CN1565583A - Chinese drugs compositions for treating diabetes and its complications - Google Patents
Chinese drugs compositions for treating diabetes and its complications Download PDFInfo
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- CN1565583A CN1565583A CN 03145334 CN03145334A CN1565583A CN 1565583 A CN1565583 A CN 1565583A CN 03145334 CN03145334 CN 03145334 CN 03145334 A CN03145334 A CN 03145334A CN 1565583 A CN1565583 A CN 1565583A
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Abstract
The invention provides a Chinese medicinal composition for treating diabetes and its complications, characterized in that the composition comprises medicament for invigorating blood circulation, facilitating urine and / or their extracts.
Description
Technical field
The present invention relates to a kind of medicine for the treatment of diabetes and complication thereof, in particular, the present invention relates to a kind of new treatment diabetes and the Chinese medicine of diabetic renal papillary necrosis or the composition and method of making the same of its extract.
Background technology
Diabetes are definitely or relatively to weaken the syndrome that causes owing to insulin secretion and/or insulin action.Because clinical manifestation is that polydipsia, polyphagia are but become thin gradually, the traditional Chinese medical science also is referred to as diabetes.Its clinical manifestation is a hyperglycemia, simultaneously with glucosuria, and the origin of diabetes name of disease that Here it is.According to the classification of modern medicine, diabetes are divided into insulin-dependent diabetes (type i diabetes) and non-insulin-dependent diabetes mellitus (type ii diabetes) two big classes.
Along with progress of research, the medicine of treatment diabetes itself comprises the use of insulin, makes hyperglycemia no longer threaten patient's life security.But because diabetic duration is long, secular diabetic complication becomes influences the diabetics quality of life and then the reason of threat diabetics life.
According to the data that WHO diabetologist committee of World Health Organization (WHO) delivered in 2002, whole world diabetics number is near 200,000,000, and wherein about 96% can be dead because of chronic complicating diseases.According to another report, Chinese diabetics number surpasses 5,000 ten thousand.Along with process of industrialization is accelerated, number of patients is continuous ascendant trend.
Diabetic renal papillary necrosis is the diabetes common complication, and its sickness rate accounts for about 50% of diabetics, and blind rate reaches 6～8%.According to statistics, 10 years diabetic history persons are arranged, 7% has retinopathy, 15 years persons about more than 25%, 15 year the person reach 63%.The pathologic basis of diabetic renal papillary necrosis is a microangiopathies, and promptly diabetes cause amphiblestroid vascular permeability to change, thereby causes serious visual loss and blind etc.
In the past, for treatment of diabetic retinopathy becomes, the method for employing mainly contains to be used the medicine of regulating vascular permeability or adopted laser surgery treatment etc.But so far and the good especially medicine of inefficacy, and operative treatment also only in the early stage effect of morbidity just better.
For diabetic renal papillary necrosis, Chinese medicine has also carried out many researchs, some prescriptions have been proposed, effect is better to a certain extent, for example: 1. determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs: have based on replenishing YIN and removing heat, with Folium Bambusae astragali seu Hedysari Decoction (Radix Astragali, Radix Rehmanniae, Radix Ophiopogonis, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Radix Scutellariae, stewing Gypsum Fibrosum, Radix Paeoniae, Radix Ginseng), Baihu Jia Renshen Tang person's (Gypsum Fibrosum, the Rhizoma Anemarrhenae, Semen oryzae sativae, Radix Glycyrrhizae, Radix Ginseng); Have based on enriching yin and nourishing kidney, with Lycium-rehmannia soup (Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Fructus Corni, Fructus Lycii, Poria, Cortex Moutan, Rhizoma Alismatis, Flos Chrysanthemi), LIUWEI DIHUANG TANG (Radix Rehmanniae Preparata, Fructus Corni, Rhizoma Dioscoreae, Rhizoma Alismatis, Poria, Cortex Moutan) person; Have based on blood circulation promoting and blood stasis dispelling, with TAOHONG SIWU TANG (Semen Persicae, Red flower, Radix Rehmanniae Preparata, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Chuanxiong etc.), blood circulation promoting and blood stasis dispelling side person.2. specially side's treatment: as " the sugar eye is bright " side of Zhu Chenyu, " the blood circulation promoting and blood stasis dispelling spirit " of He Shi etc.3. acupuncture treatment: is master point as Wu Shi after with Pishu, Jingming, ke shu, tsu san li, ball, takes the circumstances into consideration adjunct acupuncture points, receives better curative effect.But above prescription all is a clinical prescription, and retrospective summary is many, and perspective study is few, and lacks positive control more, and curative effect lacks comparability; Wherein clinical research is many, and experimentation is few, and therapeutic mechanism is not clear.Be not merely at diabetic renal papillary necrosis, comprise other diabetic complications, and can its effect be promoted extensively doubtful yet yet.
Therefore, present present situation is the more gratifying medicine based on treatment of diabetic retinopathy of Shang Weiyou.
Purpose of the present invention just is this.Purpose of the present invention provides a kind of Chinese medicine of treatment of diabetic retinopathy change or the composition and method of making the same of its extract.
Summary of the invention
The inventor etc., on the basis of prescription of in the past treating diabetic complication and treatment thought, through long-term further investigation, find, on the basis of existing proved recipe ERZHI WAN, LIUWEI DIHUANG WAN, improvements of writing out a prescription, found that contain nourishing YIN, QI invigorating at least, invigorate blood circulation, the compositions of removing heat from blood, diuretic diuretic or their extract composition, have outstanding curative effect for treatment or diabetes-alleviating complication, finished the present invention thus.
Therefore, the present invention relates to a kind of medicine for the treatment of diabetic complication, in particular, the present invention relates to the Chinese medicine that a kind of new treatment of diabetic retinopathy becomes or the composition and method of making the same of its extract, have following composition:
1. the pharmaceutical composition that is used for the treatment of diabetes or its complication is characterized in that containing nourishing YIN, QI invigorating, invigorates blood circulation, removing heat from blood, diuretic medicine and/or their extract.
2. above-mentioned 1 compositions, wherein the complication of diabetes is diabetic renal papillary necrosis.
3. above-mentioned 1 or 2 compositions is characterized in that above-mentioned nourishing YIN medicine is selected from Radix Asparagi, Herba Dendrobii, Rhizoma Polygonati Odorati, Rhizoma Polygonati, Bulbus Lilii, Fructus Lycii, Fructus Mori, Herba Ecliptae, Fructus Ligustri Lucidi, Tremella, Fructus Corni;
The QI invigorating medicine is selected from Radix Ginseng, Radix Codonopsis, Radix Pseudostellariae, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Rhizoma Dioscoreae, Semen Lablab Album, Radix Glycyrrhizae:
Blood circulation promoting medicine is selected from Rhizoma Chuanxiong, Rhizoma Corydalis, Rhizoma Curcumae Longae, rhizoma sparganic, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati, Semen Persicae, Flos Carthami, Radix Achyranthis Bidentatae, Radix Notoginseng;
The heat clearing away medicine is selected from Gypsum Fibrosum, Rhizoma Phragmitis, Fructus Gardeniae, Radix Scutellariae, Rhizoma Coptidis, Cortex Phellodendri, Radix Rehmanniae, Radix Scrophulariae, Cortex Moutan, Radix Paeoniae Rubra, Flos Lonicerae;
The diuretic medicine is selected from Poria, Polyporus, Rhizoma Alismatis, Caulis Akebiae, Herba Artemisiae Scopariae, Semen Phaseoli, Stigma Maydis, Rhizoma et Radix smilacis ocreatae.
