CN106943453A - It is a kind of to treat medicine of diabete peripheral herve pathology and preparation method thereof - Google Patents
It is a kind of to treat medicine of diabete peripheral herve pathology and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of medicine for treating diabete peripheral herve pathology and preparation method thereof, the medicine is mainly prepared from by salvianolic acid extract, tanshinone extract, arasaponin, silymarin and microcrystalline cellulose.The present invention is on the basis of the red sage root, pseudo-ginseng, silymarin, compound Chinese medicinal preparation is promoted to active component composition of medicine, using drug effect as evaluation index, active component Dismemberment study is carried out, best available part combination is determined, the nature,taste and action of former Chinese medicine is not only remained, and has pharmacology, quality controllable chemical composition system, the preparation process of specification of clear and definite compound preparation etc., so as to ensure that safety and stability.
Description
Technical field
The present invention relates to a kind of medicine for treating diabete peripheral herve pathology and preparation method thereof, belong to medicine technology
Field.
Technical background
Diabete peripheral herve pathology (DPN) is one of big complication of diabetes three, is also that diabetes are most common, most multiple
Complication that is miscellaneous, being easiest to ignorance.The lifelong DPN incidences of diabetic are more than 60%, wherein 36% has seriously refractory
Property pain, occurs after DPN, survival rate is about 53% within 3 years.Diabete peripheral herve pathology not only brings violent pain to patient
Bitterly, cause the high disability rate of diabetic and fatal rate, return patient and bring greatly spirit and financial burden, have a strong impact on
Quality of life.Announced according to diabetology branch of Chinese Medical Association《Diabetes mellitus in China and Epidemiology investigation on metabolic syndrome report
Accuse》Rapid growth situation is presented in display, the incidence of China's diabetes, and the illness rate of domestic big and medium-sized cities adult diabetes is
11.66% has been reached, has been calculated accordingly, China city diabetic has exceeded ten thousand people more than 4100,.
DPN pathogenesis is complicated and changeable, and modern medicine is not yet clear and definite for pathogenesis, temporarily without reliable curative
Thing, clinical efficacy is relatively limited.And the traditional Chinese medical science have accumulated in diabetes (diabetes) peripheral neuropathy (bi Zheng, blood-arthralgia, impotence card)
Rich experience, for early diagnosing the advantage for having highly significant with treatment.But Chinese medicine DPN still has some deficits it
Place:(1) modern medicine is very few for the research of Chinese prescription pharmacology, and such as Chinese patent drug, Empirical formula, classical prescription treatment DPN only limit to
In the analysis of curative effect, still lack the foundation of science to prove curative effect；(2) treatment by Chinese herbs is often higher than similar oral western medicine price,
And the course for the treatment of is longer, the difference of price is more obvious；(3) research for Chinese medicine DPN side effect is very few, and mechanism is not
Clearly.
Traditional Chinese medicine has the advantage of highly significant for DPN early diagnosis with treatment.Channels and collaterals oxazepan capsule is (red in original side
Ginseng, pseudo-ginseng, silymarin) on the basis of, compound Chinese medicinal preparation is promoted to active component composition of medicine, referred to by evaluation of drug effect
Mark, has carried out active component Dismemberment study, it is determined that best available part combination, has not only remained the nature and flavor work(of former Chinese medicine
Can, and have pharmacology, quality controllable chemical composition system, the preparation process of specification of clear and definite compound preparation etc., so as to ensure
Safety and stability.
The content of the invention：
The purpose of the present invention, is to provide and a kind of treats medicine of diabete peripheral herve pathology and preparation method thereof.This hair
It is bright that compound Chinese medicinal preparation is promoted to active component composition of medicine on the basis of the red sage root, pseudo-ginseng, silymarin, using drug effect as
Evaluation index, has carried out active component Dismemberment study, it is determined that best available part combination, not only remains the property of former Chinese medicine
Function of odor, and have pharmacology, quality controllable chemical composition system, the preparation process of specification of clear and definite compound preparation etc., so that
It ensure that safety and stability.
