CN102309575B - Application of medicinal composition in preparing medicament for treating diabetic complication - Google Patents
Application of medicinal composition in preparing medicament for treating diabetic complication Download PDFInfo
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Abstract
The invention relates to use of medicinal composition in preparing a medicine for treating diabetic complication. The prescription of the medicinal composition comprises 200 portions of hoantchy root, 100 portions of millettia reticulata, 25 portions of cassia twig, 25 portions of ligusticum wallichii, 50 portions of Chinese angelica, 75 portions of hirudo, 75 portions of lumbricus, 25 portions of bombyx batryticatus, 17 portions of scorpion, 25 portions of uncaria, 25 portions of safflower and 25 portions of achyranthes. The medicament forms of the medicinal composition include pills, granules, hard capsules, soft capsules, tablets, drop pills or oral liquid. The invention aims to provide novel therapeutic application of the medicinal composition to expand the clinical application range of the medicinal composition and avoid the waste of enormous medicament resources.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to the application of a kind of pharmaceutical composition in the diabetes complicated disease drug of preparation control.
Background technology
Diabetes are a kind of common chronic diseases.Along with the raising of people's living standard, the increase of aged tendency of population and fat incidence rate, the sickness rate of diabetes is year by year ascendant trend.Show according to the graduate report of Jia Chunbao diabetic foot: at present, the sickness rate of China's diabetes reaches 3% has a surplus, and the diabetics of having made a definite diagnosis reaches 4,500 ten thousand, and with about 1,500,000 speed increase in every year.People begin diabetes are all not too paid attention to, and then develop complications, and consequence is quite serious.Pedopathy, nephropathy, oculopathy, encephalopathy, heart disease, dermatosis, sexual dysfunction, oral disease etc. are the modal complication of diabetes, show if any report, the diabetic renal papillary necrosis incidence rate is approximately 37%, albuminuria 22.8%, coronary heart disease 25.4%, cerebral infarction 12.3%, hypertension 49.6%, foot gangrene 1%, neuropathy 46.5%.The chronic complicating diseases of diabetes, namely diabetic foot, oculopathy, heart disease, encephalopathy, nephropathy etc. have become the principal element that causes diabetics death, misery and cost maximum, and the control diabetic complication becomes core and the emphasis for the treatment of diabetes.But traditional treating diabetes is owing in the change that focuses on blood glucose, blood pressure for the treatment of, so diabetic complication is never effectively suppressed.Modern pharmacological research is found the pathologic basis of these complication of diabetes, and reality all is that the blood vessel scleratheroma pathological changes to corresponding organ causes, be kidney, eye, pedopathy be as main take tiny blood vessels; Brain, heart disease are take medium vessels as main, but its pathologic basis all is atherosclerosis.And cause arteriosclerotic immediate cause not lie in the height of blood glucose, and be what of blood fat, especially the situation of what and the OxLDL ELISA Ox-LDL of high density lipoprotein HDL.
The present invention writes out a prescription, and to form be experience according to for many years clinical research, and by compare the clinical preliminary test of system for apoplexy apoplex involving the channels and collaterals patient, obtains on the basis of significant curative effect comparatively to develop.Have benefiting QI and nourishing blood, the effect of the expectorant that dispels the wind, the network of invigorating blood circulation.After recipe development becomes marketing drugs, in cardiovascular and cerebrovascular diseases, play an important role always, deeply be subjected to the favor of extensive patients.The advantages such as we find this medicine except curing mainly function in a large amount of clinical uses, also have the good efficacy of control diabetic complication, and onset is rapid, and untoward reaction is few.Therefore, for the further new therapeutic use of exploitation prescription, reduce the wasting of resources of medicine, on the basis of forefathers' research in conjunction with our clinical discovery, the present invention will carry out a series of dosage form and drug efficacy study to the prescription composition, for widely clinical practice is taken a firm foundation.
Summary of the invention
The object of the present invention is to provide the new therapeutic use of a kind of pharmaceutical composition, be specifically related to the application of a kind of pharmaceutical composition in the diabetes complicated disease drug of preparation control.
Drug regimen raw material of the present invention is comprised of 25 parts of 200 parts of the Radixs Astragali, 100 parts of Caulis Spatholobis, 25 parts of Ramulus Cinnamomi, 25 parts of Rhizoma Chuanxiongs, 50 parts of Radix Angelicae Sinensis, 75 parts of Hirudos, 75 parts of Pheretimas, 25 parts of Bombyx Batryticatus, 17 parts of Scorpios, 25 parts of Ramulus Uncariae Cum Uncis, 25 parts on Flos Carthami, Radix Achyranthis Bidentatae.Pharmaceutical composition of the present invention has benefiting QI and nourishing blood, expectorant dispels the wind, the effect of the network function of invigorating blood circulation is taken and can be made patient's blood vessels network road unobstructed, recovers that QI and blood is warm moistens foster function, and refreshing machine is recovered lost hearing, the limbs bones of the body collectively must be supported, thereby improves quality of life of patients, reduces disability rate, the patient of the being seen syndrome of blood stasis due to qi deficiency of (ischemic) apoplexy apoplex involving the channels and collaterals of clinical being usually used in, wind-phlegm syndrome of static blood blocking collaterals is particularly useful for convalescent patient at present.
Technical scheme of the present invention is achieved in that water intaking trematodiasis, Pheretima, Bombyx Batryticatus, Scorpio remove impurity, by the accurate weighing of prescription, and low temperature (60 ℃) drying, co-grinding is for subsequent use; Ramulus Cinnamomi, Rhizoma Chuanxiong, Radix Angelicae Sinensis vapor distillation extract volatile oil, filter, and other collects by device respectively for volatile oil, residual filtrate and medicinal residues.Get the volatile oil beta-cyclodextrin inclusion compound, for subsequent use; All the other Radixs Astragali, Caulis Spatholobi, Ramulus Uncariae Cum Uncis, Radix Achyranthis Bidentatae and Flos Carthami, extracting in water (Ramulus Cinnamomi etc. are proposed the medicinal residues adding when decocting with water for the second time behind the oil), merge the residual filtrate after decoction liquor and Ramulus Cinnamomi etc. are carried oil, filter, be evaporated to clear paste, spray drying, the fine powders such as fine powder and Hirudo mix, and add pharmaceutic adjuvant and make the various common drug dosage forms that allow on the pharmaceutics.
