CN105617393A - Water-soluble puerarin composition and preparation method - Google Patents
Water-soluble puerarin composition and preparation method Download PDFInfo
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- CN105617393A CN105617393A CN201610034876.7A CN201610034876A CN105617393A CN 105617393 A CN105617393 A CN 105617393A CN 201610034876 A CN201610034876 A CN 201610034876A CN 105617393 A CN105617393 A CN 105617393A
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- puerarin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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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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Abstract
The invention relates to a water-soluble puerarin composition and a preparation method. The method comprises the following steps: mixing, homogenizing and drying puerarin, cyclodextrin, lecithin and maltitol at a certain ratio to finally obtain a product with relatively high solubility and bioavailability. The water-soluble puerarin composition is capable of effectively reducing side effects when prepared into medicines with different preparations as raw materials.
Description
Technical field
The present invention relates to a kind of puerarin compositions and production method, be specifically related to a kind of water soluble puerarin compositions and preparation method, belong to field of medicine production.
Background technology
Puerarin is the single composition flavonoid glycoside of one extracted from legume pueraria lobata root, there is blood circulation promoting and blood stasis dispelling, improve microcirculation, coronary artery dilator and the effect such as cerebrovascular, reduction myocardial oxygen consumption, the conventional Radix Puerariae of the traditional Chinese medical science is expelling pathogenic wind from the body surface medicine, is mainly used in the diseases such as table malaria fever without perspiration, headache stiffness of the nape and macule be not saturating. Its preparation puerarin is clinically used for treatment cardiovascular and cerebrovascular disease and retinal vascular disease, retinopathy and sudden deafness etc. Along with puerarin widely uses in clinic, relevant untoward reaction report also increases increasingly.
Monitoring finds, puerarin can cause the generation of acute intravascular hemolysis, and drug accumulation easily occurs, and produces toxicity, damages Liver and kidney, traces it to its cause, the water solublity of puerarin and fat-soluble be all not as, and affects absorption of human body, thus producing some side effect.
Summary of the invention
For solving current problem encountered, the invention provides a kind of water soluble puerarin compositions and preparation method, the method obtains after puerarin is carried out mixing homogenizing with cyclodextrin, maltose alcohol and soft phospholipid, dusted, final products can be effectively improved the dissolubility of puerarin, the bioavailability making product significantly improves, and the medicine being used for different preparations can reduce the generation of side effect.
The invention provides a kind of water soluble puerarin compositions, it is characterised in that being made up of by a certain percentage puerarin, gamma-cyclodextrin, soft phospholipid, maltose alcohol, concrete raw material weight ratio is:
Puerarin, gamma-cyclodextrin, soft phospholipid, maltose alcohol weight ratio be: 1:1 ~ 100:1 ~ 10:1 ~ 50;
Preferably, puerarin, gamma-cyclodextrin, soft phospholipid, maltose alcohol weight ratio be: 1:65:8:25.
The another solution of the present invention is:
The preparation method of a kind of water soluble puerarin compositions, comprises the steps:
(1) puerarin and gamma-cyclodextrin are added in the pure water of 6 ~ 10 times of weight and carry out ultrasonic dissolution, solution temperature 50 ~ 60 DEG C.
(2) compositions after dissolving adds a certain proportion of soft phospholipid and mixes laggard horizontal high voltage homogenizing, homogenization pressure 40 ~ 60mpa, circulation homogenizing 2 ~ 5 times.
(3) compositions after homogenizing adds a certain proportion of maltose alcohol mix homogeneously, carries out the dry acquisition composition product that dusts, baking temperature 70 ~ 85 DEG C after micro-pore-film filtration.
The present invention obtains water soluble puerarin owing to adding the higher clathrate of dissolubility and can sorbefacient fat-soluble compositions, make finally to obtain product to can be good at reaching water miscible product requirement, product can be used for manufacturing the pharmaceutical preparation that puerarin is relevant as raw material or direct finished product simultaneously, it is obtained in that good bioavailability, reduces the generation of side effect simultaneously.