In order to solve the above technical problems, the present invention is realized using following technical scheme：One kind treats diabete peripheral herve
The medicine of lesion, is calculated in parts by weight, mainly by 8-28 parts of salvianolic acid extract, 90-110 parts of tanshinone extract,
68-88 parts of 8-28 parts of arasaponin, 20-40 parts of silymarin and microcrystalline cellulose are prepared from.
In the medicine of foregoing treatment diabete peripheral herve pathology, calculate in parts by weight, mainly by salvianolic acid
15-21 parts of extract, 95-105 parts of tanshinone extract, 15-21 parts of arasaponin, 25-35 parts of silymarin and crystallite are fine
75-81 parts of element of dimension is prepared from.
In the medicine of foregoing treatment diabete peripheral herve pathology, calculate in parts by weight, mainly by salvianolic acid
18 parts of extract, 100 parts of tanshinone extract, 18 parts of arasaponin, the 78 parts of preparations of 30 parts of silymarin and microcrystalline cellulose
Form.
A kind of preparation method of the medicine of foregoing treatment diabete peripheral herve pathology, takes above-mentioned raw materials, can add auxiliary
Material, can be not added with auxiliary material, pharmaceutical preparation is made.
The preparation method of the medicine of foregoing treatment diabete peripheral herve pathology, preparation is oral formulations.
The preparation method of the medicine of foregoing treatment diabete peripheral herve pathology, the oral formulations be capsule,
Granula, tablet or pill.
The preparation method of the medicine of foregoing treatment diabete peripheral herve pathology, the capsule is prepared：More than
Four tastes, are ground into fine powder, and sieving, facing-up is mixed, and add microcrystalline cellulose, mix, and load capsule, produce.
The technical study of experimental example 1
1 instrument and reagent
The electronic analytical balances of AUY 220 (SHIMADZU)；LRH-150S constant temperature and humidities incubator (Guangdong medical apparatus and instruments factory)；
Far infrared air-blowing drying box (Shanghai He De experimental facilities Co., Ltd)；Danshinolic acid extract (lot number：20120801, in Kweiyang
Make by oneself in medical college's preparation laboratory)；Tanshinone extract (lot number：20121001, the self-control of Guiyang College of Traditional Chinese Medicine's preparation laboratory)；
Extract of panax notoginseng saponins (Kunming double star Science and Technology Ltd., lot number：090910)；Silymarin；Lactose, soluble starch,
Mannitol, microcrystalline cellulose, dextrin are pharmaceutical grade；It is pure that remaining reagent is analysis.
2 methods and result
The selection of 2.1 supplementary product kinds
2.1.1 the preparation of mixed powder
Respectively using dextrin, soluble starch, mannitol, microcrystalline cellulose, lactose as auxiliary material, design full medicinal powder and medicinal powder with
The different prescriptions of 6 of the mixed powder compatibility of auxiliary material, as shown in table 1, weigh main ingredient and auxiliary material (crossing 100 mesh sieves), mix, put dry
It is standby in dry device.
The proportion compatibility (g) of the different auxiliary material of table 1 and main ingredient
2.1.2 the measure at angle of repose
Using fixed funnel method, 3 funnels are connected and are positioned over 1cm above the drawing paper of level fixation and are highly located, it is small
In the funnel that the medicinal powder that different auxiliary material is made heart pours into the top along headwall respectively, until the cone formed under funnel
Nib contacts untill the lower mouth of bottom funnel, measure the diameter of cone bottom, calculate angle of repose α.Prescription is shown in Table
2。
The main ingredient of table 2 and influence of the auxiliary material proportion to heap density and mobility
Angle of repose is smaller, illustrates that mobility is better.It is generally acknowledged that good fluidity during α≤30 °, can meet life during α≤40 °
To the requirement of mobility during production.From result, in addition to medicinal powder adds lactose, remaining can meet production requirement everywhere,
And medicinal powder is added after microcrystalline cellulose, angle of repose is minimum, and mobility is best.
