CN103301321B - Thrombolytic active polysaccharide mixture preparation technology - Google Patents
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Abstract
The invention discloses a thrombolytic active polysaccharide mixture preparation technology. The technology is characterized by preparing a polysaccharide mixture through mixing the concentrated polysaccharide mixed liquor of dendrobium officinale, chrysanthemum and hawthorn which are extracted by adopting a composite enzymic method with the fermentation liquor of black fungus and tolypocladium sinensis mycelia. The thrombolytic active polysaccharide mixture prepared by the technology has multiple biological activities, is a Chinese herbal medicinal microbial polysaccharide mixture with good quality and no toxic and side effect in the current world, can effectively treat cerebral thrombosis acute phase diseases, and has obvious treatment and prevention functions on acute phase sequela recovery and relapse prevention as well as a special effect on the efficacy of a Chinese herbal medicinal polysaccharide and microbial mycelia polysaccharide mixture with obvious vascular wall softening and nutrition functions.
Description
Technical field
The invention belongs to medical technical field, the processing technology of the thrombolysis activity polysaccharide mixture that specifically a kind of cerebral thrombosis, the rehabilitation of myocardial infarction disease are used.
Background technology
As everyone knows, cardiovascular and cerebrovascular disease is the disease that global sickness rate is the highest, complication is maximum.Cardiovascular and cerebrovascular vessel epidemic disease has become one of principal disease threatening human life.In China, the sickness rate of cardiovascular and cerebrovascular disease, mortality rate cumulative year after year, and present the trend of rejuvenation.Along with the raising of living standards of the people, higher fatty acid, the excessive of high protein diet eaten, and along with the development of process of industrialization, the pollution of atmosphere, water, food, has all become the principal element that cardiovascular and cerebrovascular disease sickness rate is more and more higher.Cardiovascular and cerebrovascular disease still becomes harm humans health " No.1 killer ", becomes " the second cancer ".Certainly, the control of cardiovascular and cerebrovascular disease, has caused the extensive concern of the whole society.
Cardiovascular and cerebrovascular disease is that due to blood in human body in liquid viscosity index raises, the rising due to blood viscosity causes thrombosis often, myocardium brain severe ischemic, so that form thrombosis, threaten people's life.
Existing Western medicine is mainly with thrombolytic, and it is main reducing blood viscosity.The kind that reduces blood cholesterol levels and triglyceride in existing Chinese medicine is also a lot, can prevent to a certain extent the effect of heart and brain thrombosis.But, no matter be Chinese medicine, or Western medicine, its property of medicine effect is single, and effect is obviously but not lasting.That is to say its effect can only respite blood in abnormal index, can not thoroughly improve the index that exceeds standard in blood and worsen once again, other complementary effects more out of the question.Therefore, research and develop a kind of when can either effectively reduce Blood Cholesterol, triglyceride blood viscosity, blood glucose and preventing its index to raise once again, again can nutrition vessel softening, the pure Chinese medicinal preparation that supplements blood vessel wall nutritional labeling is extremely urgent.
Summary of the invention
The present invention is directed to the problems referred to above, researched and developed a kind of processing technology of thrombolysis activity polysaccharide mixture, the thrombolytic polysaccharide mixture that utilizes this processing technology to make can obviously reduce blood viscosity, blood glucose, serum specific viscosity and Fibrinogen, not only blood coagulation is had to certain resistancing action, simultaneously remarkable to angiomalacia Nutrition again.
