CN1634496A - Chinese traditional medicine composition for treating diabetes and preparation method thereof - Google Patents
Chinese traditional medicine composition for treating diabetes and preparation method thereof Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicinal composition for enlivening spleen, reducing fever and promoting the secretion of the body fluid. The invention also discloses the process for preparing the pharmaceutical composition, which is a safe and effective antihypelipidemic medicament suitable for non-insula dependent diabetes patients.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of diabetes and preparation method thereof.
Background technology
At present, diabetes have become common chronic disease.In recent years, the sickness rate of China's diabetes has the trend of increasing.Its pathological change usually involves the pathological changes of each system of whole body, as the chronic pathological changes on cardiovascular, kidney, nervous system and optical fundus, serious harm health.Classify the 3rd as at the mortality rate of American-European diabetes.Research to diabetes has been subjected to generally attention.Existing Therapeutic Method generally adopts the orally-taken blood sugar reducing medicine to reach hypoglycemic purpose.The Western medicine of common treatment diabetes has sulphanylureas (as glyburide) and biguanides (as insoral) etc., though hypoglycemic effect is better in the recent period for this class medicine, the treatment diabetes is had certain effect, and taking for a long time has certain side effect to human body.Belong to chemosynthesis medicine as insoral, its blood sugar reducing function mainly is by suppressing the absorption of intestinal to glucose, reduce the release of glyconeogenesis and glucagon or suppress insulin antibody be used for realizing.Its side effect mainly shows all has certain detrimental effect to hemogram, liver function, kidney merit, can cause patient's diabetic cardiovascular and cerebrovascular complication, occurs hypoglycemic reaction easily, and gastrointestinal is had zest, produces anorexia, feels sick, vomiting even diarrhoea etc.Therefore cause certain mental pressure to the patient.Therefore select efficient and comparatively safe Chinese medicine to treat diabetes, become the hot topic of each side's research.
Summary of the invention
The purpose of this invention is to provide the Chinese medicine composition of a kind of replenishing QI to invigorate the spleen, clearing away heat and promoting production of body fluid, be used for deficiency of both QI and YIN, the auxiliary treatment of Sheng type diabetes can be improved its thirsty polydipsia in the interior-heat, and fatigue and weakness is vexed, symptoms such as constipation.
Another object of the present invention provides a kind of preparation method of this Chinese medicine composition.
Chinese medicine composition provided by the invention is prepared from by the following weight proportion raw material:
Radix Astragali 60-360 part Rhizoma Anemarrhenae 45-270 part Radix Rehmanniae 60-360 part 60-360 Radix Ophiopogonis part
Rhizoma Dioscoreae 15-90 part Rhizoma Polygonati 15-90 part Radix Trichosanthis 30-180 part Fructus Schisandrae Chinensis 45-270 part
Radix Puerariae 30-180 part Fructus Mume 30-180 part
Chinese medicine composition of the present invention preferably is prepared from by the following weight proportion raw material:
Radix Astragali 70-240 part Rhizoma Anemarrhenae 50-180 part Radix Rehmanniae 70-240 part 70-240 Radix Ophiopogonis part
Rhizoma Dioscoreae 20-60 part Rhizoma Polygonati 20-60 part Radix Trichosanthis 40-120 part Fructus Schisandrae Chinensis 55-180 part
Radix Puerariae 40-120 part Fructus Mume 40-120 part
Chinese medicine composition of the present invention also preferably is prepared from by the following weight proportion raw material:
Radix Astragali 90-140 part Rhizoma Anemarrhenae 80-120 part Radix Rehmanniae 90-140 part 90-140 Radix Ophiopogonis part
Rhizoma Dioscoreae 25-50 part Rhizoma Polygonati 25-50 part Radix Trichosanthis 50-90 part Fructus Schisandrae Chinensis 80-120 part
Chinese medicine composition of the present invention more preferably is prepared from by the following weight proportion raw material:
120 parts of 90 portions of Radix Rehmanniae of 120 parts of Rhizoma Anemarrhenaes of the Radix Astragali 120 parts of Radix Ophiopogonis
90 parts of 60 parts of Fructus Schisandrae Chinensis of 30 parts of Radix Trichosanthis of 30 parts of Rhizoma Polygonatis of Rhizoma Dioscoreae
60 parts of 60 portions of Fructus Mumes of Radix Puerariae
Chinese medicine composition of the present invention can be prepared into various preparations by the ordinary skill in the art.
The present invention also provides a kind of preparation method of this Chinese medicine composition, and this method comprises the steps:
Get the raw material of above-mentioned weight portion, the Radix Astragali, Fructus Schisandrae Chinensis, Rhizoma Dioscoreae, powder of Radix Puerariae are broken into fine powder, sieve mixing; Six-elements such as all the other Rhizoma Anemarrhenaes decoct with water secondary, add 10 times of amounts each time, decoct 2 hours, for the second time add 8 times of amounts, decocted collecting decoction 1 hour, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.30～1.35, adds above-mentioned powder, mixing, dry below 80 ℃, be ground into fine powder, make various preparations according to the conventional preparation method of Chinese medicine then, as tablet, capsule, granule or the like.