2.1.3 the measure of heap density
Using graduated cylinder method, precision weighs 2g or so mixed powder, puts in 10mL graduated cylinders, make in the height apart from plank 5cm
Graduated cylinder Vertical Free is fallen, and repeatedly after 5 vibrations, is determined the volume of mixed powder, is determined 5 times altogether, calculate heap density, the results are shown in Table
2。
2.1.4 the measure of hydroscopicity
Take bottom to fill the glass desicator of NaCl supersaturated solutions, be put into constant temperature 24h in 25 DEG C of constant incubator, this
When drier in relative humidity be 75%.In the measuring cup bottom of constant weight, it is put into after thickness about 2mm medicinal powder, precise
It is placed in the glass desicator of NaCl supersaturated solutions and (weighs bottle cap to open), respectively at after 2,4,6,8,10,12,24,48h
Weigh (m), calculate hydroscopicity, as a result see Fig. 1.
Note：Hydroscopicity=(mAfter moisture absorption- mBefore moisture absorption)/mBefore moisture absorption× 100%
As shown in Figure 1, medicinal powder is added after microcrystalline cellulose or soluble starch, and hydroscopicity is greatly lowered.And medicine
Powder is added after dextrin, lactose or mannitol, and hydroscopicity is raised on the contrary；And in different auxiliary material with microcrystalline cellulose humidity resistance most
It is good, so shaping auxiliary materials of the selection microcrystalline cellulose as the medicinal powder.
The selection of 2.2 supplementary product consumptions
2.2.1 the preparation of mixed powder
Respectively using the microcrystalline cellulose of different amounts as auxiliary material, design medicinal powder and the mixed powder compatibility of different amounts auxiliary material
6 prescriptions, as shown in table 3, weigh main ingredient and microcrystalline cellulose (crossing 100 mesh sieves), mix, put standby in drier.
The auxiliary material of the different amounts of table 3 and the proportion compatibility (g) of main ingredient
2.2.2 the measure of angle of repose and heap density
Angle of repose and heap density are determined by 2.1.2,2.1.3 lower methods, 4 are the results are shown in Table.
Influence of the auxiliary material of the main ingredient of table 4 and different amounts to heap density and mobility
Main ingredient add different amounts microcrystalline cellulose after, angle of repose α≤40 °, convection current in production process can be met
The requirement of dynamic property.
2.2.3 the measure of hydroscopicity
Hydroscopicity is determined by 2.1.4 lower methods, Fig. 2 is as a result seen.
Main ingredient is added after the microcrystalline cellulose of different amounts, and hydroscopicity has different degrees of reduction.And main ingredient and crystallite
The ratio of cellulose is 1:When 0.5, humidity resistance is optimal, so selection 1:0.5 is the optimal shaping of medicinal powder and microcrystalline cellulose
Ratio.
The selection of 2.3 heap density and empty pocket shell
The heap density of capsule 's content is determined according to 2.1.3 lower methods, to determine the model of empty pocket shell.It the results are shown in Table 5.
The measurement result of the capsule 's content heap density of table 5
From result, the average value of 5 measurement results is 0.54g/mL.According to known to clinical and pharmacodynamic experiment result
Each taking crude drug amount be 0.17g, calculate microcrystalline cellulose consumption be 0.08g, medicinal powder gross weight 0.25g.By heap density and matter
Amount tries to achieve approx. volume for 0.46mL.By capsule number No. 1 capsulae vacuus (0.48mL ± 10%) is selected with the relation of approximate volume
It is advisable, every capsule loading amount is 0.25g.
The measure at 2.4 capsule 's content angles of repose
The angle of repose of capsule 's content is determined according to 2.1.2 lower methods, 5 times measurement result angle of repose average value is
33.88 °, show this product good fluidity, it is easy to dispense.
The measure of 2.5 critical relative moistures (CRH)
After capsule 's content drying to the constant weight prepared, the measuring cup bottom (thickness about 2mm) of constant weight is laid in,
It is respectively placed in after accurately weighed in the drying receptacle for filling various concentrations sulfuric acid and different salt supersaturated solutions and (weighs bottle cap to beat
Open), weighed after keeping 7d in 25 DEG C of constant incubators, calculate hydroscopicity, the results are shown in Table 6, Fig. 3.
The measurement result of the critical relative moisture of table 6
From result, in relative humidity more than 57.7%, its hydroscopicity rises rapidly capsule 's content.Using hydroscopicity as
Ordinate, relative humidity is mapped for abscissa, is fitted by the quadratic linear of sucting wet curve, is obtained curvilinear equation；It is bent by moisture absorption
The tangent line mapping of line, the critical relative moisture (CRH) for obtaining the capsule 's content is 66%.
