Diabetes are a kind of common endocrine-metabolic diseases.Its sickness rate has the trend that increases year by year, be listed in the third-largest disease after cardiovascular disease and tumor in developed country, deadly and the disability rate of diabetes and complication thereof has become world medicine man stubborn problem, annual countries in the world are expended huge fund this disease are studied, but produce little effect.At present the domestic and international chemical synthetic drug that adopts treats that to exist curative effect low, the defective that toxic and side effects is big, and for a long time with easily producing serious adverse reactions such as lactate acidemia, ketonemia, country such as U.S. has banned use of biguanides at present as: phenformin; Often curative effect is better in just with several weeks for sulfonylureas (tolbutamide, glyburide), and using after 6-12 month has patient 10-15% to lose curative effect suddenly, and reason is not bright, and the outstanding easily generation of old person serious ketoacidosis can take place and causes death.With producing antibody, biological activity reduces insulin for a long time, and dosage increases, and then causes regulatory mechanism compensation response-can cause hyperinsulinemia and blood glucose fluctuation.
The traditional Chinese medical herbal treatment diabetes have history remote, and the traditional Chinese medical science claims that diabetes are " diabetes ", and are divided into " on disappear ", " in disappear ", " diabetes due to kidney-deficiency " three types according to the primary and secondary difference of symptom performance.Based on polydipsia, polyuria, polyphagia take second place " on disappear "; Based on polyphagia, polydipsia, polyuria take second place " in disappear "; Based on polyuria, polydipsia, polyphagia take second place " diabetes due to kidney-deficiency ".Traditional treatment by Chinese herbs, the doctor needs according to different patients and dialectical evolution is very inconvenient, and patient is also very time-consuming bothersome when taking, and prescription drugs can not satisfy need of industrial production, so also be difficult to satisfy a large amount of patients' demand.At present domestic clinical also have adopt patent medicine to treat, but these Chinese patent medicines generally all are applicable to diabetes (diabetes) generally, so poor effect.As the Radix Ginseng metformin that uses clinically (include the Radix Astragali, Radix Ginseng, pollen, the Radix Rehmanniae, Radix Ophiopogonis, know not, Gypsum Fibrosum, Poria, Rhizoma Dioscoreae, Radix Glycyrrhizae, Cortex Lycii, Stigma Maydis), it generally is used for treating diabetes, its effective percentage only is 63.3%, (see the Kuang Anzong chief editor, Hunan science tech publishing house publishes " diabetes are in China " P279) and according to the tcm syndrome differentiation and typing treatment, curative effect is then also low.Clinical present employed diabetes pill (include Radix Astragali 5%, the Radix Rehmanniae 15%, pollen 24%, every ball and contain glyburide 0.25mg) is though curative effect is better, because it includes chemical synthetic drug, so still there is the inherent defective of chemical synthetic drug.
The objective of the invention is to execute the improvement opinion, provide a kind of and be adapted to " diabetes due to kidney-deficiency " diabetes mellitus type especially according to differential diagnosis in tcm, and curative effect height, pharmaceutical composition that toxic and side effects is little.
The object of the present invention is achieved like this, based on pathogenetic understanding and the Therapeutic Principle of motherland's medical science to diabetes, dialectical executing controlled, Therapeutic Principle to " diabetes due to kidney-deficiency " diabetes mellitus type adopts blood circulation promoting and blood stasis dispelling, training spleen reinforcing kidney filters out the Chinese herbal medicine with blood stasis dispelling enriching yin and nourishing kidney, and carries out reasonable compatibility in motherland's medical treasure-house, be prepared into glycolipid gram III number, make it in diabetes-alleviating polyuria symptom, glucose level control effectively, and delay, stop the generation of diabetic complication.