Chinese medicine composition of the present invention has been brought into play the multi-section position of Chinese medicine, the effect of many target spots, according to main cause and the rule that diabetes take place, develop, replenishing QI to invigorate the spleen, clearing away heat and promoting production of body fluid; Flavour of a drug are few, but effect is complete, and clinical confirmation not only can improve symptom significantly, but also blood sugar regulation suitably promotes the smooth rehabilitation of patient.The diabetes of the traditional Chinese medical science is to become thin or turbid urine, urine is pleasantly sweet is the disease of characteristics with polydipsia, polyphagia, polyuria, health, and the diabetes of this and modern medicine are basic identical.According to theory of Chinese medical science, the assertive evidence pathogenic characteristic should be that the deficiency of YIN is this, and is scorching for marking.If course of disease delay is with the passing of time, then deficiency of YIN affecting YANG, cause impairment of both QI and YIN.At the characteristics of containing in primary disease deficiency of both QI and YIN, the interior-heat, the choice of drug Radix Astragali of the present invention is that monarch drug tonifying Qi and lifting yang, benefit are defended weekly form; Selecting the Rhizoma Anemarrhenae, Radix Rehmanniae, Radix Ophiopogonis is ministerial drug, to help monarch's nourishing YIN and clearing away heat, promoting the production of body fluid to quench thirst; Select Radix Trichosanthis, Fructus Schisandrae Chinensis, Rhizoma Dioscoreae, Rhizoma Polygonati, Radix Puerariae is an adjuvant drug, helps monarch's invigorating the spleen and replenishing QI, YIN nourishing and the production of body fluid promoting; Fructus Mume is for having made the effect of yin fluid astringing.Full side plays replenishing QI to invigorate the spleen, replenishing YIN and removing heat, promoting the production of body fluid to quench thirst altogether, so conform to the medicine card.Clinically to thirst and liking drink, polyphagia polyphagia, that To Be Protected from Heat is vexed, fatigue and weakness, the symptom effects of having clear improvement such as lazy speech, the red constipation of urinating of breathing hard, total effective rate is more than 80%; The clinical symptoms integration relatively has remarkable decline (P＜0.05) before and after the treatment.This group 35 example clinical showing, medicine of the present invention can not only obviously improve the clinical symptoms of primary disease, and can reduce fasting glucose preferably, and total effective rate is 85.71%; Reduce by 2 hours after the meal blood glucose, total effective rate is 80%; Reduce twenty-four-hour urine sugar quantitatively, total effective rate 82.86%, on an empty stomach, 2 hours after the meal blood glucose and twenty-four-hour urine sugar quantitatively average relatively have significant difference (P＜0.05) before and after the treatment, and medication in a short time finds no toxic and side effects and untoward reaction.Medicine of the present invention is a kind of hypoglycemic medicine safely and effectively, can be used for non-islets of langerhans dependent diabetes patient and takes.
Beneficial effect
One, pharmacodynamics test research
Prove that through zoopery every day, gastric infusion 1.78g/kg continuous 10 days, can obviously reduce the mice hyperglycemia that alloxan causes.After irritating stomach 0.89g, 1.78g/kg to normal mouse in addition, gavage the D/W of 2.5g/kg again, record mouse blood sugar at different time and be starkly lower than matched group.Illustrate that this medicine has obvious regulating action to the carbohydrate metabolism of mice.
This medicine has the effect of replenishing QI to invigorate the spleen, clearing away heat and nourishing YIN, secretion-promoting thirst-quenching and treating diabetes.Cure mainly according to its function, this experiment purpose is to observe its pharmacological action of checking.
Experiment equipment
Laboratory animal: Kunming mouse, available from Institute of Genetics, Academia Sinica's Experimental Animal Center, the quality certification number: DB11/019.1-92
Experimental drug: medicine of the present invention, lot number is 951027, is provided by the Beijing Yadong Biology Pharmacy Co., Ltd.Make the even suspension of desired concn during test with 0.5% methyl fiber sodium.
Insoral; Lot number is 951106, and is commercially available.
Reagent: glucose assays test kit, lot number are 951027, are produced by the Beijing Chemical Plant
Alloxan, SIGMA Co. produces
Instrument: VZS-723 spectrophotometer, electronic balance etc.
Method and result
(1) medicine of the present invention is to the influence of alloxan diabetes mice hyperglycemia
1, makes hyperglycemia model and grouping
Get 80 of body weight 20 ± 1g Male Kunming strain mice, water is can't help in fasting, and after 3 hours, tail vein injection alloxan normal saline solution 85mg/kg (0.4ml/ only) causes hyperglycemia model, in addition with 20 mouse tail vein injections (0.4ml/ only) normal saline, as the normal control animal.After 72 hours above-mentioned mice fasting be can't help water after 10 hours, get blood from eye socket, glucose oxidase method is every mouse blood sugar concentration then.
Select blood glucose to be higher than close 60 of 200mg/dl and blood glucose value from 80 diabetic mices, being divided into four groups at random is model group, the big small dose group of medicine of the present invention and insoral group, 15 every group.
