of invention: Health food capable of decreasing blood sugar Granted publication date: 20081029 License type: Exclusive License Record date: 20120727 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20160804 Address after: 100000, Tongzhou District Zhongguancun science and Technology Park, Tongzhou Park, Jinqiao Technology Industrial base, No. 5-5 middle section of Ring Road, Beijing Patentee after: Beijing Hong Tianli Pharmaceutical Co.,Ltd. Address before: 101102, Beijing Zhongguancun science and Technology Park, Jinqiao Science and technology industrial base, Central Road, No. 5-5, Tongzhou District Patentee before: Jia Hongzhang |
|
| CP02 | Change in the address of a patent holder | ||
| CP02 | Change in the address of a patent holder |
Address after: Floors 1-3, Building 8, No. 50 Huatuo Road, Daxing Biomedical Industry Base, Zhongguancun Science and Technology Park, Daxing District, Beijing 102609 Patentee after: Beijing Hong Tianli Pharmaceutical Co.,Ltd. Address before: 5-5 huanke Middle Road, Jinqiao Science and technology industrial base, Tongzhou Park, Zhongguancun Science and Technology Park, Tongzhou District, Beijing Patentee before: Beijing Hong Tianli Pharmaceutical Co.,Ltd. |