CN103550290B - Chinese medicinal composition for treating type 2 diabetes - Google Patents

Abstract

The invention relates to a Chinese medicinal composition for treating type 2 diabetes. The Chinese medicinal composition for treating the type 2 diabetes is characterized in that active ingredients of the Chinese medicinal composition for treating the type 2 diabetes are prepared from the following raw materials in parts by weight: 20-40 parts of milkvetch, 20-40 parts of root of kudzu wine, 5-15 parts of wrinkled gianthyssop herb, 5-15 parts of dandelion and 5-10 parts of honeysuckle. The Chinese medicinal composition for treating the type 2 diabetes can be granules, capsules, tablets or pills. Clinical verifications show that the Chinese medicinal composition for treating the type 2 diabetes has the effects of invigorating splenic yang, tonifying spleen and improving insulin resistance and has an obvious curative effect when being used for treating the type 2 diabetes.

Description

A kind of Chinese medicine composition for the treatment of type 2 diabetes mellitus

Technical field:

The present invention relates to medicinal preparation, be specifically related to the pharmaceutical preparation not determining structure from medicinal plants.

Background technology:

Modern medicine study shows, the patient of type 2 diabetes mellitus all has insulin resistant in various degree.Insulin resistant (insulin resistance, IR) refer to that the insulin of normal physiological degree in body is to around target tissue, as liver, muscle, blood vessel, cerebral tissue, fat histiocyte can not produce a kind of pathological state of its corresponding biological effect.IR is not only the important pathologic basis that type 2 diabetes mellitus occurs, and is the common risk factors of the diseases such as hypertension, ischemic heart desease, cerebral infarction, obesity, metabolic syndrome.Improve insulin-resistant states for the treatment of above-mentioned disease and prevention, to there is important clinical and be worth and practical significance.

The current medicine improving insulin resistant is mainly chemical synthetic drug Study of Thiazolidinedione derivatives as Insulin Sensitizer, as pioglitazone, rosiglitazone etc.Its drug mechanism is mainly, and by peroxide activator enzyme paraphyte activated receptor transcription factor, increases the glucose uptake of target tissue insulin-mediated, thus reduces insulin resistant.But above-mentioned chemical synthetic drug is comparatively large to the toxic and side effects of Liver and kidney, is not suitable for patient's long-term taking, and the short time takes curative effect and is often difficult to manifest.Therefore, find side effect less, can be applicable to long-term taking, to have the medicine improving insulin resistant determination curative effect become significant medical urgently to be resolved hurrily and technical barrier.

Chinese medicine insulin resistant also achieves many achievements, in view of herbal toxic effect is less, even have no side effect, can be applicable to the advantage of patient's long-term taking, the medicine finding desirable improvement insulin resistant from tcm field has become the focus that world-wide medical experts and scholars pay close attention to.At present, Chinese medicine insulin resistant mostly is replenishing QI to invigorate the spleen, dispelling phlegm and eliminating dampness, YIN nourishing, heat clearing away, invigorates blood circulation, the square medicine of the method composition of soothing the liver, the kidney invigorating, as the SHENQI JIANGTANG KELI (the accurate word Z10950075 of traditional Chinese medicines) that Lunan Pharmacy Co. Ltd produces, this hypoglycemic granule is made up of flavour of a drug such as stem and leaf of Radix Ginseng saponin, Fructus Schisandrae Chinensis, the Radix Astragali, Rhizoma Dioscoreae, Radix Rehmanniae, Fructus Lycii.But the display of the Clinical results of the present inventor, above-mentioned SHENQI JIANGTANG KELI is to improve the curative effect in fasting glucose, insulin index still not ideal enough.

Summary of the invention:

Technical problem to be solved by this invention is to provide a kind of Chinese medicine composition for the treatment of type 2 diabetes mellitus, and this Chinese medicine composition has yang invigorating spleen invigorating, improves effect of insulin resistant, treats the evident in efficacy of type 2 diabetes mellitus.

The technical scheme that the present invention will solve the problem is as follows:

Treat a Chinese medicine composition for type 2 diabetes mellitus, it is characterized in that the active ingredient of this Chinese medicine composition is made up of the raw material of Chinese medicine medicine of following weight portion: the Radix Astragali 20-40, Radix Puerariae 20-40, Herba Pogostemonis 5-15, Herba Taraxaci 5-15, Flos Lonicerae 5-10.