2, administration, survey blood sugar concentration
5 group mice difference gastric infusions, the heavy dose of group of medicine of the present invention 1.78g/kg, small dose group 0.89g/kg, insoral group 80mg/kg, model group and normal control group are given equivalent solvent, continuous 10 days, in administration in 1 day after 1 hour, eye socket is got blood, surveys fasting glucose concentration (fasting be can't help water 10 hours, and method is with aforementioned).Relatively between normal control group and the model group, difference between each administration group the results are shown in Table 1.
Table 1 medicine of the present invention is to the influence of alloxan diabetes mice hyperglycemia
The dosage animal
Blood glucose value mg/dl (the chamber of X ± SD)
Group P
(g/kg) before (only) administration after the administration 10 days
Normal control group solvent 15 170.6 ± 28.1 170.2 ± 30.6＜0.001
Model group solvent 15 516.7 ± 77.5 433.8 ± 30.3
Medicine group 1.78 15 520.7 ± 104.7 394.1 ± 63.8＜0.05 of the present invention
0.89 15 515.5±116.7 419.6±22.8 ＞0.05
Insoral group 0.08 15 520.0 ± 96.3 407.7 ± 8.5＜0.05
Annotate: with the model group ratio
The result shows that the mouse mainline alloxan is after 72 hours, and its blood sugar concentration is significantly higher than the normal control group.After continuous 10 days, mouse blood sugar concentration is starkly lower than model group with medicine 1.78g/kg of the present invention.0.89g/kg medicine of the present invention also can reduce blood glucose in diabetic mice, but does not have significant difference.Illustrate that medicine of the present invention has the effect of blood sugar lowering.
(2) medicine of the present invention is to the influence of normal mouse carbohydrate tolerance
Get 104 of body weight 22 ± 1g male mices, be divided into 4 groups at random, 26 every group, be divided into two batches, 13 every batch, medicine group 0.89 of the present invention, 1.78g/kg, insoral group 100mg/kg and blank group (equivalent solvent).Mice fasting 10 hours (every group every batch animal is got blood twice) before the experiment, survey and respectively organize the preceding blood sugar concentration of mice administration, after 1 hour, every mouse stomach gives the D/W of 2.5g/kg in each group mouse stomach administration, the blood sugar concentration when measuring to 0.5h, 1h behind the glucose and 2h.Relatively difference between each time administration group and the matched group the results are shown in Table 2
Table 2 medicine of the present invention is to the influence of normal mouse carbohydrate tolerance
Group dosage animal
Blood glucose value mg/dl (X ± SD)
Not other (g/kg) (only) oh 0.5h 1h 2h
Normal control group solvent 13 134.6 ± 21.9 238.9 ± 38.2 182.7 ± 24.8 162.7 ± 10.5
Medicine group 1.78 13 132.5 ± 205.9 205.9 ± 29.3 ☆ 158.9 ± 21.1 ☆ 126.0 ± 18.8 ☆ ☆ of the present invention
0.89 13 139.3±18.1 211.0±33.3 175.8±28.1 148.1±16.0☆☆
Insoral group 0.1 13 129.3 ± 18.5 183.0 ± 23.4 158.9 ± 29.1 ☆ 154.4 ± 17.2
☆☆☆
Annotate: compare ☆ P＜0.05 ☆ ☆ P＜0.01 ☆ ☆ ☆＜0.001 with matched group
The result shows, blood sugar concentration and matched group are than no significant difference before administration for two groups of medicines of the present invention, and in administration and after to glucose solution, 0.5h and 1h medicine 1.78g/kg of the present invention organizes blood sugar concentration and matched group ratio, and significant difference is all arranged.
Experiment showed, that medicine of the present invention not only has certain blood sugar reducing function to the alloxan diabetes mice, and the carbohydrate metabolism of normal mouse is had tangible regulating action.
Two, acute, long term toxicity test
1, acute toxicity test
Medicine of the present invention is irritated stomach and is given mice, and its maximum tolerated dose (MTD) is the 19.08g/kg body weight.
Experiment purpose: observe acute toxic reaction and death state that medicine gastric infusion of the present invention is produced.
Laboratory animal: Kunming kind white mice, 18～20g, ♀ ♂ half and half, the department of the Chinese Academy of Sciences of laboratory animal section of Beijing Medical University provides.The quality certification number: word is moved in＜Beijing〉8806M038 number.
Supply the reagent product: medicine of the present invention, the Beijing Yadong Biology Pharmacy Co., Ltd provides.
