CN104435447B - A kind of Ge Shan blood fat reducing slow releasing preparation and preparation method thereof - Google Patents
A kind of Ge Shan blood fat reducing slow releasing preparation and preparation method thereof Download PDFInfo
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- CN104435447B CN104435447B CN201410788343.9A CN201410788343A CN104435447B CN 104435447 B CN104435447 B CN 104435447B CN 201410788343 A CN201410788343 A CN 201410788343A CN 104435447 B CN104435447 B CN 104435447B
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- 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/488—Pueraria (kudzu)
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- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
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- 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)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
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- 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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/734—Crataegus (hawthorn)
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- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/884—Alismataceae (Water-plantain family)
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- 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
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- 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
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- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- 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, 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
- A61K2236/55—Liquid-liquid separation; Phase separation
Abstract
The present invention relates to a kind of Chinese medicine preparation, be specifically related to Ge Shan blood-fat-reducing preparation and preparation method thereof, belong to the field of Chinese medicines.It is made up of Chinese medicine extract and adjuvant; Described Chinese medicine extract by percentage by weight is: the Radix Puerariae of 32%, the Fructus Crataegi of 32%, the Rhizoma Alismatis of 15%, and the Radix Polygoni Multiflori of 13% and the Radix Angelicae Sinensis of 8% are made, and the weight ratio of described Chinese medicine extract and adjuvant is 1:2 ~ 5.Described adjuvant is made up of framework material, the filler of 10% ~ 50%, the porogen of double taste masking of 10% ~ 30% and the lubricant of 1% ~ 2% of 15% ~ 30%.Described framework material is preferably the mixture of xanthan gum and sodium alginate, xanthan gum in described mixture: the weight ratio of sodium alginate is 3:1.Described filler is preferably pregelatinized Starch; The preferred mannitol of described porogen; Described lubricant is preferably magnesium stearate.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation, be specifically related to Ge Shan blood fat reducing slow releasing preparation and preparation method thereof, belong to the field of Chinese medicines.
Background technology
Hyperlipemia is divided into former and the large class of secondary two clinically, is the result of lipid and lipoprotein metabolism disorder in numerous disease.Particularly hyperlipemia causes atherosclerosis, and cause cardiovascular and cerebrovascular vessel unexpected, the state of an illness is dangerous, prognosis mala.At present, all there is larger side effect in blood fat reducing chemical drugs conventional clinically, and life-time service, some drugs can be large because of gastrointestinal reaction, the consequences such as initiation fat soluble vitamin absorption is bad.In addition, because the individual variation of crowd is comparatively large, also bigger difference is existed with reaction to the curative effect of medicine.So, along with the development of the combination of Chinese and Western medicine and deepening continuously to Chinese medicine research, according to Traditional Chinese Medicine theory, in conjunction with contemporary Chinese medicine research achievement, dialectically to combine with differential diagnosis of diseases, select suitable drug matching application, be beneficial to long-term taking, side reaction is little, simultaneously the new type natural compound Chinese medicinal preparation of the balance of scalable human body body function, to treatment hyperlipemia, prevention cardiovascular and cerebrovascular disease and senile pathological changes important in inhibiting.
Slow releasing preparation (sustainedreleasepreparation) refers to by suitable method, delay the processes such as medicine release in vivo, absorption, distribution, metabolism and excretion, thus reach a class preparation of the objects such as prolong drug effect, minimizing toxic and side effects.Its " peak valley " phenomenon that ordinary preparation frequent drug administration can be avoided to occur, makes Drug safety, effectiveness and adaptability increase.The current complicated component due to Chinese medicine extract, Sustained Release Preparations of Chinese Medicinal also exists adjuvant screening difficulty in preparation, the technical problems such as forming technology difference and drug releasing rate instability.Ge Shan blood-fat-lowering granule comes from the clinical experience side for many years of Anhui Province famous physician Mr. Gao Daofan.Prescription is made up of Radix Puerariae, Fructus Crataegi (parched), Rhizoma Alismatis, Radix Polygoni Multiflori Preparata and Radix Angelicae Sinensis five kinds of Chinese medicine.Be mainly used in the hyperlipemia that various inducement causes clinically, the features such as have rapid-action, curative effect is high, and side effect is little.But the preparation that gone on the market at present only has Ge Shan blood-fat-lowering granule a kind of, and medicining times is many, and in patient body, blood drug level is unstable, can not effectively play its pharmacological action, far can not meet clinical needs.