4. above-mentioned 1 or 2 compositions is characterized in that containing Fructus Ligustri Lucidi, Fructus Corni, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Cortex Moutan, Radix Notoginseng, Herba Ecliptae, Rhizoma Dioscoreae, Poria, Radix Achyranthis Bidentatae, Rhizoma et Radix smilacis ocreatae and/or their extract.
5. above-mentioned 1 or 2 compositions, in crude drug, it consists of and contains 20～50 weight portion YIN-tonifying drug, 10～30 weight portion Qi-tonifying drugs, 10～40 weight portion blood circulation promoting medicines, 5～20 weight portion heat removing and blood cooling medicine and 20～50 weight portion diuretic medicines.
6. above-mentioned 1 or 2 compositions, in crude drug, it consists of and contains 25～45 weight portion YIN-tonifying drug, 10～20 weight portion Qi-tonifying drugs, 15～35 weight portion blood circulation promoting medicines, 5～10 weight portion heat removing and blood cooling medicine and 20～40 weight portion diuretic medicines.
7. each compositions of above-mentioned 1-6, wherein the weight proportion of each composition or each composition raw material is:
12 parts of 12 parts of Fructus Corni of 15 portions of Herba Ecliptaes of Fructus Ligustri Lucidi
6 parts of 12 portions of Radix Notoginseng of 15 parts of Radix Salviae Miltiorrhizaes of Rhizoma Dioscoreae
10 parts in 10 parts of Poria of 10 portions of Rhizoma Alismatis of Cortex Moutan
10 parts of 15 parts of Radix Achyranthis Bidentataes of Rhizoma et Radix smilacis ocreatae
8. each compositions of above-mentioned 1-7 is characterized in that this pharmaceutical composition is made powder, tablet, piece agent or granule, medicinal tea or capsule.
9. above-mentioned 8 medicine is capsule.
10. above-mentioned 1～9 each compositions is used for treatment or prevent diabetes or its complication.
11. above-mentioned 10 purposes, diabetic complication are diabetic renal papillary necrosis.
The specific embodiment
Below specifically narrate.
Diabetic renal papillary necrosis (hereinafter to be referred as DRP) belongs to retinopathy, according to theory of Chinese medical science, for pathogeny, draws as drawing a conclusion: diabetes with the passing of time, damage of essence liquid is few, can not on hold the order network, the order eyeball loses supports; Or hepatic and renal YIN deficiency day is very, hyperactivity of YANG due to deficiency of YIN, and hyperactivity of deficient fire, the order network of burning, and cause blurred vision, in addition blind.Be exactly because the long-term diabetes of suffering from cause body each several part unbalance (deficiency of YIN of suffering from a deficiency of the kidney) in other words, cause retina to lose nourishing, even sustain damage, cause a series of pathological changes.Modern doctor is tame by examination of ocular fundus, fluoroscopic visualization etc. are observation method intuitively, and primary disease has been done the research of science from aspects such as hemorheology, microcirculation, blood biochemistry, find that " blood stasis " has important function in its pathogeny, therefore, the traditional Chinese medical science to the relatively more consistent understanding of its pathogenesis is at present: suffering from a deficiency of the kidney is that root, the deficiency of YIN are this, and blood stasis is mark.Control when giving consideration to both the incidental and fundamental, figure merit slowly.
At present, the square medicine of the treatment primary disease of having reported all carries out on this basis, for the suffer from a deficiency of the kidney purpose of the deficiency of YIN of adjustment, is to write out a prescription to adjust and obtain in the basis mostly with the LIUWEI DIHUANG TANG.
The principal agent of LIUWEI DIHUANG TANG comprises hematonic Radix Rehmanniae Preparata, YIN-tonifying drug Fructus Corni, Qi-tonifying drug Rhizoma Dioscoreae, diuretic medicine Rhizoma Alismatis, Poria, blood-cooling drugs Cortex Moutan etc., the inventor etc. find if replace the hematonic Radix Rehmanniae Preparata with other nourishing YIN medicine such as Fructus Ligustri Lucidi, Herba Ecliptae, can strengthen the effect of nourishing the liver and kidney, in addition, if in prescription, add activating blood and removing stasis drug such as Radix Salviae Miltiorrhizae, Radix Notoginseng etc., can in nourishing the liver and kidney, increase the effect of blood circulation-activating eyesight-improving newly.
Thus, the present invention finds the following pharmaceutical composition that is used for the treatment of diabetes or its complication, it is characterized in that containing nourishing YIN, QI invigorating, invigorates blood circulation, removing heat from blood, diuretic medicine and/or their extract.
Specifically, above-mentioned nourishing YIN medicine has Radix Ophiopogonis, Radix Asparagi, Herba Dendrobii, Rhizoma Polygonati Odorati, Rhizoma Polygonati, Bulbus Lilii, Fructus Lycii, Fructus Mori, Herba Ecliptae, Fructus Ligustri Lucidi, Tremella, Fructus Corni etc.Preferred Radix Ophiopogonis, Fructus Lycii, Fructus Mori, Herba Ecliptae, Fructus Ligustri Lucidi, Fructus Corni, most preferably Herba Ecliptae, Fructus Ligustri Lucidi, Fructus Corni.
The QI invigorating medicine has Radix Ginseng, Radix Codonopsis, Radix Pseudostellariae, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Rhizoma Dioscoreae, Semen Lablab Album, Radix Glycyrrhizae etc.Preferably ginseng, the Radix Astragali, Rhizoma Dioscoreae, Radix Glycyrrhizae.Rhizoma Dioscoreae most preferably.
Blood circulation promoting medicine has Rhizoma Chuanxiong, Rhizoma Corydalis, Rhizoma Curcumae Longae, rhizoma sparganic, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati, Semen Persicae, Flos Carthami, Radix Achyranthis Bidentatae, Radix Notoginseng etc.Preferred Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Semen Persicae, Flos Carthami, Radix Achyranthis Bidentatae, Radix Notoginseng, most preferably Radix Salviae Miltiorrhizae, Radix Notoginseng, Radix Achyranthis Bidentatae.
The heat clearing away medicine has Rhizoma Phragmitis, Fructus Gardeniae, Radix Scutellariae, Rhizoma Coptidis, Cortex Phellodendri, (life) Radix Rehmanniae, Radix Scrophulariae, Cortex Moutan, Radix Paeoniae Rubra, Flos Lonicerae etc.Preferred Radix Rehmanniae, Cortex Moutan, Radix Paeoniae Rubra, Flos Lonicerae, most preferably Cortex Moutan.
The diuretic medicine has Poria, Polyporus, Rhizoma Alismatis, Caulis Akebiae, Herba Artemisiae Scopariae, Semen Phaseoli, Stigma Maydis, Rhizoma et Radix smilacis ocreatae etc.Preferred Poria, Rhizoma Alismatis, Semen Phaseoli, Stigma Maydis, Rhizoma et Radix smilacis ocreatae, most preferably Poria, Rhizoma Alismatis, Rhizoma et Radix smilacis ocreatae.
The ratio of each component in the present composition, distinguish to some extent according to the medicine difference that is adopted, for example compare according to relative weight, in the per unit dosage present composition, in crude drug, can contain 20～50 weight portions, preferred 25～45 weight portion YIN-tonifying drug, 10～30 weight portions, preferred 10～20 weight portion Qi-tonifying drugs, 10～40 weight portions, preferred 15～35 weight portion blood circulation promoting medicines, 5～20 weight portions, preferred 5～10 weight portion heat removing and blood cooling medicine and 20～50 weight portions, preferred 20～40 weight portion diuretic medicines.Certainly, those skilled in the art also can make variation to this according to notion of the present invention on basis of the present invention, and the various variations of making based on this also belong to scope of the present invention.
