CN101698053A - Traditional Chinese medicine composite for treating diabetes and preparation method thereof - Google Patents
Traditional Chinese medicine composite for treating diabetes and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composite for treating diabetes and a preparation method thereof. The effective components contained in the traditional Chinese medicine composite are selected from rehmannia root, white mulberry root-bark, coptis root, ophiopogon root, mulberry leaf, radix puerariae, kadsura longepedunculata, radix salviae miltiorrhizae, rhizoma alismatis, astragalus root or herba epimedii. The traditional Chinese medicine composite has the functions of nourishing yin, reducing fever, supplementing qi and promoting blood circulation, is used for the adjuvant treatment of diabetes with the symptoms of extreme heat due to the deficiency of yin and blood stasis, can improve the symptoms of thirst, polydipsia, polyphagy, diuresis, marasmus, testiness, limb numbness and the like, especially has a good effect for the diabetes with the symptoms of the extreme heat due to the deficiency of yin and the blood stasis and has no obvious side effect.
Description
Technical field
The present invention relates to field of medicaments, is a kind of Chinese medicine composition for the treatment of diabetes and preparation method thereof specifically.
Background technology
Diabetes are a kind of commonly encountered diseases, frequently-occurring disease, and sickness rate is very high in the general population, and extension and rejuvenation trend are arranged at present, and the mankind are endangered seriously, cause great body and mind infringement to the patient.Therefore, actively develop the research of diabetes, become key subjects.The medicine of treatment diabetes is a lot, and Western medicine mainly contains insulin, is used for symptomatic treatment, but expense is higher, and the patient has dependency after using; Herbal species is a lot, but most therapeutic effect is not good.
Summary of the invention
Purpose of the present invention just provides a kind of Chinese medicine composition for the treatment of diabetes.
Another object of the present invention just provides the preparation method of this Chinese medicine composition.
In order to realize the object of the invention, the invention provides a kind of Chinese medicine composition for the treatment of diabetes, form by effective ingredient and pharmaceutically acceptable carrier, described effective ingredient is made by weight by following bulk drugs: Radix Rehmanniae 12-18, Cortex Mori 8-12, Rhizoma Coptidis 25-35, Radix Ophiopogonis 8-12, Folium Mori 8-12, Radix Puerariae 12-18, Fructus Schisandrae Sphenantherae 8-12, Radix Salviae Miltiorrhizae 12-18, Rhizoma Alismatis 25-35, Radix Astragali 12-18, Herba Epimedii 8-12.
Preferably make by weight: Radix Rehmanniae 15, Cortex Mori 10, Rhizoma Coptidis 30, Radix Ophiopogonis 10, Folium Mori 10, Radix Puerariae 15, Fructus Schisandrae Sphenantherae 10, Radix Salviae Miltiorrhizae 15, Rhizoma Alismatis 30, the Radix Astragali 15, Herba Epimedii 10 by following bulk drugs.
The invention provides the preparation method of the Chinese medicine composition of treatment diabetes, comprise lower alcohol reflux, extract,, obtain the ethanol extract of above-mentioned raw materials above-mentioned raw materials medicinal 65%～95%.
The invention provides the preparation method of the Chinese medicine composition of treatment diabetes, comprise, filter, obtain the water extract of above-mentioned raw materials medicine above-mentioned raw materials medicine decocting together.Be preferably crude drug is cut into coarse grain, add 8～12 times of water gagings, 60～100 ℃ of heating, stirred 1～2 hour, and filtered, behind the filtrate high speed centrifugation, the polysulfonamides membrane filtration, filtrate is evaporated to the clear paste of relative density about 0.8～1.5 (60 ℃) under the condition of 60～110 ℃ of temperature, vacuum 0.08～0.09MPa, add right amount of auxiliary materials, 75～100 ℃ of dry materials temperature, atomizing pressure 0.06～0.09MPa, spraying frequency speed 30～40kg/h, spray drying, promptly.
Pharmaceutical composition of the present invention can with receivable carrier pharmaceutically, for example: filler such as starch, microcrystalline Cellulose etc.; Binding agent such as vitamin derivative, starch etc.; Disintegrating agent such as sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose etc. are taken by the mode of oral administrations such as tablet, capsule, granule, oral liquid or pill.The mode of taking is every day 4 times, and every day, dosage was equivalent to the total crude drug 20g of drug regimen.