Character-sepia medicated powder, the little perfume (or spice) of abnormal smells from the patient
48/box of specification-0.35g/ grain (quite crude drug amount 0.78g)
Lot number-950330
Clinical dosage-8/day of adults (2.8g/60kg body weight people)
Feedstuff: Beijing dawn feed factory provides
Method and result
Get 20 of above-mentioned Kunming mouses, ♀ ♂ half and half once irritates stomach medicine 19.08g/kg of the present invention body weight (be equivalent to clinical dosage 405 times) for mice high concentration heavy dose, and the back that is administered once was observed 7 days continuously, the results are shown in following table 3:
Table 3 medicine of the present invention is to the acute toxicity test in mice result
Body weight administration 7 daily weights before the administration of dosage Mus
The mice response situation
Number (g) (g)
(g/kg) (only) X ± SD X ± SD is unmovable breathes the hair color defecation death of drinking water of ingesting
19.08 ♀ 10 18.69±0.83 26.98±1.33 (-) (-) (-) (-) (-) (-) 0
19.08 ♂ 10 19.04±1.09 27.91±1.39 (-) (-) (-) (-) (-) (-) 0
Annotate: (-) expression is normal
Above-mentioned result of the test shows that medicine of the present invention once irritates stomach for mice with 405 times (19.08g/kg body weight) of suitable adult's clinical dosage, observes 7 days, and the result does not see death, does not also see that the overt toxicity reaction occurs.So
MTD=19.08g/kg body weight (medicated powder amount)
=42.52g/kg body weight (crude drug amount)
2, long term toxicity test
Medicine 3.6g/kg of the present invention, 7.1g/kg gave the continuous gastric infusion of rat 2 months, the ingesting of animal, movable, urine, just wait all no abnormal; The main organs index of blood parameters such as the routine blood test of animal, liver, renal function and animal is all in normal range, and normal power zero difference; Histopathologic examination shows that important organs such as the heart, liver, spleen, lung, kidney, adrenal gland, trachea, testis, ovary do not have pathology and change.The above every index of two week of drug withdrawal back inspection does not all have the overt toxicity reaction, shows no cumulative toxicity.
Experiment purpose: this experimental observation medicine of the present invention is irritated the long term toxicity of mammal administration rat, sends out property complete with what understand oral administration.
Animal: 60 of cleaning level wistar kind rats, body weight is 100-110g, institute is provided by the calibrating of Ministry of Public Health pharmaceutical biological product, the quality certification number: 9209R019.
Medicine (inspection product): medicine of the present invention, lot number: 951022, provide by the Beijing Yadong Biology Pharmacy Co., Ltd, the time spent is mixed with the even suspension of desired concn with 0.5% sodium carboxymethylcellulose pyce.
Instrument: OLYMPUS BH-2 type microscope; Encore II type full automatic biochemical apparatus etc.
Method and result
60 of cleaning level wistar kind rats are divided into three groups at random by body weight, and 20 every group, ♀ ♂ half and half, 1. matched group; 2. medicine 3.6g/kg group of the present invention; 3. medicine 7.1g/kg group of the present invention, the consumption of two administration groups is amounted to by kg body weight, is equivalent to 30 times and 60 times of clinical consumption per day respectively.Each treated animal is all in gastric infusion 1ml/100g in the morning, successive administration 2 months.
(1) overview: observe the behavioral activity, urine of animal, just and appetite.Weigh weekly once before the administration and after the administration, finish until experiment.
The result shows, the ingesting of animal, activity and drainage situation are normal during the administration, and body weight gain is all right, the results are shown in Table 4 and table 5.
Table 4 medicine of the present invention is to the influence of male rat body weight gain (n=10, X ± SDg)
Medicine of the present invention medicine of the present invention
Matched group
3.6g/kg group 7.1g/kg group
Administration preceding 113.7 ± 10.8 111.4 ± 9.7 115.3 ± 9.7
One week 153.7 ± 10.0 150.5 ± 11.7 151.0 ± 12.7
Two weeks 193.4 ± 11.2 189.9 ± 12.3 194.3 ± 15.2
Three weeks 225.7 ± 12.8 222.0 ± 14.2 224.3 ± 14.1
All around 256.6 ± 11.5 250.7 ± 16.1 255.0 ± 12.6
Five weeks 281.4 ± 13.3 275.0 ± 17.4 275.5 ± 18.2
Six weeks 300.0 ± 15.7 296.4 ± 19.7 301.4 ± 11.9
Seven weeks 320.3 ± 18.2 311.1 ± 21.2 316.9 ± 14.1
Eight weeks 335.3 ± 21.1 324.8 ± 24.5 330.7 ± 16.0
Convalescent period (n=4) 344.9 ± 21.0 340.2 ± 34.4 346.6 ± 19.9
Table 5 medicine of the present invention is to the influence of female rats body weight gain (n=10, X ± SDg)
Medicine of the present invention medicine of the present invention
Matched group
3.6g/kg group 7.1g/kg group
Administration preceding 101.3 ± 5.9 104.5 ± 8.1 101.6 ± 8.1
One week 127.0 ± 5.5 131.1 ± 10.9 125.5 ± 8.6
Two week 149.4 ± 8.0 151.3 ± 6.9 144.5 ± 9.9
Three week 164.5 ± 9.5 167.4 ± 7.2 160.1 ± 9.7
All around 177.8 ± 10.2 178.4 ± 7.1 172.7 ± 10.1
Five weeks 189.5 ± 11.4 192.9 ± 7.6 185.5 ± 10.6
Six weeks 198.1 ± 13.4 203.1 ± 8.3 195.4 ± 9.9
Seven weeks 210.1 ± 12.5 210.3 ± 9.9 197.2 ± 9.5
Eight weeks 215.9 ± 13.6 215.-0 ± 9.5 207.3 ± 13.9
Convalescent period (n=4) 222.8 ± 9.8 222.2 ± 11.4 208.7 ± 10.4
(2) blood is often checked: respectively organize the rat fasting after administration finishes and can't help water 18 hours, cut tail and get blood, survey erythrocyte, leukocyte, hemoglobin, platelet with direct counting method, Wright Stain carries out counting from cell divide.