When nourishing YIN choice of drug Herba Ecliptae, Fructus Ligustri Lucidi, Fructus Corni, QI invigorating choice of drug Rhizoma Dioscoreae, blood circulation promoting medicine is selected Radix Salviae Miltiorrhizae, Radix Notoginseng, Radix Achyranthis Bidentatae for use, heat clearing away choice of drug Cortex Moutan, when diuretic choice of drug Poria, Rhizoma Alismatis, Rhizoma et Radix smilacis ocreatae, an example of preferred version of the present invention is composed as follows:
12 parts of 12 parts of Fructus Corni of 15 portions of Herba Ecliptaes of Fructus Ligustri Lucidi
6 parts of 12 portions of Radix Notoginseng of 15 parts of Radix Salviae Miltiorrhizaes of Rhizoma Dioscoreae
10 parts in 10 parts of Poria of 10 portions of Rhizoma Alismatis of Cortex Moutan
10 parts of 15 parts of Radix Achyranthis Bidentataes of Rhizoma et Radix smilacis ocreatae
Among the present invention, above-mentioned Chinese medicine ingredients not only can add with the crude drug form, also can extract it, adds after obtaining effective ingredient.With the compositions that effective ingredient is formed, not only can bring into play the therapeutic effect of above-mentioned prescription, and be convenient for carrying, can reduce patient's dosage.In addition,, can help keeping medicament contg stable, reduce the fluctuation of curative effect of medication by effective component extracting.
The consumption of the present composition, according to the crude drug meter, every day consumption between 10g (2 money)～100g (2 liang), general consumption is about 20g (4 money)～75g (1 two halves), preferred 25g (half two)～50g (1 liang) is preferably in about 30g (according to circumstances can ± about 5g).
Because contained taste of Chinese medicine is more in the present composition, dosage is bigger, is about 30g in the crude drug amount of taking every day, by every day three times, and each dose 8.3～11.7g crude drug.The course of treatment is longer, and reach 3 months each course of treatment.When selecting dosage form, need to select volume little, the dosage form of carrying taking convenience.Conventional fried preparation is inconvenient to carry and take, and therefore is difficult to satisfy above-mentioned requirements.Die from the angle of taking medicine for a long time, preferably the solid preparation made from its extract.
As solid preparation, capsule, tablet, granule etc. are arranged.If the present invention adopts solid preparation,, should make extractum earlier according to above-mentioned narration.During the refabrication granule, can add a certain amount of adjuvant and promote pelletize and extractum dissolving, can select according to the general knowledge of this area, but should avoid adopting adjuvants such as the sugar that may disturb diabetes, be not suitable for diabetic to take, dextrin as the adjuvant of granule.During the preparation compressed tablets, concrete technology for example is mixed into a certain amount of adjuvant etc. with extractum, adds system soft material, pelletize simultaneously, beats sheet.From the preparation angle, capsule can directly or only be enclosed extractum in the gelatine capsule by simple process, and technology is simple.Simultaneously owing to directly can discharge ingredient after the capsule dissolves, the medicine stripping is good, the onset piece, and curative effect is played stably, and taking convenience, volume are little, so capsule is most preferred.Certainly, guaranteeing taking convenience, under the prerequisite of taking easily, other oral or parenteral drug-delivery preparation such as oral liquid, medicated wine also can adopt.Those skilled in the art can according to concrete composition and the extraction process that adopts determine that this variation all belongs to scope of the present invention.
Below introduce preparation process of the present invention.
Belong to general knowledge well known in the art because extract the technology of extractum, do not intend this is done too much restriction among the present invention.Should illustrate that the effective ingredient of the medical material that contains in the compositions has is water miscible, there also have to be fat-soluble, contains water soluble ingredient and liposoluble constituent when having.For containing fat-soluble or containing the medical material of water solublity and liposoluble constituent simultaneously, should take at first to extract liposoluble constituent with the mode of extractions such as alcohol extraction or other organic solvent such as chloroform, ether, petroleum ether.For the medical material that contains water soluble ingredient, under the situation that does not cause drug interaction, can mix back reuse water extraction earlier to simplify technology.For the medical material that contains water solublity and liposoluble constituent simultaneously, after extracting liposoluble constituent, also can be with above-mentioned water soluble ingredient medical material water extraction.For the medical material that contains the volatile oil effective ingredient, should avoid the loss of volatile oil in leaching process, it is standby perhaps to adopt methods such as steam distillation to extract volatile oil earlier.For the heat-labile medical material of effective ingredient, can be according to the conventional way of the field of Chinese medicines, extract effective ingredient with its pulverizing or with low temperature method after, be mixed in the extractum.
More than extract and to adopt method well known in the art, can take methods such as solvent impregnated, percolation, reflux, extract, when for example extracting liposoluble constituent.Solvent is lower aliphatic alcohols such as methanol, ethanol for example, low boiling volatile solvent such as ether, petroleum ether, plant wet goods.If fat-soluble solvent and water soluble also can adopt solvent/water mixture such as alcohol/hydrate etc.When extracting water soluble ingredient, can take methods such as water logging, decoction, ultrasound wave or microwave extraction.As required, also can add medicinal acid, alkali etc. in the water and promote to extract or preserve effective ingredient.Said method also can be used in combination.
Should illustrate, for Chinese medicine, though extractum can be further purified with further decrement, but according to our practice, adopt lower common water extract of purity and alcohol-extracted extract etc., when guaranteeing curative effect, can effectively reduce production costs, from being favourable economically.
Below enumerate example and specify extraction and preparation method.
Embodiment 1.
Compositions for use is specifically composed as follows in this example:
Fructus Ligustri Lucidi 312.5g Herba Ecliptae 250g Fructus Corni 250g
Rhizoma Dioscoreae 312.5g Radix Salviae Miltiorrhizae 250g Radix Notoginseng 125g
Cortex Moutan 208g Rhizoma Alismatis 208g Poria 208g
Rhizoma et Radix smilacis ocreatae 312.5g Radix Achyranthis Bidentatae 208g
By analysis, Fructus Ligustri Lucidi, Fructus Corni, Radix Salviae Miltiorrhizae and Rhizoma Alismatis contain fat-soluble effective ingredient in the prescription, and the dissolubility of these compositions in water is less, so these medicines are adopted ethanol extraction earlier.These medicines also contain aqueous soluble active constituent simultaneously, together carry out water extraction with other medicines again after the alcohol extraction.
The concrete source of above medical material is as follows, if not special indicating then is to identify and use according to the Pharmacopoeia of the People's Republic of China one one of version in 2000.
Fructus Ligustri Lucidi: the ripe dry fruit of Oleaceae plant Fructus Ligustri Lucidi Ligustrum lucidum Ait.;
Herba Ecliptae: the dry aerial parts of feverfew Eclipta prostrata Eclipta prostrata L.;
Fructus Corni: the drying and ripening sarcocarp of Cornaceae plant Fructus Corni Cornus officinalis Sieb.et Zucc.;
Rhizoma Dioscoreae: the dry rhizome of Dioscoreaceae plant Rhizoma Dioscoreae Dioscorea opposita Thunb.;
Radix Salviae Miltiorrhizae: the dry root and rhizome of labiate Radix Salviae Miltiorrhizae Salvia multirrhiza Bge.;
Radix Notoginseng: the dry root of panax araliaceae plant Panax notoginseng (Burk.) F.H.Chen;
Cortex Moutan: the dry root bark of ranunculaceae peony Paeonia suffruticosa Andr.;
Rhizoma Alismatis: the dry tuber of Alismataceae plant Rhizoma Alismatis Alisma orientalis (Sam.) Juzep.;
Poria: the dry sclerotia of Polyporaceae fungus Poria Poria cocos (Schw.) Wolf;
Rhizoma et Radix smilacis ocreatae: the dry rhizome of liliaceous plant Rhizoma Smilacis Chinensis Smilax china L. (according to the local Chinese medicine standard in Hunan Province);
Radix Achyranthis Bidentatae: the dry root of amaranthaceous plant Radix Achyranthis Bidentatae Achyranthes bidentata Bl.