Technical scheme of the present invention is: a kind of processing technology of thrombolysis activity polysaccharide mixture, key is: this polysaccharide mixture is the concentrated polysaccharide mixed liquor of the Herba Dendrobii, Flos Chrysanthemi, the Fructus Crataegi that utilize combined-enzyme method lixiviate and is mixed and formed by the fermentation liquid of Auricularia, Cordyceps mycelium, and concrete manufacturing process steps comprises:
(1) choose Herba Dendrobii, Flos Chrysanthemi, Fructus Crataegi herbal raw material, carry out respectively following steps to obtain Dendrobium officinale polysaccharide liquid, chrysanthemum polysaccharide liquid and Hawthorn Polysaccharides liquid:
A, rinsing are to remove Chinese herbal medicine surface irregularities;
In b, the Chinese herbal medicine after rinsing, add water, then grind to form serosity with colloid mill;
C, in serosity, add the water of 5-30 times of weight, heat, be warming up to 100 ℃, then be cooled to 85 ℃, under pressure 30MPa, utilize high pressure homogenizer to process, obtain homogeneous slurry;
D, in homogeneous slurry, add compound protease lixiviate 1 ~ 2 hour, wherein, homogeneous slurry with the ratio of the weight of compound protease is: 100:(1.5 ~ 2), the cellulase that compound protease is 1:1:1 by weight ratio, pectase and protease form;
E, lixiviating solution is separated through low speed centrifuge, filtering and concentrating is removed 10-20% moisture and dry, stand-by;
(2) choose Auricularia (Auricularia auricular) (numbering AS5.452, depositary institution: institute of microbiology of the Chinese Academy of Sciences) and Cordyceps (mi litrsGordyceps) (numbering M1069, depositary institution: Guangdong Microbes Inst, Guangdong Province's culture presevation and priority application laboratory) strain, carries out respectively following steps to obtain Auricularia polycose extracting solution and Cordyceps polysaccharides extracting solution:
I, take slant strains to cultivate, the breeding of shaking table liquid, seed tank liquid spawn three-class strain is cultivated liquid spawn separately, again liquid spawn is introduced respectively to the supporting fermentation tank 3-7 days that ferments in liquid culture medium, when reaching 65-80%, mycelial growth concentration or weight in wet base ratio stop fermentation, solid residue in filtering fermentating liquid, obtains fermentation filtered solution stand-by;
II, in temperature, be not less than 90 ℃, under an ambient pressure 1.2-1.5 atmospheric pressure, in fermentation filtered solution, add the compound protease being formed by pepsin and papain to carry out pyrolysis, inactivation treatment, the filtered solution that wherein ferments is 100:(0.5 ~ 2 with the ratio of the weight of compound protease), the mass ratio of pepsin and papain is 1:1;
III, by the fermentation filtered solution through pyrolysis, inactivation treatment filter, moisture and the miscellaneous material of the concentrated 10-20% of removal, stand-by;
(3) Dendrobium officinale polysaccharide liquid, chrysanthemum polysaccharide liquid, Hawthorn Polysaccharides liquid, Auricularia polycose extracting solution and Cordyceps polysaccharides extracting solution are mixed according to following percent by volume:
Dendrobium officinale polysaccharide liquid 5-50%,
Chrysanthemum polysaccharide liquid 10-30%,
Hawthorn Polysaccharides liquid 5-15%,
Auricularia polycose extracting solution 10-40%,
Cordyceps polysaccharides extracting solution 5-35%;
(4) under gnotobasis, the mixed liquor forming after being mixed, at 60 ℃, is carried out to pressure 10 ~ 15MPa homogenizing, sub-bottle, encapsulation, sterilization become finished product.
For the polysaccharide component in the dry obtaining in further extraction step e, also improve the utilization rate of effective ingredient in material simultaneously, dry is carried out to the extraction step of secondary and three polysaccharide components.Second extraction step is as follows:
The water that adds 5-30 times of weight in e1, the dry obtaining in step e, heats, is warming up to 100 ℃, then is cooled to 85 ℃, under pressure 30MPa, utilizes high pressure homogenizer to process, and obtains homogeneous slurry;
E2, in homogeneous slurry, add compound protease lixiviate 1 ~ 2 hour, wherein, homogeneous slurry with the ratio of the weight of compound protease is: 100:(1 ~ 1.5), the cellulase that compound protease is 1:1:1 by weight ratio, pectase and protease form;
E3, lixiviating solution is separated through low speed centrifuge, filtering and concentrating is removed 10-20% moisture and dry, stand-by.
Three times extraction step is as follows, and the dry that step e3 obtains is handled as follows again:
E31, in dry, add the water of 5-30 times of weight, heat, be warming up to 100 ℃, then be cooled to 85 ℃, under pressure 30MPa, utilize high pressure homogenizer to process, obtain homogeneous slurry;
E32, in homogeneous slurry, add compound protease lixiviate 1 ~ 2 hour, wherein, homogeneous slurry with the ratio of the weight of compound protease is: 100:(0.5 ~ 1), the cellulase that compound protease is 1:1:1 by weight ratio, pectase and protease form;
E33, lixiviating solution is separated through low speed centrifuge, filtering and concentrating is removed 10-20% moisture and dry, stand-by.
The fermentation temperature of described Auricularia is 24-26 degree Celsius, and the fermentation temperature of described Cordyceps is 16-18 degree Celsius.
Pressure in described fermentation tank is 30-50MPa, and liquid culture medium carbon, nitrogen are than being 1:(16-24), inoculum concentration is 10%, and ventilation is 0.4-0.6 cube m/min, and mixing speed is 120-180 rev/min.