The result shows, the erythrocyte of matched group and each administration group (RBC), leukocyte (WBC), hemoglobin (Hb), platelet (BPC) sum and leukocyte differential count are all in range of normal value, administration group and matched group be no difference of science of statistics relatively, medicine of the present invention is described to rat marrow unrestraint phenomenon, the results are shown in Table 6 and table 7.
Table 6 medicine of the present invention is to the influence of rat hemogram (n=20, X ± SD)
Matched group medicine 3.6g/kg group of the present invention medicine 7.1g/kg group of the present invention
WBC(10
3/mm
3) 15.26±1.99 15.40±2.51 15.43±2.80
RBC(10
3/mm
3) 7.39±0.77 7.84±0.69 7.73±0.69
BPC(10
3/mm
3) 172.3±67.02 196.1±50.85 195.2±13.20
Hb(g％) 16.9±0.99 16.53±1.11 15.8±1.14
The influence that table 7 medicine of the present invention is classified to rat leukocyte (n=20, X ± SD)
Matched group medicine 3.6g/kg group of the present invention medicine 7.1g/kg group of the present invention
NL neutrality (%) 13.7 ± 4.5 11.0 ± 5.6 10.7 ± 5.6
Lgm lymph (%) 84.5 ± 5.2 87.0 ± 5.6 87.6 ± 5.6
Mon monokaryon (%) 1.5 ± 1.2 1.9 ± 1.1 1.6 ± 1.4
Eos has a liking for acid (%) 0.21 ± 0.80 0.07 ± 0.27 0.07 ± 0.27
Three, clinical experimental study
(1) physical data
This is organized in 35 examples, and case is in hospital and the outpatient from Guang-amen Hospital, China Traditional Chinese Medicine Instl, 18 examples of wherein being in hospital, outpatient service 17 examples.
(2) sex
Man's 16 examples, 45.7%; Woman's 19 examples, 54.3%; Man: woman=1: 1.19
(3) age
Maximum 65 years old age; Minimal ages 37 years old, average 56.1 years old.
(4) course of disease
The longest course of disease 20 years; The shortest course of disease 0.5 year
(5) complication
Complication with diabetes retinopathy person 9 examples; Merge coronary disease patient 3 examples, combination of syndromes peripheral neuropathy person 4 examples
(6) case is selected
1, Western medicine diagnose standard: all case all is diagnosed as non-insulin-dependent diabetes mellitus (NIDDM sees proof scheme for details) by the WHO diagnostic criteria.
2, differential diagnosis in tcm standard: select type of deficiency of both QI and YIN to close Sheng type in the interior-heat according to the Chinese Chinese medicine association Professional Committee's medicine typing standard of quenching one's thirst.Syndrome: thirst and liking drink, polyphagia polyphagia, that To Be Protected from Heat is vexed, fatigue and weakness, spontaneous sweating, breathe hard lazy speech, palpitation and insomnia, the red constipation of urinating, red tongue few tongue or Huang, wiry and frequent pulse or count accurately.
3, get rid of case standard (comprising inadaptation or rejecting standard)
(1) blood glucose is higher than normally before this medicine though the patient takes, behind diet control, increase activity etc., and fasting glucose＜7.8mmol/L (140mg/dl), or 2 hours after the meal blood glucose＜11.1mmol/L (200mg/dl).
(2) gestation or nursing women are to this medicine allergy sufferers under-18s or the above patient of 65 wind the age.
(3) noncooperationist's (refer to cooperate diet control or not medication and the person of affecting the treatment in accordance with regulations).
(4) complication such as severe cardiac, liver, kidney are arranged, or be associated with other serious primary disease, the psychotic.
(5) the diabetes ketosis is arranged, ketoacidosis and the infected in nearly 1 month.
(6) therapy discontinued less than the regulation observation period can't be judged the infull person of curative effect or data.
(7) test method
1, according to the requirement of being good for the font size medicine, this organizes 35 routine patients all on the basis of former diet control and oral antidiabetic drug, adds medicament capsule of the present invention (Main Ingredients and Appearance: Huang Shi, the Rhizoma Anemarrhenae, Radix Rehmanniae, Radix Ophiopogonis, Radix Trichosanthis, Fructus Schisandrae Chinensis, Rhizoma Dioscoreae, Rhizoma Polygonati, Radix Puerariae, Fructus Mume).
2, dose: take each 4 of capsule, every day 2 times.
3, one month course of treatment.
(8) observation item, syndrome
Mensuration such as fasting glucose, 2 hours after the meal blood glucose, routine blood test, routine urinalysis, ketoboidies, electrocardiogram, liver function, renal function.Clinical symptoms change adopts scoring method: wherein thirst and liking drink 6 minutes, the kind drink of polyphagia 5 minutes, To Be Protected from Heat vexed 3 minutes, fatigue and weakness 3 minutes, spontaneous sweating 3 minutes, breathe hard lazy speech 3 minutes, palpitation and insomnia 3 minutes, the red constipation 3 minutes of urinating, the few tongue of red tongue or yellow 2 minutes, wiry and frequent pulse or count 2 fens accurately
(9) efficacy determination
1, produce effects: treatment back disease integration descends 〉=2/3, fasting glucose＜7.2mmol/L (130mg/dl), 2 hours after the meal blood glucose＜8.3mmol/L (150Mg/dl), twenty-four-hour urine sugar quantitatively＜10.0g; Or blood glucose, twenty-four-hour urine sugar quantitatively descends more than 30% before the treatment.