3 conclusions
This prescription is made up of salvianolic acid, total-tanshinone, arasaponin and silymarin, is easier moisture absorption.This
Experiment passes through the screening to 5 kinds of conventional auxiliary materials, the hygroscopicity and mobility of relatively more each auxiliary material.Test result indicate that, different auxiliary material
There is different degrees of influence to prescription, wherein reducing hygroscopic best results with microcrystalline cellulose, mobility preferably, is helped
In control content uniformity, increase stability, and cost is relatively low, is conducive to industrialized production.
Critical relative moisture can reflect the moisture absorption situation of medicine, while ambient humidity when production is also determined with this.By
Experimental result learns that the critical relative moisture of the capsule 's content is 66%, therefore it is required that the environment of capsule shaping aborning
Humidity must be controlled below 66%, can prevent from luming because of the moisture absorption of medicinal powder, deliquescence is so as to causing drug degradation, or even become
Matter.
The drug efficacy study of experimental example 2
First, protective effect of the channels and collaterals oxazepan to diabetic animal peripheral neuropathy
1. experiment material
1.1 experimental animals
8 week old male SD rats, 180~220g of body weight, purchased from Changsha Tian Qin Bioisystech Co., Ltd, licensing
Number：SCXK (Hunan) 2015-0003.Animal feeding environment：25 ± 2 DEG C of temperature, humidity 50 ± 5%, periodicity of illumination 12 hours, freely
Diet is drunk water, and the cleaning of same time daily of the clear disk of rat is once.
1.2 animal feeds
Normal diet maintains feed using cleaning grade；High-sugar-fat-diet is made by oneself by Guiyang College of Traditional Chinese Medicine's medicament laboratory,
It is formulated as normal diet：Yolk：White granulated sugar：Lard=55:15:15:15, to ensure cleaning, the feed newly prepared is in one week
Feed.
1.3 medicines and reagent
Streptozotocin (Streptozotocin, STZ), Sigma Co., USA；Citric acid, Solution on Chemical Reagents in Shanghai head factory
(lot number：20140209)；Trisodium citrate, Chongqing Chuan Dong Chemical Co., Ltd.s (lot number：20110601；) Metformin hydrochloride intestines
Molten, Guizhou Shengjitang Pharmaceutical Co., Ltd.'s (lot number：20150717)；
Triglycerides (TG) testing cassete, Bioengineering Research Institute's (lot number is built up in Nanjing：20150720)；T-CHOL (T-
CHO Bioengineering Research Institute's (lot number is built up in) testing cassete, Nanjing：20150715)；HDL-C (HDL-C) is surveyed
Box is tried, Bioengineering Research Institute's (lot number is built up in Nanjing：20150919)；LDL-C (LDL-C) testing cassete, south
Bioengineering Research Institute's (lot number is built up in capital：20150919)；Glycosylated hemoglobin (GHb) testing cassete, bioengineering is built up in Nanjing
Research institute's (lot number:20150928).
1.4 key instruments
Accu-Chek Performa brilliance type blood glucose meters, Products Co., Ltd of Roche Diagnistics；Supercentrifuge, Town in Shanghai
Booth scientific instrument factory；PHS-3B precision pH meters, the beneficial instrument and meter Co., Ltd of upper marine rainbow；AUY220 type electronic analytical balances, day
This Shimadzu Corporation；TU-1810 ultraviolet-uisible spectrophotometers, Beijing Puxi General Instrument Co., Ltd.
2. experimental method
2.1STZ solution is prepared
2.10g citric acids, 2.94g sodium citrates are dissolved in distilled water respectively, are settled to 100ml.Take above-mentioned citric acid solution each
50ml, is fully mixed, and regulation makes pH in the range of 4.2-4.5, and 4 DEG C of buffer solution is saved backup.
Weigh 100.0mgSTZ to be dissolved in 5ml buffer solutions, injected in ice-water bath by 25mg/kg abdominal cavities, STZ liquid faces the used time
Prepare and injected in 30min and finished.