Chinese medicine composition nourishing YIN and clearing away heat of the present invention, benefiting QI for activating blood circulation is used for the hold concurrently auxiliary treatment of Blood stasis diabetes of intense heat due to deficiency of YIN, can improve thirsty, admire more, symptoms such as polyphagia, polyuria, the irritability of becoming thin, numb limbs and tense tendons, especially effective to the intense heat due to deficiency of YIN Blood stasis diabetes of holding concurrently, non-evident effect.
The specific embodiment
Following examples are used to illustrate the present invention, but are not used for limiting the scope of the invention.
The preparation of embodiment 1 granule of the present invention
Get Radix Rehmanniae 260g, Cortex Mori 260g, Rhizoma Coptidis 50g, Radix Ophiopogonis 150g, Folium Mori 150g, Radix Puerariae 150g, Fructus Schisandrae Sphenantherae 150g, Radix Salviae Miltiorrhizae 240g, Rhizoma Alismatis 150g, Radix Astragali 240g, Herba Epimedii 200g is cut into coarse grain, add 10 times of amounts of water, 90 ℃ of heating are constantly stirred and were extracted 2 hours, and coarse filtration is separated medicinal residues, the medicinal liquid high speed centrifugation, filtering with microporous membrane, filtrate decompression dope are adjuvant to the clear paste of relative density about 1.20 (60 ℃) with starch and dextrin, weight ratio by clear paste and adjuvant is 2: 1, through the boiling type fluid bed, once finish spray drying, make 1000g promptly.
The preparation of embodiment 2 capsules of the present invention
Get Radix Rehmanniae 400g, Cortex Mori 170g, Rhizoma Coptidis 50g, Radix Ophiopogonis 140g, Folium Mori 140g, Radix Puerariae 140g, Fructus Schisandrae Sphenantherae 140g, Radix Salviae Miltiorrhizae 240g, Rhizoma Alismatis 140g, Radix Astragali 240g, Herba Epimedii 200g, be cut into coarse grain and add 8 times of amounts of water, 80 ℃ of heating are constantly stirred and were extracted 2 hours, coarse filtration is separated medicinal residues, medicinal liquid high speed centrifugation, filtering with microporous membrane, the filtrate decompression dope is once finished spray drying to the clear paste of relative density about 1.05 (60 ℃), and is promptly encapsulated.
The preparation of embodiment 3 tablets of the present invention
Get Radix Rehmanniae 210g, Cortex Mori 160g, Rhizoma Coptidis 50g, Radix Ophiopogonis 140g, Folium Mori 140g, Radix Puerariae 140g, Fructus Schisandrae Sphenantherae 140g, Radix Salviae Miltiorrhizae 240g, Rhizoma Alismatis 140g, Radix Astragali 240g, Herba Epimedii 400g, be cut into coarse grain and add 12 times of amounts of water, 60 ℃ of heating are constantly stirred and were extracted 2 hours, coarse filtration is separated medicinal residues, medicinal liquid high speed centrifugation, filtering with microporous membrane, the filtrate decompression dope is once finished spray drying to the clear paste of relative density about 1.30 (60 ℃), and tabletting promptly.
The preparation of embodiment 4 oral liquids of the present invention:
Get Radix Rehmanniae 210g, Cortex Mori 200g, Rhizoma Coptidis 50g, Radix Ophiopogonis 140g, Folium Mori 140g, Radix Puerariae 140g, Fructus Schisandrae Sphenantherae 140g, Radix Salviae Miltiorrhizae 240g, Rhizoma Alismatis 140g, Radix Astragali 400g, Herba Epimedii 200g, be cut into coarse grain, add 9 times of amounts of water, 70 ℃ of heating, constantly stir and extracted 2 hours, coarse filtration is separated medicinal residues, and filtrate decompression is concentrated into 2000ml, the medicinal liquid high speed centrifugation, filtering with microporous membrane, embedding, sterilization are promptly.
The preparation of embodiment 5 watered pills of the present invention
Get Radix Rehmanniae 210g, Cortex Mori 170g, Rhizoma Coptidis 240g, Radix Ophiopogonis 140g, Folium Mori 140g, Radix Puerariae 140g, Fructus Schisandrae Sphenantherae 140g, Radix Salviae Miltiorrhizae 240g, Rhizoma Alismatis 140g, Radix Astragali 240g, Herba Epimedii 200g is ground into fine powder, adds 11 times of amounts of water, 95 ℃ of heating are constantly stirred and were extracted 2 hours, and coarse filtration is separated medicinal residues, the medicinal liquid high speed centrifugation, filtering with microporous membrane, filtrate decompression is concentrated in right amount.With fried liquid flooding ball, drying, promptly.