2. operating procedure
More than ten simply, Radix Notoginseng powder is broken into fine powder, and is standby; Cortex Moutan water flowing steam distillation is collected the about 500ml of distillate, adds the 40g beta-schardinger dextrin-, and 40 ℃ of stirrings made enclose, cold preservation 24 hours, sucking filtration, clathrate put drying below 60 ℃ in 1.5 hours, and are standby; Medicinal residues and medicinal liquid are put in addition.Get Fructus Ligustri Lucidi, Fructus Corni, Radix Salviae Miltiorrhizae, Rhizoma Alismatis and add 90% alcohol heating reflux and extract 2 times, each 2 hours, merge extractive liquid,, filter, filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.40 (60-70 ℃ of heat is surveyed), adds Radix Notoginseng fine powder 50g, mixing, 60-70 ℃ of drying is ground into coarse powder.Standby; The five tastes such as all the other Herba Ecliptaes add that medicinal residues and Cortex Moutan distillation back medicinal residues medicinal liquid decoct with water 2 times after the above-mentioned alcohol extraction, each 2 hours, merge decoction liquor, filter, filtrate is concentrated into the thick paste that relative density is 1.30-1.40 (60-70 ℃ of heat is surveyed), adds above-mentioned remaining Radix Notoginseng fine powder, mixing, 60-70 ℃ of drying under reduced pressure is ground into coarse powder.Add above-mentioned alcohol-extracted extract powder and cycloheptaamylose clathrate, fully mixing according to conventional method fill capsule, is made 1000, promptly approximately.Every heavily about 0.5g is equivalent to contain the about 2.7g of crude drug.
Embodiment 2～4
Amplify about 12 times according to above operation, repeat 3 times, the result is as shown in table 1 below.
Table 1
| Embodiment number | Embodiment 2 | Embodiment 3 | Embodiment 4 |
| Dosage (Kg) | ????31.75 | ????31.75 | ????31.75 |
| Alcohol-extracted extract heavy (g) | ????1350 | ????1250 | ????1250 |
| Add Radix Notoginseng powder (%) after the alcohol extraction | ????40％ | ????40％ | ????40％ |
| Water is promoted extractum heavy (g) | ????4750 | ????4450 | ????4400 |
| Water is carried the back and is added Radix Notoginseng powder (%) | ????60％ | ????60％ | ????60％ |
| Benexate Hydrochloride heavy (g) | ????350 | ????330 | ????320 |
| Mix back dry powder heavy (g) | ????6400 | ????5970 | ????5840 |
| Encapsulated quantity (grain) | ????12700 | ????11800 | ????11500 |
Above-mentioned three batches of products are carried out the assay of special component, result such as following table 2 according to conventional method.
Table 2
| Embodiment number | Embodiment 2 | Embodiment 3 | Embodiment 4 |
| Moisture content (%) | ????4.52 | ????3.89 | ????3.75 |
| Tanshinone content (%) | ????0.057 | ????0.060 | ????0.061 |
| Oleanolic acid content (%) | ????0.59 | ????0.61 | ????0.62 |
| Ursolic acid content (%) | ????0.37 | ????0.39 | ????0.39 |
Illustrate that the product active constituent content that adopts compositions of the present invention and preparation method to obtain is stable, be suitable for suitability for industrialized production.
Below further specify effect of the present invention by the pharmacological experiment data.
Pharmacological experimental example 1 toxicological experiment
(1) acute toxicity test:
20 Balb/c mices, body weight 18～22 grams, the male and female dual-purpose, fasting is 16 hours before the test.Get embodiment 1 capsule, peel off capsule shells after, be made into 2.0 gram (, as follows)/ml concn solution to mouse stomach with distilled water by crude drug, 0.8 milliliter/20 grams were irritated stomach 3 times in 24 hours.Observe after the administration that animal behavior changes and animal dead situation in 7 days, calculate LD
50
The animal Non Apparent Abnormality does not have death in 7 days, fails to obtain LD
50Dosis tolerata＞the 240g/kg of the present composition shows that the present composition is safer.
(2) long term toxicity test:
A SD cleaning level rat, male and female half and half, 7-9 age in week, body weight 65～75 grams.Test after taming a week.
Rat is divided into three groups at random---the heavy dose of group of administration, small dose group, negative control group, 30 every group, male and female half and half.The aqueous solution (using water dissolution after peelling off capsule shells) of giving embodiment 2 resulting compositions every day is respectively organized in administration, dosage, heavy dose of group 30g/kg, small dose group 15g/kg.Gastric infusion, matched group 1.5ml/100g, administration group administration concentration is respectively 2.0g/ml, 1.0g/ml.
Laboratory keeps 12 hours bright dark rhythm and pace of moving things, 25 ± 2 ℃ of temperature, relative humidity about 55%.Continuous 6 months.
Through animal clinical observation, hematology, biochemical, histopathologic examination, animal does not see has tangible toxicity to occur, results suggest, and clinical practice all is the comparison safe dosage in every day below the 30g/kg.
By above toxicological test result as seen, it is nontoxic that the present composition is actually.Diabetics can be taken for a long time.
Pharmacological experimental example 2. present compositions are to the effect of diabetes model rabbit.
The present invention at diabetic renal papillary necrosis (Diabetic Retinopathy DRP) does not have ready-made and perfect animal model.According to existing theoretical, this disease etiology and pathogenesis is caused by diabetes (or hyperglycemia state) that mainly main Pathophysiology is: three-hypers factor, i.e. blood capillary high-permeability, blood-hyperviscosity, platelet high activity.For this reason, the inventor etc. cause the rabbit hyperglycemia state, and kept 90 days by using alloxan, set up animal model.
1, uses this product treatment diabetic rabbit, observed cAMP (cyclic adenosine monophosphate), the 6-keto-PGF of blood glucose, clinical manifestation, retina common pathology and ultrastructure, retina local organization
1a(prostaglandin F), TXB
2The influence of platelet membrane granule protein, blood euglobulin lysis time etc. in (thromboxane element), SOD (superoxide dismutase), erythrocyte pliability, blood platelet adhesion reaction, the blood plasma.
Experiment material
Medicine and reagent:
1) present composition (the following JM that is called for short sometimes), the extract formulation of the compositions of the foregoing description 1 faces the time spent and peels off capsule shells, is made into desired concn with distilled water, and the animal consumption shows by the crude drug in whole scale.
2) SOD ria-determination test kit: Golden Shield pharmaceutical factory in Nanjing provides, and lot number is: 971205.
3) cAMP ria-determination medicine box: Suzhou Medical College thrombosis research department provides, lot number, 971120.
4) blood plasma TXB
2Test kit: Suzhou Medical College thrombosis research department provides,
5) 6-keto-PGF
1aTest kit: the same
6) α-membrane granulosa protein 140 (GMP-140) radioimmunological kit: the same.
