CN104490982B - A kind of eucommia bark depressor slow releasing preparation and preparation method thereof - Google Patents
A kind of eucommia bark depressor slow releasing preparation and preparation method thereof Download PDFInfo
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- CN104490982B CN104490982B CN201410706676.2A CN201410706676A CN104490982B CN 104490982 B CN104490982 B CN 104490982B CN 201410706676 A CN201410706676 A CN 201410706676A CN 104490982 B CN104490982 B CN 104490982B
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- cortex eucommiae
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- 238000002360 preparation method Methods 0.000 title claims abstract description 32
- 241000208688 Eucommia Species 0.000 title claims abstract description 17
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 26
- 239000004925 Acrylic resin Substances 0.000 claims abstract description 14
- 229920001661 Chitosan Polymers 0.000 claims abstract description 13
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 13
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract description 13
- 229930195725 Mannitol Natural products 0.000 claims abstract description 13
- 239000008101 lactose Substances 0.000 claims abstract description 13
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 13
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- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims abstract description 6
- 238000000034 method Methods 0.000 claims description 11
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- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 abstract description 2
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- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 abstract description 2
- 239000001856 Ethyl cellulose Substances 0.000 abstract description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 abstract description 2
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- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 abstract description 2
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- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 abstract description 2
- NKWPZUCBCARRDP-UHFFFAOYSA-L calcium bicarbonate Chemical compound [Ca+2].OC([O-])=O.OC([O-])=O NKWPZUCBCARRDP-UHFFFAOYSA-L 0.000 abstract description 2
- 229910000020 calcium bicarbonate Inorganic materials 0.000 abstract description 2
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 abstract description 2
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- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 abstract description 2
- 235000019325 ethyl cellulose Nutrition 0.000 abstract description 2
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- 238000013268 sustained release Methods 0.000 abstract description 2
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- 241000700159 Rattus Species 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 230000008816 organ damage Effects 0.000 description 3
- ZJSJQWDXAYNLNS-UHFFFAOYSA-N (+) pinoresinol-4,4'-di-O-beta-D-glucopyranoside Natural products COC1=CC(C2C3C(C(OC3)C=3C=C(OC)C(OC4C(C(O)C(O)C(CO)O4)O)=CC=3)CO2)=CC=C1OC1OC(CO)C(O)C(O)C1O ZJSJQWDXAYNLNS-UHFFFAOYSA-N 0.000 description 2
- ZJSJQWDXAYNLNS-FUPWJLLWSA-N (2s,3r,4s,5s,6r)-2-[4-[(3s,3ar,6s,6ar)-6-[3-methoxy-4-[(2s,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyphenyl]-1,3,3a,4,6,6a-hexahydrofuro[3,4-c]furan-3-yl]-2-methoxyphenoxy]-6-(hydroxymethyl)oxane-3,4,5-triol Chemical compound COC1=CC([C@@H]2[C@@H]3[C@@H]([C@H](OC3)C=3C=C(OC)C(O[C@H]4[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O4)O)=CC=3)CO2)=CC=C1O[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O ZJSJQWDXAYNLNS-FUPWJLLWSA-N 0.000 description 2
- 206010008190 Cerebrovascular accident Diseases 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- -1 Phenylpropanoid Glycosides Chemical class 0.000 description 2
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- 206010003549 asthenia Diseases 0.000 description 2
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- 238000004128 high performance liquid chromatography Methods 0.000 description 2