The preparation of embodiment 6 drop pill of the present invention
Get Radix Rehmanniae 210g, Cortex Mori 160g, Rhizoma Coptidis 50g, Radix Ophiopogonis 340g, Folium Mori 140g, Radix Puerariae 140g, Fructus Schisandrae Sphenantherae 140g, Radix Salviae Miltiorrhizae 240g, Rhizoma Alismatis 140g, Radix Astragali 240g, Herba Epimedii 200g is cut into coarse grain, adds 10 times of amounts of water, 90 ℃ of heating are constantly stirred and were extracted 2 hours, and coarse filtration is separated medicinal residues, the medicinal liquid high speed centrifugation, filtering with microporous membrane, it is 1.40 (60 ℃) clear paste that filtrate decompression is concentrated into relative density.To put in the aluminum pot with the polyethylene glycol 6000 of clear paste equivalent, be heated to 90-100 ℃, and treat to add after whole fusions above-mentioned clear paste and stir with oil bath, airtight and insulation splashes in 10-15 ℃ the liquid Paraffin at 80-90 ℃, and the drop pill of molding is inhaled the liquid Paraffin that goes to the surface, drying, promptly.
Embodiment 7 the present invention's soluble starches are that adjuvant prepares granule
Get Radix Rehmanniae 210g, Cortex Mori 160g, Rhizoma Coptidis 50g, Radix Ophiopogonis 140g, Folium Mori 340g, Radix Puerariae 140g, Fructus Schisandrae Sphenantherae 140g, Radix Salviae Miltiorrhizae 240g, Rhizoma Alismatis 140g, Radix Astragali 240g, Herba Epimedii 200g is cut into coarse grain, adds 10 times of amounts of water, 95 ℃ of heating are constantly stirred and were extracted 2 hours, and coarse filtration is separated medicinal residues, the medicinal liquid high speed centrifugation, filtering with microporous membrane, it is 1.20 (60 ℃) clear paste that filtrate decompression is concentrated into relative density.With the soluble starch is adjuvant, is 2: 1 by the ratio of clear paste and adjuvant, through the boiling type fluid bed, once finishes spray drying, makes 1000g, promptly.
Embodiment 8: the preparation of granule of the present invention
Get Radix Rehmanniae 210g, Cortex Mori 160g, Rhizoma Coptidis 50g, Radix Ophiopogonis 140g, Folium Mori 140g, Radix Puerariae 340g, Fructus Schisandrae Sphenantherae 140g, Radix Salviae Miltiorrhizae 240g, Rhizoma Alismatis 140g, Radix Astragali 240g, Herba Epimedii 200g, be cut into coarse grain, by " percolation under fluid extract item of Chinese pharmacopoeia version in 2005 is made solvent with 70% ethanol, flood and carry out percolation after 24 hours, recovered alcohol, being condensed into relative density is 1.20 (60 ℃) clear paste, is adjuvant with the dextrin, through the boiling type fluid bed, once finish spray drying, make 1000g, promptly.
The preparation of embodiment 9 capsules of the present invention
Get Radix Rehmanniae 210g, Cortex Mori 160g, Rhizoma Coptidis 50g, Radix Ophiopogonis 140g, Folium Mori 140g, Radix Puerariae 140g, Fructus Schisandrae Sphenantherae 340g, Radix Salviae Miltiorrhizae 240g, Rhizoma Alismatis 140g, Radix Astragali 240g, Herba Epimedii 200g, be cut into coarse grain and add 8 times of amounts of water, 80 ℃ of heating are constantly stirred and were extracted 2 hours, coarse filtration is separated medicinal residues, medicinal liquid high speed centrifugation, filtering with microporous membrane, the filtrate decompression dope is once finished spray drying to the clear paste of relative density about 1.05 (60 ℃), and is promptly encapsulated.