The preparation adjuvant of pharmaceutical composition of the present invention can be acceptable any excipient or carrier on the pharmaceutics.
The application of pharmaceutical composition of the present invention can be acceptable dosage form on the pharmaceutics, comprises pill, granule, hard capsule, soft capsule, tablet, drop pill, oral liquid etc.
When we are widely used in the clinical treatment cardiovascular and cerebrovascular disease with hard capsule of the present invention, chance on the phenomenon that it also has the effect of control diabetic complication, in order to further specify its therapeutic use, we are as follows with the Long-term clinical experimental summary:
We have collected 2005 to 2009 diabetes model case 2120 examples altogether, male's 1260 examples wherein, women's 860 examples, 64.28 years old mean age (40-85 year), average course of disease 7.92 (1-30).Its complication incidence is monitored, the diabetics that various complication have wherein occured is used the oral formulations of the present invention of doses, observe the therapeutic effect of oral formulations of the present invention; Compare simultaneously 2005 diabetics of complications not yet, brought into use oral formulations of the present invention and the diabetics that does not use any chemoprophylaxis complication in 2005, at the sickness rate of diabetic complication in 2009, to observe medicine of the present invention for the preventive effect of diabetic complication.
Now clinical observation result is summarized as follows.
1 preventive effect:
1.1 basic condition and medication:
Collecting 860 examples not yet has the complication case to carry out follow-up study, 63.45 ± 5.2 years old mean age, average course of disease 6.38 ± 2.6 years.Be divided into oral prevention group 460 examples of the present invention, matched group 400 examples.The oral prevention group is taken a certain amount of oral formulations of the present invention simultaneously at conventional therapy control blood glucose, oral formulations of the present invention is take capsule as representative, dosage be one time 3～4,3 times on the one, one month is 1 cycle, took continuously 2 cycles in 1 year, following the tracks of medication period is 2005 03 month in Decembers ,-2009; Matched group only is conventional therapy control blood glucose.
1.2 the diagnostic criteria of major complications
Diabetic renal papillary necrosis (DR) is by ophthalmologist's diagnosis, and the stages of DR of working out with the 3rd ophthalmology academic conference in 1985 is as the criterion: the I phase: the optical fundus is seen microaneurysm or merged little petechia; The II phase: the optical fundus is seen the yellow-white hard exudate or is merged ecchymosis; The III phase: the optical fundus is seen that white is soft and is oozed out or merge ecchymosis; The IV phase: new vessels or vitreous hemorrhage are seen in the optical fundus; The V phase: new vessels and fiber increment are seen in the optical fundus; The VI phase: new vessels and fiber increment, concurrent detachment of retina are seen in the optical fundus.Wherein, the I-III phase is simple type, and the IV-VI phase is proliferous type.
Diabetic nephropathy (DN) diagnosis: the qualitative positive of urine protein, microalbuminuria are put and are exempted from standard measure 20-200 μ g/min.
Hypertension diagnosis meets WHO/ISH hypertension definition in 1993.
Diabetic cardiopathy diagnosis: heart rate during rest＞90 time/minute; ECG change; Postural hypotension＞3.99Kpa; Ultrasoundcardiogram: ejection fraction＜0.62.
Diabetic peripheral neuropathy diagnosis: 1. symptom, sign: the clinical manifestation of feel neural and nervus motorius obstacle, be generally symmetry, lower limb are serious than upper limb; Early stage tendon hyperreflexia, the later stage weakens or disappears, and vibratory sensation weakens or disappears, and sense of touch and thermo aesthesia also reduce in various degree.2. EMG detection: before clinical symptoms occurs, electrophysiologic study can find sensory nerve conduction velocity (SCV) and motor nerve conduction velocity (MCV) slow down (normal person's SCV and MCV answer＞50m/s).
Diabetic foot diagnosis: press the Wagner staging, 0 grade: there is the ulcer of foot of generation risk factor to exist, but without ulcer; 1 grade: the skin surface ulceration, without infecting; 2 grades: darker ulcer is arranged, have influence on muscle, without the infection of abscess or bone; 3 grades: the degree of depth infects, and is swollen with osseous tissue pathological changes or pus; 4 grades: circumscribed gangrene (toe, heel or front instep); 5 grades: full foot gangrene.
Diabetic cerebrovascular disease becomes diagnosis: by the diagnostic criteria of the nineteen ninety-five whole nation the 4th cerebrovascular academic conference formulation.
1.3 result
The results detailed in following table.
Table 1 prevention group is to the influence of diabetic complication
Shown by table 1 result, oral formulations of the present invention is the generation of prevent diabetes complication obviously, can significantly reduce the sickness rate of various complication, and is wherein best with the prevention curative effect of hypertension, heart disease, cerebrovascular, nephropathy etc.
2 therapeutical effect:
2.1 basic condition and medication:
Collect the 1260 examples case that developed complications and carry out Drug therapy, study take the higher diabetic nephropathy of sickness rate, diabetes cardiovascular and cerebrovascular disease, diabetic peripheral neuritis, diabetic renal papillary necrosis as representative.Be divided into oral medication group of the present invention and matched group, the oral medication group is take granule as representative, and dosage is for once taking 4g, and 3 times on the one, one month is 1 cycle, takes medicine continuously 3 cycles; Matched group gives corresponding Primary Care.
Plant 2.2 treatment is sick:
2.2.1 the therapeutical effect to diabetic nephropathy:
2.2.1.1 physical data
320 examples are being in hospital and clinic case of 2005 03 month in Decembers ,-2009.Be divided at random oral medication group 206 examples of the present invention, matched group 114 examples by medical order.Oral medication group age 45-70 year of the present invention, average out to 55.3 ± 3.5 years old, diabetic duration 5-25, average 11.4 ± 3.8 years, complicated hypertension 100 examples, coronary heart disease 32 examples, neuropathy 24 examples, oculopathy 60 examples; Matched group age 42-70 year, average 54.5 ± 3.2 years old, diabetic duration 3-25, average 12.0 ± 2.6 years old, complicated hypertension 88 examples, 40 Cases With Coronary Heart Disease, neuropathy 24 examples, oculopathy 58 examples.Aspect and the matched group comparison not statistically significants such as treatment group age, sex, the course of disease and complication have comparability.
