CN109010387A - A kind of low toxicity Bilobanoate composition and its preparation - Google Patents

A kind of low toxicity Bilobanoate composition and its preparation Download PDF

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Publication number
CN109010387A
CN109010387A CN201810954714.4A CN201810954714A CN109010387A CN 109010387 A CN109010387 A CN 109010387A CN 201810954714 A CN201810954714 A CN 201810954714A CN 109010387 A CN109010387 A CN 109010387A
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parts
bilobanoate
composition
low toxicity
less
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CN201810954714.4A
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Chinese (zh)
Inventor
沈琴
高崎
王军
王挚豪
高勇
张曙平
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Shanghai Xingling Technology Pharmaceutical Ltd By Share Ltd
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Shanghai Xingling Technology Pharmaceutical Ltd By Share Ltd
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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
    • A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; 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
    • 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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
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  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

The present invention relates to a kind of less toxic Bilobanoate composition and its preparations, by weight percentage, including following component: general flavone, 44-55%；Bilobalide (C15H18O8), it is greater than 2.6%；Rutin, less than 4%；Quercetin is less than or equal to 0.4%；Total ginkgoic acid is less than or equal to 4ppm；Moisture, less than 5%；Hexamethylene residue is less than or equal to 0.002%；Then, tablet, granule and capsule are prepared by the low toxicity Bilobanoate composition.Low toxicity Bilobanoate composition provided by the invention and its preparation, toxic component content further decrease, and solvent residue content is low, and active principle stable content greatly improves administration safety.