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- CWVRJTMFETXNAD-FWCWNIRPSA-N 3-O-Caffeoylquinic acid Natural products O[C@H]1[C@@H](O)C[C@@](O)(C(O)=O)C[C@H]1OC(=O)\C=C\C1=CC=C(O)C(O)=C1 CWVRJTMFETXNAD-FWCWNIRPSA-N 0.000 description 1
- NLOAQXKIIGTTRE-JSWHPQHOSA-N Alisol b acetate Chemical compound O([C@@H]1[C@@H](OC(C)=O)C[C@@H](C)C=2CC[C@]3(C)[C@@]4(C)CC[C@H]5C(C)(C)C(=O)CC[C@]5(C)[C@@H]4[C@@H](O)CC3=2)C1(C)C NLOAQXKIIGTTRE-JSWHPQHOSA-N 0.000 description 1
- NLOAQXKIIGTTRE-UHFFFAOYSA-N Alisol-B-Monoacetat Natural products C=12CC(O)C3C4(C)CCC(=O)C(C)(C)C4CCC3(C)C2(C)CCC=1C(C)CC(OC(C)=O)C1OC1(C)C NLOAQXKIIGTTRE-UHFFFAOYSA-N 0.000 description 1
- 208000006820 Arthralgia Diseases 0.000 description 1
- PZIRUHCJZBGLDY-UHFFFAOYSA-N Caffeoylquinic acid Natural products CC(CCC(=O)C(C)C1C(=O)CC2C3CC(O)C4CC(O)CCC4(C)C3CCC12C)C(=O)O PZIRUHCJZBGLDY-UHFFFAOYSA-N 0.000 description 1
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- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- 206010021118 Hypotonia Diseases 0.000 description 1
- CWVRJTMFETXNAD-KLZCAUPSSA-N Neochlorogenin-saeure Natural products O[C@H]1C[C@@](O)(C[C@@H](OC(=O)C=Cc2ccc(O)c(O)c2)[C@@H]1O)C(=O)O CWVRJTMFETXNAD-KLZCAUPSSA-N 0.000 description 1
- 208000003251 Pruritus Diseases 0.000 description 1
- RXUWDKBZZLIASQ-UHFFFAOYSA-N Puerarin Natural products OCC1OC(Oc2c(O)cc(O)c3C(=O)C(=COc23)c4ccc(O)cc4)C(O)C(O)C1O RXUWDKBZZLIASQ-UHFFFAOYSA-N 0.000 description 1
- 230000003276 anti-hypertensive effect Effects 0.000 description 1
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- 239000002775 capsule Substances 0.000 description 1
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- 229940126678 chinese medicines Drugs 0.000 description 1
- CWVRJTMFETXNAD-JUHZACGLSA-N chlorogenic acid Chemical compound O[C@@H]1[C@H](O)C[C@@](O)(C(O)=O)C[C@H]1OC(=O)\C=C\C1=CC=C(O)C(O)=C1 CWVRJTMFETXNAD-JUHZACGLSA-N 0.000 description 1
- 229940074393 chlorogenic acid Drugs 0.000 description 1
- FFQSDFBBSXGVKF-KHSQJDLVSA-N chlorogenic acid Natural products O[C@@H]1C[C@](O)(C[C@@H](CC(=O)C=Cc2ccc(O)c(O)c2)[C@@H]1O)C(=O)O FFQSDFBBSXGVKF-KHSQJDLVSA-N 0.000 description 1
- 235000001368 chlorogenic acid Nutrition 0.000 description 1
- 208000020832 chronic kidney disease Diseases 0.000 description 1
- BMRSEYFENKXDIS-KLZCAUPSSA-N cis-3-O-p-coumaroylquinic acid Natural products O[C@H]1C[C@@](O)(C[C@@H](OC(=O)C=Cc2ccc(O)cc2)[C@@H]1O)C(=O)O BMRSEYFENKXDIS-KLZCAUPSSA-N 0.000 description 1
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- 229920005610 lignin Polymers 0.000 description 1
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- HKEAFJYKMMKDOR-VPRICQMDSA-N puerarin Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1C1=C(O)C=CC(C2=O)=C1OC=C2C1=CC=C(O)C=C1 HKEAFJYKMMKDOR-VPRICQMDSA-N 0.000 description 1
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- 230000035488 systolic blood pressure Effects 0.000 description 1
- 150000003505 terpenes Chemical class 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Alternative & Traditional Medicine (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to a kind of eucommia bark depressor slow releasing preparation and preparation method thereof, belong to field of traditional Chinese.It is made up of Cortex Eucommiae extract and adjuvant.Described adjuvant to be selected from hypromellose, polyacrylic resin, ethyl cellulose, cellulose acetate, chitosan, beta-schardinger dextrin-, carbomer, microcrystalline Cellulose, lactose, calcium hydrogen phosphate, starch, mannitol, sorbitol, Polyethylene Glycol, glucose, Pulvis Talci, micropowder silica gel, calcium bicarbonate or magnesium stearate one or more.In the present invention further embodiment, described adjuvant is preferably polyacrylic resin, chitosan, cellulose acetate, lactose, mannitol and magnesium stearate.The present invention, in conjunction with the feature of Cortex Eucommiae extract, select suitable adjuvant to be prepared into skeleton gel rubber sustained-release sheet, not only good stability, and slow release effect is excellent.
