Background technology
The metabolic disease of diabetes (diabetes) to be a kind of with hyperglycemia be feature, together be called " three-hypers " with hypertension, hyperlipidemia, be by the various virulence factor such as inherited genetic factors, immunologic function disorder, infected by microbes and toxin thereof, free radical toxin, Nervous and Mental Factors act on body cause hypoinsulinism, insulin resistant etc. and cause a series of metabolism disorder syndrome such as sugar, protein, fat, water and eletrolytes.Particularly to catch rate high especially for " adult diabetes mellitus " middle age more than 40 years old.Long-standing hyperglycemia during diabetes, causes various tissue, particularly eye, kidney, heart, blood vessel, neural chronic lesion, dysfunction.
Diabetes divide the diabetes of type i diabetes, type ii diabetes, gestational diabetes and other specific types.Usual concern and to study more be type i diabetes and type ii diabetes:
1. I type patients with type Ⅰ DM is a kind of autoimmune disease.Autoimmune disease is because the immune system of health is attacked self making.The pancreas beta cell of immune system to self excreting insulin of diabetics is made and is attacked and kill them, and result pancreas can not secrete enough insulins.Because insulin secretion lacks, patient need rely on exogenous insulin and supplement to sustain life.
2. type ii diabetes is Adult Onset's patients with type Ⅰ DM, how in the sequela in 35-40 year, accounts for diabetics more than 90%.The ability producing insulin in patient body not completely loses, and in some patient bodies, insulin even produces too much, but the action effect of insulin is had a greatly reduced quality, and the insulin therefore in patient body is a kind of shortage relatively.
Type ii diabetes has stronger heritability and environmental factors, and in significant heterogeneous, the performance such as polyuria, polydipsia, polyphagia can appear in its model case, become thin, i.e. " three-many-one-little " symptom, diabetes are once control badly can cause complication, cause the exhaustion pathological changes at the positions such as kidney, eye, foot, and cannot cure.
Nowadays, the most frequently used treatment means, for taking the hypoglycemic medicines such as metformin, is cured the symptoms, not the disease, can only blood sugar lowering and cannot control blood glucose, and long-term taking bring burden not only can to the health of patient, but also easily makes patient body occur Drug resistance.
TCM treatment of diabetes more holistic regulates and controls, and is obviously better than doctor trained in Western medicine improving in symptom etc.Be suitable for non-insulin-dependent diabetes mellitus (i.e. type ii diabetes), therefore the existing Chinese medicine composition needing research and development treatment diabetes.
Summary of the invention
The present invention is directed to the deficiency of existing diabetes treatment by western medicine, a kind of Chinese medicine composition for the treatment of diabetes is provided.
The technical scheme that the present invention solves the problems of the technologies described above is as follows: a kind of Chinese medicine composition for the treatment of diabetes, its raw material composition and proportioning as follows:
Fructus Corni 28 ~ 32 weight portion; Leptoradix Ginseng 36 ~ 42 weight portion; The Radix Rehmanniae 28 ~ 32 weight portion; Rhizoma Polygonati 28 ~ 32 weight portion; The Radix Astragali 18 ~ 22 weight portion; The Radix Paeoniae Alba 18 ~ 22 weight portion; Fructus Lycii 36 ~ 42 weight portion; The Rhizoma Anemarrhenae 28 ~ 32 weight portion; Radix Scrophulariae 28 ~ 32 weight portion; Rhizoma Coptidis 36 ~ 42 weight portion; Fructus Mume 28 ~ 32 weight portion; Cortex psidii guajavae 36 ~ 42 weight portion; Concha Ostreae 28 ~ 32 weight portion; Radix Stellariae 18 ~ 22 weight portion; Rhizoma Picrorhizae 28 ~ 32 weight portion; Radix Salviae Miltiorrhizae 28 ~ 32 weight portion; Ramulus Euonymi 36 ~ 42 weight portion; Aloe 14 ~ 16 weight portion; Rhizoma Polygoni Cuspidati 28 ~ 32 weight portion.
Preferably, the Chinese medicine composition of described treatment diabetes raw material composition and proportioning as follows: Fructus Corni 30 weight portion; Leptoradix Ginseng 40 weight portion; The Radix Rehmanniae 30 weight portion; Rhizoma Polygonati 30 weight portion; The Radix Astragali 20 weight portion; The Radix Paeoniae Alba 20 weight portion; Fructus Lycii 40 weight portion; The Rhizoma Anemarrhenae 30 weight portion; Radix Scrophulariae 30 weight portion; Rhizoma Coptidis 40 weight portion; Fructus Mume 30 weight portion; Cortex psidii guajavae 40 weight portion; Concha Ostreae 30 weight portion; Radix Stellariae 20 weight portion; Rhizoma Picrorhizae 30 weight portion; Radix Salviae Miltiorrhizae 30 weight portion; Ramulus Euonymi 40 weight portion; Aloe 15 weight portion; Rhizoma Polygoni Cuspidati 30 weight portion.