Description

A kind of low toxicity Bilobanoate composition and its preparation
Technical field
The invention belongs to technical field of traditional Chinese medicines, a kind of less toxic Bilobanoate composition and preparation are related generally to.
Background technique
Ginkgo leaf is a kind of curative for effect, widely used drug, its extract principle active component is flavones (Flavonoids) and terpene lactones, the former is based on Quercetin, Kaempferol and Isorhamnetin and its glucosides, and the latter is with ginkgolides (Ginkgolides) and based on Bilobalide (Bilobalide).Clinical verification ginkgo biloba p.e is to the heart, the cerebrovascular and periphery The curative effect of circulation of blood disorder disease is rather satisfied.Currently it is mainly used for treating ischemic cerebrovascular disease and its caused dizzy The adjuvant treatment of dizzy, dysaudia, senile dementia, diabetic neuropathy, pulmonary heart disease and epilepsy, such as Bilobanoate raw material Medicine and its preparation etc..
But ginkgo biloba p.e contains toxic component ginkgoic acid simultaneously, content range needs to be further decreased, with to the greatest extent It is likely to reduced patient medication injury, also, the content range of ginkgo biloba p.e effective component is excessively wide in applied code at present It is general, it is unfavorable for accurate medication, therefore, it is necessary to further investigate to Bilobanoate, to solve the problems, such as that existing product exists.
Summary of the invention
In view of the foregoing, it is an object to provide, a kind of toxicity level is few, the more accurate silver of active constituent content Apricot ketone ester and its preparation, to enhance drug safety, improve medication effect.The specific technical solution of the present invention is as follows:
A kind of low toxicity Bilobanoate composition, which is characterized in that by weight percentage, including following component: general flavone, 44-55%；Bilobalide (C15H18O8), it is greater than 2.6%；Rutin, less than 4%；Quercetin is less than or equal to 0.4%；Total ginkgo Acid is less than or equal to 4ppm；Moisture, less than 5%；Hexamethylene residue is less than or equal to 0.002%.
The low toxicity Bilobanoate composition by weight percentage, also comprises the following components: total flavonoids 24- 35%；Terpene lactone is with Bilobalide (C15H18O8), ginkalide A (C20H24O9), ginkolide B (C20H24O10) and ginkgo in Ester C (C20H24O11) total amount meter, be 6-12%.
A kind of Bilobanoate piece contains above-mentioned less toxic Bilobanoate composition.
The Bilobanoate piece, by weight, including following component: 30-45 parts of the Bilobanoate composition of low toxicity, - 55 parts of dextrin 40,75-100 parts of starch, 35-40 parts of hydroxypropyl cellulose, 15-20 parts of microcrystalline cellulose, sodium carboxymethylstarch 10- 15 parts, 1-3 parts of magnesium stearate.
The Bilobanoate piece, by weight, including following component: 40 parts of composition of the Bilobanoate of low toxicity, paste 50 parts of essence, 90 parts of starch, 37.5 parts of hydroxypropyl cellulose, 17.5 parts of microcrystalline cellulose, 12.5 parts of sodium carboxymethylstarch, magnesium stearate 2.5 part.
A kind of Bilobanoate particle contains above-mentioned less toxic Bilobanoate composition.
The Bilobanoate particle, by weight, including following component: the low toxicity Bilobanoate composition 30-45 Part, 450-500 parts of dextrin, 420-450 parts of cane sugar powder, 10-30 parts of starch, 10-30 parts of low-substituted hydroxypropyl cellulose, A Sipa It is 5-10 parts smooth.
The Bilobanoate particle, by weight, including following component: 40 parts of composition of the Bilobanoate of low toxicity, 480 parts of dextrin, 433 parts of cane sugar powder, 20 parts of starch, 20 parts of low-substituted hydroxypropyl cellulose, 7 parts of aspartame.
A kind of Bilobanoate capsule contains above-mentioned less toxic Bilobanoate composition.
The Bilobanoate capsule, by weight, including following component: the low toxicity Bilobanoate composition 35-45 Part, 30-45 parts of dextrin, 80-100 parts of starch, 15-25 parts of hydroxypropyl cellulose, 6-10 parts of sodium carboxymethylstarch, magnesium stearate 1-3 Part.
The Bilobanoate capsule, by weight, including following component: 40 parts of composition of the Bilobanoate of low toxicity, Dextrin 40 part, 90 parts of starch, 20 parts of hydroxypropyl cellulose, 8 parts of sodium carboxymethylstarch, 2 parts of magnesium stearate.
Technical solution of the present invention has the advantages that
Low toxicity Bilobanoate composition provided by the invention and its preparation, toxic component content further decrease, and solvent is residual Stay object content low, active principle content range is more accurate and stablizes, and greatly improves administration safety.
Specific embodiment
In the following, the embodiment of the present invention is described in detail, but the content should not be considered as limiting the invention Practical range.Any changes and modifications in accordance with the scope of the present application should all belong to protection of the invention and contain Within the scope of lid.In addition, it is necessary to explanation, in the absence of conflict, in the embodiment and embodiment in the invention Feature can be combined with each other.
Embodiment 1
The present embodiment is related to a kind of less toxic Bilobanoate composition, by weight percentage, including following component: it is total yellow Ketone, 44-55%；Bilobalide (C15H18O8), it is greater than 2.6%；Rutin, less than 4%；Quercetin is less than or equal to 0.4%；Total silver Apricot acid, is less than or equal to 4ppm；Moisture, less than 5%；Hexamethylene residue is less than or equal to 0.002%.