Description
Technical field
The present invention relates to a kind of eucommia bark depressor slow releasing preparation and preparation method thereof, belong to field of traditional Chinese.
Background technology
Hypertension is modal chronic disease, and be also the topmost risk factor of cardiovascular and cerebrovascular disease, apoplexy, myocardial infarction, heart failure and chronic kidney disease are its major complications.Both domestic and externally facts have proved, hypertension is can the disease of prevention and corntrol, reduces the blood pressure level of hyperpietic, can obviously reduce apoplexy and the events of heart attack, significantly improve the life quality of patient, effectively reduce Disease Spectrum.The blood pressure level of hypertensive hazardness and patient mutually outside the Pass, also depend on the situation of other diseases of other cardiovascular risk factors simultaneous, target organ damage and merging.Therefore in hypertensive definition and classification, hypertensive diagnostic criteria is fixed on systolic pressure >110mmH and (or) diastolic pressure >90mmHg, be divided into normally according to blood pressure level, outside High-normal blood pressure and 1,2,3 grade of hypertension, also carry out risk stratification according to risk factor, target organ damage and the other diseases that merges simultaneously simultaneously.
Treating hypertensive main purpose is reduce cardiovascular morbidity and dead total danger to greatest extent, therefore require that doctor is treating hypertensive while, intervene the clinical disease that all reversibility cardiovascular risk factors of patient, target organ damage and merging exist.Be below 140/90mmHg for general hyperpietic's blood pressure lowering target, for the high risk patient such as complication with diabetes or nephropathy, blood pressure should take the circumstances into consideration to be down to more low-level in the tolerant situation of patient.
The Cortex Eucommiae begin be loaded in Shennong's Herbal, clinical practice has the history of more than one thousand years, because of its invigorating the liver and kidney, bone and muscle strengthening, admittedly rushes effect that is antiabortive, blood pressure lowering, pay attention to by medical scholar.At all times in TCM Literature, have hundreds of prescription to record, inside and outside, woman, youngster, bone, Shang Ge section have.The Cortex Eucommiae clinically, is mainly used in treatment deficiency of the liver and kindey, asthenia of essence and blood, the debility of CHONG and REN meridians and hypertension.Modem medical practices proves, the Cortex Eucommiae has significant curative effect to Zhejiang, foot and knee flaccidity, hypertension, frequent micturition, the frequent fetal movement etc. of suffering from a deficiency of the kidney disease more than wet, the urine of itching under waist knee joint ache, the moon.On market, the antihypertensive effect of existing eucommia bark depressor preparation (comprising folk prescription and compound preparation) is better, good effect is achieved through clinical practice, but its preparation mostly is the common formulations such as tablet, capsule, granule, pill or oral liquid, wherein the concentration of contained drug active component and purity lower, dose is large, is unfavorable for giving full play to of drug effect.
Patent CN200610110223 discloses a kind of Cortex Eucommiae compound slow release preparation, it adopts PLA to be timbering material, but its complicated process of preparation, and it uses in Shi Xu patients with implantation tissue cavity, easily cause patient uncomfortable, in addition, Chinese medicine extract complicated component, therefore implant stability and histocompatibility poor.
Summary of the invention
An object of the present invention is to provide a kind of eucommia bark depressor slow releasing preparation, it is directly oral, good stability, and patient only needs to take medicine once every day, and blood drug level and therapeutic effect are stablized.
Technical scheme of the present invention is as follows:
A kind of eucommia bark depressor slow releasing preparation, it is made up of Cortex Eucommiae extract and adjuvant.
Described adjuvant to be selected from hypromellose, polyacrylic resin, ethyl cellulose, cellulose acetate, chitosan, beta-schardinger dextrin-, carbomer, microcrystalline Cellulose, lactose, calcium hydrogen phosphate, starch, mannitol, sorbitol, Polyethylene Glycol, glucose, Pulvis Talci, micropowder silica gel, calcium bicarbonate or magnesium stearate one or more.
