CN107890479A - A kind of Chinese medicinal capsule for treating coronary heart disease and preparation method thereof - Google Patents
A kind of Chinese medicinal capsule for treating coronary heart disease and preparation method thereof Download PDFInfo
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- 208000029078 coronary artery disease Diseases 0.000 title claims abstract description 18
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Classifications
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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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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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)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
-
- 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)
- A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
- A61K36/296—Epimedium
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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)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
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- A—HUMAN NECESSITIES
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- 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
- 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
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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 or decoction
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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
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A—HUMAN NECESSITIES
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- 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
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Abstract
The invention discloses a kind of Chinese medicinal capsule for treating coronary heart disease and preparation method thereof, the Chinese medicinal capsule of the treatment coronary heart disease includes following raw material in parts by weight：10 portions of root of herbaceous peonys, 1 1.5 parts of red ginsengs, 45 parts of barrenwort, 23 parts of Fructus Crataegis, 0.1 5 parts of Macrogol 6000s, qs pH adjuster and/or appropriate cornstarch.The present invention program adds auxiliary material Macrogol 6000 on the basis of traditional Chinese medicine extraction process by water, the extracts active ingredients rate of transform can effectively be lifted, and it can effectively prevent the moisture absorption of capsule, increase the stability of capsule, prolong and protected product quality, it is and simple with technological operation, it is easy to accomplish industrialized feature.
Description
Technical field
The invention belongs to the field of Chinese medicines, and in particular to a kind of Chinese medicinal capsule for treating coronary heart disease and preparation method thereof.
Background technology
Coronary atherosclerotic heart disease is that coronary artery occurs atherosclerotic lesion and causes blood vessel
Chamber stenosis or occlusion, heart disease caused by myocardial ischemia, anoxic or necrosis is caused, be commonly referred to as " coronary heart disease ".But it is preced with
The scope of worry may more extensively, in addition to inflammation, embolism etc. cause luminal stenosis or occlusion.The World Health Organization is by coronary heart disease
It is divided into 5 major classes：Silent ischemia (latent coronary heart disease), angina pectoris, myocardial infarction, ischemic heart failure (ischemic
Heart disease) and 5 kinds of Clinical types of sudden death.Usually it is divided into SCHD and acute coronary syndrome in clinic.
Xintongkang Capsule is made of that have the traditional Chinese medicine extraction medicinal extract such as red ginseng powder and Chinese herbaceous peony, barrenwort, Fructus Crataegi, and Chinese herbaceous peony is in side
Monarch drug in a prescription, its effective ingredient are Paeoniflorin.Xintongkang Capsule has qi and activate blood circulation, the positive yin-nourishing of temperature, eliminating stagnation to stop pain, is mainly used in the stagnation of the circulation of vital energy
Ambition shouting pain or vexed pain caused by blood stasis, fixed pain or have the tired spontaneous perspiration of god concurrently at palpitation, and dry throat is vexed, coronary heart disease, the heart twist
Pain etc., coronary flow can be dramatically increased, reduce myocardial oxygen consumption, suppress platelet aggregation, strengthen myocardial hypoxia tolerance, it is bright
Aobvious enhancing cardiac function.System《The Sanitation Ministry medicine standard》(new drug is become a full member) the 4th kind recorded, national Chinese medicine protection kind,
National essential drugs.
The extraction process of prior art Xintongkang Capsule Chinese medical concrete is water extraction and alcohol precipitation method, but we have found that in its thick medicinal extract
The extracts active ingredients rate of transform is relatively low, and data are shown, the paste-forming rate of thick medicinal extract is only 10~20%, and active ingredient is with the monarch drug in a prescription root of herbaceous peony
Middle Paeoniflorin meter, the rate of transform is averagely extracted no more than 70%, the extracts active ingredients in medicinal material are incomplete, cause herb resource unrestrained
Take serious, process costs height, and the low treatment curative effect for having a strong impact on Xintongkang Capsule of the Paeoniflorin extraction rate of transform, be pained health glue
The great difficult problem that capsule preparation technology faces.
