CN101199603B - Chinese medicine agent for treating diabetes - Google Patents
Chinese medicine agent for treating diabetes Download PDFInfo
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- CN101199603B CN101199603B CN2007101956690A CN200710195669A CN101199603B CN 101199603 B CN101199603 B CN 101199603B CN 2007101956690 A CN2007101956690 A CN 2007101956690A CN 200710195669 A CN200710195669 A CN 200710195669A CN 101199603 B CN101199603 B CN 101199603B
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Abstract
The invention discloses a Chinese drugs preparation for reducing blood sugar, which made by following crude drugs by weight: 0.9-3 parts of Astragalus root, 0.9-3 parts of codonopsis pilosula, 0.9-2.2 parts of radices puerarire, 0.7-6 parts of burdock root, 1.5-6 parts of dayflower, 0.9-1.5 parts of Armstrong and 0.15-0.9 parts of liquorice. The invention is summarized by doctor Wu huizhi based on a plurality of years of researches according to the experiences of national medical science and combining with the modern medical technique, and plays a role in invigorating spleen to replenish Qi, strengthening spleen and to benefit lung, dissipating wind and clearing heat, detumescence by detoxification and wasting thirst and reducing blood sugar. The invention is the pure Chinese drugs preparation, and has advantages of simple making technique, broad material source, low cost and good effect, and the curative effect of the invention is proven by clinical verification by a plurality of patients, so the invention can obviously release various complicating diseases of diabetes, and has short period of treatment without recrudesce. The invention is suitable for volume production and comprehensive clinic applications.
Description
Technical field
The present invention relates to a kind of hypoglycemic Chinese medicine preparation, particularly relate to the pharmaceutical preparation of making, belong to the field of Chinese medicines with Chinese medicines such as the Radix Astragali, Radix Codonopsis, Radix Puerariae, Radix Arctii, Herba Commelinae, Herba Polygoni Avicularis, Radix Glycyrrhizaes.
Background technology
Diabetes are because insulin lacks and insulin resistant in various degree relatively or definitely, cause the syndrome of carbohydrate, fat and protein metabolism disorder.Its biochemical character is to continue hyperglycemia.Be cardinal symptom with " three-many-one-little " (polydipsia, polyphagia, polyuria, become thin) clinically.
Diabetes are called diabetes in the traditional Chinese medical science, its main pathogenesis is that the deficiency of YIN is scorching, and are this with the deficiency of YIN, scorchingly are mark; Scorching very then cloudy more void and gas also consumes, cloudy more void is then scorching more very and be difficult activating QI, reciprocal causation, and it is scorching to cause the deficiency of YIN, deficiency of both QI and YIN.Pathological changes relates generally to internal organs such as lung, stomach (spleen), kidney.According to the principle of theory of Chinese medical science " deficiency syndrome should be treated by tonifying method ", " decrease then benefit ", " heat is then trembled with fear it ", " dry then moisten it ", thirty years of age clearing heat and moistening dryness, supplementing QI and nourishing YIN, the method for promoting the production of body fluid to quench thirst.Clearing heat and moistening dryness to be controlling its mark, and supplementing QI and nourishing YIN is with Zhi Qiben, and treating both the principal and secondary aspects of a disease makes scorching clearly, and gas is cloudy multiple, and body fluid is given birth to, and it is flat then to quench one's thirst.
Diabetes are a kind of commonly encountered diseases.According to international diabetes study institute (IDI) 2003 annual reports, the whole world has diabetes (after diagnosing) about 1.94 hundred million now, to break through 3.33 hundred million by 2025, the sickness rate of countries in the world diabetes is all rising, wherein 90% is type ii diabetes, the speed that developing country increases has surpassed developed country's (200% to 45%), 21 century diabetes will be popular in developing countries such as China, India.Ten thousand people's findings of the survey show that prevalence is 2.51% surplus 2004 19 provinces and cities 20 of China, and the impaired glucose tolerance prevalence is 3.2%, and estimating will increase with annual 1000000 quantity from now on.Diabetes have become the third-largest non-infective disease after cardiovascular and cerebrovascular disease and tumor, and its major complications has become that patient is disabled and the main cause of premature death.Diabetes have become the main health care issues of countries in the world.