Optionally, it also comprises the following components: total flavonoids 24-35%；Terpene lactone is with Bilobalide (C15H18O8), silver Apricot lactone A (C20H24O9), ginkolide B (C20H24O10) and ginkalide C (C20H24O11) total amount meter, be 6-12%.
In existing standard, ginkgoic acid is to use tlc scanning determination, and sensitivity is lower；Ginkgo in technical solution of the present invention Acid is measured more accurate by liquid chromatography and mass spectrometry, high sensitivity.Other above-mentioned each component contents are according to traditional Chinese medicines in 2015 editions Allusion quotation standard test, 2015 editions Chinese Pharmacopoeias are unpub, measure according to professional standard or the common method of those skilled in the art.
Preparation method: nothing takes ginkgo leaf to crush, multiple with the ethyl alcohol heating and refluxing extraction of 65-75%, filtration, and filtrate is standby With the dregs of a decoction add pure water to be heated to reflux 0.5-1 hours, and filtration, filtrate merges with above-mentioned filtrate, thick paste are condensed into, with 70-90 DEG C Pure water dissolution, stands cooling, filters, and macroporous resin column on filtrate is successively washed with 20% ethyl alcohol, 30% ethyl alcohol and 50% ethyl alcohol De-, 20% ethyl alcohol, 30% ethanol eluate are concentrated into no alcohol taste, and upper polyamide column uses ethanol elution；50% ethanol eluate with Ethanol eluate merges, and is concentrated into no alcohol taste, concentrate is extracted with hexamethylene, discards hexamethylene alkane extract, and concentrate is done by spraying It is dry, it crushes to get the less toxic Bilobanoate composition.
Pure water is used in preparation process, it is ensured that ginkgoic acid is maintained at the lower content less than existing standard, also, can drop The content of low Quercetin and rutin.
Embodiment 2
The present embodiment is related to a kind of Bilobanoate piece, the less toxic Bilobanoate composition containing embodiment 1.
Optionally, the Bilobanoate piece by weight, including following component: less toxic Bilobanoate composition 30-45 Part, -55 parts of dextrin 40,75-100 parts of starch, 35-40 parts of hydroxypropyl cellulose, 15-20 parts of microcrystalline cellulose, sodium carboxymethylstarch 10-15 parts, 1-3 parts of magnesium stearate.
Preferably, the Bilobanoate piece by weight, including following component: 40 parts of less toxic Bilobanoate composition, 50 parts of dextrin, 90 parts of starch, 37.5 parts of hydroxypropyl cellulose, 17.5 parts of microcrystalline cellulose, 12.5 parts of sodium carboxymethylstarch, stearic acid 2.5 parts of magnesium.
Preparation method: dextrin, starch, the hydroxypropyl of corresponding content is added in the less toxic Bilobanoate composition of Example 1 Cellulose, microcrystalline cellulose, sodium carboxymethylstarch mix, and make pellet, dry, and magnesium stearate is added, and mix, if being pressed into dry plate, Film coating to get.
Embodiment 3
The present embodiment is related to Bilobanoate particle, contains less toxic Bilobanoate composition described in embodiment 1.
Optionally, the Bilobanoate particle by weight, including following component: less toxic Bilobanoate composition 30- 45 parts, 450-500 parts of dextrin, 420-450 parts of cane sugar powder, 10-30 parts of starch, 10-30 parts of low-substituted hydroxypropyl cellulose, A Si Pa is 5-10 parts smooth.
Preferably, the Bilobanoate particle by weight, including following component: less toxic Bilobanoate composition 40 Part, 480 parts of dextrin, 433 parts of cane sugar powder, 20 parts of starch, 20 parts of low-substituted hydroxypropyl cellulose, 7 parts of aspartame.
Preparation method: dextrin, the cane sugar powder, shallow lake of corresponding content is added in the less toxic Bilobanoate composition of Example 1 Powder, low-substituted hydroxypropyl cellulose, aspartame mix, particle are made, dry, if be made dry particl to get.
Embodiment 4
The present embodiment is related to a kind of Bilobanoate capsule, contains less toxic Bilobanoate composition described in embodiment 1.
Optionally, the Bilobanoate capsule by weight, including following component: less toxic Bilobanoate composition 35- 45 parts, 30-45 parts of dextrin, 80-100 parts of starch, 15-25 parts of hydroxypropyl cellulose, 6-10 parts of sodium carboxymethylstarch, magnesium stearate 1- 3 parts.
Preferably, the Bilobanoate capsule by weight, including following component: less toxic Bilobanoate composition 40 Part, dextrin 40 part, 90 parts of starch, 20 parts of hydroxypropyl cellulose, 8 parts of sodium carboxymethylstarch, 2 parts of magnesium stearate.
Preparation method: dextrin, starch, the hydroxypropyl of corresponding content is added in the less toxic Bilobanoate composition of Example 1 Cellulose, sodium carboxymethylstarch mix, particle are made, dry, and magnesium stearate is added, and mix, and are packed into capsule, if dry granular is made, i.e., ?.
Compared with standards of pharmacopoeia applicable at present, less toxic Bilobanoate composition that 1-4 of the embodiment of the present invention is obtained and its Preparation, rutin, Quercetin, total ginkgoic acid, moisture content, hexamethylene residue etc. greatly reduce, and reduce patient medication injury. Meanwhile accurately controlling effective component general flavone and Bilobalide (C15H18O8) etc. content, patient medication safety is substantially improved.