2.2.1.2 diagnosis reaches by stages standard
All cases is diagnosed as type 2 diabetes mellitus according to the diabetes diagnosis standard of WHO formulation in 1999.The by stages standard that adopts international Mogensen to formulate is the clinical diabetes nephropathy phase (IV phase): definite type 2 diabetes mellitus medical history is arranged, Urinary Microalbumin Excretion rate (UAER)＞200 μ g/min or lasting 24h urine protein＞0.5g, be non selective proteinuria, blood pressure increases.Get rid of the kidney damage that other reasons causes and the albuminuria that occurs.
2.2.1.3 medication
Oral medication group of the present invention and matched group all give Primary Care: diet total amount of heat 25kcal/ (kg.d), high-quality low protein diet 0.6-0.8g/ (kg.d).The exercise therapy scheme is defined in low or moderate strength.The control fasting glucose is with insulin Novolin 30R subcutaneous injection (dosage is regulated with blood sugar level).The undesirable person of Postprandial glucose control adds with acarbose 50mg oral, 3 times/d; Benazepril 10mg is oral, 1 time/d; Persantin 10mg is oral, 3 times/d.The undesirable person of controlling of blood pressure adds Nifedipine sustained release tablets, and blood pressure is maintained below the 140/90mmHg (1mmHg=0.133kPa).The obvious person of edema adds and uses hydrochlorothiazide.Treatment group adds on this basis uses oral formulations of the present invention, and dosage is undertaken by aforementioned.
2.2.1.4 observation index
Detect index and comprise glycolated hemoglobin (HbAlc), serum flesh liver (SCr), blood urea nitrogen (BUN), 24h urine protein quantitation, serum total cholesterol (TC), triacylglycerol (TG), HDL-C (HDL-C), low-density lipoprotein cholesterol (LDL C) and UAER.Respectively check 1 time before and after the treatment.
2.2.1.5 criterion of therapeutical effect
With reference to " new Chinese medicine guideline of clinical investigations (try) " " and " diabetes (diabetes) traditional Chinese medical science TCM Differentiation of Clinical Stages and efficacy assessment standard " formulation short term effect standard of diabetes Professional Committee of Society of Internal Medicine of Chinese Chinese medicine association formulation.1. alleviate fully: fasting glucose (FPG)＜6.1mmol/L, 2h-plasma glucose (2hPG)≤8.3mmol/L, HbAlc＜6%, UAER is normal, and routine urianlysis albumen turns negative, or the 24h urine protein quantitation is normal, and graft function is normal.2. produce effects: FPG＜7.2mmol/L2 hPG≤10.8ngnol/L, HbAlc＜8%, UAER are treated front decline＞40%, and the routine urinalysis check is looked into albumen and is reduced by 2 "+", or the 24h urine protein quantitation reduces 〉=40%, and renal function improves＞40%.3. effective: FPG＜8.3mmol/L, 2hPG≤l1.1mmol/L, HbAlc and renal function make moderate progress, and UAER or urine protein quantitation are treated front decline＜40%, and routine urianlysis albumen reduces by 1 "+", or the 24h urine protein quantitation reduces＜40%.4. invalid: clinical manifestation and lab testing indices are all without improving or counter increasing the weight of.
2.2.1.6 statistical method
Measurement data is checked with T, enumeration data X
2Check.Statistical analysis adopts the SPSS13.0 statistical software.
2.2.1.7 result:
2.2.1.7.1 clinical efficacy
See table 2 for details.
Table 2 liang group diabetic nephropathy patient Clinical efficacy comparison
Annotate: compare * * P＜0.01 with matched group.
2.2.1.7.2 every lab index relatively before and after the treatment
Every lab index relatively before and after the table 3 liang group diabetic nephropathy patient treatment
Annotate: with after the treatment of control group relatively, * * P＜0.01, before and after the treatment relatively, #P＜0.05, ##P＜0.01.
Blood lipids index relatively before and after the table 4 liang group diabetic nephropathy patient treatment
Annotate: with comparison after the treatment of control group, * * P＜0.01; Compare #P＜0.05, ##P＜0.01 before and after the treatment.。
Can be found out by table 3 result, HbAlc, BUN, SCr, UAER, 24h urine protein quantitation all are decreased significantly after oral group for the treatment of of the present invention, with comparing difference before the treatment statistical significance (P＜0.01) are arranged.BUN, UAER, 24h urine protein quantitation are decreased significantly (P＜0.05) after the treatment of control group; Though HbAlc, SCr have improvement in various degree, with comparing difference not statistically significant (P＞0.05) before the treatment; Significant difference (P＜0.05, P＜0.01) is relatively all arranged on indices numerical value after oral group of the present invention and the treatment of control group.
The result finds out by table 4, and TC, TG, HDL-C, LDL-C all are significantly improved after oral group for the treatment of of the present invention, with comparing difference before the treatment statistical significance (P＜0.01) is arranged.After the treatment of control group with the treatment before comparing difference not statistically significant (P＞0.05).Significant difference (P＜0.05, P＜0.01) is relatively all arranged on indices numerical value after oral group of the present invention and the treatment of control group.
2.2.2 the therapeutical effect to diabetes complicated atherosclerotic heart disease:
2.2.2.1 physical data
The type 2 diabetes mellitus that selection meets diagnostic criteria merges coronary heart disease in March, 2005-2009 year December inpatient 300 examples, is divided at random oral medication group 168 examples of the present invention, matched group 132 examples.Treatment group age 49-71 year, average (60.5 ± 902) year; Course of disease 5-21, average (6.78 ± 2.38) year; Matched group age 51-73 year, average (57.25 ± 8.24) year; Course of disease 3-23, average (3.98 ± 2.58) year.Each organizes case all without complication and coronary heart disease family histories such as severe hypertension, myocardial infarction and hepatic and kidney function obstacles.Each organizes case physical data comparing difference not statistically significant (P＞0.05), has comparability.
2.2.2.2 diagnostic criteria
The Western medicine diagnose standard: all cases all meets the diabetes diagnosis standard of diabetologist Advisory Board of World Health Organization (WHO) (WHO) announcement in 1999, and diagnosis of coronary heart disease meets coronary heart diseases and angina pectoris name and the diagnostic criteria that WHO formulates.