Exist the medicine of a lot of treatment diabetes in the market, but Western medicine commonly used all has side effect in various degree, curative effect is not lasting, recurrence easily, and also most of Western medicine costs an arm and a leg; And the Chinese medicine of existing treatment diabetes is cured the symptoms, not the disease a bit, and some then is that uncertain therapeutic efficacy is cut.In a word, also there is not a kind of curative effect satisfactory at present, and the medicine of the treatment diabetes that have no side effect.
Summary of the invention
Therefore, still there is demand in people's medicine that curative effect is better treated diabetes.Up to now, also do not find the report of any relevant drug regimen of the present invention.The inventor is according to the invaluable experience of motherland's medical science, in conjunction with the new technique of modern medicine, and through research repeatedly, and the checking repeatedly by clinical trial, having found finally has the Chinese medicine preparation of better curative effect to treating diabetes, thereby has finished the present invention.
Purpose of the present invention just provides a kind of Chinese medicine composition of more effectively treating diabetes.
The present invention is made by following bulk drugs: Radix Astragali 0.9-3 part, Radix Codonopsis 0.9-3 part, Radix Puerariae 0.9-2.2 part, Radix Arctii 0.7-6 part, Herba Commelinae 1.5-6 part, Herba Polygoni Avicularis 0.9-1.5 part, Radix Glycyrrhizae 0.15-0.9 part.
Be preferably: 2 parts of the Radixs Astragali, 1 part of Radix Codonopsis, 2 parts of Radix Puerariaes, 1 part of Radix Arctii, 3 parts of Herba Commelinaes, 0.5 part of Herba Polygoni Avicularis, 0.5 part in Radix Glycyrrhizae.
The medicament selection Radix Astragali of the present invention, Radix Codonopsis, Radix Puerariae, Radix Arctii, Herba Commelinae, Herba Polygoni Avicularis, Radix Glycyrrhizae make up, make each efficacy of drugs produce synergism these drug regimens, strengthen invigorating the spleen and replenishing QI, the spleen invigorating lung benefiting, clearing away heat to dispel wind, removing toxic substances and promoting subsidence of swelling, the effectiveness of lowering blood sugar and preventing thirst, thus can effectively treat diabetes.
Radix Astragali slightly warm in nature, sweet in the mouth has the effect of invigorating QI to consolidate the body surface resistance, diuresis, expelling pus and toxin by strengthening QI, granulation promoting.Be used for that the deficiency of vital energy is weak, spontaneous perspiration, edema, uterine prolapse, chronic nephritis proteinuria, diabetes, open sore part disunion of a specified duration.Radix Codonopsis is flat, and sweet in the mouth is returned spleen, lung meridian.Invigorating the spleen and replenishing QI is arranged, the effect of spleen invigorating lung benefiting.Be used for deficiency of the spleen and lung, the cardiopalmus of breathing hard, deficiency of vital energy deficiency, fatigue and weakness, dyspnea with rapid breath, insufficiency of the spleen lack of appetite, the dyspnea due to deficiency cough, interior-heat is quenched one's thirst, and the edema of the face is clinical Qi-tonifying drug commonly used.Radix Astragali QI invigorating, can rise enriching spleen-QI, again can the lung benefiting consolidating superficial resistance.The Radix Codonopsis QI invigorating can only the spleen invigorating QI invigorating, the power of no consolidating superficial resistance, but Radix Codonopsis can also supplementing QI for promoting the production of body fluid, and the Radix Astragali does not then have the effect of promoting the production of body fluid.The double energy of Radix Astragali diuretic, Radix Codonopsis does not have the diuretic effect.The two share mutual enhancing drug effect.Radix Puerariae is flat, and the sweet in the mouth suffering is gone into spleen, stomach warp.The yang invigorating expelling pathogenic factors from muscles is arranged, rash antidiarrheal, relieving restlessness ends the using warming therapy effect.Be used for the treatment of typhoid fever, warm headache stiffness of the nape, dysphoria with smothery sensation is quenched one's thirst, and has loose bowels, and dysentery, skin eruption are not saturating, hypertension, angina pectoris, deafness.Radix Arctii bitter in the mouth, little sweet, cool