When in step (2), Auricularia strain carries out step I, the liquid culture medium of employing is prepared by following percentage by weight:
Testa Tritici juice 8-10%,
Corn juice 5-10%,
Murphy juice 10-15%,
Bean milk 15-20%,
Yeast powder 0.5-1%,
Sucrose 0.5-3%,
Glucose 0.5-2%,
Magnesium sulfate 0.02-0.05%,
Potassium dihydrogen phosphate 0.05-0.1%,
Peptone 0.3-1%,
Oleum Arachidis hypogaeae semen 0.3-0.6%,
Surplus is water.
When in step (2), Cordyceps strain carries out step I, the liquid culture medium of employing is prepared by following percentage by weight:
Dried silkworm chrysalis meal 1-2%,
Milk powder 2-3%,
Murphy juice 20-30%,
Bean milk 25-35%,
Semen setariae juice 10-20%,
Corn juice 10-20%,
Yeast powder 1-2%,
Sucrose 0.5-2%,
Glucose 1-3%,
Peptone 0.5-1%,
Magnesium sulfate 0.05-0.1%,
Potassium dihydrogen phosphate 0.15-0.18%,
Vitamin B1 0.5-1%
Oleum Arachidis hypogaeae semen 0.5-0.8%,
Surplus is water.
Described Herba Dendrobii is that the 4-5 of artificial growth is raw.
In described step (4), also comprise by mixed liquor at 60 ℃, the active polysaccharide liquid carrying out after pressure 15MPa homogenizing forms powder through drying process with atomizing, then powder pack to formation capsule or electuary or tablet.
The filter progress of described lixiviating solution is to adopt ultrafilter membrane or reverse osmosis membrane filtration.
The invention has the beneficial effects as follows: 1, key of the present invention is the filtration of effective polysaccharide composition of carrying by medium-height grass property of medicine enzyme process and microbial fermentation solution, generates that to be rich in the compatibility of microbial activity polysaccharide composition complementary after concentrated, reaches definite target of the present invention; 2, research is found, Herba Dendrobii forms complicated, polysaccharide cell is unsuitable permeable, except polysaccharide, also contain the materials such as dendrobine, dendrophnol, hincky acid, pectin, cellulose, the existence of these materials all can affect the leaching of polysaccharide, therefore in polysaccharide deduction process, select mechanical-physical breaking cellular wall, virgin pulp liquid 3-5 sub-high pressure breaking cellular wall repeatedly, add the lixiviate at suitable temperature of suitable compound enzymic preparation, lixiviating solution is separated through low speed centrifuge, filtering and concentrating is removed 10-20% moisture and dry, dry lixiviate 2-3 times repeatedly.Through experimental results demonstrate, combined-enzyme method lixiviate simple and fast and polysaccharide extraction rate are up to 15.67%, and the effective content of Dendrobium officinale polysaccharide is enough to produce obvious drug effect.3, the selected Flos Chrysanthemi that can strengthen curative effect, the Hawthorn Polysaccharides of proportioning carries out compatibility and can effectively strengthen medicinal effects and reach ultimate attainment; 4, Auricularia, Cordyceps mycelium carry out degree of depth fermentation process in fermentation tank, and when weight in wet base reaches 65-80%, the effective content of its polysaccharide is enough to produce obvious drug effect.Active polysaccharide mixture of the present invention empirical tests in the pharmacological evaluation that rabbit is cooked: the injection rate of 4.5-5 gs/kg can make the loose reaction of platelet aggregation produce, show the obvious inhibition to ADP, to plasma viscosity, it is obvious that serum specific viscosity celloglobulin index is improved statistical significance, cholesterol in high lipid food rabbit and triglyceride growth are had to remarkable inhibitory action, and thrombotic speed and size are had to significant curative effect.