Tcm diagnosis standard: " the new Chinese medicine guideline of clinical investigations " that meets Ministry of Health of the People's Republic of China's promulgation in 1993.The diabetes syndrome of deficiency of both qi and yin, primary symptom: parched throat is dry, fatigue and weakness; Inferior disease: polyorexia, thirst and liking drink, the lazy speech of breathing hard, dysphoria with feverish sensation in the chest palms and soles, palpitation and insomnia, dark coloured urine constipation.Add the coronary heart disease heart blood silt: stabbing pain over the chest, angor, fixing do not move, pain draw the shoulder back of the body or arm inboard, uncomfortable in chest, palpitation and uneasiness, the words purple is dim, thready and hesitant pulse, have chest pain, main symptom uncomfortable in chest it, other symptoms have 2 and tongue arteries and veins person. namely diagnosable.
2.2.2.3 Therapeutic Method
Treatment group: give aforementioned oral formulations of the present invention; Matched group: take each 10 of FUFANG DANSHEN DIWAN (sky, Tianjin Shi Li pharmaceutical Co. Ltd), every day 3 times, one after each meal.
The course for the treatment of and other: two groups of patients all carry out the diet exercise therapy of system, and cooperate oral antidiabetic drug or insulin injection treatment, strictly control blood glucose, and fasting glucose is controlled at 4.0-7.0mmol/L, and 2h-plasma glucose is controlled at 4.0-10.0mmol/L.Oral Cedocard Retard 20mg simultaneously, every day 2 times, sublingual administration nitroglycerine tablets 0.5mg and record consumption when angina pectoris attacks, the accompanied with hypertension patient adds with Angiotensin-Converting and suppresses (ACEI).Two groups of period in a medicine all stop using anti-platelet agent, lipid lowerers and the similar Chinese medicines such as aspirin, persantin.Add up curative effect after observing for 4 weeks.
2.2.2.4 observation index
Itemized record patient's angina pectoris every day attack times uncomfortable in chest, degree and persistent period, the signs such as nitroglycerin consumption and blood pressure, heart rate, picture of the tongue and pulse condition change; Blood glucose, blood fat, hemorheology, agglutinate rate of blood platelet (PAR), liver function before and after the record treatment.The variation of renal function and ECG ST-T and the reaction during the medication, blood, routine urinalysis reach does Cardiac ultrasound in case of necessity.
2.2.2.5 criterion of therapeutical effect
Diabetes glycemic control index: glycemic control is desirable: fasting glucose 4.4-6.6mmol/L, post-prandial glycemia 4.4-8.0mmol/L; Mean level: fasting glucose≤7.8mmol/L, 2h-plasma glucose≤10.0mmol/L; Glycemic control is relatively poor: fasting glucose＞7.8mmol/L or 2h-plasma glucose＞10.0mmol/L.
Angina pectoris and ECG curative effect standard: with reference to " guideline of clinical investigations of the new Chinese medicine " guideline four to diabetes and coronary heart disease.Produce effects: angina pectoris attacks number of times or nitroglycerin consumption reduce more than 80%, and resting electrocardiogram is normal, and cardinal symptom disappears or basic the disappearance, and minor symptom obviously alleviates; Effectively: angina pectoris attacks number of times or nitroglycerin consumption reduce 50%-80%, resting electrocardiogram sT section rise 〉=0.5mV, and cardinal symptom takes a turn for the better, and minor symptom obviously alleviates; Invalid: angina pectoris attacks number of times or nitroglycerin consumption reduce＜50%, and resting electrocardiogram is without improvement, and cardinal symptom is unchanged, and minor symptom has or without improvement.
2.2.2.6 statistical method
With SPSS 1 1.5 statistical softwares, measurement data adopts mean ± standard deviation
Expression is checked with t; Enumeration data X
2Check.
2.2.2.7 result
2.2.2.7.1 two groups of glycemic control situations are relatively:
See table 5 for details.
Table 5 liang group glycemic control situation relatively
By as seen from Table 5, two groups of glycemic control total effective rates are there was no significant differences (P＞0.05) relatively.
2.2.2.7.2 two groups of angina pectoris and ECG curative effect are relatively:
Table 6 liang group angina pectoris and ECG curative effect comparable situation
Annotate: compare * P＜0.05 with matched group.
By as seen from Table 6, oral formulations group of the present invention and matched group relatively have significant difference, P＜0.05 and P＜0.01.
2.2.2.3 treat as a result comparable situation of front and back blood examination for two groups:
The blood examination result relatively before and after the table 7 liang group treatment
Annotate: with comparison after the treatment of control group, #P＜0.05.
Shown by table 7 result, all can reduce whole blood viscosity, Fibrinogen, packed cell volume after two groups of treatments, wherein best with of the present invention group of curative effect, with comparison after the treatment of control group, have significant difference (P＜0.05) at Fibrinogen numerical value.
2.2.2.7.3 Blood Lipid comparable situation before and after two groups of treatments:
Blood Lipid relatively before and after the table 8 liang group treatment
Annotate: with comparison after the treatment of control group, #P＜0.05, ##P＜0.01.
Shown by table 8 result, the rear two groups of equal energy cholesterol reducing for the treatment of, triglyceride, low density lipoprotein, LDL value, improve the high density lipoprotein value, wherein best with oral group of curative effect of the present invention, with comparison after the treatment of control group, has significant difference (P＜0.05 or (P＜0.01) aspect cholesterol, triglyceride, the high density lipoprotein.
2.2.3 the effect to diabetic peripheral neuropathy
2.2.3.1 physical data
Collect 2005 03 month in December ,-2009 outpatient service patients of 320 examples, be divided at random oral group of the present invention, matched group.Treatment group age 34-70 year, average (50.2 ± 7.4) year; Diabetic duration 5-21, average (9.0 ± 1.2) year; The peripheral neuropathy course of disease 1 month-6 years, average (4.1 ± 0.9) year; Complication: retinopathy 102 examples, from cataract 86 examples, hyperlipemia 128 examples, early diabetic nephropathy 62 examples, hypertension 110 examples, coronary atherosclerotic heart disease 82 examples.Matched group age 29-69 year, average (48.6 ± 6.9) year; Diabetic duration 5-20, average (8.8 ± 1.5) year; The peripheral neuropathy course of disease 2 months-5.5 years, average (4.0 ± 0.8) year; Complication: retinopathy 104 examples, cataract 93 examples, hyperlipemia 130 examples, early diabetic nephropathy 61 examples, hypertension 108 examples, coronary atherosclerotic heart disease 86 examples.Two groups of physical data contrasts, there was no significant difference (P＞0.05) has comparability.