in nature is returned lung, heart channel.Has clearing away heat to dispel wind, the effect of removing toxic substances and promoting subsidence of swelling; Cure mainly anemopyretic cold, headache, cough, pyretic toxicity swelling of the face, laryngopharynx swelling and pain, toothache swelling of the gum, rheumatic arthralgia, carbuncle furuncle poison, hemorrhoid proctoptosis.Herba Commelinae is cold in nature, sweet in the mouth, light.Heat-clearing and toxic substances removing is arranged, the effect of inducing diuresis to remove edema.Be used for anemopyretic cold, hyperpyrexia, laryngopharynx swelling and pain, edema oliguria, the puckery pain of pyretic stranguria, the swollen furuncle of pain.The Herba Polygoni Avicularis bitter in the mouth, cold nature is returned urinary bladder channel.Relieving stranguria by diuresis, killing parasites for relieving itching.Be used for the bladder pyretic stranguria, oliguria with reddish urine drenches the puckery pain of drop, skin eczema, pudendal pruritus leukorrhagia.Radix Glycyrrhizae property is flat, sweet in the mouth, GUIXIN, lung, spleen, stomach warp.But invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.Be used for weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, the anxious pain of extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
Prescription of the present invention is established according to Chinese medical theory and modern medical theory, modern pharmacological research proves in the prescription of the present invention, contain flavones ingredient calycosin (calycosin), 3-hydroxyl-9 in the Radix Astragali, 10-dimethoxy Lignum pterocarpi indici alkane, contain astragaloside I, V, III (astragaloside I, V, III), can reduce the fragility of blood vessel, the expansion coronary vasodilator be arranged, increase the effect of coronary flow, and have cough-relieving, eliminate the phlegm, relieving asthma, antimicrobial activity.Radix Codonopsis has the effect of two-ways regulation blood glucose.Contain puerarin in the Radix Puerariae, the effect of the tip of improvement circulation is arranged.The modern medicine handle can cause that atherosclerotic factor calls metabolism syndrome, and metabolism syndrome is the important step that diabetes produce complication, and puerarin energy microcirculation improvement is so also have the effect that improves diabetic complication.Arrange in pairs or groups from medicine, Radix Puerariae can be offset the hot of Radix Codonopsis, and the side's of making medicine is more gentle.Contain inulin in the Fructus Arctii, function of polysaccharide is arranged.Contain a large amount of high fibers in the Radix Arctii, the absorption and the intake of the generation of diabetes and development and dietary fiber are closely related, so Radix Arctii helps the glycemic control of diabetics, can obviously improve the fluctuation situation of blood glucose, blood sugar lowering.Radix Arctii can blood circulation promoting, detoxicating intestine, moist skin, cholesterol reducing and blood glucose, prevent hypertension and apoplexy.Herba Commelinae has the effect of heat-clearing and toxic substances removing, also can diuresis.Herba Polygoni Avicularis zoopery proof has diuresis, and the output of urine amount, potassium, sodium is increased.The enoxolone that contains in the Radix Glycyrrhizae has the effect of significant reduction serum cholesterol, beta lipoprotein and triglyceride to rabbit or rat experiment Atherosclerosis Model.
Prescription of the present invention is scientific and reasonable, compatibility is precise and appropriate comprehensively.Find in the modern medicine study that these Chinese medicines are used, can remove sugared toxin, fundamentally solved the problem that causes diabetes, block the generation of each organ complication.Through clinical verification, to blood sugar lowering, to remove the glucose in urine effect obvious, the generation of diabetic complication capable of blocking, and have no side effect.
Preparation method of the present invention is implemented according to following steps:
1. select: select 7 kinds of Chinese crude drugs of the present invention according to weight proportion.
2. clean: 7 kinds of medical materials are poured in the container washed 4～6 times
3. oven dry: the medical material of cleaning is directly put into dehydrator, and oven dry is 30 minutes in 35 ℃ constant temperature.