2, effective: treatment back disease integration descends 〉=1/3, fasting glucose＜8.3mmol/L (150mg/dl), 2 hours after the meal blood glucose＜10.0mmol/L (180mg/dl), twenty-four-hour urine sugar quantitatively＜25.0g; Or blood glucose, twenty-four-hour urine sugar quantitatively descends more than 10% before the treatment.
3, invalid: treatment back symptom does not have obvious improvement, and blood sugar urinary sugar descends and do not reach These parameters.
(10) therapeutic outcome and analysis
1, blood sugar lowering curative effect
This is organized 35 examples and is the course of treatment (one month) of taking medicine, and reduction fasting glucose, 2 hours after the meal blood glucose, the quantitative curative effects of 24h glucose in urine see Table 8:
Blood glucose, glucose in urine change before and after the table 8 35 routine patient treatments
The produce effects enabledisable adds up to total effective rate
N ％ N ％ N ％ N ％
Fasting glucose 16 45.17 14 40 5 14.29 35 85.71
2h blood glucose 15 42.86 13 37.14 7 20 35 80 after the meal
24h glucose in urine quantitative 13 37.15 16 45.71 6 17.14 35 82.86
2, index changes
This organize 35 routine patients treat before and after fasting glucose, after the meal the quantitative average of 2h blood glucose, 24h glucose in urine relatively there were significant differences, P＜0.01 sees Table 9
Detection index variation before and after the table 9 35 routine patient treatments (X ± SD)
Before treating, N treats back t value P value
Fasting glucose (mol/l) 35 11.8 ± 3.37 8.15 ± 3.49 3.23＜0.01
2h blood glucose (mol/l) 35 15.47 ± 3.47 12.09 ± 3.30 4.18＜0.001 after the meal
The 24h glucose in urine is (g) 35 34.78 ± 39.71 11.61 ± 11.72 3.31＜0.01 quantitatively
3, to the curative effect of main syndrome
See table 10 for details
Symptom integral relatively before and after table 10 treatment
Before treating, N treats back P value
Xerostomia happiness drink 31 2.70 ± 1.31 1.01 ± 1.01＜0.05
To Be Protected from Heat vexed 33 0.97 ± 1.01 0.25 ± 0.44＜0.05
Fatigue and weakness 35 1.30 ± 0.98 0.55 ± 0.56＜0.05
Spontaneous sweating 28 0.09 ± 0.84 0.25 ± 0.57＜0.05
The lazyness of breathing hard speech 28 1.63 ± 0.82 0.71 ± 0.60＜0.05
Palpitation and insomnia 28 0.66 ± 0.8 10.17 ± 0.33＜0.05
Red constipation 16 0.55 ± 0.69 0.11 ± 0.34＜0.05 of urinating
Polyphagia polyphagia 17 0.99 ± 1.41 0.32 ± 0.87＜0.05
As can be seen from Table 10,35 routine diabetic treatment back symptoms are obviously improved P＜0.05
The main therapeutic effect of syndrome table of table 11
The N produce effects does not effectively have effective percentage
Xerostomia happiness drink 31 17 12 2 93.55
Polyphagia polyphagia 17 791 94.12
To Be Protected from Heat vexed 33 10 20 3 90.91
Fatigue and weakness 35 14 18 3 91.43
Spontaneous sweating 28 7 12 9 67.86
The lazyness of breathing hard speech 28 9 13 6 78.57
Palpitation and insomnia 28 11 14 3 89.29
The red constipation 16 14 20 100.00 of urinating
Symptom integral relatively before and after table 12 treatment
The produce effects enabledisable is always effective
N N ％ N ％ N ％ N ％
35 7 20 22 63 6 17 29 83
Table 12 expression symptom total effective rate is 83%
4, resemble, pulse condition changes
See table 13 for details
Picture of the tongue, pulse condition change list before and after table 13 treatment
The picture of the tongue pulse condition
N
The few tongue yellow and thin fur stringy and rapid pulse of red tongue is counted accurately
Treat preceding 35 19 16 33 2
Treatment back 35 14 11 29 2
Untoward reaction
After taking before and after the Drug therapy type ii diabetes of the present invention, measuring blood urea nitrogen, hemogram, urine protein, liver function, EKG, treatment, all find to change.The patient does not find any untoward reaction at period in a medicine.
Discuss
One, has the effect that improves the type ii diabetes clinical symptoms
This group Clinical results shows that this medicine is a deficiency of both QI and YIN for Chinese medical discrimination, and Sheng person has the good curing effect in the interior-heat, can improve and face the celebrating symptom.Become to improve clinical symptoms.Especially improve the xerostomia happiness and drink, it is vexed that To Be Protected from Heat, and spontaneous sweating is more obvious, and economic meter is learned and handled, equal P＜0.01, and difference has significance.
Two, the effect that has certain reduction type ii diabetes patient blood, glucose in urine.