All the other reagent and equipment are the commercially available prod.
Animal
Healthy white big ear rabbit, body weight 1.2-1.5kg, male and female half and half.
Key instrument
SCOT portable blood sugar analyzer, FJ-2008PV-immunity calculating instrument (Plant No. 262), 2332 spectrophotometers (Shanghai the 3rd analytical tool factory), ELT viscometer (Chengdu Instruement Factory), WPT-III platelet adhesion instrument (gulf, jiangsu wuxi Shitang medical electronics factory) etc.Experimental technique and result
(1), experimental technique
1. modeling method
Adopt following method: get health large ear rabbit, fasting after 12 hours ear vein blood sampling with GLUCO SCOT portable blood sugar analyzer measuring blood value, select animal intravenous injection alloxan (from the Sigma company) 200mg/ml of blood glucose value below 10mg/ml for use, the fasting glucose of blood sampling mensuration again after 48 hours, get blood glucose value the above person of 200mg/kg as laboratory animal, matched group is with the method injecting normal saline, each group was respectively at the 20th day, 40 days, 60 days, measure fasting glucose, with the animal of fasting blood sugar greater than 20mg/ml, respectively inject alloxan one time with method again, to keep hyperglycemia state, monitor fasting glucose after the injection simultaneously, surveyed fasting glucose in the 61st day again, go into to be elected to be next step grouping and administration experiment greater than the animal of 20mg/ml with blood sugar concentration.
2. animal divides into groups and medication
Get 60 days white big ear rabbit of modeling and be divided into following 5 groups at random, 12 every group, other gets 8 normal rabbits of raising the same period, and fasting glucose is organized in contrast the following person of 10mg/ml.
Matched group (normal control group): irritate on an empty stomach with distilled water 8ml/kg every day.
Model group (model group matched group): irritate on an empty stomach with distilled water 8ml/kg every day.
The high group of JM (the heavy dose of group of the present composition, as follows): concentration 0.36g/ml, consumption 8ml/kg.
Organize among the JM: 0.18g/ml, 8ml/kg.
JM group: 0.09g/ml, 8ml/kg.
3. collection of specimens and processing
1) blood sample collection
Fasting 12 hours, platelet adhesion reaction, euglobulin lysis time, erythrocyte pliability, blood plasma α-membrane granulosa protein 140 (GMP-140) are surveyed in the heart blood sampling before the anesthesia.
2) the retina of right eye tissue is done electron microscope specimen and routine pathology inspection
With administration 30 days respectively organize rabbit with pentobarbital anesthesia after, the animal right eye is extracted out eye-chamber liquid by camera oculi anterior, inject the about 1ml of 2.5% glutaraldehyde solution then and do perfusion fixation, take out eyeball rapidly, cut off cornea gently, peel off crystalline lens and vitreous body, with half places 2.5% glutaraldehyde outside the retinal tissue clip of cup-shaped, to make electron microscopic examination, half does common pathology inspection with 10% formalin fixed in addition.With the retinal tissue piece, put spend the night in the 2.5% glutaraldehyde fixative (4 ℃) after, under anatomical lens, cut the thicker little blood vessel in surface, with 1%OsO
4The back is fixing, the dehydration of gradient acetone, and EPON812 soaks, embedding, the section of LKBIII type ultramicrotome, acetic acid uranium-citron lead plumbate dyeing, the H-600 of Hitachi type transmission electron microscope observing.Second half retinal tissue is cut into slices routinely, HE dyeing, om observation.
3) retina of left eye homogenate preparation of specimen
Take out the left side eyeball simultaneously, on the ice moat by on method strip out retina, get filter paper and inhale and remove surperficial blood, after weighing, normal saline on the rocks is made 5% homogenate with Syrup-homogenizing instrument, and homogenate is through 4000 rev/mins of low-temperature centrifugations after 25 minutes, get supernatant and put-20 ℃ of refrigerators preservations, be used to survey SOD activity, TXB
2, 6-keto-PGF
1a, cAMP.
4) observation index and detection method
1. blood sugar detection: with portable GLUCO SCOT instrument measuring blood, all from the quiet blood measuring blood of getting of ear edge.
2. SOD measures: adopt SOD ria-determination test kit (from Nanjing Golden Shield pharmaceutical factory) to measure.Organize to specifications and serum processing and mensuration.
3. retinal tissue cyclic adenosine monophosphate (cAMP): the radioimmunoassay medicine box that Suzhou Medical College thrombosis research department provides, carry out the detection of this index with the tissue homogenate supernatant.
4. retinal tissue TXB
2, 6-Keto-PGF
1aAssay method: retinal tissue liquid is handled the same, and detection method is undertaken by the radioimmunological kit description.
6. the erythrocyte pliability detects: detect with millipore filters, concrete grammar: with the blood specimen sodium citrate anticoagulant of gathering, get the about 1ml of anticoagulation, measure its packed cell volume after, with 5 times (adding the 4ml normal saline) of normal saline dilution, to dilute blood is put in 10 milliliters of syringes, filter through micropore filter (acetate fiber filter membrane, aperture are 5 μ m) again, through centrifugal, detect packed cell volume in the filtrate, calculate and filter percentage rate.
6. platelet adhesion mensuration
Heart extracting blood 2.7ml places the silication test tube that contains 3.13% liquor sodii citratis 0.3ml, gently mixing.Getting 1.5ml anticoagulation adding capacity subsequently is in the spherical glass bottle of 12ml, aryballos is fixed on the tumbler of platelet adhesion instrument, changes 15 minutes with 3 rev/mins speed, and blood is fully contacted with the bottle wall.Respectively getting 1ml blood during the rotation back (adheres to preceding) from annular bottle (adhering to the back) and in the test tube joins respectively in the Boiling tube that fills 3.13% liquor sodii citratis 19ml, cover the test tube mouth with plastic foil, topple over repeatedly 3 times, make it even, at room temperature left standstill 2 hours, and got the test tube supernatant liquid and carry out platelet count.Each tested specimen is all done duplicate determination, gets its average, calculates platelet adhesion rate.
7. the mensuration of blood plasma euglobulin lysis time (ELT)
Heart extracting blood is pressed the preceding method separated plasma, gets fresh plasma 0.5ml, be added in advance and contain in the taper centrifuge tube of 9ml acetic acid solution after the cooling, be placed on built-in 30 minutes of 4 ℃ of refrigerators behind the mixing, euglobulin is flocculent deposit separates out, centrifugal (3000 rev/mins) 5 minutes.Supernatant gently inclines, keep the precipitation part, centrifuge tube is upside down on the filter paper about 2 minutes, exhausts the residue acid solution, again centrifuge tube is placed in 37 ± 0.1 ℃ of glass waters bath with thermostatic control, add 0.5ml pH9.0 boric acid solution, carefully stir with thin Glass rod, make resolution of precipitate, add 0.025mol/L calcium chloride solution mixing again, about 1-2 minute, liquid in pipe began to solidify.Record is formed into the consoluet time of grumeleuse from grumeleuse, and this process required time is ELT, with 10000 divided by ELT, is lytic activity unit again.
8. clinical observation: modeling begins grouping and administration after 60 days, because that the animal blood glucose level is kept is higher, the normal physiological function is affected in the body, and certain clinical symptoms and sign appear in animal, and we add up body weight and mortality rate.
4) statistical procedures: owing to use the alloxan modeling, animal mortality rate midway is higher, and to detect index more in addition, and experiment divides many batches to be carried out, and comprehensively each batch experimental result guarantees every group of sample number greater than 6 examples, and the result organizes a t check.