4. sterilization: use ultraviolet radiation 30 minutes.
5. 7 flavor medical materials are crushed to 100 mesh sieve fine powders jointly, can obtain the powder medicine of hypoglycemic drug.
6. the powder medicine is made capsule preparations according to existing known method.
The powder medicine of medicine of the present invention can add various conventional adjuvant required when preparing different dosage form, be prepared into a kind of peroral dosage form commonly used as disintegrating agent, lubricant, binding agent etc. with the method for Chinese medicinal of routine, as pill, powder, tablet, capsule, oral liquid etc.
The specific embodiment
Describe by the following examples, but not as limitation of the present invention.
Embodiment one
Weigh each raw material according to following weight parts:
2 parts of the Radixs Astragali, 1 part of Radix Codonopsis, 2 parts of Radix Puerariaes, 1 part of Radix Arctii, 3 parts of Herba Commelinaes, 0.5 part of Herba Polygoni Avicularis, 0.5 part in Radix Glycyrrhizae.
Embodiment two
Weigh each raw material according to following weight parts:
0.9 part of the Radix Astragali, 0.9 part of Radix Codonopsis, 0.9 part of Radix Puerariae, 0.7 part of Radix Arctii, 1.5 parts of Herba Commelinaes, 0.9 part of Herba Polygoni Avicularis, 0.15 part in Radix Glycyrrhizae.
Embodiment three
Weigh each raw material according to following weight parts:
3 parts of the Radixs Astragali, 3 parts of Radix Codonopsis, 2.2 parts of Radix Puerariaes, 6 parts of Radix Arctiis, 6 parts of Herba Commelinaes, 1.5 parts of Herba Polygoni Avicularis, 0.9 part in Radix Glycyrrhizae.
Clinical trial
In order to verify beneficial effect of the present invention, the inventor has carried out the pharmacodynamics test and the clinical observation on the therapeutic effect test of medicine.Drug nomenclature of the present invention is " duck sole of the foot blood sugar lowering is flat ", and below the flat capsule preparations of duck sole of the foot blood sugar lowering is all adopted in test.
Physical data
This test is gathered out-patient's 68 examples altogether in three cooperation hospitals, and wherein male's 35 examples account for 51.5%, women's 33 examples, account for 48.5%, men and women's ratio is 1: 0.94, maximum 72 years old age, minimal ages 26 years old, age cohorts was the highest 23 examples with 41～50 years old, accounted for 33.8%, 41～60 years old 38 example, account for 55.9%, each age group formation sees Table 1.
Table 1 age group constitutes
Study subject is selected
One, diagnostic criteria
The standard that adopts WHO in 1999 to formulate allly meets that one of following condition person is diagnosable to be diabetes.
1, diabetic symptom is arranged, blood glucose 〉=11.1mmol/L (200mg/dl), or fasting glucose 〉=7.8mmol/L any time.
2, diabetic symptom is arranged and blood glucose does not reach above-mentioned standard, carry out 75g oral glucose tolerance test (OGTT), 2 hours blood glucose 〉=11.1mmol/L.
3,, remove above-mentioned standard exterior palpi and add a standard in addition, promptly OGTT1 hour blood glucose 〉=11.1mmol/L, another time OGTT2 hour blood glucose 〉=11.1mmol/L, or another time fasting glucose 〉=7.8mmol/L as the non-diabetic symptom.
Two, case is included standard in
Meet above-mentioned diagnostic criteria person, and two groups age, 2h blood glucose and 24h glucose in urine there are no significant difference on an empty stomach and after the meal, routine urinalysis, serum paddy ammonia-acetone acid transaminase are through check there are no significant difference, and data has comparability.
Three, case exclusion standard
Though 1, patient's blood glucose before flat with duck sole of the foot blood sugar lowering is higher than normally, by diet control, increases fasting glucose＜7.8mmol/L such as activity, or 2 hours after the meal blood glucose＜11.1mmol/L.
2, gestation or women breast-feeding their children are to this medicine allergy sufferers the under-18s patient age.
