CN106109625A - A kind of preparation method of the Chinese medicine preparation for heart failure treatment - Google Patents

A kind of preparation method of the Chinese medicine preparation for heart failure treatment Download PDF

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CN106109625A
CN106109625A CN201610629385.7A CN201610629385A CN106109625A CN 106109625 A CN106109625 A CN 106109625A CN 201610629385 A CN201610629385 A CN 201610629385A CN 106109625 A CN106109625 A CN 106109625A
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extractum
extract
radix
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CN106109625B (en
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吴伦
苏阳
刘莉
谢宁
田振坤
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Heilongjiang University of Chinese Medicine
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/533—Leonurus (motherwort)
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    • 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)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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    • 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)
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    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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    • 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
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps

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Abstract

The present invention relates to the preparation method of a kind of Chinese medicine preparation for heart failure treatment, belong to the field of Chinese medicines.Specifically comprise the following steps that (1) weighs the Radix Astragali, Ramulus Cinnamomi, Herba Epimedii, Poria, Semen Lepidii (Semen Descurainiae), the Rhizoma Atractylodis Macrocephalae, Herba Leonuri, Herba Agrimoniae and Radix Glycyrrhizae；After pulverizing by proportioning, respectively with the water reflux, extract, three times of 8 10 times amount, 8 10 times amount and 8 10 times amount, extraction time be 2h every time, filters also merging filtrate, and recovered under reduced pressure obtains extractum 1；(2) weighing 15g Radix Salviae Miltiorrhizae uses 80% ethanol of 10 times amount, 10 times amount and 8 times amount to extract at 80 DEG C, and the time is 2h, and recovered under reduced pressure obtains extractum 2；(3) weigh Radix Pseudostellariae 20g, wear into fine powder and cross 200 mesh sieves；Take extractum 1 and extractum 2 is vacuum dried to obtain dry powder, mixing, Radix Pseudostellariae fine powder and extract dry powder are mixed to obtain Chinese medicine composition, and mixes with the adjuvant of corresponding weight portion, add 60% appropriate amount of ethanol and pelletize, be dried, fill capsule, to obtain final product.