Active ingredient described in such scheme is obtained by following method:

(1) Herba Pogostemonis, Herba Taraxaci, the Flos Lonicerae way of distillation are extracted, obtain volatile oil and residue;

(2) residue that the Radix Astragali, Radix Puerariae and step (1) obtain is mixed, add the water of 6 ~ 12 times at every turn, decoct 2 ~ 3 times, merge each decocting liquid, leave standstill after 12 hours, filter, obtain filtrate;

(3) by filtrate evaporation and concentration to paste, add the ethanol precipitate with ethanol that volumetric concentration is 40% ~ 80%, stir leave standstill 24 hours, by supernatant liquid filtering, decompression recycling ethanol, and the extractum being concentrated into that density is 1.18 ~ 1.36, then drying and crushing powdered;

(4) powder obtained with step (3) after volatile oil beta-cyclodextrin inclusion compound step (1) obtained mixes, and is ground into fine powder and get final product.

Chinese medicine composition of the present invention is common oral agents, and this oral agents is granule, capsule, tablet or the pill be made up according to a conventional method of above-mentioned active ingredient and the acceptable adjuvant of medical science.

Modern medicine study result shows, insulin receptor downstream effector molecule signal path defect is one of major reason of insulin resistant formation.GLUT4 (glucose transporter4, GLUT-4), as glucose transporter important under insulin-mediated, is that glucose enters histiocytic key factor.The obstacles such as the expression of GLUT – 4 and transposition are the important mechanism producing insulin resistant, and with the picked-up obstacle of glucose and Insulin receptor INSR after deficiency disorders closely related.Having scholar to test proof, there is obvious insulin resistant in the rat that GLUT – 4 gene is knocked, and the risk that diabetes occur comparatively normal rats significantly increases, and improves GLUT – 4 albumen or gene expression in tissue and can improve the insulin resistant of tissue.The low result producing insulin resistant with transposition obstacle of the expression of GLUT – 4 is the energy metabolism impairment causing glucose, i.e. the generation minimizing of energy, now patient often has weak, asthenia, the clinical manifestation of weak breath homenergic deficiency.And these performances meet the CM syndrome differentiation criterion of Qi in TCM deficiency syndrome.Chinese medicine is thought, The spleen and stomach provide the material basis of the acquired, source of generating QI and blood.The generation of gas depends on transporting, the lucid yang sending up function of spleen, and the gas of generation is again by the transporting the lucid yang sending up function of spleen, and especially the lucid yang sending up function gasifies, and then produce power.As can be seen here, glucose belongs to the category of Qi in TCM as the cereal nutrient of body, and the utilization of glucose then belongs to the category of gasification.Can be understood as thus, insulin resistant is one of important mechanism producing gasification obstacle, and the transporting of spleen and the lucid yang sending up dysfunction are the important pathology links producing insulin resistant.Transporting and the lucid yang sending up function of spleen are mainly transported, compress and change raw, and the low and transposition obstacle of the expression of GLUT – 4 resembles from the traditional Chinese medical science learns transporting and the lucid yang sending up dysfunction that thinking aspect can be understood as spleen, especially its lucid yang sending up function.

Based on above-mentioned theory, the present inventor intervenes GLUT – 4 with yang invigorating spleen invigorating method and treats insulin resistant for general thought and carry out prescription, and in side, the Radix Astragali, the spleen invigorating of Radix Puerariae benefiting qi and raising yang are monarch, and Herba Pogostemonis, Herba Taraxaci yang invigorating are minister, Flos Lonicerae helps all medicine yang invigorating on the one hand, on the other hand get its sweet cold property, that closes with Herba Taraxaci is cool, with the warm-dryness syndrome of Radix Astragali (processed), Radix Puerariae, Herba Pogostemonis, for adjuvant, all medicine YIN and YANG balancing, all tool rises floating property, plays the merit of yang invigorating spleen invigorating altogether.

The effect of traditional Chinese medicine composition for treating type 2 diabetes mellitus of the present invention, is confirmed by the statistical result of following clinical experiment.

1, patient profile: select the patient meeting type 2 diabetes mellitus and insulin resistant diagnostic criteria for 2009 ~ 2011 years, totally 63 examples.Wherein male 37 example, women 26 example.All patients all takes western medicines in treatment history before accepting Drug therapy of the present invention, and the medication treatment time is all more than 3 months.

2, case selection standard: by (WHO) diabetes diagnostic criterion, fasting blood glucose level >7.mmol/L selects case; Get rid of and have severe cardiac, liver, kidney illness, severe infections and diabetic complication, malignant tumor, trimester of pregnancy women breast-feeding their children, the patients such as spiritedness disease or medical history; Uncooperative or therapy discontinued person does not list this observation of curative effect scope in.

3, patient source: all cases is all from the outpatient of No.2 Hospital Attached to Guangzhou Traditional Chinese Medicial Univ.

