CN105343012A - Eucommia polysaccharide effervescent granule and preparation method thereof - Google Patents
Eucommia polysaccharide effervescent granule and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a eucommia polysaccharide effervescent granule. The eucommia polysaccharide effervescent granule comprises eucommia polysaccharide crystals, an adhesive, a diluent, an effervescent disintegrant and a lubricant, the adhesive is a 5% polyvinylpyrrolidone and anhydrous ethanol solution, the diluent is lactose, the effervescent disintegrant comprises an acidic component and an alkaline component, the acidic component is citric acid or tartaric acid, the alkaline component is potassium bicarbonate or sodium bicarbonate, and the lubricant is polyethylene glycol. The eucommia polysaccharide effervescent granule has the advantages of obvious curative effect on cerebral stroke patients, short treatment course, fast effectiveness, and no toxic or side effects, and is worth to be popularized.
Description
Technical field
The invention belongs to Chinese drug preparation technique field, be specifically related to a kind of eucommia bark polycose effervescent granule and preparation method thereof.
Background technology
Imaging in Patients with Cerebral Ischemia Disease is also known as apoplexy, and the traditional Chinese medical science claims apoplexy, is the disease of serious threat human health and quality of life.The display of statistical data that official website of Ministry of Health of the People's Republic of China provides, cerebrovascular disease in 2007 is all number two position in city and country disease death reason, is only second to malignant tumor.Wherein the mortality rate in city is 111.5/10 ten thousand, accounts for 18.0% of total death toll; Rural area is 119.7/10 ten thousand, accounts for 20.6% of total death toll.In survivor, patient 50-70% leaves over the deformity such as paralysis, aphasia, has a strong impact on work and life, and causes very large economy and mental burden to society and family.Along with improving constantly of people's living standard, the acceleration of social senilization, its sickness rate also has the trend increased, and the trend of oriented middle age development.Therefore, studying and combating cerebrovascular has important social meaning, domestic and international neuroscience workers always in unremitting effort to seek and to find safe, reliable and effective medicine.The TCM modern preparations easy to use with apoplexy preventive and therapeutic effect has broad application prospects and significant economic benefits.
The Cortex Eucommiae (EucommiaulmoidesOliv, EUO) has another name called thinks celestial, the think of second month in a season, kapok etc., and in China south from the Five Ridges, the wide area on north to Great Wall is generally planted, and is the distinctive plant resources of China.The history that the Cortex Eucommiae is used as medicine existing more than 2,000 years, Shennong's Herbal is classified as the top grade of medicine, tool invigorating the spleen and replenishing QI, hard muscles and bones, and Qiang Zhi is antiabortive, takes effect of enduring hardships of making light of one's life by commiting suicide for a long time.Carrying the Cortex Eucommiae in " Chinese medicine voluminous dictionary " and Compendium of Material Medica, returning through entering liver, kidney channel.Eucommia bark polycose (EucommiaulmoidesOlivPolysaccharides, EOP) is the water-soluble sugar composition extracted from the dry bark of the Eucommiaceae plant Cortex Eucommiae, is the another active component of the Cortex Eucommiae of discovered in recent years.Seminar's early-stage Study finds that EOP has and improves body's hypoxia tolerance, antiinflammatory, the anti-immunocompetence of enhancing body, has significant protective effect to the bone marrow depression that cyclophosphamide causes, and without obvious adverse reaction.Short Term Clinical application and the pre-test result of zoopery in early stage all show the brain infarction area that EOP obviously can reduce ischemia-reperfusion rat.
At present, about eucommia bark polycose extraction and use also rare open, the exploitation of eucommia resource and high value utilize still to be existed a lot of difficult, eucommia bark polycose is made effervescent granule and is used for the treatment of stroke patient and has no report at present.
Summary of the invention
For making up the deficiencies in the prior art, the invention provides a kind of eucommia bark polycose effervescent granule and preparation method thereof, Patients with Apoplexy After has obvious curative effects.
The present invention is achieved through the following technical solutions:
A kind of eucommia bark polycose effervescent granule, its special character is: comprise following component: eucommia bark polycose crystallization, binding agent, diluent, gas-producing disintegrant and lubricant; Described binding agent is 5% polyvinylpyrrolidone and ethanol solution; Described diluent is lactose; Described gas-producing disintegrant comprises acidic components and basic component, and acidic components are citric acid or tartaric acid, and basic component is potassium bicarbonate or sodium bicarbonate; Described lubricant is Polyethylene Glycol.