Description

A kind of preparation method of the Chinese medicine preparation for heart failure treatment
Technical field
The present invention relates to the preparation method of a kind of Chinese medicine preparation for heart failure treatment, belong to the field of Chinese medicines.
Background technology
Heart failure is owing to any cardiac structure or dysfunction cause ventricular filling or one group that penetrates that blood ability is impaired Complex clinical syndrome, its main clinical manifestation be dyspnea and activity tolerance limited, and fluid retention (pulmonary venous pleonaemia and outer All edema).Heart failure is the serious of various heart disease and end stage eventually, and sickness rate is high, be current most important cardiovascular diseases it One.
Heart failure is a name of disease with pathophysiological change as foundation of modern medicine, there is no in traditional Chinese medical science traditional literature This name, but it is based on its clinical manifestation and feature thereof, the historical development of thousands of years is no lack of the description to heart failure and spy Rope, heart failure belongs to the disease categories such as the traditional Chinese medical science " cardiopalmus ", " the syndrome of dyspnea ", " phlegm retention ", " edema ", " thoracic obstruction " more.
The clinical experience side of ginseng stilbene Yi Xinfangshi Heilongjiang University of Chinese Medicine Liu Li professor, professor Liu Li refers to ancient books, root According to clinical experience for many years, induction and conclusion, for heart failure etiology and pathogenesis, it is proposed that the therapeutic rules of " QI invigorating warming YANG, activating blood and promoting diuresis ", Ginseng stilbene benefit heart side is formed according to prescription accordingly.Side's medicine: the Radix Astragali 20 parts, Radix Pseudostellariae 20 parts, Ramulus Cinnamomi 10 parts, Herba Epimedii 15 parts, Poria 20 parts, Semen Lepidii (Semen Descurainiae) 15 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, Radix Salviae Miltiorrhizae 15 parts, Herba Leonuri 15 parts, Herba Agrimoniae 30 parts and 10 parts of Radix Glycyrrhizae.Radix Pseudostellariae in side, The Radix Astragali is monarch drug, QI invigorating warming YANG；Radix Aconiti Lateralis Preparata is with the warm soil of the kidney warming, with aid yang qi；Ramulus Cinnamomi can help Radix Aconiti Lateralis Preparata warming YANG and promoting blood circulation, moreover it is possible to flat Spin inverse, treat " dyspnea and expectoration "；Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling diuretic is to control its mark, and Semen Lepidii (Semen Descurainiae) is let out the heap soil or fertilizer over and around the roots of lung qi and closed and regulating fluid apssage, The therapeutic method to keep the adverse QI flowing downwards is relievingd asthma；Radix Glycyrrhizae is with coordinating the actions of various ingredients in a prescription.
Although ginseng stilbene benefit heart side obtains splendid curative effect clinically, but owing to it is Chinese medicine decoct, causes Patient uses inconvenience, and the stability of decoct is the best, is unfavorable for joining popularization and the clinical practice of stilbene benefit heart side.
Summary of the invention
An object of the present invention is to provide the preparation method of a kind of Chinese medicinal capsule preparation for heart failure treatment, specifically walks Rapid as follows:
(1) weigh Radix Astragali 20g, Ramulus Cinnamomi 10g, Herba Epimedii 15g, Poria 20g, Semen Lepidii (Semen Descurainiae) 15g, Rhizoma Atractylodis Macrocephalae 15g, Herba Leonuri 15g, Herba Agrimoniae 30g and Radix Glycyrrhizae 10g；After pulverizing by proportioning, respectively with 8-10 times amount, 8-10 times amount and the water reflux, extract, of 8-10 times amount Three times, extraction time is 2h every time, filters and merging filtrate, and recovered under reduced pressure obtains extractum 1；
(2) weighing 15g Radix Salviae Miltiorrhizae uses 80% ethanol of 10 times amount, 10 times amount and 8 times amount to extract at 80 DEG C, the time For 2h, recovered under reduced pressure obtains extractum 2；
(3) weigh Radix Pseudostellariae 20g, wear into fine powder and cross 200 mesh sieves；Take extractum 1 and extractum 2 is vacuum dried to obtain dry powder, mixing, Radix Pseudostellariae fine powder and extract dry powder are mixed to obtain Chinese medicine composition, and mixes with the adjuvant of corresponding weight portion, add 60% ethanol and fit Amount is pelletized, and is dried, fill capsule, to obtain final product.
In one embodiment, described adjuvant is selected from starch, beta-schardinger dextrin-, carbomer, microcrystalline Cellulose, hydroxypropyl first Base cellulose, low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, Polyethylene Glycol (PEG), vitamin E polyethylene glycol succinum Acid esters, sodium carboxymethyl cellulose, methylcellulose, ethyl cellulose, mannitol, sodium lauryl sulphate, cross-linked carboxymethyl are fine Dimension element sodium, lactose, polyvinylpyrrolidone (PVP), crospolyvinylpyrrolidone, magnesium stearate, Pulvis Talci, micropowder silica gel, One or more in aspartame, orange flavor, sodium bicarbonate, sodium carbonate.The adjuvant used of above-mentioned preparation and preparation method Adjuvant and the preparation method that all can use its routine prepare.