In addition, in the filling process of Xintongkang Capsule, it has been found that its Chinese medicine extract dry powder wettability is stronger, Yi Jie
It is block, sticky, cause it is filling after capsule tablet weight variation it is larger, content declines, disintegration time limited extends etc. has a strong impact on capsule quality
The problem of, currently only slow down the moisture absorption rate of body weight gain of extract dry powder by controlling bottling department ambient humidity, but technology controlling and process is stable
Property is poor, and risk is higher.
It was found that controlling the pH value of extract solution to add in pained health Chinese medicinal capsule medicinal extract extraction process by water in development process
Auxiliary material Macrogol 6000, it can effectively lift the extracts active ingredients rate of transform and capsule stability can be dramatically increased.According to this
Invention preparation method, active ingredient Paeoniflorin averagely extracts the rate of transform not less than 90% in medicinal extract extraction, preparation-obtained glue
24h, moisture absorption weightening unobvious are deposited under the relative humidity of capsule 75%, disintegration time limited without being obviously prolonged, effectively prevents the moisture absorption of capsule,
Increase the stability of capsule, while it is low and Chinese medical concrete is done to solve the extracts active ingredients rate of transform in Xintongkang Capsule production
The bibulous problem of powder.
Macrogol 6000 (PEG6000) is the high molecular polymer that oxirane forms with water condensation, and molecular formula is with HO
(CH2CH2O) nH is represented, wherein n represents the average of oxyethylene group, and it is a kind of nontoxic, nonirritant, is widely used in various
In pharmaceutical preparation, the matrix of emulsion, suppository is typically used as, can also be used as plasticizer and sustained release materials'use.
The content of the invention
The purpose of the present invention is low and tcm product is because hygroscopicity is strong for the existing Chinese medicine effective component extracting rate of transform
A kind of the problem of causing quality unstable, there is provided Chinese medicinal capsule preparation method for treating coronary heart disease.
The purpose of the present invention can be achieved through the following technical solutions：
A kind of Chinese medicinal capsule for treating coronary heart disease, including following raw material in parts by weight：10 portions of root of herbaceous peonys, 1-1.5 parts are red
Ginseng, 4-5 parts barrenwort, 2-3 parts Fructus Crataegi, 0.1-5 parts Macrogol 6000, qs pH adjuster and/or appropriate cornstarch.
A kind of Chinese medicinal capsule for treating coronary heart disease of the present invention, preferably includes following raw material in parts by weight：10
Part root of herbaceous peony, 1-1.5 parts red ginseng, 4-5 parts barrenwort, 2-3 parts Fructus Crataegi, 0.5-2 parts Macrogol 6000, qs pH adjuster
And/or appropriate cornstarch.
Wherein, the one or more in the preferred organic acid of described pH adjusting agent, further preferred fumaric acid, citric acid,
One or more in malic acid, tartaric acid；Particularly preferred citric acid.
The Chinese medicinal capsule of described treatment coronary heart disease is preferably prepared by the following method to obtain：
1) root of herbaceous peony of formula ratio, barrenwort, Fructus Crataegi are taken, adds water, is matched somebody with somebody with pH adjusting agent regulation pH value of solution to 2-6, addition
The Macrogol 6000 just measured；The addition of its reclaimed water be the root of herbaceous peony, barrenwort, 10-12 times of Fructus Crataegi medicinal material gross mass；
2) 2-8h is extracted at 30-50 DEG C of temperature, filtered, filtrate is concentrated into thick；
3) plus alcohol alcohol precipitation, standing 24-36h, filtering, filtrate decompression concentrate, and obtain thick medicinal extract；
4) red ginseng powder of formula ratio and thick medicinal extract combination drying obtained by step 3) are weighed, is crushed, is crossed 60 mesh sieves and medicinal extract is made
Dry powder, filling capsule, being supplied with cornstarch for every 0.3g loadings of deficiency, produce.