2.2 models are set up and are grouped
120 cleaning grade SD male rats, after adaptability is raised one week, are randomly divided into Normal group (15) and modeling
Group (105), Normal group is fed with normal diet, and modeling group is fed with high-sugar-fat-diet, and body weight is recorded weekly., will during 8w
The STZ liquid of precooling is injected in modeling group abdominal cavity under the conditions of water 12 hours is can't help in fasting, injection finish after rat ad lib, drink
Random blood sugar is surveyed in blood sampling after water, 72h, and the modeling success rat more than 11.1mol/L is grouped for selection, Normal group injection
Equivalent citrate buffer solution is tested.
Experiment is divided into 7 groups：Normal group, model group, Methycobal group, channels and collaterals relax (JLS) low dose group, channels and collaterals relax
(JLS) high dose group, channels and collaterals oxazepan (JLSN) low dose group, channels and collaterals oxazepan (JLSN) high dose group.
2.3 indexs and detection method
2.3.1 Sciatic Nerve Conduction Velocity is determined
Using 10% chloraldurate as anesthetic, according to rat weight, by 350mg/kg standard intraperitoneal injection of anesthesia, anesthesia
Prone position is fixed afterwards.Stimulating electrode is inserted at the incisura ischiadica of right side, recording electrode is placed between the right toe of vola the 2nd, reference electrode
In the middle of stimulating electrode and recording electrode.Stimulated with pulse square wave, the wide 0.1ms of ripple, 1.5 times of threshold values of stimulus intensity, every 2 thorns
More than 5s is spaced between swashing.Since computer recording there is the time of action potential stimulating nerve to distal muscle, that is, hides
Phase.Replication 10 times, calculates average value.Animal metapedes is stretched with natural limbs state and backbone angular rear ramp at 45 °,
The distance between along animal body surface Accurate Determining stimulating electrode to recording electrode.Substitute into formula：MNCV (m/s)=stimulating electrode with
In distance/incubation period between recording electrode, seek the Sciatic Nerve Conduction Velocity for calculating ischial tuberosity to ankle.
2.3.2 each group rat blood serum SOD, MDA comparision contents
After the completion of rat sciatic nerve conduction of velocity is determined, abdominal aortic blood, 3000r/min centrifugation 10min separation blood
Clearly, to be measured in -20 DEG C of preservations, operation is carried out in strict accordance with specification.
2.3.3 the pathological change of om observation sciatic nerve form
Put to death after rat, take out right side incisura ischiadica to the 2cm sciatic nerves of distal end, cold saline is rinsed, and is put into 4%
It is fixed in paraformaldehyde, conventional dehydration, FFPE, Hematoxylin-eosin dyeing, light Microscopic observation channels and collaterals oxazepan Capsule in Rats
The influence of sciatic nerve morphosis.So that sciatic nerve fibre structure is fuzzy, arrangement disorder；Axon atrophy, denaturation, size and form
Irregularly；Sheath structure is fuzzy, denaturation；Schwann cell reduction or denaturation etc. are the positive.To administration experiment in 8 weeks, normally
Control group, model group, Methycobal group, JLS low dose groups, JLS high doses group, JLS low dose groups, JLS high dose groups rat point
Not Wei 9,7,8,7,7,7,7.
2.3.4 data processing
Statistical analysis is carried out using SPSS16.0 softwares, experimental data is with mean ± standard deviationRepresent, compare between group
Relatively use one-way analysis of variance；During heterogeneity of variance, examined using Kruskal-WallisH, p<0.05 has statistics for difference
Meaning.
3. result
3.1 each group rat sciatic nerve conduction of velocity compare
Compared with normal group, model group rats Sciatic Nerve Conduction Velocity substantially slows down, with significant difference (p<
0.01), each treatment group can delay slowing down for Sciatic Nerve Conduction Velocity in addition to channels and collaterals relax low dose group, and its apoplex involving the channels and collaterals relaxes high agent
Amount group curative effect is optimal, there was no significant difference compared with normal group (p>0.05) 7 and Fig. 4, be the results are shown in Table.