The preparation of embodiment 10 tablets of the present invention
Get Radix Rehmanniae 210g, Cortex Mori 160g, Rhizoma Coptidis 50g, Radix Ophiopogonis 140g, Folium Mori 140g, Radix Puerariae 140g, Fructus Schisandrae Sphenantherae 140g, Radix Salviae Miltiorrhizae 240g, Rhizoma Alismatis 340g, Radix Astragali 240g, Herba Epimedii 200g, be cut into coarse grain and add 12 times of amounts of water, 60 ℃ of heating are constantly stirred and were extracted 2 hours, coarse filtration is separated medicinal residues, medicinal liquid high speed centrifugation, filtering with microporous membrane, the filtrate decompression dope is once finished spray drying to the clear paste of relative density about 1.30 (60 ℃), and tabletting promptly.
The preparation of embodiment 11 granules of the present invention
Get Radix Rehmanniae 210g, Cortex Mori 360g, Rhizoma Coptidis 50g, Radix Ophiopogonis 140g, Folium Mori 140g, Radix Puerariae 140g, Fructus Schisandrae Sphenantherae 140g, Radix Salviae Miltiorrhizae 240g, Rhizoma Alismatis 140g, Radix Astragali 240g, Herba Epimedii 200g is cut into coarse grain, add 10 times of amounts of water, 90 ℃ of heating are constantly stirred and were extracted 2 hours, and coarse filtration is separated medicinal residues, the medicinal liquid high speed centrifugation, filtering with microporous membrane, filtrate decompression dope are adjuvant to the clear paste of relative density about 1.20 (60 ℃) with starch and dextrin, weight ratio by clear paste and adjuvant is 2: 1, through the boiling type fluid bed, once finish spray drying, make 1000g promptly.
Experimental example 1: the effect of investigating Chinese medicine composition of the present invention by clinical trial
1. Therapeutic Method
1.1 curative effect judging standard: work out referring to new Chinese medicine treatment diabetes clinical research guideline.
(1), produce effects: treatment back symptom disappears substantially, 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 symptom is obviously improved, 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 descend more than 10% before the treatment.
(3) invalid: treatment back symptom does not have obvious improvement, and blood glucose, glucose in urine descend and do not reach above-mentioned standard.
1.2 patient's situation
101 examples, the intense heat due to deficiency of YIN Blood stasis diabetics of holding concurrently proves and sees thirsty polydipsia 97 examples, polyorexia 92 examples, polyuria 91 examples, 80 examples of becoming thin, irritated irritability 38 examples, numb limbs and tense tendons 70 examples, vexed 99 examples that To Be Protected from Heat, vexed in the heart pain 78 examples, unusual 100 examples of picture of the tongue, abnormal pulse condition 100 examples.
1.3 therapeutic scheme: oral granule 1 bag of the present invention, four times a day, be three months the course of treatment, fill in the observation table weekly once after the treatment beginning, evaluation is imitated in the establishment of diagnosis and treatment, at least make the above academic title of the observation table person of filling in tool resident jointly by an attending doctor and a resident.
Treatment group: embodiment 1 described Chinese medicine composition.
The oral diabetes pill of matched group 1 patient, every day 2 times, each ball is available from a pharmaceutcal corporation, Ltd in the wide medicine group.
The oral JIANGTANGSHU JIAONANG of matched group 2 patients, every day 3 times, each 5, available from Jilin Huinan Tiantai Pharmaceutical Co., Ltd..
2. therapeutic outcome
2.1 treatment group and matched group 1, matched group 2 total effectses see Table 1.
Table 1 treatment group and matched group 1,2 total effectses
2.2 clinical indices curative effect
The main clinical indices of diabetes is that blood glucose and twenty-four-hour urine sugar are quantitative.The clinical indices curative effect relatively sees Table 2 before and after the treatment of treatment group and matched group 1 case blood glucose, urine sugar value.(X±SD)
Table 2 treatment group and matched group 2 clinical indices curative effects are relatively
*P＜0.05
**P＜0.01
Treatment group and matched group 1 case fasting glucose, blood glucose, twenty-four-hour urine sugar quantitatively self were relatively learned by statistics and are handled respectively before and after the treatment in 2 hours after the meal, P＜0.01, difference has utmost point significance, illustrates that treatment group and matched group 1 all have better therapeutic effect.