Summary of the invention
For the technical problem existed at present, the invention provides a kind of Ge Shan blood fat reducing slow releasing preparation and preparation method thereof, reducing patient medication frequency is once-a-day, makes the release of medicine more stable, improves drug effect.
An object of the present invention is to provide a kind of Ge Shan blood fat reducing slow releasing preparation, it is made up of Chinese medicine extract and adjuvant; Described Chinese medicine extract by percentage by weight is: the Radix Puerariae of 32%, the Fructus Crataegi of 32%, the Rhizoma Alismatis of 15%, and the Radix Polygoni Multiflori of 13% and the Radix Angelicae Sinensis of 8% are made, and the weight ratio of described Chinese medicine extract and adjuvant is 1:2 ~ 5.
In one embodiment of the invention, described adjuvant by 15% ~ 30% framework material, the filler of 10% ~ 50%, the porogen of double taste masking of 10% ~ 30% and the lubricant of 1% ~ 2% form.
In another embodiment of the invention, described framework material is hypromellose, xanthan gum, one of carbomer and sodium alginate or their mixture.Described filler is microcrystalline Cellulose, lactose, calcium hydrogen phosphate, pregelatinized Starch or their mixture.Described porogen is mannitol, sorbitol, Polyethylene Glycol or glucose.Described lubricant is Pulvis Talci, micropowder silica gel or magnesium stearate.
In the present invention further embodiment, described framework material is preferably the mixture of xanthan gum and sodium alginate, xanthan gum in described mixture: the weight ratio of sodium alginate is 3:1.Described filler is preferably pregelatinized Starch; The preferred mannitol of described porogen; Described lubricant is preferably magnesium stearate.
Another object of the present invention is to provide a kind of method preparing described Ge Shan blood-fat-lowering granule, and concrete steps are as follows:
(1) the Rhizoma Alismatis drying of corresponding weight portion is ground into fine powder respectively;
(2) Radix Puerariae of corresponding weight portion, Fructus Crataegi, Radix Polygoni Multiflori and Radix Angelicae Sinensis are added 8 times amount soak by water three times, be 1.5 hours at every turn, filters, merging filtrate, and when being concentrated into 60 DEG C, relative density is the extractum of 1.10 ~ 1.20; Add ethanol and reach 70% to alcohol content, stir evenly, leave standstill, get supernatant and reclaim ethanol, drying and crushing obtains fine powder,
(3) the fine powder mix homogeneously that fine powder step (1) obtained, step (2) obtain, add the mixing of the framework material of corresponding weight portion, filler and porogen again, soft material is made as wetting agent with dehydrated alcohol, granulate, dry, granulate adds lubricant mixing, and tabletting, to obtain final product.
In embodiment further, the granularity that Rhizoma Alismatis described in step (1) is pulverized is 100 ~ 200 object fine powders, and the fineness that more preferably described Rhizoma Alismatis is pulverized is 150 object fine powders.Described in step (2), the granularity of fine powder is 150 orders.
The present invention is directed to the relevant feature of Callicarpa nudiflora extract, select suitable relevant auxiliary materials, thus obtain that a kind of moulding process is good, good stability and the stable Ge Shan blood fat reducing slow releasing preparation of drug releasing rate.
Detailed description of the invention
Further will illustrate the present invention below.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
Step 1: Rhizoma Alismatis 15kg is dried and crushed into fine powder, crosses 150 mesh sieves for subsequent use;
Step 2: by the Radix Puerariae of the 32kg of corresponding weight portion, the Fructus Crataegi of 32kg, the Radix Polygoni Multiflori of 13kg and the Radix Angelicae Sinensis of 8kg add 8 times amount soak by water three times, each 1.5 hours, filter, merging filtrate, and when being concentrated into 60 DEG C, relative density is the extractum of 1.10 ~ 1.20; Add ethanol and reach 70% to alcohol content, stir evenly, leave standstill, get supernatant and reclaim ethanol, drying and crushing obtains fine powder,
Step 3: the fine powder mix homogeneously that fine powder step (1) obtained, step (2) obtain, add the xanthan gum of corresponding weight portion, sodium alginate, pregelatinized Starch and mannitol mixing again, soft material is made as wetting agent with 70% ethanol, granulate, drying, granulate adds magnesium stearate mixing, tabletting, the heavy 500mg of sheet, to obtain final product.The weight ratio of described adjuvant and Chinese medicine extract is 3:1, and the percentage by weight of xanthan gum, sodium alginate, pregelatinized Starch, mannitol and magnesium stearate is respectively 30%:10%:40%:19%:1%.