Further, described Chinese medicine composition makes capsule, granule, pill or decoction by adding or not adding adjuvant.
Described adjuvant is various pharmaceutically conventional adjuvant and/or excipient, include, but is not limited to saccharide (as lactose, dextrose plus saccharose), starch (as corn starch and potato starch), cellulose and its derivates is (as sodium carboxymethyl cellulose, ethyl cellulose and methylcellulose), tragacanth gum powder, Fructus Hordei Germinatus, gelatin, Talcum, kollag (as stearic acid and magnesium stearate), calcium sulfate, vegetable oil, as Oleum Arachidis hypogaeae semen, Oleum Gossypii semen, Oleum sesami, olive oil, Semen Maydis oil and cupu oil, polyhydric alcohol is (as propylene glycol, glycerol, Sorbitol, mannitol and Polyethylene Glycol), alginic acid, emulsifying agent (as Tween), wetting agent (as sodium lauryl sulfate), coloring agent, flavoring agent, tablet agent, stabilizing agent, antioxidant, antiseptic, apirogen water, isotonic saline solution and phosphate buffer etc.Adjuvant can improve stability, the activity and biological effectiveness etc. of formula as required, or when oral, produce acceptable mouthfeel or abnormal smells from the patient.
In Chinese medicine composition of the present invention, Fructus Corni liver and kidney tonifying in side, astringent or styptic treatment for spontaneous sweating vital essence; Leptoradix Ginseng's strongly invigorating primordial QI, promoting the production of body fluid to quench thirst; Radix Rehmanniae replenishing YIN and removing heat, promotes the production of body fluid and moisturizes.Three medicines match, and gather the effect of Replenishing QI and nourishing YIN, clearing away heat and promoting production of body fluid altogether, are monarch drug altogether.Minister with Rhizoma Polygonati, Radix Astragali nourishing kidney lung moistening, invigorating the spleen and benefiting QI; The Radix Paeoniae Alba, Fructus Lycii tonifying liver kidney yin; The Rhizoma Anemarrhenae, Radix Scrophulariae, Rhizoma Coptidis let out clearly lung dryness of the stomach heat and YIN nourishing, to increase the merit of monarch drug.Fructus Mume yin fluid astringing promoting the production of body fluid to quench thirst; Cortex psidii guajavae, Concha Ostreae are restrained astringent or styptic treatment for spontaneous sweating; Radix Stellariae, Rhizoma Picrorhizae enter cloudy point clearind deficient heat; Radix Salviae Miltiorrhizae, Ramulus Euonymi blood circulation promoting and blood stasis dispelling; Aloe, Rhizoma Polygoni Cuspidati relieving constipation by purgation are adjuvant drug altogether.
Second aspect present invention discloses the preparation method of the Chinese medicine composition of aforementioned therapies diabetes, is decocting method, comprises the following steps:
1) soak: according to the formula of Chinese medicine composition, raw material is put into 8 ~ 10 times amount cold water and soak 20 ~ 40 minutes;
2) decoct: the medical material big fire soaked be fried open, after a turn little fire decocts 40 ~ 60 minutes, isolated by filtration obtains medicinal residues and filtrate;
3) secondary decocts: the water again adding 4 ~ 6 times amount in the medicinal residues of previous step, turns little fire and decocts 30 ~ 40 minutes, cross leaching filtrate after big fire is fried open;
4) combining step 2) and step 3) filtrate, it is 1.05 ~ 1.15 that low-temperature evaporation is concentrated into relative density, obtains the decoction of Chinese medicine composition.
The invention also discloses the preparation method of the Chinese medicine composition of another kind for the treatment of diabetes, be decoction and alcohol sedimentation technique, comprise the following steps:
1. decoct: according to the formula of Chinese medicine composition, in raw material, add the water of 8 ~ 10 times amount, heating decoction 1 ~ 2 hour; After solid-liquid separation, add the water of 4 ~ 6 times amount, heating decoction 1 ~ 1.5 hour, merges the filtrate of twice decoction;
2. filtrate low-temperature evaporation being concentrated into relative density is 1.15 ~ 1.2, under stirring condition, slowly adds the 95%v/v alcoholic solution of 2 times amount, and stir 18 ~ 25 minutes, Cryoprecipitation 36 ~ 60 hours, inclines and supernatant, filters;
3. Distillation recovery ethanol, then to continue evaporation and concentration to relative density be 1.25 ~ 1.35, places and make precipitation complete for 20 ~ 28 hours, filter, filtrate at low-temperature evaporation to paste;
4. in the thick paste of previous step, add adjuvant and make soft material, mixing, makes granule, dry, obtains the granule of Chinese medicine composition.