2.2.3.2 diagnostic criteria
1. diabetes diagnosis meets WHO diagnostic criteria in 1999, is diagnosed as the type 2 diabetes mellitus patient; 2. typical diabetic symptom and diabetic peripheral nerve symptom are arranged; 3. abnormal electromyography: sensation is or/and nervus motorius conduction speed＜40m/s, and myoelectric potential increases more than 20%.
2.2.3.3 exclusion standard
1. the age is the patient who reaches below 25 years old more than 70 years old; 2. gestation or age of sucking; 3. complication with diabetes acute complications person; 4. serious hepatorenal damage person; 5. the peripheral neuropathy due to the other reasons.
2.2.3.4 Therapeutic Method
Two groups are all carried out first diabetes conventional therapy (comprising diet control), begin paired observation behind blood glucose Satisfactory Control 14d.Treatment group gives oral granular formulation of the present invention, Buflomedil Hydrochloride (the promise woods that lives, Beijing benefit people factory processed) 150mg adds respectively normal saline 250mL, intravenous drip, every day 1 time; Matched group gives Buflomedil Hydrochloride 150mg and adds quiet of normal saline 250mL, every day 1 time.
2.2.3.5 curative effect judging standard
Draft with reference to " disease of tcm Standardization of diagnosis and curative effect " and pertinent literature that State Administration of Traditional Chinese Medicine promulgates.Produce effects: numb limbs and tense tendons, pain complete obiteration, nerve conduction velocity increase more than the 5m/s; Effectively: limbs pain obviously alleviates, and feeling of numbness makes moderate progress, and it is above but less than 5m/s that NCV increases 2m/s; Invalid: numb limbs and tense tendons, pain are unchanged, even increase the weight of, and NCV increases less than 2m/s or do not increase.
2.2.3.6 result
2.2.3.6.1 two groups of curative effect comparable situation:
Table 9 liang group curative effect relatively
Shown by table 9 result, two administration groups all can obviously be improved the diabetic peripheral neuropathy symptom, and total effective rate is all more than 92%, and wherein best with of the present invention group of curative effect, total effective rate reaches 96.8%.
Nerve conduction velocity comparison before and after the table 10 liang group treatment (m/s,
)
Annotate: compare * P＜0.05, * * P＜0.01 before and after the treatment.
Shown by table 10 result, more all can significantly accelerate the conduction velocity of pathological changes nerve before and after the treatment of two administration groups, wherein oral group of the present invention has better trend.
2.2.4 the therapeutical effect to diabetic renal papillary necrosis
2.2.4.1 physical data
Collect in March, 2005-2009 year December clinic case 320 examples; Age 40-85 year, average 56.7 ± 3.8 years old; Diabetes medical history 5-32, average 14.3 ± 3.5 years; Retinopathy medical history 1-30, average 3.9 ± 1.5 years; Retinopathy is 158 of III phases by stages, 482 of IV phases.All cases of including observation in all meet following condition: (1) has been clarified a diagnosis and has been the patient of diabetes (I type or II type), adopts definition, diagnosis and classification (1989) standard of WHO consultation report diabetes and complication thereof; (2) accept complete ophthalmologic examination; (3) fundus fluorescein angiography inspection and optical fundus autochromy data more than 1 time are arranged; (4) clinical diagnosis pathological changes is III phase or IV phase diabetic renal papillary necrosis by stages, with reference to the definite by stages standard of the 3rd the ophthalmology conference in the whole nation in 1985; (5) Chinese medical discrimination belongs to deficiency of both QI and YIN, syndrome of static blood blocking collaterals.Except following situation person: the patient who does not meet inclusive criteria; Be associated with other retinopathys; Be associated with the patient of other oculopathy such as glaucoma, uveitis; Be associated with the patient of serious cardiovascular, cerebrovascular, liver and disease of hematopoietic system; Be associated with the patient of diabetic nephropathy generation renal failure; Gestation or women breast-feeding their children; Use the patient of similar effect Chinese medicine.MethodsThe cases enrolled is divided into oral group of matched group of the present invention (simple laser therapy) at random, and each organizes data difference not statistically significant (P＞0.05), has comparability.
2.2.4.2 differential diagnosis in tcm standard
Deficiency of both QI and YIN, syndrome of static blood blocking collaterals diagnostic criteria: primary symptom is dry mouth and throat, fatigue and weakness, chest pain, hypochondriac pain, lumbago, backache, the position is fixed, or is twinge, numb limbs and tense tendons, pain night is very: inferior disease is polyorexia, thirst and liking drink, the lazy speech of breathing hard, dysphoria with feverish sensation in the chest palms and soles, palpitation and insomnia, the red constipation of urinating, squamous and dry skin, lip is purple dark, facial ecchymosis; The few body fluid of dark tongue quality, thin fur or flower stripping, thready and rapid pulse without strength, or string, or heavy and puckery.Possess primary symptom, inferior disease more than 3, the optical fundus blood capillary changes, and is and namely diagnosable in conjunction with the tongue pulse condition.
2.2.4.3 Therapeutic Method
Each group all adopts the retinal photocoagulation treatment, adjusts at any time energy in the treatment, reaches II level hot spot with least energy output and is advisable.Full retinal photocoagulation: select gold-tinted or the green-yellow light of Multi-wavelength krypton laser, divide and finish for 4 times.Make first grid light for the 1st time solidifying, from beyond the macula area hemal arch, be connected with full Retinal coagulation zone; Parameter is hot spot 200 μ m, time of exposure 0.2s, II level hot spot; Can alleviate the macular edema that full retinal photocoagulation increases the weight of.Extend to several times later on periphery, parameter is hot spot, rear best equator 200-300 μ m, and the equator is to peripheral 300-500 μ m, time of exposure 0.2s, II level hot spot.Light coagulates 1 week of interval, and each light condensation point is counted 300-500, total 1200-2000 point.Treatment group gives oral formulations of the present invention in addition, and dosage such as aforementioned can be used 1-3 the course for the treatment of according to the state of an illness.Completed treatment is checked and examined vision, optical fundus (preset lens inspection behind the mydriasis) and fluorescence fundus angiography after 3 months, and carries out efficacy determination.