The each group rat sciatic nerve conduction of velocity of table 7 compare (m/s)
Note：Compared with normal group,*p<0.05,**p<0.01；Compared with model group,#p<0.05,##p<0.01
3.2 each group rat blood serum SOD, MDA comparision contents
Compared with normal group, model group SOD is remarkably decreased, and MDA significantly rises, difference has statistical significance (p<
0.01)；Channels and collaterals relax and channels and collaterals oxazepan high dose group activity of SOD in serum is significantly higher than model group (p<And low dose group (p 0.05)>
0.05)；Each administration group MDA water in addition to channels and collaterals relax low dose group is substantially less than model group (p<0.05), channels and collaterals oxazepan high dose
Group MDA reducing effects are most obvious, (the p that compares that there was no significant difference between each group group>0.05) 8, be the results are shown in Table.
Each group rat blood serum SOD, MDA comparision contents (x ± s, nmol/ml) of table 8
Note：Compared with normal group,*p<0.05,**p<0.01；Compared with model group,#p<0.05,##p<0.01
The pathological change of 3.3 om observation sciatic nerve forms
8 weeks os hypogastroidale nerve fibre queueing disciplines, form is being administered normal, nerve fibre aixs cylinder and its week in normal rats
Enclose myelin and dye aubergine, the visible lines in nerve fibre center are dyed to be with marrow outside darkviolet, as axon, aixs cylinder
Sheath is surrounded, and the neurokeratin network of visible network structure is caused because myelin is dissolved during film-making in piece.On myelin side
Edge is close to the visible ovate Schwann nucleus of myelin.The visible obvious damage of os hypogastroidale nerve in 8 weeks is administered in model group rats
Change, nerve fibre attenuates and arrangement disorder, and axon atrophy even disappears, myelin vacuolar degeneration, and schwann cell is reduced.Each administration
Group rat is administered 8 weeks os hypogastroidale nerves and the pathological change similar to model group also occurs, but has different degrees of mitigation, wherein
Positive Methycobal group is better than other groups with channels and collaterals oxazepan high dose group.Each group rat sciatic nerve pathomorphology change is shown in Fig. 5
And Fig. 6.
2nd, to the influence of diabetic animal sensory nerve
1. experiment material
1.1 experimental animals
4 week old C57BL/j mouse 150, male, body weight 18-22g, purchased from Changsha Tian Qin Bioisystech Co., Ltd, is moved
Thing quality certification number：SCXK (Hunan) 2015-0007.8 week old male SD rats, 180~220g of body weight is diligent biological purchased from Changsha day
Technology Co., Ltd., credit number：SCXK (Hunan) 2015-0003.Animal feeding environment：25 ± 2 DEG C of temperature, humidity 50 ± 5%,
Periodicity of illumination 12 hours, free diet drinking-water, animal litter cleaning of same time daily is once.
1.2 animal feeds
Normal diet maintains feed using cleaning grade；High-sugar-fat-diet is made by oneself by Guiyang College of Traditional Chinese Medicine's medicament laboratory,
It is formulated as normal diet：Yolk：White granulated sugar：Lard=55:15:15:15, to ensure cleaning, the feed newly prepared is in one week
Feed.
1.3 medicines and reagent
Streptozotocin (Streptozotocin, STZ), Sigma Co., USA；Citric acid, Solution on Chemical Reagents in Shanghai head factory
(lot number：20140209)；Trisodium citrate, Chongqing Chuan Dong Chemical Co., Ltd.s (lot number：20110601；) Mecobalamin (more may be used
Protect), defend material (China) pharmaceutcal corporation, Ltd, lot number：1411052.
1.4 key instruments
Accu-Chek Performa brilliance type blood glucose meters, Products Co., Ltd of Roche Diagnistics；PHS-3B precision pH meters, on
Marine rainbow benefit instrument and meter Co., Ltd；AUY220 type electronic analytical balances, Japanese Shimadzu Corporation；Constant water bath box；YLS-3E types
Electronics tenderness instrument, Jinan Yi Yan development in science and technology Co., Ltd.
2 experimental methods
The measure of 2.1 mouse tenderness values
The right rear solid end metacarpus of mouse is done into fixed point mark before experiment, a period of time in quiet environment is placed in, by mouse in tenderness
Tenderness value is determined on instrument, the pain fugue reactions such as shout, rear solid end shrinks occurs as Judging index using mouse.