In the present invention further embodiment, described adjuvant is preferably polyacrylic resin, chitosan, cellulose acetate, lactose, mannitol and magnesium stearate.Described polyacrylic resin can select No. II, domestic polyacrylic resin or EudragitL100-55 (German rohm).
In one embodiment of the invention, the weight portion of described eucommia bark depressor slow releasing preparation consists of:
In one embodiment of the invention, the weight portion of described eucommia bark depressor slow releasing preparation consists of:
In another embodiment of the invention, the weight portion of described eucommia bark depressor slow releasing preparation consists of:
In a preferred embodiment of the present invention, the weight portion of described eucommia bark depressor slow releasing preparation consists of:
Another object of the present invention is to provide a kind of method preparing above-mentioned eucommia bark depressor slow releasing preparation, and concrete steps are as follows:
(1) Cortex Eucommiae extract, polyacrylic resin, chitosan, cellulose acetate, lactose and mannitol are uniformly mixed 15 minutes in high-speed mixer, obtain uniformed powder;
(2) in powder body, add appropriate 30% ethanol to granulate, vacuum drying makes water content lower than 5%, crosses 16 mesh sieves, and add magnesium stearate mixing, method tabletting, to obtain final product routinely.
In the present invention, Cortex Eucommiae extract source is not limit, and it can be the extract of Folium Eucommiae, root, stem or flower, also can their mixture, and said extracted thing is all adopted this area routine techniques means preparation or directly obtained by commercial means.
Usually containing lignin, iridoids, Phenylpropanoid Glycosides class, terpenoid and polysaccharide compound in traditional Cortex Eucommiae extract, composition is comparatively complicated, the problem such as less stable and blood drug level instability is easily there is after being prepared into slow releasing preparation, the present invention is in conjunction with the feature of Cortex Eucommiae extract, suitable adjuvant is selected to be prepared into skeleton gel rubber sustained-release sheet, not only good stability, and slow release effect is excellent.
Accompanying drawing explanation
Fig. 1: the plasma concentration curve after slow releasing tablet prepared by Oral Administration in Rats embodiment 1-2
Detailed description of the invention
The present invention is illustrated below in conjunction with accompanying drawing and further detailed description in detail.It is pointed out that following explanation is only illustrating the technical scheme that application claims is protected, any restriction not to these technical schemes.The content that protection scope of the present invention is recorded with appended claims is as the criterion.
Embodiment 1
(1) 300g Cortex Eucommiae extract, 150g polyacrylic resin, 100g chitosan, 50g cellulose acetate, 150g lactose and 100g mannitol are uniformly mixed 15 minutes in high-speed mixer, obtain uniformed powder;
(2) in powder body, add appropriate 30% ethanol to granulate, vacuum drying makes water content lower than 5%, crosses 16 mesh sieves, and add the mixing of 2g magnesium stearate, method tabletting, to obtain final product routinely.The heavy 300mg of sheet, suppresses 290.
Embodiment 2
(1) 300g Cortex Eucommiae extract, 100g polyacrylic resin, 150g chitosan, 100g cellulose acetate, 100g lactose and 100g mannitol are uniformly mixed 15 minutes in high-speed mixer, obtain uniformed powder;
(2) in powder body, add appropriate 30% ethanol to granulate, vacuum drying makes water content lower than 5%, crosses 16 mesh sieves, and add the mixing of 2g magnesium stearate, method tabletting, to obtain final product routinely.The heavy 300mg of sheet, suppresses 290.
The Cortex Eucommiae extract adopted in embodiment 1 and 2 is the water extract (weight ratio of root, stem and leaf is 1:1:1) of Cortex Eucommiae root, stem and leaf, preparation method adopts more traditional aqueous extraction-alcohol precipitation technology, 8 times of water gaging reflux, extract, 3 times, each 1h, merging filtrate, concentrated, adjust ethanol content to 90%, spend the night, filter rear concentrate drying and get final product.