2.2.4.4 efficacy determination
(1) vision criterion: the general ETDRS test chart of international ophthalmology Epidemiological study is used in examination of visual acuity, checks that distance is 4m, to correct defects of vision as foundation.〉=10 letters of vision rising are produce effects, and rising 0-10 letter is that effectively the descender is invalid.(2) optical fundus criterion: add up optical fundus retina microangioma number and ooze out area (PD), and compare.(3) angiography criterion: the optical fundus fluorescein angiography shows that original new vessels disappears, and without new new vessels and vitreous hemorrhage, retinal capillary disappears effective for treating without perfusion area, otherwise is invalid.
2.2.4.5 statistical procedures
Measurement data with
T check and X are adopted in expression
2Check.
2.2.4.6 result
2.2.4.6.1 the eyesight improving degree is relatively after two groups of treatments:
The eyesight improving degree relatively after the table 11 liang group treatment
Table 11 result shows, adds the therapeutic scheme of using oral formulations of the present invention more more remarkable than the simple curative effect of laser therapy diabetic retinopathy of using, and total effective rate has reached about 90%.
2.2.4.6.2 examination of ocular fundus index comparable situation before and after two groups of treatments:
The fundus observation index relatively before and after the table 12 liang group treatment
Annotate: with comparison after the treatment of control group, #P＜0.05, ##P＜0.01.
Shown by table 12 result, treat rear retina microangioma number, retinal hemorrhages and ooze out all front obviously minimizings for the treatment of of area for two groups, wherein add with oral formulations more remarkable treatment effect of the present invention, relatively rear with matched group (using merely laser therapy) treatment, have significant difference (P＜0.05 or P＜0.01).
2.2.4.6.3 optical fundus fluorescein angiography situation is relatively after two groups of treatments:
Optical fundus fluorescein angiography situation relatively after the table 13 liang group treatment
Annotate: compare #P＜0.05 with matched group.
Shown by table 13 result, add and use the therapeutic scheme of oral formulations of the present invention more more remarkable than simple laser therapy curative effect, relatively reach significant difference (P＜0.05) with matched group.
Can find out by above-mentioned clinical research, oral formulations of the present invention can effectively be prevented and treated the generation of multiple diabetic complication, its mechanism of action has common point, each internal organs atherosclerosis of whole body is closely related with significantly preventing and treating, clinical observation result has concordance with treatment mechanism, in the future widely clinical practice lays the first stone.
The specific embodiment
Embodiment 1
Water intaking trematodiasis 75g, Pheretima 75g, Bombyx Batryticatus 25g, Scorpio 17g remove impurity, by the accurate weighing of prescription, and low temperature (60 ℃) drying, mixed powder is broken into fine powder, crosses 100 mesh sieves, and is for subsequent use; Ramulus Cinnamomi 25g, Rhizoma Chuanxiong 25g, Radix Angelicae Sinensis 50g add 6 times of water gagings, and vapor distillation extracted volatile oil in 6 hours, filter, and other collects by device respectively for volatile oil, residual filtrate and medicinal residues.Get the β-CD of 3 times of amounts of volatile oil and the distilled water of 2 times of amounts, add volatile oil and grind 40 minutes to pasty state, low temperature (50 ℃) drying is ground into fine powder, crosses 100 mesh sieves, and is for subsequent use; All the other Radix Astragali 200g, Caulis Spatholobi 100g, Ramulus Uncariae Cum Uncis 25g, Radix Achyranthis Bidentatae 25g and Flos Carthami 25g, soaked 30 minutes, decoct 3 times, time is 1.5 hours, amount of water is respectively 14,12,12 times (Ramulus Cinnamomi etc. are proposed the medicinal residues adding when decocting for the second time behind the oil) merges the residual filtrate after decoction liquor and Ramulus Cinnamomi etc. are carried oil, filters, being evaporated to relative density is the clear paste of 1.25-1.30 (65 ℃ of surveys), spray drying, fine powder mixes with fine powders such as Hirudos, adds 45% ethanol wet granulation of 2 times of amounts, cold drying (≤60 ℃) 1 hour, granulate, with the Benexate Hydrochloride mix homogeneously, the capsule of packing into No. 1, make 1000, and get final product.Usage and dosage: once take the 3-4 grain, 3 times on the one.
Embodiment 2
Water intaking trematodiasis 75g, Pheretima 75g, Bombyx Batryticatus 25g, Scorpio 17g remove impurity, by the accurate weighing of prescription, and low temperature (60 ℃) drying, mixed powder is broken into fine powder, crosses 100 mesh sieves, and is for subsequent use; Ramulus Cinnamomi 25g, Rhizoma Chuanxiong 25g, Radix Angelicae Sinensis 50g add 6 times of water gagings, and vapor distillation extracted volatile oil in 6 hours, filter, and other collects by device respectively for volatile oil, residual filtrate and medicinal residues.Get the β-CD of 3 times of amounts of volatile oil and the distilled water of 2 times of amounts, add volatile oil and grind 40 minutes to pasty state, low temperature (50 ℃) drying is ground into fine powder, crosses 100 mesh sieves, and is for subsequent use; All the other Radix Astragali 200g, Caulis Spatholobi 100g, Ramulus Uncariae Cum Uncis 25g, Radix Achyranthis Bidentatae 25g and Flos Carthami 25g, soaked 30 minutes, decoct 3 times, time is 1.5 hours, amount of water is respectively 14,12,12 times (Ramulus Cinnamomi etc. are proposed the medicinal residues adding when decocting for the second time behind the oil) merges the residual filtrate after decoction liquor and Ramulus Cinnamomi etc. are carried oil, filters, being evaporated to relative density is the clear paste of 1.25-1.30 (65 ℃ of surveys), spray drying, fine powder mixes with fine powders such as Hirudos, adds 45% ethanol wet granulation of 2 times of amounts, cold drying (≤60 ℃) 1 hour, granulate is with Benexate Hydrochloride mix homogeneously, granulate, the 1000g granule is made in packing.Usage and dosage: once take 34g, 3 times on the one.