3, noncooperationist's (can not 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, psychotic.
5, insulin-dependent patient, or diabetes ketosis in nearly month, ketoacidosis and the infected.
6, the therapy discontinued person less than the regulation observation period can't judge the infull person of curative effect or data.
Test method
One, case group technology
Take the randomized control study method, when qualified case entered test, employing secondary random number method was divided into the treatment group with case and matched group is treated.Wherein, 45 examples are organized in treatment, matched group 23 examples.
Two, Therapeutic Method
1, treatment group: take the flat capsule preparations of duck sole of the foot blood sugar lowering, every day 3 times, each 2.
2, matched group: take diabetes pill, every day 3 times, each 5.
3, the course of treatment: equal 4 weeks of treatment group and matched group are a course of treatment.
4, observe certainly from this very day, require patient's other all hypoglycemic medicines of stopping using.
Three, observed content
1, safety is observed
(1) pulse, breathing, blood pressure, body weight;
(2) blood, urine, stool routine examination chemical examination;
(3) blood fat, liver, kidney function test.
2, health giving quality is observed
On an empty stomach and 2 hours after the meal blood glucose, twenty-four-hour urine sugar detection by quantitative, weekly after the medication.
All observation index are noted the observation and the record of untoward reaction all with charting.
Four, statistical procedures method
Ranked data are analyzed with Ridit, and group data relatively with the X2 check, check with t by measurement data.
Result of the test
One, criterion of therapeutical effect
1, produce effects: treatment back fasting glucose＜7.2mmol/L, 2 hours after the meal blood glucose＜8.3mmol/L, 24 hours blood glucose quantitatively＜10.0g; Or blood glucose, twenty-four-hour urine sugar quantitatively descends more than 30% before the treatment.
2, effective: treatment back fasting glucose＜8.3mmol/L, 2 hours after the meal blood glucose＜10.0mmol/L, 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: after treating for 4 weeks, blood glucose, glucose in urine descend and do not reach above-mentioned standard.
Two, efficacy analysis
1, total effects compares between two groups: see Table 2
Table 2 liang group total effects relatively
Through check X2=0.032, P＜0.05
Treatment group total effective rate (comprising produce effects and effective) is 80.0% (36/45), and matched group is 65.2% (15/23), and the difference of two groups of curative effects has significance meaning (P＜0.05), and the flat clinical efficacy of duck sole of the foot blood sugar lowering is better than diabetes pill.
2, the comparison of blood (urine) sugar value situation of change before and after the treatment between two groups: see Table 3
Blood (urine) sugar value situation of change compares (X ± S) before and after table 3 treatment
Annotate: compare before and after the group internal therapy: P＜0.01; Compare between group: P
1＜0.05
Table 3 data shows, the fasting glucose of treatment group, 2 hours after the meal blood glucose and twenty-four-hour urine sugar quantitatively treatment back descend obviously, in the group before and after self relatively, its difference all has highly significant meaning (P＜0.01); Comparison between treatment group and matched group, comparing difference has statistical significance (P between group
1＜0.05).
4, each hospital's matched group total effects relatively: see Table 4
Each hospital's matched group total effects of table 4 relatively
Learn check by statistics, X2=0.036, P＞0.05, each institute's matched group total effects compares there was no significant difference (P＞0.05).
Discuss
One, the randomized control study method is adopted in this test, and total qualified experimenter's 68 examples are divided into duck sole of the foot blood sugar lowering at random and bring treatment group 45 example and diabetes pill matched group 23 examples under control.The total effects analysis result, treatment group total effective rate is 80.0%, 65.2%, two group of comparing difference of matched group has statistical significance (P＜0.05).To fasting glucose, 2 hours after the meal blood glucose and the quantitative drop-out value of twenty-four-hour urine sugar relatively, two groups of differences also have statistical significance (P
1＜0.05).Diabetes pill is the patent medicine commonly used of treatment diabetes (diabetes), and the result of this test shows that the flat Comparison of therapeutic with diabetes pill of duck sole of the foot blood sugar lowering has statistical significance, and the curative effect of duck sole of the foot Jiangtangwan pill is better than diabetes pill.