Embodiment 3
Investigate correlated samples stability according to the stability guideline of Chinese Pharmacopoeia 2010 editions two annex, investigate the placement medicine stability of 60 days under 25 DEG C 45 DEG C and relative humidity 75% condition.HPLC method is adopted to measure the content of pinoresinol diglucoside and chlorogenic acid in slow releasing preparation.
In addition, for embodying the superiority of granule of the present invention, ad hoc fixed following comparative example:
Comparative example 1: adjuvant is 150g chitosan, 150g cellulose acetate, 150g lactose, 100g mannitol and 2g magnesium stearate, and other are with embodiment 1;
Comparative example 2: adjuvant is 150g polyacrylic resin, 150g chitosan, 150g lactose, 100g mannitol and 2g magnesium stearate, other are with embodiment 1;
Comparative example 3: see embodiment 5 in patent documentation CN200610110223 description; In preparation, save other Chinese medicines only retain the Cortex Eucommiae.
Place under 45 DEG C and relative humidity 75% condition and respectively organize Effective Component of Chinese Medicine content (n=10) afterwards in 60 days
Embodiment 4
Release medium, for imitating human gastrointestinal tract environment (being 0.1mol/L hydrochloric acid before 2h, is the PBS buffer of pH6.8 after 2h), investigates the release of slow releasing tablet prepared by each embodiment respectively.
Release investigation method: the content first being measured puerarin, citric acid and Alisol B monoacetate in slow releasing tablet by HPLC, then release medium will be put into lot number slow releasing tablet and investigate release.
The release research in rat body of embodiment 5 slow releasing tablet
Get SD rat, after fasting 12h, gastric infusion (in Cortex Eucommiae extract 100mg/kg), gets blood in 1,4,8,12 and 24h eyeball respectively, and adopt HPLC-MS to measure each time point blood drug level, concrete outcome is see accompanying drawing 1.
Result as can be seen from accompanying drawing, not very stable in drug release process in slow releasing tablet prepared by comparative example 1 and 2, significantly prominent phenomenon of releasing is had to occur, and slow releasing tablet drug release rate prepared by embodiment 1 and 2 is comparatively steady, obvious pinoresinol diglucoside content still can be detected after 24 hours in blood.
Content of the present invention merely illustrates some claimed specific embodiments; one of them or more described technical characteristic can be combined with arbitrary one or more technical scheme in technical scheme; these technical schemes obtained through combination also in the application's protection domain, just as these technical schemes obtained through combination in the disclosure of invention concrete record.
Claims (4)
1. an eucommia bark depressor slow releasing preparation, the weight portion of described eucommia bark depressor slow releasing preparation consists of:
Cortex Eucommiae extract 30 parts;
Polyacrylic resin 10 ~ 15 parts;
Chitosan 10 ~ 15 parts;
Cellulose acetate 5 ~ 10 parts;
Lactose 10 ~ 15 parts;
10 parts, mannitol;
Magnesium stearate 2 parts.
2. slow releasing preparation according to claim 1, is characterized in that, the weight portion of described eucommia bark depressor slow releasing preparation consists of:
Cortex Eucommiae extract 30 parts;
Polyacrylic resin 15 parts;
Chitosan 10 parts;
Cellulose acetate 5 parts;
Lactose 15 parts;
10 parts, mannitol;
Magnesium stearate 2 parts.
3. slow releasing preparation according to claim 1, is characterized in that, the weight portion of described eucommia bark depressor slow releasing preparation consists of:
Cortex Eucommiae extract 30 parts;
Polyacrylic resin 10 parts;
Chitosan 15 parts;
Cellulose acetate 10 parts;
Lactose 10 parts;
10 parts, mannitol;
Magnesium stearate 2 parts.
4. prepare a method for the eucommia bark depressor slow releasing preparation described in any one of claim 1-3, concrete steps are as follows:
(1) Cortex Eucommiae extract, polyacrylic resin, chitosan, cellulose acetate, lactose and mannitol are uniformly mixed 15 minutes in high-speed mixer, obtain uniformed powder;
(2) in powder body, add appropriate 30% ethanol to granulate, vacuum drying makes water content lower than 5%, crosses 16 mesh sieves, and add magnesium stearate mixing, method tabletting, to obtain final product routinely.
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