Experimental result
1, to the influence of blood glucose
The result by table 3 as seen, the blood glucose of animal pattern is apparently higher than the normal control group.After with present composition JM treatment, blood sugar level has to a certain degree decline, compares with model control group, and the 15th day each administration group blood sugar level has obvious reduction after administration, and reduction in the 30th day is more obvious, and reducing difference has statistical significance.
The influence of table 3 pair diabetic rabbit blood glucose (X ± SD)
| Group | Example number n | Blood sugar level (mg/ml) | |||||
| Before the modeling | Before the administration | After the administration 15 days | Reduce difference | After the administration 30 days | Reduce difference | ||
| Normal control | ?8 | ??7.5±1.3 | ??7.6±10** | ??7.1±0.9 | ??0.4±10 | ??7.4±12 | ??0.2±11 |
| Model | ?6 | ??7.6±1.4 | ??67.9±6.7 | ??55.7±8.1 | ??12.1±4.5 | ??39.9±7.7 | ??28.0±1.9 |
| The JM height | ?9 | ??7.7±0.9 | ??68.2±6.8 | ??38.3±±4.8 | ??29.8±7.6** | ??23.4±5.4 | ??44.8±9.0** |
| Among the JM | ?8 | ??7.9±1.3 | ??65.3±7.5 | ??42.8±7.6 | ??22.5±11.4* | ??25.7±6.5 | ??39.6±8.2** |
| JM is little | ?6 | ??8.1±1.4 | ??66.8±6.6 | ??44.3±5.9 | ??22.5±3.6** | ??28.9±6.2 | ??37.9±7.5* |
Compare *, P＜0.05, * *: P＜0.01 with model group;
2, clinical observation
1), to the influence of diabetic animal clinical manifestation
With the normal control animal relatively, occur the ingesting increase, weight loss, drinking-water of model group animal increases, with people's clinical diabetes polydipsia, easily hungry, become thin similar.Every sign is organized in treatment and the symptom performance is lighter.Variation to body weight is added up, by table 4 as seen, the zoic model with hyperglycemia average weight does not only increase, descend on the contrary, with the normal control group relatively be obvious decline, through with after the JM treatment, than weight loss slowing down in various degree arranged with model group, wherein the big or middle dosage group of JM weight increase is respectively 9.7%, 7.6%.
The influence of table 4 pair body weight (X ± SD)
| Group | The example number | Before the administration | After the administration 30 days | Weight increase % |
| Normal control | ????8 | ????1.91±0.27 | ????2.59±0.30** | ????35.8±8.9** |
| Model | ????6 | ????1.46±0.33 | ????1.30±0.27 | ????-10.6±5.6 |
| The JM height | ????9 | ????1.41±0.31 | ????1.56±0.28 | ????9.7±10.3** |
| Among the JM | ????8 | ????1.37±0.29 | ????1.48±0.34 | ????7.6±3.0** |
| JM is little | ????6 | ????1.36±0.39 | ????1.30±0.31 | ????-3.7±5.1 |
Compare * *: P＜0.01 with model group.
2), to the influence of the mortality rate of diabetic rabbit
Secular hyperglycemia state, rabbit has higher mortality rate, and each group mortality rate during modeling in 60 days is about 50%, and dead animal is included the statistics that medicine may exert an influence in after 1 week of administration, result's statistics sees table 5 for details, and each administration group of JM has the trend that reduces animal dead.
Animal thing death condition during rabbit modeling of table 5 glycosuria and the administration
| Group | Number of animals before the modeling | The mortality rate (%) of modeling in 1 week of administration | 1 all total routine numbers (n) after the administration | Death toll after full 1 week of administration | Finish administration cycle number of animals | 1 week of administration back mortality rate % |
| Normal control | ????8 | ????0 | ????8 | ????0 | ????8 | ?????0 |
| Model | ????25 | ????48 | ????12 | ????6 | ????6 | ?????50 |
| The JM height | ????23 | ????52.2 | ????12 | ????3 | ????9 | ?????25 |
| Among the JM | ????24 | ????50 | ????12 | ????4 | ????8 | ?????33.3 |
| JM is little | ????23 | ????52.2 | ????12 | ????6 | ????6 | ?????50 |
3, to the histological influence of retinal vessel pathology
The animal of finishing the administration cycle is all made retinal tissue routine pathology and electron microscopic examination.Each group of macroscopy shows no obvious abnormalities.
Visible minority animal has obvious edema under the light microscopic, thick, distortion that small artery luminal stenosis, venule have, and local venule anfractuosity expansion, blood capillary has obvious distortion.Under the Electronic Speculum, it is narrow that each group all can have been seen the little lumen of vessels of basilar part, the endotheliocyte qualitative change is thin, often be segmental dissolving, fracture, edema under the basement membrane, the common collagen fiber of endothelium fracture place are exposed, and smooth muscle cell dense patch and dense body, myofilament are still high-visible, mitochondrion swelling is in various degree arranged, cavity change and reticulum dilatation etc. in the endotheliocyte.The obvious degeneration of pericyte's mitochondrion, endotheliocyte has the endochylema projection with nuclear for middle mind-set tube chamber, increases the weight of luminal stenosis, and capillary basement membrane thickens.See in the retinal pigment epithelium that lipochondrion increases.The model control group performance obviously and seriously, statistics the pathological changes number occurs and sees Table 6.
Pathological examination shows: certain pathological change appears in diabetic model group retinal blood tubing, and light microscopic is not only seen the minority animal pathological change.The modeling animal can be seen the changes such as mitochondrion, endoplasmic reticulum and plasmolysis of vascular endothelial cell mostly under the Electronic Speculum, and it is rare than model control group that routine number average appears in the administration treated animal, occurs less with the JM high dose group.Be each group difference of objective evaluation, comprehensive light microscopic and Electronic Speculum result, adopt the pathology integration method to compare, because the light microscopic finding is more serious change, so increase the weight of the light microscopy checking weighted value, each group light microscopy checking is divided into 2 to unusual zoometer, light microscopic intact animal score is 0, the pathological change zoometer is appearred in the Electronic Speculum result be divided into 1, intact animal's score is 0, then every routine animal light microscopic and Electronic Speculum score addition are each routine pathology integration, average integral between relatively each is organized, carrying out measurement data handles, the results are shown in Table 6, the high group of JM compares with model group, can obviously reduce pathology integration (P＜0.05), and prompting JM has the effect of better prevention rabbit diabetic renal papillary necrosis.
Table 6 rabbit retina pathology check result (X ± SD)
| Group | Finish total routine number of administration cycle (n) | Dosage/kg | The unusual number of animals of light microscopy checking | Electronic Speculum blood check vessel cellular abnormality example number | The pathological changes integral mean value |
| Normal control | ??????8 | ???8.0ml | ?????0 | ?????0 | ?????0 |
| Model | ??????6 | ???8.0ml | ?????3(50.0) | ?????6(100) | ?????2.00±1.09 |
| The JM height | ??????9 | ???3.0g | ?????1(11.1) | ?????3(33.3) | ?????0.56±1.01* |
| Among the JM | ??????8 | ???1.5g | ?????2(25.0) | ?????4(50.0) | ?????1.00±1.31 |
| JM is little | ??????6 | ???0.8g | ?????2(33.3) | ?????6(100) | ?????1.67±1.03 |
Compare *: P＜0.05 (in the bracket is percentage rate) with model group.
4, to the influence of retinal tissue SOD
By table 7 as seen, the rabbit of long-term hyperglycemia state, its retinal tissue SOD activity is starkly lower than the normal control group, and after the drug application treatment, JM height, middle dosage group can obviously improve diabetic animal retinal tissue SOD activity.