This group Clinical results shows that it is 85.71% that this medicine reduces type ii diabetes patient fasting glucose total effective rate; Reduce by 2 hours after the meal blood glucose, total effective rate is 80%; Reduce twenty-four-hour urine sugar quantitatively, total effective rate 82.86%, on an empty stomach, 2 hours after the meal blood glucose and twenty-four-hour urine sugar quantitatively average relatively have significant difference (P＜0.05) before and after the treatment.
Three, have no side effect
Medicine of the present invention is not found recent untoward reaction in clinical observation, check contrasts such as the hemogram before and after the treatment, routine urinalysis, liver function, kidney merit, electrocardiogram, no change.Pointing out this medicine is a kind of safe orally-taken blood sugar reducing Chinese medicine.
The specific embodiment
Further specify technical scheme of the present invention below by specific embodiment.
Embodiment 1
60 parts of 45 portions of Radix Rehmanniae of 60 parts of Rhizoma Anemarrhenaes of the Radix Astragali 60 parts of Radix Ophiopogonis
45 parts of 30 parts of Fructus Schisandrae Chinensis of 15 parts of Radix Trichosanthis of 15 parts of Rhizoma Polygonatis of Rhizoma Dioscoreae
30 parts of 30 portions of Fructus Mumes of Radix Puerariae
Get the raw material of above-mentioned weight portion, the Radix Astragali, Fructus Schisandrae Chinensis, Rhizoma Dioscoreae, powder of Radix Puerariae are broken into fine powder, sieve mixing; Six-elements such as all the other Rhizoma Anemarrhenaes decoct with water secondary, add 10 times of amounts for the first time, decoct 2 hours, for the second time add 8 times of amounts, decocted collecting decoction 1 hour, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.30～1.35, adds above-mentioned powder, mixing, dry below 80 ℃, be ground into fine powder, make various preparations according to the conventional preparation method of Chinese medicine then, as tablet, capsule, granule or the like.
Embodiment 2
120 parts of 90 portions of Radix Rehmanniae of 120 parts of Rhizoma Anemarrhenaes of the Radix Astragali 120 parts of Radix Ophiopogonis
90 parts of 60 parts of Fructus Schisandrae Chinensis of 30 parts of Radix Trichosanthis of 30 parts of Rhizoma Polygonatis of Rhizoma Dioscoreae
60 parts of 60 portions of Fructus Mumes of Radix Puerariae
Get the raw material of above-mentioned weight portion, the Radix Astragali, Fructus Schisandrae Chinensis, Rhizoma Dioscoreae, powder of Radix Puerariae are broken into fine powder, sieve mixing; Six-elements such as all the other Rhizoma Anemarrhenaes decoct with water secondary, add 10 times of amounts each time, decoct 2 hours, for the second time add 8 times of amounts, decocted collecting decoction 1 hour, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.30～1.35, adds above-mentioned powder, mixing, dry below 80 ℃, be ground into fine powder, make various preparations according to the conventional preparation method of Chinese medicine then, as tablet, capsule, granule or the like.
Embodiment 3
240 parts of 180 portions of Radix Rehmanniae of 240 parts of Rhizoma Anemarrhenaes of the Radix Astragali 240 parts of Radix Ophiopogonis
180 parts of 120 parts of Fructus Schisandrae Chinensis of 60 parts of Radix Trichosanthis of 60 parts of Rhizoma Polygonatis of Rhizoma Dioscoreae
120 parts of 120 portions of Fructus Mumes of Radix Puerariae
Get the raw material of above-mentioned weight portion, the Radix Astragali, Fructus Schisandrae Chinensis, Rhizoma Dioscoreae, powder of Radix Puerariae are broken into fine powder, sieve mixing; Six-elements such as all the other Rhizoma Anemarrhenaes decoct with water secondary, add 10 times of amounts for the first time, decoct 3 hours, for the second time add 8 times of amounts, decocted collecting decoction 2 hours, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.30～1.35, adds above-mentioned powder, mixing, dry below 80 ℃, be ground into fine powder, make various preparations according to the conventional preparation method of Chinese medicine then, as tablet, capsule, granule or the like.
Embodiment 4
360 parts of 270 portions of Radix Rehmanniae of 360 parts of Rhizoma Anemarrhenaes of the Radix Astragali 360 parts of Radix Ophiopogonis
270 parts of 180 parts of Fructus Schisandrae Chinensis of 90 parts of Radix Trichosanthis of 90 parts of Rhizoma Polygonatis of Rhizoma Dioscoreae
180 parts of 180 portions of Fructus Mumes of Radix Puerariae
Get the raw material of above-mentioned weight portion, the Radix Astragali, Fructus Schisandrae Chinensis, Rhizoma Dioscoreae, powder of Radix Puerariae are broken into fine powder, sieve mixing; Six-elements such as all the other Rhizoma Anemarrhenaes decoct with water secondary, add 10 times of amounts each time, decoct 3 hours, for the second time add 8 times of amounts, decocted collecting decoction 2 hours, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.30～1.35, adds above-mentioned powder, mixing, dry below 80 ℃, be ground into fine powder, make various preparations according to the conventional preparation method of Chinese medicine then, as tablet, capsule, granule or the like.