Before and after treatment group and matched group 1 fasting glucose difference relatively, u=2.26, P＜0.05, difference has significance, before and after the 2 hours after the meal blood glucose diversity ratio, t '=4.03, t '＞t ' 0.05, P＜0.05, difference has significance; Twenty-four-hour urine sugar quantitatively front and back difference compares, t=3.51, and P＜0.001, difference has utmost point significance.Illustrate that treatment group effect is better than matched group 1.
2.7 untoward reaction
Treatment has all been carried out liver function, renal function, three big conventional sense before and after organizing 101 routine patient treatments.Liver, kidney merit mile abnormality before the four routine patient treatments, wherein an example treatment back recovers normal, and its excess-three example is improved not obvious, but does not also increase the weight of.Other 97 routine patients do not find obvious adverse reaction, no obvious toxic-side effects.
Conclusion:
1, Chinese medicine composition of the present invention not only the drug effect effect be better than JIANGTANGSHU JIAONANG, also be better than the drug effect effect of diabetes pill.
2, diabetes close with the blood stasis relation still.The deficiency of YIN is scorching, and the bright liquid consumption in Tianjin causes the moon and thanks to can not carry the blood operation, and the stasis of blood resistance of blood behavior is the main cause that forms blood stasis, and its many complication is as the thoracic obstruction, numb limbs and tense tendons etc., how by due to the blood stasis.With the passing of time diabetes delay, intenseness of heat consumption gas, deficiency of YIN affecting YANG, the time of visible impairment of both QI and YIN or deficiency in both YIN and YANG.Also have from the beginning of promptly hold concurrently deficiency of vital energy person or yang deficiency person, it is discouraged relevant mostly to be innate deficiency of YANG in the body.And that the deficiency of vital energy can not promote blood is capable, and the yang deficiency cold coagulation can not warm blood vessels, can cause blood stasis again.
Claims (5)
1. a Chinese medicine composition for the treatment of diabetes is characterized in that, is made up of effective ingredient and pharmaceutically acceptable carrier, described effective ingredient is made by weight by following bulk drugs: Radix Rehmanniae 12-18, Cortex Mori 8-12, Rhizoma Coptidis 25-35, Radix Ophiopogonis 8-12, Folium Mori 8-12, Radix Puerariae 12-18, Fructus Schisandrae Sphenantherae 8-12, Radix Salviae Miltiorrhizae 12-18, Rhizoma Alismatis 25-35, Radix Astragali 12-18, Herba Epimedii 8-12.
2. treat the Chinese medicine composition of diabetes according to claim 1, it is characterized in that, described effective ingredient is made by weight by following bulk drugs: Radix Rehmanniae 15, Cortex Mori 10, Rhizoma Coptidis 30, Radix Ophiopogonis 10, Folium Mori 10, Radix Puerariae 15, Fructus Schisandrae Sphenantherae 10, Radix Salviae Miltiorrhizae 15, Rhizoma Alismatis 30, the Radix Astragali 15, Herba Epimedii 10.
3. treat the Chinese medicine composition of diabetes as claimed in claim 1 or 2, it is characterized in that, described Chinese medicine composition is made tablet, capsule, granule, oral liquid or pill.
As claim 1～3 arbitrary as described in the preparation method of Chinese medicine composition of treatment diabetes, it is characterized in that lower alcohol reflux, extract, with above-mentioned raw materials medicinal 65～95%, obtain the ethanol extract of above-mentioned raw materials.
As claim 1～3 arbitrary as described in the preparation method of Chinese medicine composition of treatment diabetes, it is characterized in that may further comprise the steps: crude drug is cut into coarse grain, add 8～12 times of water gagings, 60～100 ℃ of heating, stirred 1～2 hour, filter, behind the filtrate high speed centrifugation, the polysulfonamides membrane filtration, filtrate is 60～110 ℃ of temperature, be evaporated to the clear paste of relative density about 0.8～1.5 (60 ℃) under the condition of vacuum 0.08～0.09MPa, add right amount of auxiliary materials, 75～100 ℃ of dry materials temperature, atomizing pressure 0.06～0.09MPa, spraying frequency speed 30～40kg/h, spray drying.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102271698A (en) * | 2009-05-25 | 2011-12-07 | 成都中汇制药有限公司 | Pharmaceutical composition and use for preparing medicament thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102271698A (en) * | 2009-05-25 | 2011-12-07 | 成都中汇制药有限公司 | Pharmaceutical composition and use for preparing medicament thereof |
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Application publication date: 20100428 |