The measure of 2.2 Rat Tall Flick temperature thresholds
Rat is loosely limited in mouse cage, tail point, which is placed in constant water bath box, enters water 2cm or so, initial 38 DEG C of water temperature,
Water temperature, as temperature when record rat leaves the water surface because of water temperature rise whipping, whipping temperature are raised with 2 DEG C per minute heating
Threshold value.
2.3 data processings
Statistical analysis is carried out using SPSS16.0 softwares, experimental data is with mean ± standard deviationRepresent, compare between group
Relatively use one-way analysis of variance；During heterogeneity of variance, examined using Kruskal-WallisH, p<0.05 has statistics for difference
Meaning.
3. result
The measure of 3.1 mouse tenderness values
Compared with normal group, remaining each group mouse Pain-threshold is substantially reduced, and difference has conspicuousness (p<0.01 or p<
0.05)；Compared with model group, each administration group mouse pain threshold has different degrees of rise, its apoplex involving the channels and collaterals oxazepan high dose group
Effect is optimal, has significant difference (p compared with model group<0.05) 9 and Fig. 7, be the results are shown in Table.
The comparison (x ± s, g) of each group mouse Pain-threshold of table 9
Note：Compared with normal group, * p<0.05, * * p<0.01 is compared with model group, #p<0.05, ##p<0.01
The measure of 3.2 Rat Tall Flick temperature thresholds
As seen from table, compared with normal group, different degrees of rising occurs in remaining each group whipping temperature threshold, wherein more
It can protect a group elevation amplitude minimum, and there was no significant difference (p>0.05), illustrate that the medicine has good improvement result to whipping temperature；
Compared with model group, except channels and collaterals relax in addition to low dose group, remaining each administration group whipping temperature threshold is compared with model group to be had significantly
Sex differernce (p<0.01) 10 and Fig. 8, be the results are shown in Table.
The comparison (x ± s, DEG C) of each group Rat Tall Flick temperature threshold of table 10
Note：Compared with normal group, * p<0.05, * * p<0.01 is compared with model group, #p<0.05, ##p<0.01
Compared with prior art, the present invention lifts compound Chinese medicinal preparation on the basis of the red sage root, pseudo-ginseng, silymarin
For active component composition of medicine, using drug effect as evaluation index, active component Dismemberment study has been carried out, it is determined that best available position
Combination, the nature,taste and action of former Chinese medicine is not only remained, and have the pharmacology of clear and definite compound preparation, quality controllable chemical composition
System, preparation process of specification etc., so as to ensure that safety and stability.
Brief description of the drawings
Fig. 1 is the hydroscopicity of different prescription mixed powders；
Fig. 2 is influence of the auxiliary material of main ingredient and different amounts to hydroscopicity；
Fig. 3 is critical relative moisture figure；
Fig. 4 is that each group rat sciatic nerve conduction of velocity compares；
Fig. 5 is each group rat blood serum SOD comparision contents；
Fig. 6 is each group rat blood serum MDA comparision contents；
Fig. 7 is the comparison of each group mouse Pain-threshold；
Fig. 8 is the comparison of each group Rat Tall Flick temperature threshold.
Invention is further described with reference to embodiment, but is not intended as to the foundation of the invention limited.
Embodiment：
Embodiment 1
Raw material：Salvianolic acid extract 18g, tanshinone extract 100g, arasaponin 18g, silymarin 30g and
Microcrystalline cellulose 78g.
Technique：Salvianolic acid extract, tanshinone extract, arasaponin and silymarin, are ground into fine powder, mistake
Sieve, facing-up is mixed, and adds microcrystalline cellulose, is mixed, and is loaded capsule, is produced.
Specification：0.5g/.
Usage and dosage：It is 2-3 every time, daily 2-3 times.
Major function：Supplementing qi and nourishing yin, righting and battalion, row is stagnant to promote blood circulation, the effect of active pain relieving, for Diabetes Peripheral nerve
Inflammation, diabetes vegetative nerve functional disturbance.