Claims (11)

1. a kind of low toxicity Bilobanoate composition, which is characterized in that by weight percentage, including following component: general flavone, 44-55%；Bilobalide is greater than 2.6%；Rutin, less than 4%；Quercetin is less than or equal to 0.4%；Total ginkgoic acid, be less than etc. In 4ppm；Moisture, less than 5%；Hexamethylene residue is less than or equal to 0.002%.
2. low toxicity Bilobanoate composition according to claim 1, which is characterized in that by weight percentage, further include Following component: total flavonoids 24-35%；Terpene lactone is with Bilobalide, ginkalide A, ginkolide B and ginkalide C Total amount meter, be 6-12%.
3. a kind of Bilobanoate piece, which is characterized in that contain less toxic Bilobanoate composition of any of claims 1 or 2.
4. Bilobanoate piece according to claim 3, which is characterized in that by weight, the Bilobanoate piece includes Following component: 30-45 parts of the Bilobanoate composition of low toxicity, -55 parts of dextrin 40,75-100 parts of starch, hydroxypropyl cellulose 35-40 parts, 15-20 parts of microcrystalline cellulose, 10-15 parts of sodium carboxymethylstarch, 1-3 parts of magnesium stearate.
5. Bilobanoate piece according to claim 4, which is characterized in that by weight, the Bilobanoate piece includes Following component: 40 parts of composition of the Bilobanoate of low toxicity, 50 parts of dextrin, 90 parts of starch, 37.5 parts of hydroxypropyl cellulose, crystallite 17.5 parts of cellulose, 12.5 parts of sodium carboxymethylstarch, 2.5 parts of magnesium stearate.
6. a kind of Bilobanoate particle, which is characterized in that contain less toxic Bilobanoate composition as claimed in claim 1 or 2.
7. Bilobanoate particle according to claim 6, which is characterized in that by weight, the Bilobanoate particle Including following component: 30-45 parts of the Bilobanoate composition of low toxicity, 450-500 parts of dextrin, 420-450 parts of cane sugar powder, starch 10-30 parts, 10-30 parts of low-substituted hydroxypropyl cellulose, 5-10 parts of aspartame.
8. Bilobanoate particle according to claim 7, which is characterized in that by weight, the Bilobanoate particle Including following component: 40 parts of composition of the Bilobanoate of low toxicity, 480 parts of dextrin, 433 parts of cane sugar powder, 20 parts of starch, low substitution 20 parts of hydroxypropyl cellulose, 7 parts of aspartame.
9. a kind of low toxicity Bilobanoate composition capsule, which is characterized in that contain less toxic Bilobanoate as claimed in claim 1 or 2 Composition.
10. Bilobanoate capsule according to claim 9, which is characterized in that by weight, the Bilobanoate capsule Including following component: 30-45 parts of the Bilobanoate composition of low toxicity, 35-45 parts of dextrin, 80-100 parts of starch, hydroxypropyl is fine 15-25 parts of element of dimension, 6-10 parts of sodium carboxymethylstarch, 1-3 parts of magnesium stearate.
11. Bilobanoate capsule according to claim 10, which is characterized in that by weight, the bilobanone ester gum Capsule includes following component: 40 parts of composition of the Bilobanoate of low toxicity, dextrin 40 part, and 90 parts of starch, 20 parts of hydroxypropyl cellulose, 8 parts of sodium carboxymethylstarch, 2 parts of magnesium stearate.
CN201810954714.4A 2018-08-21 2018-08-21 A kind of low toxicity Bilobanoate composition and its preparation Pending CN109010387A (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1508542A (en) * 1998-03-19 2004-06-30 �Ϻ�������Ƽ�ҩҵ�ɷ����޹�˾ Ginkgo leaf composition, and preparing method and use thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1508542A (en) * 1998-03-19 2004-06-30 �Ϻ�������Ƽ�ҩҵ�ɷ����޹�˾ Ginkgo leaf composition, and preparing method and use thereof

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