The preparation method of Chinese medicinal capsule of the present invention, comprises the following steps：
1) root of herbaceous peony of formula ratio, barrenwort, Fructus Crataegi are taken, adds water, is matched somebody with somebody with pH adjusting agent regulation pH value of solution to 2-6, addition
The Macrogol 6000 just measured；The addition of its reclaimed water be the root of herbaceous peony, barrenwort, 10-12 times of Fructus Crataegi medicinal material gross mass；
2) 2-8h is extracted at 30-50 DEG C of temperature, filtered, filtrate is concentrated into thick；
3) plus alcohol alcohol precipitation, standing 24-36h, filtering, filtrate decompression concentrate, and obtain thick medicinal extract；
4) red ginseng powder of formula ratio and thick medicinal extract combination drying obtained by step 3) are weighed, is crushed, is crossed 60 mesh sieves and medicinal extract is made
Dry powder, filling capsule, being supplied with cornstarch for every 0.3g loadings of deficiency, produce.
One or more in the preferred organic acid of pH adjusting agent described in step 1), further preferred fumaric acid, citric acid,
Malic acid, tartaric acid.
It is preferably described in step 1) to adjust pH value of solution to 2-4 with pH adjusting agent.
Further preferably described in step 1) with pH adjusting agent is citric acid, regulation pH value of solution to 2~4.
Preferably described addition alcohol makes alcohol content reach 65-70% in step 3).
Drying mode described in step 4) is preferably dried under reduced pressure, is spray-dried or is freeze-dried.
Beneficial effect：The present invention is that the active ingredient rate of transform is relatively low in being extracted based on Xintongkang Capsule Chinese medical concrete, made
The problem of standby obtained Chinese medicine preparation is easier to moisture absorption, and long-term placement can extend capsule disintegration time limited.Present inventors have unexpectedly found that tradition
Auxiliary material Macrogol 6000 is added on the basis of medicinal extract extraction process by water, can effectively lift the extracts active ingredients rate of transform, and energy
Dramatically increase capsule stability.According to preparation method of the present invention, active ingredient Paeoniflorin averagely extracts the rate of transform in medicinal extract extraction
Not less than 90%, 24h is deposited under the preparation-obtained relative humidity of capsule 75%, moisture absorption weightening unobvious, disintegration time limited is without bright
It is aobvious to extend, the moisture absorption of capsule is effectively prevented, increases the stability of capsule, prolongs and has protected product quality, and it is simple with technological operation,
It is easily achieved industrialized feature.
Embodiment
The extraction rate of transform in following embodiments is to be calculated as follows formula to calculate gained：
Extract gross mass × 100% of target component in gross mass/medicinal material of target component in the rate of transform=thick paste.
Embodiment 1
Capsule is prepared with technique by following formulas, data are listed in the table below 1.
The root of herbaceous peony (paeoniflorin content 4.4%) of formula ratio, barrenwort, Fructus Crataegi is weighed to add in extractor, it is closed, add
10 times of medicinal material total amounts of water, solution ph is adjusted to 4 or so with pH adjusting agent, add the auxiliary material of formula ratio, 50 DEG C of soak extraction 2h,
Filtering, filtrate decompression are concentrated into thick liquid, and it is 65% to add 95% ethanol to alcohol content, stands 24h, is filtered, and filtrate decompression is dense
Contract to obtain thick paste, is mixed with formula ratio red ginseng powder and dry, pulverize into fine powder jointly, crosses 60 eye mesh screens and obtains Chinese medical concrete dry powder, directly
Connect filling into capsule, appropriate amount of starch supplies every 0.3g sample-loading amount, produces Xintongkang Capsule.
The extraction rate of transform is calculated after taking middle thick paste measure paeoniflorin content, Xintongkang Capsule is placed in 75% relative humidity
Lower storage 24h, moisture absorption rate of body weight gain and disintegration time limited situation is measured by sampling.