Last aspect of the present invention discloses the application of aforementioned Chinese medicine composition in preparation treatment type Ⅱdiabetes mellitus medicine.
The invention has the beneficial effects as follows: Chinese medicine composition supplementing QI and nourishing YIN of the present invention, clearing away heat and promoting production of body fluid.To hold concurrently syndrome of deficiency of both qi and yin for the scorching impairment of body fluid of type ii diabetes, disease sees thirsty polydipsia, and urine volume is frequently many, and rapid digestion of food and polyorexia, body is gradually thin, fatigue and weakness, spontaneous sweating, dysphoria with feverish sensation in the chest palms and soles, turbid urine, constipation etc.
Detailed description of the invention
Be described principle of the present invention and feature below, example, only for explaining the present invention, is not intended to limit scope of the present invention.
The preparation of embodiment 1 Chinese medicine composition decoction
1. Traditional Chinese medicine composition formula
Fructus Corni 30g, Leptoradix Ginseng 40g, Radix Rehmanniae 30g; Rhizoma Polygonati 30g, Radix Astragali 20g, Radix Paeoniae Alba 20g, Fructus Lycii 40g, Rhizoma Anemarrhenae 30g, Radix Scrophulariae 30g, Rhizoma Coptidis 40g; Fructus Mume 30g, Cortex psidii guajavae 40g, Concha Ostreae 30g, Radix Stellariae 20g, Rhizoma Picrorhizae 30g, Radix Salviae Miltiorrhizae 30g, Ramulus Euonymi 40g, Aloe 15g, Rhizoma Polygoni Cuspidati 30g.
2. preparation method
1) above-mentioned medical material is placed in steel steamer, is about 8 times amount of medical material with cool water quantity, soak 30 minutes;
2) soaked medical material is fried open with high heat, turns temperature fire and decoct 50 minutes, leach medicinal liquid;
3) after leaching medicinal liquid, again add 5 times amount cold water and be fried open, turn temperature fire and decoct 40 minutes, leach medicinal liquid;
4) by above-mentioned steps 2) with step 3) medicinal liquid merge, mix, filter, filtrate low-temperature evaporation is concentrated into the decoction that relative density is 1.1.
The preparation of embodiment 2 traditional Chinese medicine particle
1. Traditional Chinese medicine composition formula
Fructus Corni 28g, Leptoradix Ginseng 42g, Radix Rehmanniae 28g; Rhizoma Polygonati 32g, Radix Astragali 22g, Radix Paeoniae Alba 18g, Fructus Lycii 36g, Rhizoma Anemarrhenae 32g, Radix Scrophulariae 28g, Rhizoma Coptidis 36g; Fructus Mume 28g, Cortex psidii guajavae 42g, Concha Ostreae 32g, Radix Stellariae 18g, Rhizoma Picrorhizae 28g, Radix Salviae Miltiorrhizae 28g, Ramulus Euonymi 42g, Aloe 14g, Rhizoma Polygoni Cuspidati 32g.
2. preparation method
1. by above-mentioned medical material, the water that first time adds water about 10 times amount, heats decoction 1.5 hours; The water of about 4 times amount that add water for the second time, heating decoction 1.5 hours, merging filtrate, filters.
2. filtrate low-temperature evaporation is concentrated into relative density is 1.15, and under fully stirring, slowly add 95% ethanol of 2 times amount, stir 20 minutes, Cryoprecipitation 48 hours, inclines and supernatant, filters.
3. Distillation recovery ethanol, then to continue evaporation and concentration to relative density be 1.3, cold place places 24 hours, makes precipitation complete, filters, filtrate at low-temperature evaporation to paste, for subsequent use.
4. thick paste is placed in container, add dextrin (dextrin and thick paste mass ratio are 1:2) and volumetric concentration be 70% alcoholic solution make soft material, mixing, makes granule, dry, obtains Chinese medicinal composition granules.
The preparation of embodiment 3 Chinese medicinal composition capsules
1. Traditional Chinese medicine composition formula
Fructus Corni 32g, Leptoradix Ginseng 36g, Radix Rehmanniae 32g; Rhizoma Polygonati 28g, Radix Astragali 18g, Radix Paeoniae Alba 22g, Fructus Lycii 42g, Rhizoma Anemarrhenae 28g, Radix Scrophulariae 32g, Rhizoma Coptidis 42g; Fructus Mume 32g, Cortex psidii guajavae 36g, Concha Ostreae 28g, Radix Stellariae 22g, Rhizoma Picrorhizae 32g, Radix Salviae Miltiorrhizae 32g, Ramulus Euonymi 36g, Aloe 16g, Rhizoma Polygoni Cuspidati 28g.