Duck sole of the foot blood sugar lowering is brought the efficacy analysis result who treats non-insulin-dependent diabetes mellitus under control and is shown, treatment back patient's fasting glucose, 2 hours after the meal blood glucose and twenty-four-hour urine sugar is all obviously reductions before the treatment quantitatively, relatively, its difference has highly significant meaning (P＜0.01) before and after the treatment.The evident in efficacy of duck sole of the foot blood sugar lowering pancake blood glucose is described.
In addition, in process of the test, the inventor finds that duck sole of the foot blood sugar lowering is flat certain hypotensive effect, is more suitable for following the diabetic of hypertension symptom to use.
Two, in whole clinical trial process, two groups of patients all have no adverse reaction, and show that this medicine takes safety.
Three, this research is under " new Chinese medicine clinical trial guideline " instructs, take the randomized controlled trial method, clinical trial protocol design is rigorous, science, analysis of comparable through between group, every distributing equilibrium good comparability such as two groups of patients' sex, age, blood (urine) sugar value and the course of disease, thus the objectivity and the comparability of research conclusion guaranteed.
Conclusion
This result of the test shows that the effect of duck sole of the foot blood sugar lowering pancake blood glucose is definite, for non-insulin-dependent diabetes mellitus definite good curative effect is arranged, and in the process of the test, does not see that untoward reaction takes place.This test confirmation duck sole of the foot blood sugar lowering is brought prescription under control rationally, and treatment non-insulin-dependent diabetes mellitus determined curative effect, safe and reliable has no side effect, and is satisfactory for result.
Claims (2)
1. hypoglycemic medicine is characterized in that this medicine made by following bulk drugs: Radix Astragali 0.9-3 part, Radix Codonopsis 0.9-3 part, Radix Puerariae 0.9-2.2 part, Radix Arctii 0.7-6 part, Herba Commelinae 1.5-6 part, Herba Polygoni Avicularis 0.9-1.5 part, Radix Glycyrrhizae 0.15-0.9 part.
2. hypoglycemic medicine, wherein the consumption of each crude drug is: 2 parts of the Radixs Astragali, 1 part of Radix Codonopsis, 2 parts of Radix Puerariaes, 1 part of Radix Arctii, 3 parts of Herba Commelinaes, 0.5 part of Herba Polygoni Avicularis, 0.5 part in Radix Glycyrrhizae.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2007101956690A CN101199603B (en) | 2007-12-05 | 2007-12-05 | Chinese medicine agent for treating diabetes |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2007101956690A CN101199603B (en) | 2007-12-05 | 2007-12-05 | Chinese medicine agent for treating diabetes |
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| Publication Number | Publication Date |
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| CN101199603A CN101199603A (en) | 2008-06-18 |
| CN101199603B true CN101199603B (en) | 2011-07-20 |
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| CN2007101956690A Expired - Fee Related CN101199603B (en) | 2007-12-05 | 2007-12-05 | Chinese medicine agent for treating diabetes |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1462189A (en) * | 2001-05-03 | 2003-12-17 | 霍洛麦德药物有限公司 | Midicial herbal compound for prevention and treatment of diabetes |
| CN1686529A (en) * | 2005-05-20 | 2005-10-26 | 李素梅 | Ready prepared Chinese medicine for treating diabetes |
| CN1745835A (en) * | 2004-09-07 | 2006-03-15 | 朱智文 | Diabetes mellitus pill and prescription thereof |
-
2007
- 2007-12-05 CN CN2007101956690A patent/CN101199603B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1462189A (en) * | 2001-05-03 | 2003-12-17 | 霍洛麦德药物有限公司 | Midicial herbal compound for prevention and treatment of diabetes |
| CN1745835A (en) * | 2004-09-07 | 2006-03-15 | 朱智文 | Diabetes mellitus pill and prescription thereof |
| CN1686529A (en) * | 2005-05-20 | 2005-10-26 | 李素梅 | Ready prepared Chinese medicine for treating diabetes |
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| CN101199603A (en) | 2008-06-18 |
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