The specific embodiment
Key problem in technology of the present invention is that in the mixture of institute's proportioning, Herba Dendrobii, Flos Chrysanthemi, Hawthorn Polysaccharides and Auricularia, Cordyceps mycelium polyoses content reach specified standard, and the content of medium-height grass property of medicine polysaccharide and Auricularia, Cordyceps mycelial concentration in liquid fermentation tank are depended in the realization of this standard completely, the concrete grammar of realizing this index is:
Choose the iron-sheet dendrobe fresh product of growth in 4-5 years, add suitable quantity of water chopping, after colloid mill defibrination, carry out three grades of processing of extracting polysaccharide liquid.Coagulation is: in the serosity after colloid mill defibrination, add the water of 5-30 times of weight to be warming up to 100 ℃, then while being down to 85 ℃, under high pressure 30MPa pressure, utilize high pressure homogenizer to carry out broken wall treatment, obtain homogeneous slurry; In homogeneous slurry, add compound protease lixiviate 1 ~ 2 hour, wherein, homogeneous slurry with the ratio of the weight of compound protease is: 100:(1.5 ~ 2), the cellulase that compound protease is 1:1:1 by weight ratio, pectase and protease form; Moisture and dry that lixiviating solution is separated through low speed centrifuge, filtering and concentrating is removed 10-20%, obtain one-level Dendrobium officinale polysaccharide liquid.Two stage treatment is: to the dry leaching in above-mentioned coagulation step, again add water, intensification, lower the temperature and utilize high pressure homogenizer to carry out broken wall treatment, in homogeneous slurry, add again compound protease lixiviate as above 1 ~ 2 hour, wherein, homogeneous slurry with the ratio of the weight of compound protease is: 100:(1 ~ 1.5), and then moisture and dry separated, that filtering and concentrating is removed 10-20%, obtain secondary Dendrobium officinale polysaccharide liquid; Then, aforementioned dry is carried out to tertiary treatment again, again to adding water, intensification, cooling in dry caught on a filter in two stage treatment, utilize high pressure homogenizer to carry out broken wall treatment, in homogeneous slurry, add again compound protease lixiviate as above 1 ~ 2 hour, wherein, homogeneous slurry with the ratio of the weight of compound protease is: 100:(0.5 ~ 1), and then moisture and dry separated, that filtering and concentrating is removed 10-20%, obtain three grades of Dendrobium officinale polysaccharide liquid.One-level obtained above, secondary, three grades of Dendrobium officinale polysaccharide liquid are mixed and usingd as stand-by Dendrobium officinale polysaccharide liquid.
Choose Flos Chrysanthemi, processing with above-mentioned Herba Dendrobii is the same, just at high pressure 30MPa pressure, carry out a coagulation to obtain the polysaccharide liquid of Flos Chrysanthemi, and no longer carry out the processing procedures that secondary, three grades extract polysaccharide liquid, choose again Fructus Crataegi, also carry out the treatment step of above-mentioned same Flos Chrysanthemi to obtain the polysaccharide liquid of Fructus Crataegi.Stand-by Dendrobium officinale polysaccharide liquid, chrysanthemum polysaccharide liquid, Hawthorn Polysaccharides liquid are incorporated in holding vessel and keep temperature 60 C stand-by.Polyoses content is respectively that Dendrobium officinale polysaccharide liquid 15.67%, chrysanthemum polysaccharide liquid 6.32%, Hawthorn Polysaccharides liquid are 8.43%.
Choose edible Auricularia strain (Auricularia auricular), the concrete optional bacterium numbering that is used in the preservation of Institute of Micro-biology of the Chinese Academy of Sciences is AS5.452 kind, Cordyceps strain (mi litrsGordyceps), specifically can select Guangdong Microbes Inst, Guangdong Province's culture presevation and priority application laboratory bacterium numbering are M1069 kind, select the strain of new fertile shape to do cultivation strain, take slant strains to cultivate, the breeding of shaking table liquid, seed tank liquid spawn three-class strain is cultivated each liquid spawn separately, again liquid spawn is introduced respectively to supporting fermentation tank ferments 3-7 days in supporting liquid culture medium, when reaching 65-80%, mycelial growth concentration or weight in wet base ratio stop fermentation, solid residue in filtering fermentating liquid obtains corresponding strain fermentation filtered solution.In temperature, be not less than 90 ℃, under 1.2-1.5 atmospheric pressure of ambient pressure, above two kinds of fermentations are added in filtered solutions concentration be 0.5-1.5% by etc. the pepsin of weight and the compound protease that papain forms, carry out afterwards pyrolysis, inactivation treatment, by two kinds of strain fermentation filtered solutions through pyrolysis, inactivation treatment further filter, concentrated remove 10-20% moisture content and foreign material be incorporated in storage tank temperature keep 60 ℃ stand-by.
Then by above said by two class polysaccharide extraction liquids (polysaccharides of traditional Chinese medicine liquid and microbial activity polysaccharide extraction liquid) according to the following percent by volume homogenizing (pressure 10 ~ 15 kilograms be mixed into mixture) that is mixed, formation thrombolysis activity polysaccharide mixture:
Dendrobium officinale polysaccharide liquid 5-50%,
Chrysanthemum polysaccharide liquid 10-30%,
Hawthorn Polysaccharides liquid 5-15%,
Auricularia polycose extracting solution 10-40%,
Cordyceps polysaccharides extracting solution 5-35%;
The dosage form of this thrombolysis activity polysaccharide mixture can be liquid syrup, also can be by dry powder or capsule or electuary or the tablet of making of spraying.