4, Therapeutic Method:

(1) classified data: selected case is divided into treatment group and matched group according to principle of randomization.Treatment group 31 example, wherein man 17 example, female 14 example, 49 ~ 74 years old age, average (59.7 ± 6.4) year.Matched group 32 example, wherein man 20 example, female 12 example, 51 ~ 74 years old age, average (59.3 ± 6.9) year.The sex of two group objects, age structure, no significant difference, has comparability.

(2) method of administration: treatment group gives the granule prepared according to the method for embodiment in detailed description of the invention 1, each 1 bag, every day 3 times; Matched group gives SHENQI JIANGTANG KELI (Lunan Pharmacy Co. Ltd, authentication code: the accurate word Z10950075 of traditional Chinese medicines), each 3 grams, every day 3 times.

Two groups were all a course for the treatment of with 30 days, evaluated curative effect after the course for the treatment of.

5, observation index:

(1) safety observations: comprise general life index (blood pressure, heart rate, breathing), routine blood test, routine urinalysis, darling renal function inspection and untoward reaction and detect.General life index once a day, tells patient method, advises itself and household to be recorded in detail; Other indexs, before and after treatment, each inspection once.

(2) observation of curative effect: fasting glucose (FBG) adopts Roche P800 automatic clinical chemistry analyzer to detect; Fasting insulin (FINS) adopts chemoluminescence method to detect (reference range is 20.90-195.00pmol/L).Insulin resistance index (HOMA-IR), computing formula is (fasting glucose × fasting insulin)/22.5.

(3) statistical method: adopt statistic software SPSS 17.0 to carry out statistical analysis.Treat front and back and compare between two groups and adopt average independent samples t test, confidence interval is 95%, P<0.05 is significant difference, has statistical significance.

6, efficacy assessment standard: the guideline of clinical investigations with reference to " new Chinese medicine guideline of clinical investigations " new Chinese medicine treatment diabetes is formulated.

Effective: fasting glucose, fasting insulin decrease beyond 40% before treatment;

Effective: fasting glucose, fasting insulin decrease beyond 20% before treatment;

Invalid: fasting glucose, fasting insulin without decline, or decline do not reach effective standard.

Result:

(1) treatment group (present composition) and matched group two groups of comparitive study, in table 1:

Table 1 liang group comparitive study

Two groups all using effective+effective and calculate total effective rate as virtual value.Treatment group total effective rate is 90.32%, and matched group is 63.75%, two groups and compares, and has significant difference (P<0.05).Illustrate that the curative effect of the present composition is better than control drug SHENQI JIANGTANG KELI.

(2) treatment group and fasting glucose, fasting insulin and insulin resistance index before and after treatment of control group compare in table 2:

Fasting glucose, fasting insulin before and after table 2 liang group treatment, the change of insulin resistance index

Before and after two groups of treatments, fasting glucose, fasting insulin and insulin resistance index all have significant difference (P<0.05), show that the present composition and control drug all can reduce fasting glucose, and improve insulin-resistant states.Fasting glucose, fasting insulin and insulin resistance index after present composition treatment compare with matched group, P<0.05, there is significant difference, after the treatment of the present composition, each index value is significantly lower than matched group, shows that present composition curative effect is better than matched group.

In clinical observation process, do not find that medicine of the present invention has any bad toxicity, show that this medicine is a safe and effective preparation.

The above results shows, the present composition can reduce blood glucose, and improves insulin-resistant states.

Detailed description of the invention

Embodiment 1(granule):

Get the Radix Astragali 300 grams, Radix Puerariae 300 grams, Herba Pogostemonis 100 grams, Herba Taraxaci 100 grams and Flos Lonicerae 75 grams and make granule according to following steps:

(1) Herba Pogostemonis, Herba Taraxaci, the Flos Lonicerae way of distillation are extracted, obtain volatile oil and residue;

(2) residue that the Radix Astragali, Radix Puerariae and step (1) obtain is mixed, add the water of 10 times at every turn, decoct 2 times, merge each decocting liquid, leave standstill after 12 hours, filter, obtain filtrate;

(3) by filtrate evaporation and concentration to paste, add the ethanol precipitate with ethanol that volumetric concentration is 60%, stir, leave standstill 24 hours, by supernatant liquid filtering, decompression recycling ethanol, and the extractum being concentrated into that density is 1.18 ~ 1.36, then dry, pulverize powdered;

(4) powder obtained with step (3) after volatile oil beta-cyclodextrin inclusion compound step (1) obtained mixes, and is ground into fine powder;

(5) gained fine powder adds appropriate lactose and dextrin, wet granulation, dry, granulate, altogether obtained 150 grams of granules, and pack, is distributed into 10 grams/bag.