Eucommia bark polycose effervescent granule of the present invention, component also comprises the additives such as carboxymethyl starch sodium, orange flavor, micropowder silica gel, magnesium stearate.
Eucommia bark polycose effervescent granule of the present invention, it is 25% that described eucommia bark polycose crystallization accounts for weight fraction, and it is 1% that lubricant accounts for weight fraction, and gas-producing disintegrant soda acid mass ratio is 1:1.3.
The preparation method of eucommia bark polycose effervescent granule of the present invention, comprises the following steps:
(1) pulverized by Cortex Eucommiae, use alcohol reflux 4-5h, cold filtration, filtering residue dries to obtain material previously treated;
(2) distilled water that above-mentioned material previously treated adds its 8-12 times volume decocts 2-3h in 70-80 DEG C of aqueous solution, filter, the distilled water of filtering residue continuation 8-12 times of volume decocts 2-3h in 70-80 DEG C of aqueous solution, repetition like this 2 times, merge 3 filtrates, filtrate is concentrated into the 1/8-1/12 of original volume in 65-75 DEG C, obtains crude extract;
(3) get crude extract and add chloroform and n-butyl alcohol, vibration, centrifugal, be separated, this repeats 3 times aqueous phase for another example, obtains final aqueous phase solution; Aqueous phase solution ethanol precipitate with ethanol, hold over night, successively by dehydrated alcohol, acetone, washed with diethylether precipitation, precipitation is dried, and obtains eucommia bark polycose crystallization;
(4) above-mentioned eucommia bark polycose crystallization and diluent, gas-producing disintegrant acidic components are mixed, add binding agent to granulate, after drying, mix homogeneously with the gas-producing disintegrant basic component powder of drying, granulate always mixes, and mixes, wet grain drying with lubricant, granulate, obtains product eucommia bark polycose effervescent granule.
The preparation method of the eucommia bark polycose effervescent granule of the invention described above, in step (2), material previously treated decocts temperature and is preferably 75 DEG C, and decocting time is preferably 2.5h, and filtrate thickening temperature is preferably 70 DEG C.
The preparation method of the eucommia bark polycose effervescent granule of the invention described above, the volume adding chloroform in step (3) is 1/5 of crude extract, and the volume adding n-butyl alcohol is 1/25 of crude extract, and duration of oscillation is 12min, centrifugation time is 15min, and centrifugal rotational speed is 3500 turns/min.
The preparation method of the eucommia bark polycose effervescent granule of the invention described above, in step (3), the process of aqueous phase solution preferably adopts the ethanol of 90%, and the volume adding ethanol is 5 times of aqueous phase solution.
Further, the preparation method of the eucommia bark polycose effervescent granule of the invention described above, in step (4), particle drying temperature is preferably 50 DEG C, and sodium bicarbonate powder order number is 40 orders.
The invention has the beneficial effects as follows: the present invention extracts eucommia bark polycose crystallization from the Cortex Eucommiae, method is simple, and yield is high, and purity is good, be aided with additive and be prepared into effervescent granule, preparation method is simple, and it is good to drink mouthfeel, and clinical effectiveness shows to have significant curative effect to patient with cerebral apoplexy, short treating period, instant effect, safe without toxic side effect, is worthy to be popularized.
Detailed description of the invention
Embodiment 1
Eucommia bark polycose Effervescent Granule Components: eucommia bark polycose crystallization 25g, citric acid 23g, potassium bicarbonate 31g, lactose 8g, 5% polyvinylpyrrolidone (PVP-K30) ethanol solution 4g, polyethylene glycol 6000 1g, carboxymethyl starch sodium 5g, orange flavor 1.5g, micropowder silica gel 1g, magnesium stearate 0.5g.
The preparation method of the eucommia bark polycose effervescent granule of the present embodiment, comprises the following steps:
(1) get Cortex Eucommiae 400g, pulverize, add 95% alcohol reflux 4.5h of its 4 times of volumes, cold filtration, filtering residue dries the material previously treated being and extracting polysaccharide.