Medicine of the present invention (glycolipid gram III number) is made (consumption is a weight portion) by following raw material as active ingredient:
Cortex Lycii 10-20 part, Radix Ginseng 10-20 part, Radix Trichosanthis 10-20 part, Radix Rehmanniae 10-20 part, Herba Leonuri 5-10 part, Scolopendra 3-8 part, Fructus Lycii 5-10 part, Endothelium Corneum Gigeriae Galli 5-10 part, Radix Aucklandiae 3-8 part, Radix Salviae Miltiorrhizae 5-10 part, Carapax et Plastrum Testudinis 5-10 part, Radix Morindae Officinalis 5-10 part, Ootheca Mantidis 5-10 part, Fructus Corni 5-10 part.
The optimum weight proportioning of medicine of the present invention is:
Cortex Lycii 12-15 part, Radix Ginseng 12-15 part, Radix Trichosanthis 12-15 part, Radix Rehmanniae 12-15 part, Herba Leonuri 6-8 part, Scolopendra 3-5 part, Fructus Lycii 5-7 part, Endothelium Corneum Gigeriae Galli 5-7 part, Radix Aucklandiae 3-5 part, Radix Salviae Miltiorrhizae 5-7 part, Carapax et Plastrum Testudinis 5-7 part, Radix Morindae Officinalis 5-7 part, Ootheca Mantidis 5-7 part, Fructus Corni 5-7 part.
Radix Ginseng in the present invention's prescription can substitute with the Leptoradix Ginseng.
Medicine of the present invention can be prepared into various oral formulations such as tablet, capsule, oral liquid, electuary.
Medication preparation of the present invention becomes the method for electuary (being glycolipid gram III electuary) to be:
1, the Radix Ginseng with said ratio weight soaks decoction 1-2 hour separately, leaves and takes filtrate, and medicinal residues decoct with water 1 hour, continue to employ twice filtrate merging to be ginseng liquid, and medicinal residues oven dry, pulverizing, it is stand-by to cross 120 mesh sieves.
2, above-mentioned prescription (except that Radix Ginseng) is taken by weighing by proportioning weight, soaked 2 hours, decocted 1-2 hour, filter, leave and take filtrate, medicinal residues add water, decoct 1 hour, merge twice filtrate (for admixing medical solutions), and are stand-by, abandon medicinal residues.
3, Radix Ginseng medicinal liquid and admixing medical solutions are merged, be concentrated into thick paste after, add the Radix Ginseng powder, 120 mesh sieves are crossed in mixing, drying, pulverizing, sterilization, packing.
Medicine of the present invention is applicable to based on the polyuria symptom, have polyphagia, polydipsia concurrently, other symptom has that soreness of the waist and knees, fear of cold, tinnitus, deafness, binocular are dim-sighted, numb limbs and tense tendons or hemiplegia, purplish tongue or ecchymosis is arranged, stringy pulse or thin non-insulin-dependent diabetes mellitus.
The usage and dosage of medicine of the present invention is: each 5 grams, every day 4 times, half an hour ante cibum, clothes were last, had been taken at bed time.General logotype is after three months, look the state of an illness and the dose that cuts down according to the circumstance to maintenance dose (be every day 2-3 time).Still note diet, exercise and emotion during keeping treatment.
The important inventive point of medicine of the present invention is: the compatibility between the each component produces the effect of good blood circulation promoting and blood stasis dispelling, training spleen reinforcing kidney, the needs that adapted to " diabetes due to kidney-deficiency " diabetes mellitus type homeostasis, its " polyuria " symptom obviously alleviates, and blood glucose, blood fat also obviously reduce.
The therapeutic effect of medicine of the present invention has obtained checking by system's clinical experiment of 100 routine patients.
Its experimental technique is:
1, the type ii diabetes people (meeting the diagnostic criteria of WHO type ii diabetes) of subjects, selection prescription on individual diagnosis, patient is based on the polyuria symptom, have polyphagia, polydipsia concurrently, other symptom has that soreness of the waist and knees, fear of cold, tinnitus, deafness, binocular are dim-sighted, numb limbs and tense tendons or hemiplegia, purplish tongue or ecchymosis is arranged, stringy pulse or thin.