Claims (6)
1, a kind of Chinese medicine composition for the treatment of diabetes is characterized in that: it is to be prepared from by the following weight proportion raw material:
Radix Astragali 60-360 part Rhizoma Anemarrhenae 45-270 part Radix Rehmanniae 60-360 part 60-360 Radix Ophiopogonis part
Rhizoma Dioscoreae 15-90 part Rhizoma Polygonati 15-90 part Radix Trichosanthis 30-180 part Fructus Schisandrae Chinensis 45-270 part
Radix Puerariae 30-180 part Fructus Mume 30-180 part.
2, Chinese medicine composition as claimed in claim 1 is characterized in that: the weight proportion of described raw material is:
Radix Astragali 70-240 part Rhizoma Anemarrhenae 50-180 part Radix Rehmanniae 70-240 part 70-240 Radix Ophiopogonis part
Rhizoma Dioscoreae 20-60 part Rhizoma Polygonati 20-60 part Radix Trichosanthis 40-120 part Fructus Schisandrae Chinensis 55-180 part
Radix Puerariae 40-120 part Fructus Mume 40-120 part.
3, Chinese medicine composition as claimed in claim 2 is characterized in that: the weight proportion of described raw material is:
Radix Astragali 90-140 part Rhizoma Anemarrhenae 80-120 part Radix Rehmanniae 90-140 part 90-140 Radix Ophiopogonis part
Rhizoma Dioscoreae 25-50 part Rhizoma Polygonati 25-50 part Radix Trichosanthis 50-90 part Fructus Schisandrae Chinensis 80-120 part
Radix Puerariae 50-90 part Fructus Mume 50-90 part.
4, Chinese medicine composition as claimed in claim 3 is characterized in that: the weight proportion of described raw material is:
120 parts of 90 portions of Radix Rehmanniae of 120 parts of Rhizoma Anemarrhenaes of the Radix Astragali 120 parts of Radix Ophiopogonis
90 parts of 60 parts of Fructus Schisandrae Chinensis of 30 parts of Radix Trichosanthis of 30 parts of Rhizoma Polygonatis of Rhizoma Dioscoreae
60 parts of 60 portions of Fructus Mumes of Radix Puerariae.
5, as any described Chinese medicine composition of claim 1-4, it is characterized in that: it is tablet, capsule, granule.
6, as the preparation method of any described Chinese medicine composition of claim 1-4, it is characterized in that: this method comprises the steps:
The Radix Astragali, Fructus Schisandrae Chinensis, Rhizoma Dioscoreae, the powder of Radix Puerariae of getting above-mentioned weight portion are broken into fine powder, sieve mixing; Remaining Rhizoma Anemarrhenae, Radix Rehmanniae, Radix Ophiopogonis, Rhizoma Polygonati, Radix Trichosanthis, Fructus Mume decoct with water secondary, add 10 times of amounts for the first time, decoct 2 hours, add for the second time 8 times of amounts, decocted 1 hour, collecting decoction filters, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.30～1.35, add above-mentioned powder, mixing, dry below 80 ℃, be ground into fine powder, make various preparations according to the conventional preparation method of Chinese medicine then.
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| CN 200410096748 CN1283300C (en) | 2004-12-06 | 2004-12-06 | Chinese traditional medicine composition for treating diabetes and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102600384A (en) * | 2012-03-05 | 2012-07-25 | 广州蓝韵医药研究有限公司 | Bamboo shoot product for treating diabetes mellitus and preparation method thereof |
| CN103416663A (en) * | 2013-08-28 | 2013-12-04 | 山东卫康生物医药科技有限公司 | Whole-grain complete-nutrition formulation food for diabetics |
| CN105168873A (en) * | 2015-08-14 | 2015-12-23 | 兰为民 | Traditional Chinese medicine composition conditioning diabetes and preparation method therefor |
| CN109568489A (en) * | 2018-12-18 | 2019-04-05 | 漳州市吾梓贸易有限公司 | A kind of Chinese medicine composition and preparation method thereof for treating diabetes |
| CN111956747A (en) * | 2020-09-02 | 2020-11-20 | 陈爱红 | A pharmaceutical composition for treating type 2 diabetes and preparation method thereof |
-
2004
- 2004-12-06 CN CN 200410096748 patent/CN1283300C/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102600384A (en) * | 2012-03-05 | 2012-07-25 | 广州蓝韵医药研究有限公司 | Bamboo shoot product for treating diabetes mellitus and preparation method thereof |
| CN103416663A (en) * | 2013-08-28 | 2013-12-04 | 山东卫康生物医药科技有限公司 | Whole-grain complete-nutrition formulation food for diabetics |
| CN105168873A (en) * | 2015-08-14 | 2015-12-23 | 兰为民 | Traditional Chinese medicine composition conditioning diabetes and preparation method therefor |
| CN109568489A (en) * | 2018-12-18 | 2019-04-05 | 漳州市吾梓贸易有限公司 | A kind of Chinese medicine composition and preparation method thereof for treating diabetes |
| CN111956747A (en) * | 2020-09-02 | 2020-11-20 | 陈爱红 | A pharmaceutical composition for treating type 2 diabetes and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1283300C (en) | 2006-11-08 |
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