Detailed description of the invention
Detailed content and the detailed description of the invention thereof of the present invention are further illustrated below. Should be appreciated that specific embodiment described herein is only for explaining the present invention, be not used to limit invention.
Embodiment 1:
A kind of water soluble puerarin compositions and preparation method, in turn include the following steps:
(1) puerarin that 1kg content is 98% and 50kg gamma-cyclodextrin are added in the pure water of 306kg and carry out ultrasonic dissolution, solution temperature 50 DEG C.
(2) compositions after dissolving adds the soft phospholipid of 1kg and mixes laggard horizontal high voltage homogenizing, homogenization pressure 40mpa, circulation homogenizing 2 times.
(3) compositions after homogenizing adds 10kg maltose alcohol mix homogeneously, carries out the dry acquisition composition product that dusts, baking temperature 70 DEG C after micro-pore-film filtration.
Embodiment 2:
A kind of water soluble puerarin compositions and preparation method, in turn include the following steps:
(1) puerarin that 1kg content is 98% and 100kg gamma-cyclodextrin are added in the pure water of 1010kg and carry out ultrasonic dissolution, solution temperature 60 DEG C.
(2) compositions after dissolving adds the soft phospholipid of a certain proportion of 10kg and mixes laggard horizontal high voltage homogenizing, homogenization pressure 60mpa, circulation homogenizing 5 times.
(3) compositions after homogenizing adds 50kg maltose alcohol mix homogeneously, carries out the dry acquisition composition product that dusts, baking temperature 85 DEG C after micro-pore-film filtration.
Embodiment 3:
A kind of water soluble puerarin compositions and preparation method, in turn include the following steps:
(1) puerarin that 1kg content is 98% and 65kg gamma-cyclodextrin are added in the pure water of 462kg and carry out ultrasonic dissolution, solution temperature 54 DEG C.
(2) compositions after dissolving adds 8kg lecithin and mixes laggard horizontal high voltage homogenizing, homogenization pressure 52mpa, circulation homogenizing 4 times.
(3) compositions after homogenizing adds 25kg maltose alcohol mix homogeneously, carries out the dry acquisition composition product that dusts, baking temperature 80 DEG C after micro-pore-film filtration.
Product embodiment 1 ~ 3 obtained carries out solubility experiment with puerarin raw material, dissolubility with high effective liquid chromatography for measuring compositions, method particularly includes: accurately weigh a certain amount of compositions, join in 25 ml pure waters, sonic oscillation 10 minutes at room temperature 25 DEG C, filter, filtrate stands after 2 hours as test liquid, methanol aqueous solution with 25% is mobile phase, by octadecyl silane chromatographic column under 250nm wavelength, external standard method puerarin content, the dissolubility obtained, and the quality being dissolved in aqueous solution puerarin and the mass percent of puerarin in weighed solid matter and puerarin dissolution rate result such as table 1:
| Sequence number | Experimental series | Puerarin dissolubility mg/mL | Puerarin dissolution rate |
| 1 | Embodiment 1 | 43.3 | 94.2% |
| 2 | Embodiment 2 | 46.4 | 95.6% |
| 3 | Embodiment 3 | 55.2 | 98.1% |
| 4 | Puerarin raw material | 4.4 | 1.2% |
By the puerarin compositions finished product obtained in above-described embodiment is detected, it is thus achieved that well dissolubility result, effectively raise the bioavailability of product, be suitable for the large-scale production of industry.
Claims (6)
1. a water soluble puerarin compositions, it is characterised in that: described compositions is made up of by a certain percentage puerarin, cyclodextrin, soft phospholipid, maltose alcohol.
2. a water soluble puerarin compositions, it is characterised in that: puerarin, cyclodextrin, soft phospholipid, maltose alcohol weight ratio be: 1:1 ~ 100:1 ~ 10:1 ~ 50.
3. compositions as claimed in claim 1, it is characterised in that: puerarin, cyclodextrin, soft phospholipid, maltose alcohol weight ratio be: 1:65:8:25.
4. the purposes of compositions as claimed in claim 1 or 2, it is characterised in that: described compositions is used for manufacturing the medicine of different preparation type as raw material or finished product.