(2) in material previously treated, the distilled water adding 10 times of volumes extracts 2.5h in 75 DEG C of water-baths, filters, filtering residue continues in 75 DEG C of water-baths, to extract 2.5h with the distilled water of 10 times of volumes, so repeats 2 times, merges 3 filtrates, filtrate is concentrated into 1/10 of original volume in 70 DEG C, obtains crude extract.
(3) get crude extract and add the chloroform of 1/5 times of volume and the n-butyl alcohol of 1/25 times of volume, vibration 12min, centrifugal 15min under 3500 turns/min, is separated to obtain aqueous phase solution, and this repeats 3 times aqueous phase for another example, obtains final aqueous phase solution.Aqueous phase solution 90% ethanol precipitate with ethanol of 5 times of volumes, hold over night, successively by dehydrated alcohol, acetone, washed with diethylether precipitation, precipitation is dried, and obtains eucommia bark polycose crystallization.
(4) above-mentioned eucommia bark polycose crystallization 25g is mixed homogeneously with 8g lactose, 23g citric acid powder and carboxymethyl starch sodium 5g, orange flavor 1.5g, micropowder silica gel 1g, magnesium stearate 0.5g, granulate as binding agent with 4g5% polyvinylpyrrolidone (PVP-K30) ethanol solution, after drying, mix homogeneously with the potassium bicarbonate 40 order powder 31g of drying, granulate always mixes, mix with 1g polyethylene glycol 6000, wet granular in 50 DEG C of dryings, granulate.
Embodiment 2
Eucommia bark polycose Effervescent Granule Components: eucommia bark polycose crystallization 56g, tartaric acid 40g, potassium bicarbonate 52g, lactose 50g, 5% polyvinylpyrrolidone (PVP-K30) ethanol solution 8g, polyethylene glycol 6000 2.2g, carboxymethyl starch sodium 10g, orange flavor 3g, micropowder silica gel 2g, magnesium stearate 0.8g.
The preparation method of the eucommia bark polycose effervescent granule of the present embodiment, comprises the following steps:
(1) get Cortex Eucommiae 400g, pulverize, with 95% alcohol reflux 4h of 4 times of volumes, cold filtration, filtering residue dries the material previously treated being and extracting polysaccharide.
(2) in material previously treated, the distilled water adding 8 times of volumes extracts 3h in 70 DEG C of water-baths, filters, filtering residue continues in 70 DEG C of water-baths, to extract 3h with the distilled water of 8 times of volumes, so repeats 2 times, merges 3 filtrates, filtrate is concentrated into 1/8 of original volume in 65 DEG C, obtains crude extract.
(3) get crude extract and add the chloroform of 1/5 times of volume and the n-butyl alcohol of 1/25 times of volume, vibration 12min, centrifugal 15min under 3500 turns/min, be separated, and this repeats 3 times aqueous phase for another example, obtains final aqueous phase solution.Aqueous phase solution 90% ethanol precipitate with ethanol of 5 times of volumes, hold over night, successively by dehydrated alcohol, acetone, washed with diethylether precipitation, precipitation is dried, and obtains eucommia bark polycose crystallization.
(4) above-mentioned eucommia bark polycose crystallization 56g is mixed homogeneously with 50g lactose, 40g tartaric acid powder and carboxymethyl starch sodium 10g, orange flavor 3g, micropowder silica gel 2g, magnesium stearate 0.8g, granulate as binding agent with 8g5% polyvinylpyrrolidone (PVP-K30) ethanol solution, after drying, mix homogeneously with the potassium bicarbonate 40 order powder 52g of drying, granulate always mixes, mix with polyethylene glycol 6000, wet granular in 50 DEG C of dryings, granulate.
Embodiment 3
Eucommia bark polycose Effervescent Granule Components: eucommia bark polycose crystallization 50g, citric acid 46g, sodium bicarbonate 62g, lactose 15g, 5% polyvinylpyrrolidone (PVP-K30) ethanol solution 8g, polyethylene glycol 6000 2g, carboxymethyl starch sodium 10g, orange flavor 4g, micropowder silica gel 2g, magnesium stearate 1g.
The preparation method of the eucommia bark polycose effervescent granule of the present embodiment, comprises the following steps:
(1) get Cortex Eucommiae 400g, pulverize, add 95% alcohol reflux 5h of its 4 times of volumes, cold filtration, filtering residue dries the material previously treated being and extracting polysaccharide.