The influence of table 7 couple retinal tissue SOD (X ± SD)
| Group | Example number (n) | Dosage/kg | ???SOD(U/100mg?pro) |
| Normal control | ????8 | ????8.0ml | ??????2.3±0.9 |
| Model | ????6 | ????8.0ml | ??????0.7±0.6 |
| The JM height | ????9 | ????3.0g | ??????1.5±0.6* |
| Among the JM | ????8 | ????1.5g | ??????1.6±0.7* |
| JM is little | ????6 | ????0.8g | ??????1.0±1.2 |
Compare * P＜0.05 with model group.
5. to the influence of cAMP content in the diabetic rabbit retinal tissue
By table 8 as seen, the diabetes model animal is compared with the intact animal, and cAMP obviously descends in the retinal tissue, and difference has statistical significance (p＜0.01).After the high group treatment of JM, cAMP is significantly improved, and compares with model group, and difference has statistical significance (P＜0.05).
The influence of table 8 pair diabetic rabbit retinal tissue cAMP content (X ± SD)
| Group | Number of animals (n) | Dosage/kg | CAMP content (pm/ml) |
| Normal control | ????8 | ????8.0ml | ????37.5±5.8** |
| Model | ????6 | ????8.0ml | ????27.9±4.6 |
| The JM height | ????9 | ????3.0g | ????36.5±4.2** |
| Among the JM | ????8 | ????1.5g | ????31.2±4.9 |
| JM is little | ????6 | ????0.8g | ????29.9±6.6 |
Compare * *: P＜0.01 with model group;
6, to diabetic animal retina TXB
2, 6-Keto-PGF
1aInfluence
Table 9 pair diabetic animal retinal tissue
TXB
2, 6-Keto-GF
1aInfluence (X ± SD)
| Group | Number of animals (n) | Dosage/kg | ????TXB 2(pg/ml) | ????6-K-PGF1a(pg/ml) |
| Normal control | ????8 | ????8.0ml | ????17.7±3.5** | ????22.2±3.1 |
| Model | ????6 | ????8.0ml | ????26.3±4.2 | ????13.2±5.1 |
| The JM height | ????9 | ????3.0g | ????22.3±4.0 | ????17.3±4.1 |
| Among the JM | ????8 | ????1.5g | ????24.5±5.9 | ????15.7±4.0 |
| JM is little | ????6 | ????0.8g | ????24.9±6.3 | ????15.3±5.8 |
By table 9 as seen, the TXB of diabetes model animal retinal tissue
2Obvious increase, 6-Keto-PGF
1aObviously reduce, after with the JM treatment, the TXB of animal
2Reduction trend is arranged, 6-Keto-PGF
1aHave to a certain degree and raise.
7. to the influence of α-membrane granulosa protein 140 (GMP-140) in the diabetic animal blood plasma
140 of α in the table 10 pair blood plasma-membrana granulosa egg
(GMP-140) influence (X ± SD)
| Group | Number of animals (n) | Dosage/kg | ????GMP-140(ng/ml) |
| Normal control | ????8 | ????8.0ml | ????5.6±3.1** |
| Model | ????6 | ????8.0ml | ????19.4±5.2 |
| The JM height | ????9 | ????3.0g | ????14.2±4.2* |
| Among the JM | ????8 | ????1.5g | ????17.5±6.7 |
| JM is little | ????6 | ????0.8g | ????17.9±6.5 |
Compare *, P＜0.05, * *: P＜0.01 with model group.
α-membrane granulosa protein 140 is the index of platelet activation degree in the body, and by table 10 as seen, the α-membrane granulosa protein 140 of diabetic animal obviously increases, and after the JM treatment, α-membrane granulosa protein 140 has reduction effect or trend in the diabetic animal blood plasma.
8. the erythrocyte pliability is influenced
Detected erythrocytic pliability by MF method, represented that to filter percentage rate the erythrocyte of diabetic animal obviously descends by the ratio of micropore, its pliability descends, the JM high dose group can obviously be resisted this effect, improves erythrocytic plasticity, pliability, the results are shown in Table 11.
Table 11JM is to the influence of diabetic rabbit erythrocyte micropore filtration rate (X ± SD)
| Group | Number of animals (n) | Dosage/kg | Erythrocyte filtration rate % |
| Normal control | ????8 | ????8.0ml | ????65.6±11.5 |
| Model | ????6 | ????8.0ml | ????31.4±9.8 |
| The JM height | ????9 | ????3.0g | ????45.2±11.0 |
| Among the JM | ????8 | ????1.5g | ????43.4±12.5 |
| JM is little | ????6 | ????0.8g | ????37.9±11.3 |
9.JM influence to the diabetic rabbit platelet adhesion reaction
Compare with the normal control group, the platelet adhesion rate of model group obviously increases, and each group of JM has the trend that reduces the diabetic animal platelet adhesion rate.
Table 12JM is to the influence of platelet adhesion rate (X ± SD)
| Group | Number of animals (n) | Dosage/kg | Platelet adhesion rate % |
| Normal control | ????8 | ????8.0ml | ????26.4±4.9 |
| Model | ????6 | ????8.0ml | ????36.7±7.8 |
| The JM height | ????9 | ????3.0g | ????32.5±5.8 |
| Among the JM | ????8 | ????1.5g | ????32.6±6.4 |
| JM is little | ????6 | ????0.8g | ????35.1±5.6 |
10, JM is to the influence of diabetic rabbit blood euglobulin lysis time
By table 13 as seen, compare with the normal control group, the cellulase lytic activity unit of model group animal obviously reduces, and shows that diabetes cause the body fibrinolytic to descend, and JM all improves to fibrinolytic unit.
Table 13JM is to the influence of diabetic animal fibrinolytic (X ± SD)
| Group | Number of animals (n) | Dosage/kg | The u of fibrinolysin lytic activity unit |
| Normal control | ????8 | ????8.0ml | ?65.4±7.5 |
| Model | ????6 | ????8.0ml | ?47.8±11.2 |
| The JM height | ????9 | ????3.0g | ?51.5±8.9 |
| Among the JM | ????8 | ????1.5g | ?51.06±9.7 |
| JM is little | ????6 | ????0.8g | ?49.6±10.7 |
By above-mentioned data as seen, after the JM treatment, above-mentioned every index all have in various degree slow down the effect or trend, the result shows that JM all has the improvement effect to the main pathology physical signs of these three aspects of disease, the prompting present composition this disease is had therapeutical effect preferably.
Pharmacological experimental example 3.The present composition is to diabetes model rat blood sugar and hemorheological influence
Experimental technique
1, modeling type method
Select the pure lines male Wistar rat of growing up for use, body weight 210-250 gram, measure fasting glucose, remove the undesired animal of blood glucose, after the fasting 6 hours, every Mus lumbar injection streptozotocin is (from Sigma company, citrate buffer (pH4.5) preparation with 0.1mmol/L) 65mg/kg brings out diabetes, adopt the Mus tail survey fasting glucose of bleeding after three days, is experimental diabetic animal with blood glucose greater than 40mg/ml and glucose in urine lasting masculin person, divides 5 groups at random with animal, 10 every group, other establishes 10 of normal control groups, surveys the blood glucose of respectively organizing the administration front and back simultaneously.
Each organizes after grouping is gastric infusion every day, and dosage sees Table 14, after continuous two weeks, plucks eyeball and gets the following hemorheology index of blood work:
1. whole blood viscosity: adopt Japanese ELD type cone-plate speed change rotating cylinder viscometer, get and cut speed and be 1.92S
-1, print record automatically.