2. preparation method
1. by above-mentioned medicinal material drying, mixing, shatters into fine powder, all should pass through No. six sieves.
2. by above-mentioned medicinal powder, No. 1 capsule is loaded under drying regime, each weight 0.5 gram.
The animal experiment of embodiment 4 traditional Chinese medicine composition for treating diabetes
1. the structure of animal model of diabetes mellitus type II
(the high-sugar-fat-diet formula that high fat diet adopts is: Adeps Sus domestica 15% to select health male SD rat in 7 week age to give high fat diet, sucrose 20%, cholesterol 5%, common Mus feedstuff 60%, is mass percentage) after 8 weeks, lumbar injection streptozotocin (0.5% streptozotocin 30mg/kg, 0.1mmol/L citrate buffer solution, pH4.4), after injection 7d, type Ⅱdiabetes mellitus rat 50 is successfully prepared.
2. experimental technique and result
Using untreated 10 SD rats as blank group; Using 50 type Ⅱdiabetes mellitus rat Stochastic choice 10 successfully constructing only as model control group, remaining rat model stochastic averagina is divided into two groups, be respectively Chinese medicine composition group (Chinese medicine composition of the present invention), and glyburide group (Glibenclamide Tablets, purchased from Guangdong three just Pharmaceutical Group company limited).Chinese drug-treated group gastric infusion every day 1 time (Chinese medicine composition decoction 10ml/kg prepared by embodiment 1), glyburide group medication every day (7.8mg/kg), model control group and blank group such as to give respectively at the normal saline (every 100g gives 1mL) of capacity, continuous use 30d.Respectively at after medicine the 15th day, 30 days, fasting 12h, surveyed blood glucose 1 time, the results are shown in Table 1.
Table 1 Chinese medicine composition is on the impact of mouse blood sugar
Compare with model control group, * P < 0.05, * * P < 0.01.
From upper table 1, Chinese medicine composition of the present invention, compared with model control group, significantly can reduce the blood glucose of the type Ⅱdiabetes mellitus rat that streptozotocin brings out, have remarkable result to treating diabetes.
The effect of embodiment 5 Chinese medicine composition clinical treatment diabetes
1. case selection:
Case is pressed WHO diabetes diagnostic criterion and is selected, and is II diabetics, and meets the dialectical standard of deficiency of both QI and YIN disease in " guideline of clinical investigations of new Chinese medicine treatment diabetes (diabetes) ".
Accept Patients with 300 Cases for medical treatment altogether, be divided into treatment group and matched group at random: treatment group 120 example, wherein man 60 example, female 60 example, the age at 38 ~ 65 years old, the course of disease 3 ~ 15 years; Severity extent: slight 23 examples, moderate 64 example, severe 33 example.Matched group 120 example, wherein man 63 example, female 57 example, 38 ~ 65 years old age, the course of disease 3 ~ 15 years; Severity extent: slight 24 examples, moderate 68 example, severe 28 example.
2. Therapeutic Method:
Keep on a diet all on request for two groups.The Chinese medicine composition decoction 200-250ml of the oral embodiment 1 for the treatment of group, every day 2 times, in, before dinner, 30min drinks; The oral diabetes pill of matched group (Guangzhou Zhongyi Medicine Industry Co., Ltd), each 8, every day 3 times, the early, middle and late warm water of 30min before the meal clothes send.Two groups of drug treatments are 60 days.
3. clinical development standard
With reference to curative effect determinate standard in " guideline of clinical investigations of new Chinese medicine treatment diabetes (diabetes) " that Ministry of Public Health is formulated.
4. therapeutic outcome:
Therapeutic effect the results are shown in following table 2.
Table 2 traditional Chinese medicine composition for treating effect
Group |
Total number of cases |
Effective |
Effectively |
Invalid |
Total effective rate |
Treatment group |
120 |
40 |
60 |
20 |
83.3% |
Matched group |
120 |
44 |
61 |
15 |
87.5% |
The effect of visible Chinese medicine composition of the present invention is close to the curative effect of existing Remedies for diabetes.To improvement thirsty polydipsia, rapid digestion of food and polyorexia, polyuria, fatigue and weakness, spontaneous sweating, dysphoria with feverish sensation in the chest palms and soles, turbid urine, the total effective rate that constipation etc. are clinical, treatment group is better than matched group, and the curative effect disclosing the capsule of described Chinese medicine composition is better than matched group.
The foregoing is only preferred embodiment of the present invention, not in order to limit the present invention, within the spirit and principles in the present invention all, any amendment done, equivalent replacement, improvement etc., all should be included within protection scope of the present invention.