Embodiment 2-5
Except following table content, other preparation technologies, with embodiment 1, specifically see the following form:
Embodiment 6 sustained-release tablets is tested
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 Ge Shan blood-fat-lowering granule that comparative example 1 is produced for Shandong Lvyin Pharmaceutical Co., Ltd.
The release research in rat body of embodiment 7 slow releasing tablet
Get SD rat, after fasting 12h, gastric infusion (in Chinese medicine 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 as follows:
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 (2)
1. a Ge Shan blood fat reducing slow releasing preparation, is characterized in that, it is made up of Chinese medicine extract and adjuvant; Described Chinese medicine extract by percentage by weight is: the Radix Puerariae of 32%, the Fructus Crataegi of 32%, the Rhizoma Alismatis of 15%, and the Radix Polygoni Multiflori of 13% and the Radix Angelicae Sinensis of 8% are made, and the weight ratio of described Chinese medicine extract and adjuvant is 1:2 ~ 5;
Described adjuvant is made up of framework material, the filler of 10% ~ 50%, the porogen of double taste masking of 10% ~ 30% and the lubricant of 1% ~ 2% of 15% ~ 30%;
Described framework material is the mixture of xanthan gum and sodium alginate, xanthan gum in described mixture: the weight ratio of sodium alginate is 3:1;
Described filler is pregelatinized Starch; Described porogen mannitol; Described lubricant is magnesium stearate.
2. prepare a method for slow releasing preparation according to claim 1, it is characterized in that, concrete steps are as follows:
(1) the Rhizoma Alismatis drying of corresponding weight portion is ground into fine powder respectively;
(2) Radix Puerariae of corresponding weight portion, Fructus Crataegi, Radix Polygoni Multiflori and Radix Angelicae Sinensis are added 8 times amount soak by water three times, be 1.5 hours at every turn, filters, merging filtrate, and when being concentrated into 60 DEG C, relative density is the extractum of 1.10 ~ 1.20; Add ethanol and reach 70% to alcohol content, stir evenly, leave standstill, get supernatant and reclaim ethanol, drying and crushing obtains fine powder,
(3) the fine powder mix homogeneously that fine powder step (1) obtained, step (2) obtain, then add the mixing of the framework material of corresponding weight portion, filler and porogen, make soft material with dehydrated alcohol as wetting agent, granulate, dry, granulate adds lubricant mixing, tabletting, to obtain final product.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410788343.9A CN104435447B (en) | 2014-12-16 | 2014-12-16 | A kind of Ge Shan blood fat reducing slow releasing preparation and preparation method thereof |
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| CN201410788343.9A CN104435447B (en) | 2014-12-16 | 2014-12-16 | A kind of Ge Shan blood fat reducing slow releasing preparation and preparation method thereof |
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| CN104435447A CN104435447A (en) | 2015-03-25 |
| CN104435447B true CN104435447B (en) | 2016-01-20 |
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| CN108744062B (en) * | 2018-07-28 | 2021-05-11 | 武汉大学人民医院（湖北省人民医院） | Injection type high-strength degradable porous magnesium phosphate bone repair material |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1537544A (en) * | 2003-04-15 | 2004-10-20 | 安徽省医学科学研究所 | Composition of medicine for lowering fat, and its prepn. method |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1537544A (en) * | 2003-04-15 | 2004-10-20 | 安徽省医学科学研究所 | Composition of medicine for lowering fat, and its prepn. method |
Non-Patent Citations (1)
| Title |
|---|
| 《缓释片剂的研究概况》;徐济恒等;《安徽化工》;20110228;第37卷(第1期);27-29 * |
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Effective date of registration: 20220803 Address after: 276600 west side of the middle section of Gongye Third Road, high tech Zone, Linyi City, Shandong Province Patentee after: Shandong jingyutang Pharmaceutical Co.,Ltd. Address before: 276600 Shandong Linyi high tech Zone Industrial third road and Qiyang Road intersection shandongjing Yutang National Medicine Co.,Ltd. Patentee before: JINGYUTANG PHARMACEUTICAL CO.,LTD. |
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