In one embodiment, the weight ratio of described Chinese medicine composition and adjuvant is 10: 0.6.
In another embodiment, described adjuvant is microcrystalline Cellulose, vitamin E polyethylene glycol succinic acid ester and A Ba This is sweet, and the weight ratio of three is 1: 0.1～0.4: 0.2.
In one specifically embodiment, described adjuvant be microcrystalline Cellulose, vitamin E polyethylene glycol succinic acid ester and Aspartame, the weight ratio of three is 1: 0.3: 0.2.
The present invention gropes to have obtained the preferred plan of supplementary product kind, proportioning and consumption, in employing by lot of experiments research Stating adjuvant can overcome Chinese medicinal capsule preparation to affect the problem of medicine stability due to hygroscopicity, prepared by preparation method of the present invention Chinese medicinal capsule preparation greatly improves the stability of said preparation.
Detailed description of the invention
Also can understand that the present invention, wherein said embodiment illustrate some preparation or users by embodiment further Method.It is to be appreciated, however, that these embodiments are not intended to the present invention.The change of currently known or exploitation further the present invention Change within being considered within the scope of the invention described herein and claimed below.
The preparation of embodiment 1 Chinese medicinal capsule
(1) weigh Radix Astragali 20g, Ramulus Cinnamomi 10g, Herba Epimedii 15g, Poria 20g, Semen Lepidii (Semen Descurainiae) 15g, Rhizoma Atractylodis Macrocephalae 15g, Herba Leonuri 15g, Herba Agrimoniae 30g and Radix Glycyrrhizae 10g；After pulverizing by proportioning, respectively with the water reflux, extract, three times of 10 times amount, 10 times amount and 8 times amount, carry The time that takes is 2h every time, filters and merging filtrate, and recovered under reduced pressure obtains extractum 1；
(2) weighing 15g Radix Salviae Miltiorrhizae uses 80% ethanol of 10 times amount, 10 times amount and 8 times amount to extract at 80 DEG C, the time For 2h, recovered under reduced pressure obtains extractum 2；
(3) weigh Radix Pseudostellariae 20g, wear into fine powder and cross 200 mesh sieves；Take extractum 1 and extractum 2 is vacuum dried to obtain dry powder, mixing, By Radix Pseudostellariae fine powder and extract dry powder and the microcrystalline Cellulose of corresponding weight portion, vitamin E polyethylene glycol succinic acid ester and A Ba This is sweet (counting with adjuvant weight ratio 10: 0.6 by Chinese medicine composition, interpolation adjuvant amount is 2.2g, and the weight ratio of three is 1: 0.3: 0.2) mixing, adds 60% appropriate amount of ethanol and pelletizes, be dried, fill capsule, obtain (300mg/ grain).
Embodiment 2 Chinese medicinal capsule study on the stability
Investigate correlated samples stability according to the stability guideline of 2010 editions two annex of Chinese Pharmacopoeia, investigate respectively The medicine stability of 120 days is placed under the conditions of placing 36 months, 45 DEG C and relative humidity 75% at 25 DEG C.HPLC method is used to survey Determine astragaloside and the content of salvianolic acid B in Chinese medicinal capsule.
Place each group Effective Component of Chinese Medicine content (n=10) after 36 months for 25 DEG C
Comparative example 1 for replacing with hydroxypropyl methyl cellulose, other adjuvants and method with real by microcrystalline Cellulose in adjuvant Execute example 1；
Comparative example 2 is for replace with lactose, other adjuvants and method with embodiment 1 by microcrystalline Cellulose in adjuvant；
Comparative example 3 for vitamin E polyethylene glycol succinic acid ester in adjuvant being replaced with Macrogol 4000, other adjuvants and Method is with embodiment 1；
Comparative example 4 is Chinese medicine composition and the weight ratio of adjuvant is 10: 1, and other adjuvants and method are with embodiment 1.
Each group Effective Component of Chinese Medicine content (n=10) after placing 60 days under the conditions of 45 DEG C and relative humidity 75%
Embodiment 3 Chinese medicinal capsule preparation contents particles measures angle of repose
The angle of repose of granule before employing fixed funnel method (Xi Nianzhu edits " pharmaceutics " third edition) mensuration sample fill, and And the content uniformity of sample is measured according to pertinent regulations under 2010 editions annex I L items of Chinese Pharmacopoeia.
Present invention merely illustrates some claimed specific embodiments, one of them or more skill Technical characteristic described in art scheme can be combined with arbitrary one or more technical schemes, and these are combined and obtain Technical scheme also in the application protection domain, combined just as these and the technical scheme that obtains is open in the present invention In content as concrete record.