Embodiment 2
Raw material：Salvianolic acid extract 21g, tanshinone extract 105g, arasaponin 21g, silymarin 35g and
Microcrystalline cellulose 81g.
Technique：Salvianolic acid extract, tanshinone extract, arasaponin and silymarin, are ground into fine powder, mistake
Sieve, facing-up is mixed, and adds microcrystalline cellulose, is mixed, and is loaded capsule, is produced.
Specification：0.5g/.
Usage and dosage：It is 2-3 every time, daily 2-3 times.
Major function：Supplementing qi and nourishing yin, righting and battalion, row is stagnant to promote blood circulation, the effect of active pain relieving, for Diabetes Peripheral nerve
Inflammation, diabetes vegetative nerve functional disturbance.
Embodiment 2
Raw material：Salvianolic acid extract 15g, tanshinone extract 95g, arasaponin 15g, silymarin 25g and
Microcrystalline cellulose 75g.
Technique：Salvianolic acid extract, tanshinone extract, arasaponin and silymarin, are ground into fine powder, mistake
Sieve, facing-up is mixed, and adds microcrystalline cellulose, is mixed, and is loaded capsule, is produced.
Specification：0.5g/.
Usage and dosage：It is 2-3 every time, daily 2-3 times.
Major function：Supplementing qi and nourishing yin, righting and battalion, row is stagnant to promote blood circulation, the effect of active pain relieving, for Diabetes Peripheral nerve
Inflammation, diabetes vegetative nerve functional disturbance.
Claims (7)
1. a kind of medicine for treating diabete peripheral herve pathology, it is characterised in that：Calculate in parts by weight, it is mainly total by the red sage root
8-28 parts of phenolic acid extract, 90-110 parts of tanshinone extract, 8-28 parts of arasaponin, 20-40 parts of silymarin and crystallite
68-88 parts of cellulose is prepared from.
2. the medicine of diabete peripheral herve pathology is treated as claimed in claim 1, it is characterised in that：In parts by weight
Calculate, mainly by 15-21 parts of salvianolic acid extract, 95-105 parts of tanshinone extract, 15-21 parts of arasaponin, fine grinding
75-81 parts of 25-35 parts of silibin and microcrystalline cellulose are prepared from.
3. the medicine of diabete peripheral herve pathology is treated as claimed in claim 2, it is characterised in that：In parts by weight
Calculate, mainly by 18 parts of salvianolic acid extract, 100 parts of tanshinone extract, 18 parts of arasaponin, 30 parts of silymarin and
78 parts of microcrystalline cellulose is prepared from.
4. a kind of preparation method of the medicine for the treatment of diabete peripheral herve pathology as any one of claim 1-3,
It is characterized in that：Above-mentioned raw materials are taken, auxiliary material can be added, auxiliary material can be not added with, pharmaceutical preparation is made.
5. the preparation method of the medicine of diabete peripheral herve pathology is treated as claimed in claim 4, it is characterised in that：It is described
Pharmaceutical preparation is oral formulations.
6. the preparation method of the medicine of diabete peripheral herve pathology is treated as claimed in claim 5, it is characterised in that：It is described
Oral formulations are capsule, granule, tablet or pill.
7. the preparation method of the medicine of diabete peripheral herve pathology is treated as claimed in claim 6, it is characterised in that：It is described
Capsule is prepared：The taste of the above four, is ground into fine powder, and sieving, facing-up is mixed, and adds microcrystalline cellulose, mixes, and loads glue
Capsule, is produced.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109528658A (en) * | 2018-12-29 | 2019-03-29 | 安徽草珊瑚生物科技有限公司 | A kind of compound probiotic freeze-dried powder |
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| CN1839819A (en) * | 2005-01-28 | 2006-10-04 | 海口绿科南药研究开发有限公司 | Medicinal composition containing tanshinone and its preparation process and usage |
| CN101647855A (en) * | 2008-08-13 | 2010-02-17 | 贵阳中医学院 | Traditional Chinese medicine preparation for treating diabetic neuropathy and preparation method thereof |
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| CN109528658A (en) * | 2018-12-29 | 2019-03-29 | 安徽草珊瑚生物科技有限公司 | A kind of compound probiotic freeze-dried powder |
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Application publication date: 20170714 |