Table 1
Research is found, is not added with PEG-6000 or is added the experimental group of other auxiliary materials, the Paeoniflorin extraction rate of transform and disintegration
There is extension phenomenon under high humidity conditions in time limit, and the extraction rate of transform increases after adding Tween-80 and RH40, but is being disintegrated
Improvement is had no on time limit, there is also the problem of disintegration time limited extension, only add PEG-6000 to increase extraction rate of transform value
More than 90% and can is kept for the disintegration time limited of capsule be basically unchanged, and adds the stability of capsule.
Embodiment 2
Capsule is prepared with technique by following formulas, data are listed in the table below 2.
The root of herbaceous peony (paeoniflorin content 4.4%) of formula ratio, barrenwort, Fructus Crataegi is weighed to add in extractor, it is closed, add
12 times of medicinal material total amounts of water, solution ph is adjusted to 4 or so with pH adjusting agent, add the auxiliary material of formula ratio, 30 DEG C of soak extraction 8h,
Filtering, filtrate decompression are concentrated into thick liquid, and it is 70% to add 95% ethanol to alcohol content, stands 24h, is filtered, and filtrate decompression is dense
Contract to obtain thick paste, is mixed with formula ratio red ginseng powder and dry, pulverize into fine powder jointly, crosses 60 eye mesh screens and obtains Chinese medical concrete dry powder, directly
Connect filling into capsule, appropriate amount of starch supplies every 0.3g sample-loading amount, produces Xintongkang Capsule.
The extraction rate of transform is calculated after taking middle thick paste measure paeoniflorin content, Xintongkang Capsule is placed in 75% relative humidity
Lower storage 24h, moisture absorption rate of body weight gain and disintegration time limited situation is measured by sampling.
Table 2
Research is found, as long as prescription monarch drug in a prescription is the root of herbaceous peony, even if changing prescription dosage, adds root of herbaceous peony 1%-50% PEG-
6000 can solve the problems, such as that the extracts active ingredients rate of transform is low, while be also prevented from the moisture absorption of capsule, ensure disintegration time limited, improve
Product quality.
Embodiment 3
Capsule is prepared with technique by following formulas, data are listed in the table below 3.
The root of herbaceous peony (paeoniflorin content 4.4%) of formula ratio, barrenwort, Fructus Crataegi is weighed to add in extractor, it is closed, add
10 times of medicinal material total amounts of water, solution ph is adjusted to 4 or so with pH adjusting agent, adds 40 DEG C of soak extraction 5h of auxiliary material of formula ratio,
Filtering, filtrate decompression are concentrated into thick liquid, and it is 70% to add 95% ethanol to alcohol content, stands 24h, is filtered, and filtrate decompression is dense
Contract to obtain thick paste, is mixed with formula ratio red ginseng powder and dry, pulverize into fine powder jointly, crosses 60 eye mesh screens and obtains Chinese medical concrete dry powder, directly
Connect filling into capsule, appropriate amount of starch supplies every 0.3g sample-loading amount, produces Xintongkang Capsule.
The extraction rate of transform is calculated after taking middle thick paste measure paeoniflorin content, Xintongkang Capsule is placed in 75% relative humidity
Lower storage 24h, moisture absorption rate of body weight gain and disintegration time limited situation is measured by sampling.
Table 3
Research is found, on the basis of the present invention program, the pH value of extract solution, Paeoniflorin are adjusted using organic acid one kind reagent
It is higher to extract the rate of transform, and moisture absorption rate of body weight gain is better than inorganic acids pH adjusting agent, and disintegration time limited extends also unobvious.
Claims (10)
1. a kind of Chinese medicinal capsule for treating coronary heart disease, it is characterised in that including following raw material in parts by weight：10 portions of root of herbaceous peonys,
1-1.5 parts red ginseng, 4-5 parts barrenwort, 2-3 parts Fructus Crataegi, 0.1-5 parts Macrogol 6000, qs pH adjuster and/or appropriate
Cornstarch.
A kind of 2. Chinese medicinal capsule for treating coronary heart disease as claimed in claim 1, it is characterised in that including in parts by weight with
Lower raw material：It is 10 portions of root of herbaceous peonys, 1-1.5 parts red ginseng, 4-5 parts barrenwort, 2-3 parts Fructus Crataegi, 0.5-2 parts Macrogol 6000, appropriate
PH adjusting agent and/or appropriate cornstarch.