Embodiment 2(granule):

Get the Radix Astragali 240 grams, Radix Puerariae 370 grams, Herba Pogostemonis 130 grams, Herba Taraxaci 70 grams and Flos Lonicerae 65 grams and make granule according to following steps:

(1) Herba Pogostemonis, Herba Taraxaci, the Flos Lonicerae way of distillation are extracted, obtain volatile oil and residue;

(2) residue that the Radix Astragali, Radix Puerariae and step (1) obtain is mixed, add the water of 6 times at every turn, decoct 3 times, merge each decocting liquid, leave standstill after 12 hours, filter, obtain filtrate;

(3) by filtrate evaporation and concentration to paste, add the ethanol precipitate with ethanol that volumetric concentration is 80%, stir, leave standstill 24 hours, by supernatant liquid filtering, decompression recycling ethanol, and the extractum being concentrated into that density is 1.18 ~ 1.36, then drying and crushing powdered;

(4) powder obtained with step (3) after volatile oil beta-cyclodextrin inclusion compound step (1) obtained mixes, and is ground into fine powder;

(5) gained fine powder adds appropriate lactose and dextrin, wet granulation, dry, granulate, altogether obtained 150 grams of granules, and pack, is distributed into 10 grams/bag.

Embodiment 3(granule):

Get the Radix Astragali 370 grams, Radix Puerariae 230 grams, Herba Pogostemonis 60 grams, Herba Taraxaci 130 grams and Flos Lonicerae 85 grams and make granule according to following steps:

(1) Herba Pogostemonis, Herba Taraxaci, the Flos Lonicerae way of distillation are extracted, obtain volatile oil and residue;

(2) residue that the Radix Astragali, Radix Puerariae and step (1) obtain is mixed, add the water of 12 times at every turn, decoct 2 times, merge each decocting liquid, leave standstill after 12 hours, filter, obtain filtrate;

(3) by filtrate evaporation and concentration to paste, the ethanol precipitate with ethanol of 40%, stir, leave standstill 24 hours, by supernatant liquid filtering, decompression recycling ethanol, and the extractum being concentrated into that density is 1.18 ~ 1.36, then drying and crushing powdered;

(4) powder obtained with step (3) after volatile oil beta-cyclodextrin inclusion compound step (1) obtained mixes, and is ground into fine powder;

(5) gained fine powder adds appropriate lactose and dextrin, wet granulation, dry, granulate, and obtained 150 grams of granules, pack, is distributed into 10 grams/bag.

Embodiment 4(capsule):

By drug particles prepared by the method according to embodiment 1, load gelatine capsule, make capsule.

Embodiment 5(tablet):

Add water moistening by embodiment 1 granule, tabletting, makes tablet.

Embodiment 6(pill):

The volatile oil appropriate amount of starch that step (1) obtains in embodiment 1 absorbs, the molding molding heart, and the fine powder obtained with step (3) in embodiment 1 is with general method for making molding, with clear water capping, dry, selects ball, obtained water pill agent.

Claims (2)

1. treat a Chinese medicine composition for type 2 diabetes mellitus, it is characterized in that, the active ingredient of this Chinese medicine composition is made up of the raw material of Chinese medicine medicine of following weight portion: the Radix Astragali 20-40, Radix Puerariae 20-40, Herba Pogostemonis 5-15, Herba Taraxaci 5-15, Flos Lonicerae 5-10;

Described active ingredient is obtained by following method:

(1) Herba Pogostemonis, Herba Taraxaci, the Flos Lonicerae way of distillation are extracted, obtain volatile oil and residue;

(2) residue that the Radix Astragali, Radix Puerariae and step (1) obtain is mixed, add the water of 6 ~ 12 times at every turn, decoct 2 ~ 3 times, merge each decocting liquid, leave standstill after 12 hours, filter, obtain filtrate;

(3) by filtrate evaporation and concentration to paste, add the ethanol precipitate with ethanol that volumetric concentration is 40% ~ 80%, stir leave standstill 24 hours, by supernatant liquid filtering, decompression recycling ethanol, and the extractum being concentrated into that density is 1.18 ~ 1.36, then drying and crushing powdered;

(4) powder obtained with step (3) after volatile oil beta-cyclodextrin inclusion compound step (1) obtained mixes, and is ground into fine powder and get final product.

2. a kind of Chinese medicine composition for the treatment of type 2 diabetes mellitus according to claim 1, is characterized in that, described Chinese medicine composition is granule, capsule, tablet or pill.