Provide the embodiment that the percent by volume of two class polysaccharide extraction liquids is mixed below:
Table 1
The liquid culture medium proportioning embodiment following (percentage by weight) of Auricularia:
Table 2
The liquid culture medium proportioning embodiment following (percentage by weight) of Cordyceps:
Table 3
Said Auricularia above, in liquid culture medium layoutprocedure in Cordyceps breeding tank, by peeling potatoes and eye, section adds 6-10 times of weight water boils and stirs as pasty state, Semen Maydis powder adds 25-30 times of weight water boils of water, Semen setariae adds 30-40 times of weight water boils, Testa Tritici skin keeps 30 minutes after adding 20-25 times of weight water boils, with 4-6 jin of Semen Glyciness, make 100 jin of bean milk, above semi-finished product form said potato juice through getting filtrate by 6-8 layers of filtered through gauze, corn juice, Semen setariae juice, Testa Tritici juice, bean milk, then according to the proportion compatibility providing above, accurately take required various compound, finally carry out steam high-voltage sterilizing, standby below being cooled to 30 ℃.
The result in clinical application of thrombolysis activity polysaccharide mixture of the present invention shows to have following advantage:
1, the thrombolysis activity polysaccharide mixture of manufacturing with the inventive method, through the corresponding property of medicine, pharmacological testing, effective medicinal component polysaccharide of polysaccharide mixture, dendrobine, the total hincky acid of dendrophnol, pectin, cellulose etc. can powerfully be cleared up blood toxicity, improve blood of human body microcirculation, hepatoprotective function of gallbladder promoting, strong muscle blood fat reducing, benefiting qi and nourishing blood, balancing blood pressure, powerful blood sugar lowering.Polysaccharide mixture can significantly increase the activity of tested rabbit anticoagulation kinase, extend clotting time, suppress the formation of thrombosis, significantly the activity of Platelet Activating Factor, has suppressed the platelet aggregation that collagen and arachidonic acid are induced, improved microcirculation, accelerated blood flow, prevented thrombosis, made blood mobility index super normal, thereby prevented heart infarction, cerebral infarction, coronary atherosclerosis, so therapeutic effect is remarkable.
2, reduce blood pressure, blood sugar lowering: with spontaneous hypertensive rat, test, administration group adds 5% polysaccharide mixture in feedstuff, and matched group does not add, and after surrounding, visible administration group blood pressure obviously reduces, and the cholesterol level in blood plasma and liver also declines.
3, this thrombolysis activity polysaccharide mixture proves by further toxicological test, not containing antiseptic.Strengthening in 60 times of situations of human clinical's dose, to the diet of examination rabbit, feces, hair matter activity characteristic, body weight gain all loses obvious impact, each organizes experimental animal routine blood test (leukocyte, erythrocyte number, platelet, reticulocyte, hematochrome) all within normal range, the hepatic and renal function of each matched group rabbit is all in normal range, other organs is observed all no abnormal through prolonged application, this polysaccharide mixture has no side effect as seen.
4, this mixture has passed through further acute toxicological experiment: by 80 milliliters/day of human doses, be standard, amount to 100 milliliters of/day maximal doses to 100 milliliters of experimental rabbits gavages, 140 milliliters of continuous quadratics without Novel presentation.180 milliliters of rabbit performances are for the third time quiet few moving, and after 30 minutes, recovering normal, analyzing reason is due to stomach rises.In seven days, diet, feces, hair color, respiratory activity are all normal, and test of many times also occurs without dead, clinical 200 milliliters/kilogram of the dosage human body maximum amounts of restraining oneself that provide, visible property of medicine safety.
For showing the therapeutic effect of thrombolysis activity polysaccharide mixture of the present invention, select cardiovascular and cerebrovascular disease acute stage 180 of convalescents later, be divided into two groups, experimental group 100 examples, matched group 80 examples.
Therapeutic scheme:
Experimental group: 100 examples are inactive conventional thromboembolism treatment medicine all, takes polysaccharide mixture of the present invention, every day 3 times, each 20-40 milliliter, one day one-period, 4 days is 1 course for the treatment of.
Matched group: 80 examples are all taken conventional therapy product, wherein drug dosage and test group match, and take four days.
Curative effect judging standard:
((the relevant efficacy assessment standard in new Chinese medicine clinical guidance principle) of WHOHe China health formulation (is nimodipine [the rear integration of integration-treatment before treatment]/integration before treating in A World Health Organization (WHO)
*100%.