5. the preparation method of a water soluble puerarin compositions, it is characterised in that: comprise the steps:
(1) puerarin and cyclodextrin are added in the pure water of 6 ~ 10 times of weight and carry out ultrasonic dissolution, solution temperature 50 ~ 60 DEG C;
(2) compositions after dissolving adds a certain proportion of soft phospholipid and mixes laggard horizontal high voltage homogenizing, homogenization pressure 40 ~ 60mpa, circulation homogenizing 2 ~ 5 times;
(3) compositions after homogenizing adds a certain proportion of maltose alcohol mix homogeneously, carries out the dry acquisition composition product that dusts, baking temperature 70 ~ 85 DEG C after micro-pore-film filtration.
6. the preparation method of a water soluble puerarin compositions, it is characterised in that: comprise the steps:
(1) puerarin and cyclodextrin are added in the pure water of 7 times of weight and carry out ultrasonic dissolution, solution temperature 54 DEG C;
(2) compositions after dissolving adds a certain proportion of soft phospholipid and mixes laggard horizontal high voltage homogenizing, homogenization pressure 52mpa, circulation homogenizing 4 times;
(3) compositions after homogenizing adds a certain proportion of maltose alcohol mix homogeneously, carries out the dry acquisition composition product that dusts, baking temperature 80 DEG C after micro-pore-film filtration.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610034876.7A CN105617393A (en) | 2016-01-20 | 2016-01-20 | Water-soluble puerarin composition and preparation method |
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| CN201610034876.7A CN105617393A (en) | 2016-01-20 | 2016-01-20 | Water-soluble puerarin composition and preparation method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111418850A (en) * | 2020-04-23 | 2020-07-17 | 吉林省慈卫归朴生物科技有限公司 | Composition for dispelling effects of alcohol and protecting liver and preparation method thereof |
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| CN1562062A (en) * | 2004-04-20 | 2005-01-12 | 徐卫臣 | Kakonein solid dispersion and its preparing method |
| CN1939328A (en) * | 2005-09-30 | 2007-04-04 | 北京赛生药业有限公司 | Puerarin injection |
| CN101023956A (en) * | 2006-02-23 | 2007-08-29 | 香港赛马会中药研究院有限公司 | Oral puerarin phosphate composition capsule and preparing method |
| CN103432101A (en) * | 2013-09-03 | 2013-12-11 | 沈阳药科大学 | Nanosuspension osmotic pump type sustained-release system of insoluble drugs and preparation method thereof |
| CN104138601A (en) * | 2014-07-21 | 2014-11-12 | 江苏天晟药业有限公司 | Oral puerarin compound and preparing method thereof |
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2016
- 2016-01-20 CN CN201610034876.7A patent/CN105617393A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1562062A (en) * | 2004-04-20 | 2005-01-12 | 徐卫臣 | Kakonein solid dispersion and its preparing method |
| CN1939328A (en) * | 2005-09-30 | 2007-04-04 | 北京赛生药业有限公司 | Puerarin injection |
| CN101023956A (en) * | 2006-02-23 | 2007-08-29 | 香港赛马会中药研究院有限公司 | Oral puerarin phosphate composition capsule and preparing method |
| CN103432101A (en) * | 2013-09-03 | 2013-12-11 | 沈阳药科大学 | Nanosuspension osmotic pump type sustained-release system of insoluble drugs and preparation method thereof |
| CN104138601A (en) * | 2014-07-21 | 2014-11-12 | 江苏天晟药业有限公司 | Oral puerarin compound and preparing method thereof |
Non-Patent Citations (1)
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| 谢捷，等: "磷脂和羟丙基-beta-环糊精对葛根素溶解度的影响", 《中成药》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111418850A (en) * | 2020-04-23 | 2020-07-17 | 吉林省慈卫归朴生物科技有限公司 | Composition for dispelling effects of alcohol and protecting liver and preparation method thereof |
| CN111418850B (en) * | 2020-04-23 | 2023-01-24 | 吉林省慈卫归朴生物科技有限公司 | Composition for relieving alcoholism and protecting liver and preparation method thereof |
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