2. plasma viscosity: adopt Shanghai Medical Univ's capillary viscosimeter, calculate blood plasma by required time of capillary tube with the normal saline of volume ratio by the capillary tube required time.
3. erythrocyte sedimentation rate: with the hematocrit pipe of the long 100mm of internal diameter 2.8mm, the erythrocyte sedimentation rate behind the observation 1h
4. packed cell volume; Continue experiment with the hematocrit pipe behind the record erythrocyte sedimentation rate,, ask packed cell volume with the centrifugal 30min of 3000 rev/mins speed.
5. plasma fibrinogen: the biuret method of saltouing.
Experimental result
By table 14 as seen, blood glucose in diabetic rats is apparently higher than normal rat, and each administration group of JM and model group relatively have in various degree reduction effect or trend.
Table 14JM is to the influence of blood glucose in diabetic rats (X ± SD)
| Group | The example number | Dosage (/kg) | Blood sugar level (mg/ml) | |||
| Before the modeling | During administration | After the administration 15 days | Reduce difference | |||
| Normal control | ????10 | ????10ml | ????9.5±1.0 | ????9.4±1.2** | ????9.6±1.5** | ????-0.2±1.1** |
| Model | ????10 | ????10ml | ????9.4±1.2 | ????46.7±7.4 | ????36.5±8.1 | ????10.3±5.4 |
| The JM height | ????10 | ????5.6g | ????8.9±1.6 | ????45.3±7.2 | ????22.7±4.5** | ????22.6±5.4** |
| Among the JM | ????10 | ????2.8g | ????8.8±1.5 | ????42.7±7.8 | ????31.0±7.2 | ????11.6±8.1 |
| JM is little | ????10 | ????1.4g | ????9.6±1.7 | ????44.3±6.2 | ????31.6±6.2 | ????12.7±9.0 |
**：P＜0.01
Table 15 pair hemorheology alone n diabetic rats influence (X ± SD)
| Group | The whole blood contrast viscosity ratio) 1/ second | (plasma viscosity (ratio) | Packed cell volume (%) | Erythrocyte sedimentation rate (mm/h) | Fibrin (g/L) |
| Normal control | ????27.8±7.2** | ???1.6±0.1 | ??48.6±6.7** | ??1.2±0.9** | ?2.3±0.4 |
| Model | ????62.4±11.5 | ???1.8±0.1 | ??67.8±5.9 | ??2.2±0.5 | ?1.6±0.5 |
| The JM height | ????45.5±6.7** | ???1.7±0.1 | ??56.0±6.9** | ??1.6±0.5** | ?1.9±0.8 |
| Among the JM | ????49.7±11.8* | ???1.8±0.2 | ??57.7±7.6** | ??1.6±0.8 | ?2.0±0.7 |
| JM is little | ????45.8±12.3** | ???1.7±0.1 | ??60.3±6.4 | ??1.8±1.2 | ?1.9±0.9 |
Compare *: P＜0.05, * *: P＜0.01 with model group.
By table 15 as seen, hemorheological indexes of diabetes model rat and normal control group relatively have obvious change, show as blood viscosity, packed cell volume, erythrocyte sedimentation rate and all descend, and fibrinogen content increases.Each index of each administration group of JM changes obviously slows down or sluggish trend is arranged.
The change of blood sugar and the hemorheological indexes of the rat diabetes that causes with streptozotocin have been detected, the animal pattern performance has blood glucose obviously to increase, hemorheological property shows as blood viscosity, blood plasma viscosity, packed cell volume, erythrocyte sedimentation rate and all descends, and fibrinogen content increases.Each administration group of JM has certain blood sugar reducing function, each index of above-mentioned hemorheology is changed to have slow down effect or trend.Results suggest JM has certain therapeutical effect to DRP.
Claims (11)
1. be used for the treatment of or the pharmaceutical composition of prevent diabetes or its complication, it is characterized in that containing nourishing YIN, QI invigorating, invigorate blood circulation, removing heat from blood, convergence, diuretic diuretic and/or their extract.
2. according to the compositions of claim 1, wherein the complication of diabetes is diabetic renal papillary necrosis.
3. according to the compositions of claim 1 or 2, it is characterized in that above-mentioned nourishing YIN medicine is selected from Radix Asparagi, Herba Dendrobii, Rhizoma Polygonati Odorati, Rhizoma Polygonati, Bulbus Lilii, Fructus Lycii, Fructus Mori, Herba Ecliptae, Fructus Ligustri Lucidi, Tremella, Fructus Corni;
The QI invigorating medicine is selected from Radix Codonopsis, Radix Pseudostellariae, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Rhizoma Dioscoreae, Semen Lablab Album, Radix Glycyrrhizae:
Blood circulation promoting medicine is selected from Rhizoma Chuanxiong, Rhizoma Corydalis, Rhizoma Curcumae Longae, rhizoma sparganic, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati, Semen Persicae, Flos Carthami, Radix Achyranthis Bidentatae, Radix Notoginseng;
The heat clearing away medicine is selected from Rhizoma Phragmitis, Fructus Gardeniae, Radix Scutellariae, Rhizoma Coptidis, Cortex Phellodendri, Radix Rehmanniae, Cortex Moutan, Radix Paeoniae Rubra, Flos Lonicerae;
The diuretic medicine is selected from Poria, Polyporus, Rhizoma Alismatis, Caulis Akebiae, Herba Artemisiae Scopariae, Semen Phaseoli, Stigma Maydis, Rhizoma et Radix smilacis ocreatae.
4. according to the compositions of claim 1 or 2, it is characterized in that containing Fructus Ligustri Lucidi, Fructus Corni, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Cortex Moutan, Radix Notoginseng, Herba Ecliptae, Rhizoma Dioscoreae, Poria, Radix Achyranthis Bidentatae, Rhizoma et Radix smilacis ocreatae and/or their extract.
5. according to the compositions of claim 1 or 2, it is characterized in that, contain 20～50 weight portion YIN-tonifying drug, 10～30 weight portion Qi-tonifying drugs, 10～40 weight portion blood circulation promoting medicines, 5～20 weight portion heat removing and blood cooling medicine and 20～50 weight portion diuretic medicines in crude drug.
6. according to the compositions of claim 1 or 2, it is characterized in that, contain 25～45 weight portion YIN-tonifying drug, 10～20 weight portion Qi-tonifying drugs, 15～35 weight portion blood circulation promoting medicines, 5～10 weight portion heat removing and blood cooling medicine and 20～40 weight portion diuretic medicines in crude drug.
7. according to each compositions of claim 1～6, wherein each composition in the weight proportion of raw material is:
12 parts of 12 parts of Fructus Corni of 15 portions of Herba Ecliptaes of Fructus Ligustri Lucidi
6 parts of 12 portions of Radix Notoginseng of 15 parts of Radix Salviae Miltiorrhizaes of Rhizoma Dioscoreae
10 parts in 10 parts of Poria of 10 portions of Rhizoma Alismatis of Cortex Moutan
10 parts of 15 parts of Radix Achyranthis Bidentataes of Rhizoma et Radix smilacis ocreatae
8. according to each compositions of claim 1～7, it is characterized in that the dosage form of this pharmaceutical composition is tablet, piece agent or granule, medicinal tea or capsule.
9. pharmaceutical composition according to Claim 8 is capsule.
Claim 1～9 each combination treatment or the purposes of prevent diabetes or its complication.
11. according to the purposes of claim 10, diabetic complication is a diabetic renal papillary necrosis.
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