Effective: front lower more than 2/3 compared with medicine after TCM symptom score medicine, neurologic defect integration declines >=50%.
Effective: Chinese medicine symptom integral decline 1/3-2/3, neurologic defect integration decline < 20%.
After the course for the treatment of, clinical effectiveness evaluation:
1, on blood flow degree learn index to affect evaluation result as shown in table 4:
Table 4
| Group | Effective (number of cases) | Effectively (number of cases) | Invalid (number of cases) | Worsen (number of cases) | Total effective rate |
| Experimental group | 81 | 17 | 2 | 0 | 98% |
| Matched group | 7 | 26 | 47 | 0 | 41.25% |
As can be seen from Table 4,100 cardiovascular and cerebrovascular diseases acute stages later convalescent are taken to polysaccharide mixture of the present invention and do therapeutic test, after 4 days course for the treatment of, total effective rate is up to 98%.
2、
Table 5
| Group | Whole blood contrast viscosity | Plasma viscosity | The nearly former viscosity of whole blood |
| Experimental group (before taking) | 5.88±1.03 | 2.43±0.54 | 8.24±1.84 |
| Experimental group (after taking) | 5.00±1.42 | 1.39±0.37 | 7.31±1.63 |
| Matched group (before medicine) | 5.02±1.59 | 1.96±0.79 | 8.05±1.75 |
| Matched group (after medicine) | 4.97±1.32 | 1.81±0.58 | 7.62±1.47 |
As can be seen from Table 5,100 cardiovascular and cerebrovascular diseases acute stages later convalescent are taken to polysaccharide mixture of the present invention and do therapeutic test, after the course for the treatment of, whole blood contrast viscosity, plasma viscosity, the nearly former viscosity of whole blood all have remarkable reduction.
Table 6
| Group | Packed cell volume | Celloglobulin mg% | Erythrocyte electrophoretic time |
| Experimental group (before taking) | 43.24±4.25 | 348.46±71.96 | 23.19±3.56 |
| Experimental group (after taking) | 44.85±3.58 | 311.98±68.26 | 21.57±4.48 |
| Matched group (before medicine) | 45.37±5.86 | 389.87±84.06 | 23.84±4.25 |
| Matched group (after medicine) | 43.56±6.12 | 341.78±76.36 | 22.53±3.88 |
Experimental group (after taking) P < 0.05, matched group (after medicine) P < 0.01.
As can be seen from Table 6,100 cardiovascular and cerebrovascular diseases acute stages later convalescent are taken to polysaccharide mixture of the present invention and do therapeutic test, after the course for the treatment of, packed cell volume, celloglobulin, erythrocyte electrophoretic time all have remarkable reduction.
In addition, for showing the therapeutic effect of thrombolysis activity polysaccharide mixture of the present invention to hyperlipidemia disease, select 100 of hyperlipidemia patients, be divided into two groups, experimental group 50 examples, matched group 50 examples.
Therapeutic scheme:
Experimental group: 50 examples are inactive conventional hyperlipidemia medicine all, takes polysaccharide mixture of the present invention, every day 3 times, each 20-40 milliliter, one day one-period, 4 days is 1 course for the treatment of.
Matched group: 50 examples are not all taken any hyperlipidemia treatment product.
Curative effect judging standard:
With reference to Ministry of Public Health, tried the standard that in 15 class clinical drug research guidelines (trying), relevant adjustment hypolipidemic medicine is studied and defined.
Effective: reach following any one person: TC decline >=20, TG decline >=40, TDG-C rising >=10mg/dl, AL declines >=20%.
Effective: to reach following any one person: TC decline 10-19%, TG decline 20-39%, HDG-C rising 1-9mc/dl, AL decline 10-20%.
Invalid: not reach effective standard person.
Worsen: reach following any one person: TC rising >=10%, TG rising 10%, HDC-C decline >=4mg/dl, AL rises >=10%.
After the course for the treatment of, clinical effectiveness evaluation:
Table 7
| Group | Effective (number of cases) | Effectively (number of cases) | Invalid (number of cases) | Total effective rate |
| Experimental group | 23 | 26 | 1 | 98% |
| Matched group | 6 | 21 | 23 | 54% |
As can be seen from Table 7,50 hyperlipidemia patients are taken to polysaccharide mixture of the present invention and do therapeutic test, after 4 days course for the treatment of, total effective rate is up to 98%.