3. a kind of Chinese medicinal capsule for treating coronary heart disease as claimed in claim 1, it is characterised in that described pH adjusting agent is to have
One or more in one or more in machine acid, preferably fumaric acid, citric acid, malic acid, tartaric acid；Further preferred lemon
Lemon acid.
4. a kind of Chinese medicinal capsule for treating coronary heart disease as any one of claim 1-3, it is characterised in that described controls
The Chinese medicinal capsule for treating coronary heart disease is prepared by the following method to obtain：
1) root of herbaceous peony of formula ratio, barrenwort, Fructus Crataegi are taken, adds water, pH value of solution is adjusted to 2-6 with pH adjusting agent, adds formula ratio
Macrogol 6000；The addition of its reclaimed water be the root of herbaceous peony, barrenwort, 10-12 times of Fructus Crataegi medicinal material gross mass；
2) 2-8h is extracted at 30-50 DEG C of temperature, filtered, filtrate is concentrated into thick；
3) plus alcohol alcohol precipitation, standing 24-36h, filtering, filtrate decompression concentrate, and obtain thick medicinal extract；
4) red ginseng powder of formula ratio and thick medicinal extract combination drying obtained by step 3) are weighed, is crushed, is crossed 60 mesh sieves and extract dry powder is made,
Filling capsule, being supplied with cornstarch for every 0.3g loadings of deficiency, is produced.
5. the preparation method of the Chinese medicinal capsule as described in claim 1-3, comprises the following steps：
1) root of herbaceous peony of formula ratio, barrenwort, Fructus Crataegi are taken, adds water, pH value of solution is adjusted to 2-6 with pH adjusting agent, adds formula ratio
Macrogol 6000；The addition of its reclaimed water be the root of herbaceous peony, barrenwort, 10-12 times of Fructus Crataegi medicinal material gross mass；
2) 2-8h is extracted at 30-50 DEG C of temperature, filtered, filtrate is concentrated into thick；
3) plus alcohol alcohol precipitation, standing 24-36h, filtering, filtrate decompression concentrate, and obtain thick medicinal extract；
4) red ginseng powder of formula ratio and thick medicinal extract combination drying obtained by step 3) are weighed, is crushed, is crossed 60 mesh sieves and extract dry powder is made,
Filling capsule, being supplied with cornstarch for every 0.3g loadings of deficiency, is produced.
6. the Chinese medicinal capsule preparation method described in claim 5, it is characterised in that pH adjusting agent described in step 1) is organic acid
In one or more, selected from fumaric acid, citric acid, malic acid, tartaric acid.
7. the Chinese medicinal capsule preparation method described in claim 5, it is characterised in that molten with pH adjusting agent regulation described in step 1)
Liquid pH to 2-4.
8. the Chinese medicinal capsule preparation method described in claim 6-7, it is characterised in that with pH adjusting agent be lemon described in step 1)
Lemon acid, regulation pH value of solution to 2~4.
9. the Chinese medicinal capsule preparation method described in claim 5, it is characterised in that alcohol is added described in step 3) reaches alcohol content
To 65-70%.
10. the Chinese medicinal capsule preparation method described in claim 5, it is characterised in that drying mode described in step 4) is dry for decompression
Dry, spray drying or freeze-drying.
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Citations (1)
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| US20160184381A1 (en) * | 2010-11-13 | 2016-06-30 | Sirbal, Ltd. | Herbal Combinations for Treatment of a Skin Condition |
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| US20160184381A1 (en) * | 2010-11-13 | 2016-06-30 | Sirbal, Ltd. | Herbal Combinations for Treatment of a Skin Condition |
Non-Patent Citations (2)
| Title |
|---|
| 杨明: "《中药药剂学》", 31 July 2016, 中国中医药出版社 * |
| 梁安鹏，等: "《药物集成.5 中成药及民族药制剂》", 30 June 2008, 中国医药科技出版社 * |
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