Embodiment 3
Water intaking trematodiasis 75g, Pheretima 75g, Bombyx Batryticatus 25g, Scorpio 17g remove impurity, by the accurate weighing of prescription, and low temperature (60 ℃) drying, mixed powder is broken into fine powder, crosses 100 mesh sieves, and is for subsequent use; Ramulus Cinnamomi 25g, Rhizoma Chuanxiong 25g, Radix Angelicae Sinensis 50g add 6 times of water gagings, and vapor distillation extracted volatile oil in 6 hours, filter, and other collects by device respectively for volatile oil, residual filtrate and medicinal residues.Get the β-CD of 3 times of amounts of volatile oil and the distilled water of 2 times of amounts, add volatile oil and grind 40 minutes to pasty state, low temperature (50 ℃) drying is ground into fine powder, crosses 100 mesh sieves, and is for subsequent use; All the other Radix Astragali 200g, Caulis Spatholobi 100g, Ramulus Uncariae Cum Uncis 25g, Radix Achyranthis Bidentatae 25g and Flos Carthami 25g, soaked 30 minutes, decoct 3 times, time is 1.5 hours, amount of water is respectively 14,12,12 times (Ramulus Cinnamomi etc. are proposed the medicinal residues adding when decocting for the second time behind the oil), merge the residual filtrate after decoction liquor and Ramulus Cinnamomi etc. are carried oil, filter, being evaporated to relative density is the clear paste of 1.25-1.30 (65 ℃ of surveys), spray drying, and fine powder mixes with fine powders such as Hirudos, cold drying (≤60 ℃) 1 hour, with the Benexate Hydrochloride mix homogeneously, with gelatin, (1: 1: 0.3-0.45) melt heat preservation for standby use behind the glue, medicated powder added an amount of vegetable oil (soybean oil or salad oil) and stirs evenly for water and glycerol, colloid mill grinds to form the pastel of even thickness, the decompression degasification, 1000 soft capsules are made in compacting.Usage and dosage: once take the 3-4 grain, 3 times on the one.
Embodiment 4
Water intaking trematodiasis 75g, Pheretima 75g, Bombyx Batryticatus 25g, Scorpio 17g remove impurity, by the accurate weighing of prescription, and low temperature (60 ℃) drying, mixed powder is broken into fine powder, crosses 100 mesh sieves, and is for subsequent use; Ramulus Cinnamomi 25g, Rhizoma Chuanxiong 25g, Radix Angelicae Sinensis 50g add 6 times of water gagings, and vapor distillation extracted volatile oil in 6 hours, filter, and other collects by device respectively for volatile oil, residual filtrate and medicinal residues.Get the β-CD of 3 times of amounts of volatile oil and the distilled water of 2 times of amounts, add volatile oil and grind 40 minutes to pasty state, low temperature (50 ℃) drying is ground into fine powder, crosses 100 mesh sieves, and is for subsequent use; All the other Radix Astragali 200g, Caulis Spatholobi 100g, Ramulus Uncariae Cum Uncis 25g, Radix Achyranthis Bidentatae 25g and Flos Carthami 25g, soaked 30 minutes, decoct 3 times, time is 1.5 hours, amount of water is respectively 14,12,12 times (Ramulus Cinnamomi etc. are proposed the medicinal residues adding when decocting for the second time behind the oil), merge the residual filtrate after decoction liquor and Ramulus Cinnamomi etc. are carried oil, filter, being evaporated to relative density is the clear paste of 1.25-1.30 (65 ℃ of surveys), spray drying, and fine powder mixes with fine powders such as Hirudos, cold drying (≤60 ℃) 1 hour, with the Benexate Hydrochloride mix homogeneously, drying under reduced pressure is ground into powder, adds appropriate amount of starch, micropowder silica gel and magnesium stearate, granulate, compacting is in blocks, and coating is made 1000 tablets.Usage and dosage: once take the 3-4 sheet, 3 times on the one.
Embodiment 5
Water intaking trematodiasis 75g, Pheretima 75g, Bombyx Batryticatus 25g, Scorpio 17g remove impurity, by the accurate weighing of prescription, and low temperature (60 ℃) drying, mixed powder is broken into fine powder, crosses 100 mesh sieves, and is for subsequent use; Ramulus Cinnamomi 25g, Rhizoma Chuanxiong 25g, Radix Angelicae Sinensis 50g add 6 times of water gagings, and vapor distillation extracted volatile oil in 6 hours, filter, and other collects by device respectively for volatile oil, residual filtrate and medicinal residues.Get the beta-schardinger dextrin-of 3 times of amounts of volatile oil and the distilled water of 2 times of amounts, add volatile oil and grind 40 minutes to pasty state, low temperature (50 ℃) drying is ground into fine powder, crosses 100 mesh sieves, and is for subsequent use; All the other Radix Astragali 200g, Caulis Spatholobi 100g, Ramulus Uncariae Cum Uncis 25g, Radix Achyranthis Bidentatae 25g and Flos Carthami 25g, soaked 30 minutes, decoct 3 times, time is 1.5 hours, amount of water is respectively 14,12,12 times (Ramulus Cinnamomi etc. are proposed the medicinal residues adding when decocting for the second time behind the oil), merge the residual filtrate after decoction liquor and Ramulus Cinnamomi etc. are carried oil, filter, being evaporated to relative density is the clear paste of 1.25-1.30 (65 ℃ of surveys), spray drying, fine powder mixes with fine powders such as Hirudos, and cold drying (≤60 ℃) 1 hour is with the Benexate Hydrochloride mix homogeneously, drying under reduced pressure is ground into powder, join in 3: 1 the molten polyethylene glycol 4000-polyethylene glycol 6000 of 4 times of amounts, stir, be transferred to pill dripping machine, dripping becomes ball, remove the dimethicone on surface, packing is made the 1000g drop pill.Usage and dosage: once take 34g, 3 times on the one.