Table 8
| Group | TC | TG | HDL-C | AL |
| Experimental group | 184.54±18.65 | 172.56±14.49 | 39.54±2.72 | 4.29±1.02 |
| Matched group | 184.54±18.65 | 163.92±11.38 | 39.99±2.57 | 3.78±0.84 |
Experimental group P < 0.05, matched group P < 0.01.
By above every evidence, polysaccharides of traditional Chinese medicine and microbial activity polysaccharide mixture are as a kind of newtype drug, the suitable hyperlipemia index reducing in five of blood fat is had to fairly obvious effect, further in this polysaccharide mixture of analytical proof, contain abundant total amino acids, dendrobine, dendrophnol, Herba Dendrobii ammonia, various trace elements, cellulose etc., so this active polysaccharide mixture has powerful cleaning blood toxicity, improve blood of human body microcirculation, hepatoprotective function of gallbladder promoting, strong muscle blood fat reducing, nourishing Tianjin, strengthen the spleen and stomach, benefiting qi and nourishing blood, balancing blood pressure, potent blood sugar lowering, strong thrombus-dissolving, further the mixture of analytical proof thrombolytic mixing polysaccharide has many-sided biological activity, high-quality and Chinese herbal medicine microbial polysaccharide mixture without any side effects in the world today.Can effectively treat heart cerebral thrombosis acute phase disease, the sequela of acute stage is recovered and prevented that recurrence from having significant Prevention effect, has special effect to angiomalacia Nutrition significant medium-height grass property of medicine polysaccharide and microbial bacteria mycelium polysaccharide mixture pharmacodynamic feature again simultaneously.
Claims (9)
1. the processing technology of a thrombolysis activity polysaccharide mixture, it is characterized in that: this polysaccharide mixture is the concentrated polysaccharide mixed liquor of the Herba Dendrobii, Flos Chrysanthemi, the Fructus Crataegi that utilize combined-enzyme method lixiviate and is mixed and formed by the fermentation liquid of Auricularia, Cordyceps mycelium, concrete manufacturing process steps comprises:
(1) choose Herba Dendrobii, Flos Chrysanthemi, Fructus Crataegi herbal raw material, carry out respectively following steps to obtain Dendrobium officinale polysaccharide liquid, chrysanthemum polysaccharide liquid and Hawthorn Polysaccharides liquid:
A, rinsing are to remove Chinese herbal medicine surface irregularities;
In b, the Chinese herbal medicine after rinsing, add water, then grind to form serosity with colloid mill;
C, in serosity, add the water of 5-30 times of weight, heat, be warming up to 100 ℃, then be cooled to 85 ℃, under pressure 30MPa, utilize high pressure homogenizer to process, obtain homogeneous slurry;
D, in homogeneous slurry, add compound protease lixiviate 1 ~ 2 hour, wherein, homogeneous slurry with the ratio of the weight of compound protease is: 100:(1.5 ~ 2), the cellulase that compound protease is 1:1:1 by weight ratio, pectase and protease form;
E, lixiviating solution is separated through low speed centrifuge, filtering and concentrating is removed 10-20% moisture and dry, stand-by;
(2) choose the strain of Auricularia and Cordyceps, carry out respectively following steps to obtain Auricularia polycose extracting solution and Cordyceps polysaccharides extracting solution:
I, take slant strains to cultivate, the breeding of shaking table liquid, seed tank liquid spawn three-class strain is cultivated liquid spawn separately, again liquid spawn is introduced respectively to the supporting fermentation tank 3-7 days that ferments in liquid culture medium, when reaching 65-80%, mycelial growth concentration stops fermentation, solid residue in filtering fermentating liquid, obtains fermentation filtered solution stand-by;
II, in temperature, be not less than 90 ℃, under an ambient pressure 1.2-1.5 atmospheric pressure, in fermentation filtered solution, add the compound protease being formed by pepsin and papain to carry out pyrolysis, inactivation treatment, the filtered solution that wherein ferments is 100:(0.5 ~ 2 with the ratio of the weight of compound protease), the mass ratio of pepsin and papain is 1:1;
III, by the fermentation filtered solution through pyrolysis, inactivation treatment filter, moisture and the miscellaneous material of the concentrated 10-20% of removal, stand-by;
(3) Dendrobium officinale polysaccharide liquid, chrysanthemum polysaccharide liquid, Hawthorn Polysaccharides liquid, Auricularia polycose extracting solution and Cordyceps polysaccharides extracting solution are mixed according to following percent by volume:
Dendrobium officinale polysaccharide liquid 5-50%,
Chrysanthemum polysaccharide liquid 10-30%,
Hawthorn Polysaccharides liquid 5-15%,
Auricularia polycose extracting solution 10-40%,
Cordyceps polysaccharides extracting solution 5-35%;
(4) under gnotobasis, the mixed liquor forming after being mixed, at 60 ℃, is carried out to pressure 10 ~ 15MPa homogenizing, sub-bottle, encapsulation, sterilization become finished product.