(2) in material previously treated, the distilled water adding 12 times of volumes extracts 2h in 80 DEG C of water-baths, filters, filtering residue continues in 80 DEG C of water-baths, to extract 2h with the distilled water of 12 times of volumes, so repeats 2 times, merges 3 filtrates, filtrate is concentrated into 1/12 of original volume in 75 DEG C, obtains crude extract.
(3) get crude extract and add the chloroform of 1/5 times of volume and the n-butyl alcohol of 1/25 times of volume, vibration 12min, centrifugal 15min under 3500 turns/min, is separated to obtain aqueous phase solution, and this repeats 3 times aqueous phase for another example, obtains final aqueous phase solution.Aqueous phase solution 90% ethanol precipitate with ethanol of 5 times of volumes, hold over night, successively by dehydrated alcohol, acetone, washed with diethylether precipitation, precipitation is dried, and obtains eucommia bark polycose crystallization.
(4) above-mentioned eucommia bark polycose crystallization 50g is mixed homogeneously with 15g lactose, 46g citric acid powder and carboxymethyl starch sodium 10g, orange flavor 4g, micropowder silica gel 2g, magnesium stearate 1g, granulate as binding agent with 8g5% polyvinylpyrrolidone (PVP-K30) ethanol solution, after drying, mix homogeneously with the sodium bicarbonate 40 order powder 62g of drying, granulate always mixes, mix with 2g polyethylene glycol 6000, wet granular in 50 DEG C of dryings, granulate.
Embodiment 4
From year February in March, 2011 to 2012, eucommia bark polycose effervescent granule of the present invention to be applied in Tai'an City Hospital of Traditional Chinese Medicine and Tai'an Traditional Chinese Medicine Hospital Two by the present inventor can stroke patient Experiment on therapy 79 example of oral drugs, divide 2 groups and carry out clinical observation: A group is cerebral infarction, also claim ischemic cerebrovascular, comprise transient ischemic attack (being also transient cerebral ischemic attack), cerebral thrombosis, cerebral embolism and lacunar cerebral infarcts etc.; B group is hemorrhagic apoplexy, also claims hemorrhagic apoplexy, comprises cerebral hemorrhage and subarachnoid hemorrhage.Each group does not drop to the patient of time Primary plateaus according to routine clinical treatment facial hemiparalysis after 1 month, dysphonia, hemiplegia, takes EOP effervescent granule 1 month, observe clinical efficacy.
Curative effect determinate standard
Criterion of therapeutical effect is with reference to criterion of therapeutical effect relevant in " disease of tcm judgement criterion of therapeutical effect ".
Effective: clinical symptoms disappears substantially, test chamber checks that each index of correlation is close to normal level.
Effective: clinical symptom relief, test chamber checks that each index of correlation makes moderate progress, and sign is improved.
Invalid: clinical symptoms is without being clearly better or increasing the weight of.
Clinical efficacy result is as shown in the table:
| Group | Patient numbers | Effective number/effective percentage (%) | Efficiently individual quantity/effective percentage (%) | Invalid number/inefficiency (%) | Total effective rate (%) |
| A group | 47 | 24/51.1 | 20/42.6 | 3/6.4 | 93.7 |
| B group | 32 | 18/56.3 | 11/34.4 | 3/9.3 | 90.7 |
Above-mentioned explanation is not limitation of the present invention, and the present invention is also not limited in above-mentioned citing, and the change that those skilled in the art make in essential scope of the present invention, remodeling, interpolation or replacement also should belong to protection scope of the present invention.
Claims (9)
1. an eucommia bark polycose effervescent granule, is characterized in that: comprise following component: eucommia bark polycose crystallization, binding agent, diluent, gas-producing disintegrant and lubricant; Described binding agent is 5% polyvinylpyrrolidone ethanol solution; Described diluent is lactose; Described gas-producing disintegrant comprises acidic components and basic component, and acidic components are citric acid or tartaric acid, and basic component is potassium bicarbonate or sodium bicarbonate; Described lubricant is Polyethylene Glycol.