Embodiment 6
Water intaking trematodiasis 75g, Pheretima 75g, Bombyx Batryticatus 25g, Scorpio 17g remove impurity, by the accurate weighing of prescription, and low temperature (60 ℃) drying, mixed powder is broken into fine powder, crosses 100 mesh sieves, and is for subsequent use; Ramulus Cinnamomi 25g, Rhizoma Chuanxiong 25g, Radix Angelicae Sinensis 50g add 6 times of water gagings, and vapor distillation extracted volatile oil in 6 hours, filter, and other collects by device respectively for volatile oil, residual filtrate and medicinal residues.Get the beta-schardinger dextrin-of 3 times of amounts of volatile oil and the distilled water of 2 times of amounts, add volatile oil and grind 40 minutes to pasty state, low temperature (50 ℃) drying is ground into fine powder, crosses 100 mesh sieves, and is for subsequent use; All the other Radix Astragali 200g, Caulis Spatholobi 100g, Ramulus Uncariae Cum Uncis 25g, Radix Achyranthis Bidentatae 25g and Flos Carthami 25g, soaked 30 minutes, decoct 3 times, time is 1.5 hours, amount of water is respectively 14,12,12 times (Ramulus Cinnamomi etc. are proposed the medicinal residues adding when decocting for the second time behind the oil), merge the residual filtrate after decoction liquor and Ramulus Cinnamomi etc. are carried oil, filter, being evaporated to relative density is the clear paste of 1.25-1.30 (65 ℃ of surveys), mix with fine powders such as Hirudos, with the Benexate Hydrochloride mix homogeneously, other gets the 2.5g sodium benzoate again, 80g sucrose adds water 150ml, boils, add in the extractum, stir evenly, add water to 1000ml, stir evenly, fill, sterilization adds water to 1000ml, namely gets oral liquid.Usage and dosage: shake up before drinking, once take 30-40ml, 3 times on the one.
Embodiment 7
Water intaking trematodiasis 75g, Pheretima 75g, Bombyx Batryticatus 25g, Scorpio 17g remove impurity, by the accurate weighing of prescription, and low temperature (60 ℃) drying, mixed powder is broken into fine powder, crosses 100 mesh sieves, and is for subsequent use; Ramulus Cinnamomi 25g, Rhizoma Chuanxiong 25g, Radix Angelicae Sinensis 50g add 6 times of water gagings, and vapor distillation extracted volatile oil in 6 hours, filter, and other collects by device respectively for volatile oil, residual filtrate and medicinal residues.Get the beta-schardinger dextrin-of 3 times of amounts of volatile oil and the distilled water of 2 times of amounts, add volatile oil and grind 40 minutes to pasty state, low temperature (50 ℃) drying is ground into fine powder, crosses 100 mesh sieves, and is for subsequent use; All the other Radix Astragali 200g, Caulis Spatholobi 100g, Ramulus Uncariae Cum Uncis 25g, Radix Achyranthis Bidentatae 25g and Flos Carthami 25g, soaked 30 minutes, decoct 3 times, time is 1.5 hours, amount of water is respectively 14,12,12 times (Ramulus Cinnamomi etc. are proposed the medicinal residues adding when decocting for the second time behind the oil), merge the residual filtrate after decoction liquor and Ramulus Cinnamomi etc. are carried oil, filter, being evaporated to relative density is the clear paste of 1.25-1.30 (65 ℃ of surveys), spray drying, fine powder mixes with fine powders such as Hirudos, and cold drying (≤60 ℃) 1 hour is with the Benexate Hydrochloride mix homogeneously, drying under reduced pressure is ground into powder, with the general ball of 60% ethanol, polishing, drying namely gets the 1000g micropill.Usage and dosage: once take 3-4g, 3 times on the one.
Claims (6)
1. a pharmaceutical composition treats and/or prevents application in the diabetes complicated disease drug in preparation, it is characterized in that according to the weight portion meter, the raw material of making this pharmaceutical composition active component is: 200 parts of the Radixs Astragali, 100 parts of Caulis Spatholobis, 25 parts of Ramulus Cinnamomi, 25 parts of Rhizoma Chuanxiongs, 50 parts of Radix Angelicae Sinensis, 75 parts of Hirudos, 75 parts of Pheretimas, 25 parts of Bombyx Batryticatus, 17 parts of Scorpios, 25 parts of Ramulus Uncariae Cum Uncis, 25 parts on Flos Carthami, 25 parts of Radix Achyranthis Bidentataes.
2. pharmaceutical composition as claimed in claim 1 treats and/or prevents application in the diabetes complicated disease drug in preparation, it is characterized in that described pharmaceutical composition is pill, granule, hard capsule, soft capsule, tablet, drop pill or oral liquid.
3. pharmaceutical composition as claimed in claim 2 treats and/or prevents application in the diabetes complicated disease drug in preparation, it is characterized in that described pharmaceutical composition is hard capsule.
4. treat and/or prevent application in the diabetes complicated disease drug such as claim 1,2 or 3 described pharmaceutical compositions in preparation, it is characterized in that described diabetic complication is cardiovascular and cerebrovascular disease, nephropathy, retinopathy, diabetic foot, skin pruritus, sexual dysfunction, oral disease or peripheral neuritis pathological changes.
5. pharmaceutical composition as claimed in claim 4 treats and/or prevents application in the diabetes complicated disease drug in preparation, it is characterized in that described diabetic complication is cardiovascular and cerebrovascular disease.
6. pharmaceutical composition as claimed in claim 5 treats and/or prevents application in the diabetes complicated disease drug in preparation, it is characterized in that described cardiovascular and cerebrovascular disease is atherosclerotic heart disease.
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| CN102727570A (en) * | 2012-07-11 | 2012-10-17 | 成都中医药大学附属医院 | External pharmaceutical composition for treating diabetic foot as well as preparation method and application of external pharmaceutical composition |
| CN103656488B (en) * | 2013-11-20 | 2016-04-20 | 界首市中医院 | A kind of Chinese medicine composition for the treatment of diabetes complicated diabetic foot |
| CN104027662A (en) * | 2014-02-23 | 2014-09-10 | 刘静 | Traditional Chinese medicine for treating diabetic foot and preparing method thereof |
| EP3146976B1 (en) * | 2014-05-23 | 2021-01-13 | Korea Institute of Oriental Medicine | Pharmaceutical composition for preventing or treating macular degeneration, containing natural mixture extract as active ingredient |
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| CN100493533C (en) * | 2005-12-26 | 2009-06-03 | 昆明市中医医院 | Medicine for treating diabetes peripheral neuropathy |
| CN101199618A (en) * | 2007-12-17 | 2008-06-18 | 李乃新 | Shenling know luo capsule |
| CN101361802B (en) * | 2008-09-28 | 2011-03-23 | 中国人民解放军第四军医大学 | Traditional Chinese medicine formulation for treating diabetes complication disease |
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