2, randomized controlled design: with " diabetes due to kidney-deficiency " the type diabetes patient of above-mentioned selection by sex, age, occupation, diabetic duration, diabetes family history, to have or not equilibriums such as concurrent hypertension or coronary heart disease, blood glucose, blood fat be two groups, be defined as test group (48 example) and matched group (52 example) with simple random sampling then, test group is taken each 5 grams of medicine of the present invention, four times a day, matched group is taken the Radix Ginseng metformin, each 5, every day 4 times, experimental result sees Table 1, table 2.
Table 1: blood glucose (mg/dl) situation of change in two groups of therapeutic processes
After treating February before the treatment
N x ± s n x ± s test group 48 208 ± 59 45 164 ± 42
*Matched group 52 190 ± 40 50 189 ± 45
* represents P<0.01
Table 2: the situation of change of triglyceride (mg/dl) in two groups of research process
After treating February before the treatment
N x ± s n x ± s test group 48 178 ± 82 45 163 ± 65
*Matched group 52 188 ± 158 50 186 ± 178
* represent P<0.05
Above experimental result shows, medicine of the present invention all is better than the Radix Ginseng metformin to blood sugar lowering, the lipid-lowering effect of " diabetes due to kidney-deficiency " diabetes mellitus type, embody medicine of the present invention and complied with and debate the Therapeutic Principle that disease executing controlled, produced the not available good efficacy of Chinese patent medicine of existing treatment diabetes.It is 86% that medicine of the present invention is used for the treatment of its effective percentage of " diabetes due to kidney-deficiency " diabetes mellitus type, (criterion of therapeutical effect is with reference to " clinical disease diagnosis is according to curing the improvement standard " of The General Logistics Department of PLA's revision in 1987), the effect of agents alleviate diabetics polyuria symptom of the present invention is significantly better than the remission effect of Radix Ginseng metformin.Medicine of the present invention is not found any toxic and side effects through clinic trial 2 years.So medicine of the present invention has the little new drug of definite curative effect toxic and side effects for the clinicist provides a kind of to " diabetes due to kidney-deficiency " the type patient in the diabetes, and has made things convenient for clinicist's medication.
Embodiment 1:
1, take by weighing Radix Ginseng 20 grams, soaked 1 hour, decocted 1.5 hours, leave and take filtrate, medicinal residues boiled 1 hour after adding water again, and twice filtrate merges (being ginseng liquid), and medicinal residues are dried, pulverize, crossed 120 mesh sieves (being the Radix Ginseng powder), and are stand-by.
2, get Cortex Lycii 20 grams, Radix Trichosanthis 20 grams, the Radix Rehmanniae 20 grams, Herba Leonuri 10 grams, Scolopendra 8 grams, Fructus Lycii 10 grams, Endothelium Corneum Gigeriae Galli 10 grams, the Radix Aucklandiae 8 grams, Radix Salviae Miltiorrhizae 10 grams, Carapax et Plastrum Testudinis 10 grams, Radix Morindae Officinalis 10 grams, Ootheca Mantidis 10 grams, Fructus Corni 10 grams, add water to submerge, steeped 2 hours, decocted 1.5 hours, filter, leave and take filtrate, medicinal residues add water, decoct 1 hour again, merge twice medicinal liquid (for admixing medical solutions), continue to employ, discard medicinal residues.
3, Radix Ginseng medicinal liquid and admixing medical solutions are merged, be concentrated into thick paste after, add Radix Ginseng powder, drying, pulverizing, cross 120 mesh sieves, sterilization, packing.
The preparation method of embodiment 2-5 is with embodiment 1, and just the weight proportion of prescription is different, and curative effect is suitable substantially, and is wherein remarkable with embodiment 3 curative effects.