2. the preparation method of eucommia bark polycose effervescent granule according to claim 1, is characterized in that: comprise the following steps:
(1) pulverized by Cortex Eucommiae, use alcohol reflux 4-5h, cold filtration, filtering residue dries to obtain material previously treated;
(2) distilled water that above-mentioned material previously treated adds its 8-12 times volume decocts 2-3h in 70-80 DEG C of aqueous solution, filter, the distilled water of filtering residue continuation 8-12 times of volume decocts 2-3h in 70-80 DEG C of aqueous solution, repetition like this 2 times, merge 3 filtrates, filtrate is concentrated into the 1/8-1/12 of original volume in 65-75 DEG C, obtains crude extract;
(3) get crude extract and add chloroform and n-butyl alcohol, vibration, centrifugal, be separated, this repeats 3 times aqueous phase for another example, obtains final aqueous phase solution; Aqueous phase solution ethanol precipitate with ethanol, hold over night, successively by dehydrated alcohol, acetone, washed with diethylether precipitation, precipitation is dried, and obtains eucommia bark polycose crystallization;
(4) above-mentioned eucommia bark polycose crystallization and diluent, gas-producing disintegrant acidic components are mixed, add binding agent to granulate, after drying, mix homogeneously with the gas-producing disintegrant basic component powder of drying, granulate always mixes, and mixes, wet grain drying with lubricant, granulate, obtains product eucommia bark polycose effervescent granule.
3. eucommia bark polycose effervescent granule according to claim 1, is characterized in that: also comprise carboxymethyl starch sodium, orange flavor, micropowder silica gel, magnesium stearate.
4. eucommia bark polycose effervescent granule according to claim 1, is characterized in that: it is 25% that described eucommia bark polycose crystallization accounts for weight fraction, and it is 1% that lubricant accounts for weight fraction, and gas-producing disintegrant soda acid mass ratio is 1:1.3.
5. the preparation method of eucommia bark polycose effervescent granule according to claim 2, it is characterized in that: the volume adding chloroform in step (3) is 1/5 of crude extract, the volume adding n-butyl alcohol is 1/25 of crude extract, duration of oscillation is 12min, centrifugation time is 15min, and centrifugal rotational speed is 3500 turns/min.
6. the preparation method of eucommia bark polycose effervescent granule according to claim 2, is characterized in that: in step (3), the process of aqueous phase solution adopts the ethanol of 90%, and the volume adding ethanol is 5 times of aqueous phase solution.
7. the preparation method of eucommia bark polycose effervescent granule according to claim 2, is characterized in that: in step (2), material previously treated decocts temperature is 75 DEG C, and decocting time is 2.5h, and filtrate thickening temperature is 70 DEG C.
8. the preparation method of eucommia bark polycose effervescent granule according to claim 2, is characterized in that: in step (4), particle drying temperature is 50 DEG C.
9. the preparation method of eucommia bark polycose effervescent granule according to claim 2, is characterized in that: in step (4), gas-producing disintegrant basic component powder order number is 40 orders.
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Cited By (3)
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| CN108324742A (en) * | 2018-03-20 | 2018-07-27 | 福建容益菌业科技研发有限公司 | Sparassis crispa electuary and preparation method thereof |
| CN108433000A (en) * | 2018-03-20 | 2018-08-24 | 福建容益菌业科技研发有限公司 | Sparassis crispa sobering-up beverage and preparation method thereof |
| CN116284483A (en) * | 2023-03-24 | 2023-06-23 | 中国药科大学 | Method for extracting eucommia ulmoides leaf polysaccharide with assistance of low-frequency polarized electric field |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108324742A (en) * | 2018-03-20 | 2018-07-27 | 福建容益菌业科技研发有限公司 | Sparassis crispa electuary and preparation method thereof |
| CN108433000A (en) * | 2018-03-20 | 2018-08-24 | 福建容益菌业科技研发有限公司 | Sparassis crispa sobering-up beverage and preparation method thereof |
| CN108324742B (en) * | 2018-03-20 | 2021-02-02 | 福建容益菌业科技研发有限公司 | Sparassis crispa medicinal granules and preparation method thereof |
| CN108433000B (en) * | 2018-03-20 | 2021-08-31 | 福建容益菌业科技研发有限公司 | Sparassis crispa sobering-up beverage and preparation method thereof |
| CN116284483A (en) * | 2023-03-24 | 2023-06-23 | 中国药科大学 | Method for extracting eucommia ulmoides leaf polysaccharide with assistance of low-frequency polarized electric field |
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Application publication date: 20160224 |