2. the processing technology of a kind of thrombolysis activity polysaccharide mixture according to claim 1, is characterized in that: in step e, described dry is handled as follows again:
E1, in dry, add the water of 5-30 times of weight, heat, be warming up to 100 ℃, then be cooled to 85 ℃, under pressure 30MPa, utilize high pressure homogenizer to process, obtain homogeneous slurry;
E2, in homogeneous slurry, add compound protease lixiviate 1 ~ 2 hour, wherein, homogeneous slurry with the ratio of the weight of compound protease is: 100:(1 ~ 1.5), the cellulase that compound protease is 1:1:1 by weight ratio, pectase and protease form;
E3, lixiviating solution is separated through low speed centrifuge, filtering and concentrating is removed 10-20% moisture and dry, stand-by.
3. the processing technology of a kind of thrombolysis activity polysaccharide mixture according to claim 2, is characterized in that: in step e3, described dry is handled as follows again:
E31, in dry, add the water of 5-30 times of weight, heat, be warming up to 100 ℃, then be cooled to 85 ℃, under pressure 30MPa, utilize high pressure homogenizer to process, obtain homogeneous slurry;
E32, in homogeneous slurry, add compound protease lixiviate 1 ~ 2 hour, wherein, homogeneous slurry with the ratio of the weight of compound protease is: 100:(0.5 ~ 1), the cellulase that compound protease is 1:1:1 by weight ratio, pectase and protease form;
E33, lixiviating solution is separated through low speed centrifuge, filtering and concentrating is removed 10-20% moisture and dry, stand-by.
4. the processing technology of a kind of thrombolysis activity polysaccharide mixture according to claim 1, is characterized in that: the fermentation temperature of described Auricularia is 24-26 degree Celsius, and the fermentation temperature of described Cordyceps is 16-18 degree Celsius.
5. the processing technology of a kind of thrombolysis activity polysaccharide mixture according to claim 1, it is characterized in that: the pressure in described fermentation tank is 30-50MPa, liquid culture medium carbon, nitrogen are than being 1:(16-24), inoculum concentration is 10%, ventilation is 0.4-0.6 cube m/min, and mixing speed is 120-180 rev/min.
6. the processing technology of a kind of thrombolysis activity polysaccharide mixture according to claim 1, is characterized in that: when in step (2), Auricularia strain carries out step I, the liquid culture medium of employing is prepared by following percentage by weight:
Testa Tritici juice 8-10%,
Corn juice 5-10%,
Murphy juice 10-15%,
Bean milk 15-20%,
Yeast powder 0.5-1%,
Sucrose 0.5-3%,
Glucose 0.5-2%,
Magnesium sulfate 0.02-0.05%,
Potassium dihydrogen phosphate 0.05-0.1%,
Peptone 0.3-1%,
Oleum Arachidis hypogaeae semen 0.3-0.6%,
Surplus is water.
7. the processing technology of a kind of thrombolysis activity polysaccharide mixture according to claim 1, is characterized in that: when in step (2), Cordyceps strain carries out step I, the liquid culture medium of employing is prepared by following percentage by weight:
Dried silkworm chrysalis meal 1-2%,
Milk powder 2-3%,
Murphy juice 20-30%,
Bean milk 25-35%,
Semen setariae juice 10-20%,
Corn juice 10-20%,
Yeast powder 1-2%,
Sucrose 0.5-2%,
Glucose 1-3%,
Peptone 0.5-1%,
Magnesium sulfate 0.05-0.1%,
Potassium dihydrogen phosphate 0.15-0.18%,
Vitamin B1 0.5-1%
Oleum Arachidis hypogaeae semen 0.5-0.8%,
Surplus is water.
8. the processing technology of a kind of thrombolysis activity polysaccharide mixture according to claim 1, it is characterized in that: in described step (4), also comprise by mixed liquor at 60 ℃, carry out pressure 15MPa homogenizing active polysaccharide liquid afterwards and form powder through drying process with atomizing, then powder is packed and formed capsule or tablet.
9. the processing technology of a kind of thrombolysis activity polysaccharide mixture according to claim 1, is characterized in that: the filter progress of described lixiviating solution is to adopt ultrafilter membrane or reverse osmosis membrane filtration.
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