Claims (5)

1. a preparation method for the Chinese medicinal capsule preparation treated for heart failure, specifically comprises the following steps that
(1) Radix Astragali 20g, Ramulus Cinnamomi 10g, Herba Epimedii 15g, Poria 20g, Semen Lepidii (Semen Descurainiae) 15g, Rhizoma Atractylodis Macrocephalae 15g, Herba Leonuri 15g, red crowned crane are weighed Grass 30g and Radix Glycyrrhizae 10g；After pulverizing by proportioning, respectively with 8-10 times amount, 8-10 times amount and the water reflux, extract, three of 8-10 times amount Secondary, extraction time is 2h every time, filters and merging filtrate, and recovered under reduced pressure obtains extractum 1；
(2) weighing 15g Radix Salviae Miltiorrhizae uses 80% ethanol of 10 times amount, 10 times amount and 8 times amount to extract at 80 DEG C, and the time is 2h, recovered under reduced pressure obtains extractum 2；
(3) weigh Radix Pseudostellariae 20g, wear into fine powder and cross 200 mesh sieves；Take extractum 1 and extractum 2 is vacuum dried to obtain dry powder, mixing, will too Son ginseng fine powder and extract dry powder mix to obtain Chinese medicine composition, and mix with the adjuvant of corresponding weight portion, add 60% appropriate amount of ethanol system Grain, is dried, fill capsule, to obtain final product.
The preparation method of Chinese medicinal capsule preparation the most according to claim 1, it is characterised in that described adjuvant selected from starch, Beta-schardinger dextrin-, carbomer, microcrystalline Cellulose, hydroxypropyl methyl cellulose, low-substituted hydroxypropyl cellulose, carboxymethyl cellulose Calcium, Polyethylene Glycol (PEG), vitamin E polyethylene glycol succinic acid ester, sodium carboxymethyl cellulose, methylcellulose, ethyl cellulose Element, mannitol, sodium lauryl sulphate, cross-linking sodium carboxymethyl cellulose, lactose, polyvinylpyrrolidone (PVP), cross-link poly-second One in alkene pyrrolidone, magnesium stearate, Pulvis Talci, micropowder silica gel, aspartame, orange flavor, sodium bicarbonate, sodium carbonate Or it is several.
The preparation method of Chinese medicinal capsule preparation the most according to claim 1, it is characterised in that described Chinese medicine extract and auxiliary The weight ratio of material is 10: 0.6.
The preparation method of Chinese medicinal capsule preparation the most according to claim 2, it is characterised in that described adjuvant is microcrystalline cellulose Element, vitamin E polyethylene glycol succinic acid ester and Aspartame, the weight ratio of three is 1: 0.1～0.4: 0.2.
The preparation method of Chinese medicinal capsule preparation the most according to claim 4, it is characterised in that described adjuvant is microcrystalline cellulose Element, vitamin E polyethylene glycol succinic acid ester and Aspartame, the weight ratio of three is 1: 0.3: 0.2.
CN201610629385.7A 2016-08-03 2016-08-03 A kind of preparation method of Chinese medicine preparation for heart failure treatment Active CN106109625B (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005281278A (en) * 2004-03-31 2005-10-13 Daicho Kikaku:Kk Nutrient, digestive organ agent, antidepressant, climacteric disorder agent, anti-senile dementia agent, anti-alzheimer agent, muscle reinforcing agent and anti-inflammatory agent
CN1927331A (en) * 2006-01-25 2007-03-14 宋春光 Chinese medicine preparation for curing chronic heart failure

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005281278A (en) * 2004-03-31 2005-10-13 Daicho Kikaku:Kk Nutrient, digestive organ agent, antidepressant, climacteric disorder agent, anti-senile dementia agent, anti-alzheimer agent, muscle reinforcing agent and anti-inflammatory agent
CN1927331A (en) * 2006-01-25 2007-03-14 宋春光 Chinese medicine preparation for curing chronic heart failure

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
金娟等: "参芪益心方对CHF大鼠心肌细胞凋亡指数及Bax、Bcl-2表达的影响", 《山东中医杂志》 *

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