CN107970297A - A kind of medicine of tranquilizing and allaying excitement - Google Patents
A kind of medicine of tranquilizing and allaying excitement Download PDFInfo
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- CN107970297A CN107970297A CN201711134777.7A CN201711134777A CN107970297A CN 107970297 A CN107970297 A CN 107970297A CN 201711134777 A CN201711134777 A CN 201711134777A CN 107970297 A CN107970297 A CN 107970297A
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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)
- A61K36/69—Polygalaceae (Milkwort family)
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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
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
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- 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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- 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
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- 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
- A61K36/481—Astragalus (milkvetch)
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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
- A61K36/484—Glycyrrhiza (licorice)
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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)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
- A61K36/638—Ligustrum, e.g. Chinese privet
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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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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/67—Piperaceae (Pepper family), e.g. Jamaican pepper or kava
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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)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
- A61K36/725—Ziziphus, e.g. jujube
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- 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)
- A61K36/74—Rubiaceae (Madder family)
- A61K36/744—Gardenia
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Abstract
A kind of medicine of tranquilizing and allaying excitement, belongs to the field of Chinese medicines.The purpose of the present invention is the medicine using tcm theory, mainly a kind of tranquilizing and allaying excitement based on tranquilizing and allaying excitement.Active ingredient is made in the present invention:Polygala, Poria cocos, the vine of multiflower knotweed, spina date seed, cortex albiziae, Radix Paeoniae Alba, Angelica sinensis, radix astragali, honey-fried licorice root, white pepper, the fruit of glossy privet, stir-baked FRUCTUS GARDENIAE.The present invention has the characteristics that easily absorption, curative effect performance is rapid, it is simple to prepare, easy to carry compared with traditional Chinese medicine medicine materical crude slice, is a kind of most common formulation of tcm clinical practice easy to take.It there is no the Chinese medicinal granular formulation based on " tranquilizing and allaying excitement " of listing at present, there is good clinical efficacy.
Description
Technical field
The invention belongs to the field of Chinese medicines.
Background technology
Insomnia is most common sleep disordered disease, is accelerated in social rhythm, today of intensified competition, insomnia into
For a kind of very universal phenomenon.The adult that China has more than 1/3 every year perplexs by insomnia.Insomnia can cause patient burnt
Consider, the depressed or feared state of mind, and cause cerebration efficiency to decline, hinder social function.Insomnia and angiocardiopathy, spiritual disease
The incidence of disease and case fatality rate it is increased related, while bring a series of social concern, such as accident, absence from work without reason, increasingly
As the killer for threatening human health.Therefore, the treatment of insomnia can not be ignored.
The content of the invention
The purpose of the present invention is the medicine using tcm theory, mainly a kind of tranquilizing and allaying excitement based on tranquilizing and allaying excitement.
The present invention be made active ingredient parts by weight composition be:
70~80 Poria cocos of polygala, 140~160 vine of multiflower knotweed, 70~80 spina date seed 140~160
70~80 Radix Paeoniae Alba of cortex albiziae, 70~80 Angelica sinensis, 140~160 radix astragali 140~160
70~80 white pepper of honey-fried licorice root, 70~80 fruit of glossy privet, 140~160 stir-baked FRUCTUS GARDENIAE 140~160.
The present invention be made active ingredient weight composition be:Polygala 75g, Poria cocos 150g, vine of multiflower knotweed 75g, spina date seed 150g,
Cortex albiziae 75g, Radix Paeoniae Alba 75g, Angelica sinensis 150g, radix astragali 150g, honey-fried licorice root 75g, white pepper 75g, 150 g of the fruit of glossy privet, stir-baked FRUCTUS GARDENIAE
150g。
The present invention has the characteristics that easily absorption, curative effect performance is rapid, it is simple to prepare, and compared with traditional Chinese medicine medicine materical crude slice, carries
It is convenient, it is a kind of most common formulation of tcm clinical practice easy to take.It there is no the Chinese medicine based on " tranquilizing and allaying excitement " of listing at present
Granular preparation, has good clinical efficacy.Curative for effect, toxic side effect is few, have the characteristics that safely, effectively, it is quality controllable,
And there is independent intellectual property right, currently on the market without same veriety, market potential is big, after developing into preparation, has good society
Can benefit and economic benefit.
Brief description of the drawings
Fig. 1 is moisture equilibrium at dry side curve map.
Embodiment
This preparation prescription shares " 12 kinds " Chinese medicine, function " tranquilizing and allaying excitement, nourishing qi and blood "(Treatment insomnia), formulation "
Granula ".
The present invention be made active ingredient parts by weight composition be:
70~80 Poria cocos of polygala, 140~160 vine of multiflower knotweed, 70~80 spina date seed 140~160
70~80 Radix Paeoniae Alba of cortex albiziae, 70~80 Angelica sinensis, 140~160 radix astragali 140~160
70~80 white pepper of honey-fried licorice root, 70~80 fruit of glossy privet, 140~160 stir-baked FRUCTUS GARDENIAE 140~160.
The present invention be made active ingredient weight composition be:Polygala 75g, Poria cocos 150g, vine of multiflower knotweed 75g, spina date seed 150g,
Cortex albiziae 75g, Radix Paeoniae Alba 75g, Angelica sinensis 150g, radix astragali 150g, honey-fried licorice root 75g, white pepper 75g, 150 g of the fruit of glossy privet, stir-baked FRUCTUS GARDENIAE
150g。
Preparation method:
12 taste of the above, be separately added into 6,4,4 times amount water, decoct three times, every time 1 it is small when, collecting decoction, filtration, filtrate concentration
To relative density 1.20~1.25(80℃), add superfine silica gel powder, appropriate soluble starch, mix, particle is made, it is dry, it is made
1000g, to obtain the final product.
Embodiment 1
The present invention be made active ingredient parts by weight composition be:
70 Poria cocos of polygala, 140 vine of multiflower knotweed, 70 spina date seed 140
70 Radix Paeoniae Alba of cortex albiziae, 70 Angelica sinensis, 140 radix astragali 140
70 white pepper of honey-fried licorice root, 70 fruit of glossy privet, 140 stir-baked FRUCTUS GARDENIAE 140;
Preparation method is same as above.
Embodiment 2
The present invention be made active ingredient parts by weight composition be:
75 Poria cocos of polygala, 150 vine of multiflower knotweed, 75 spina date seed 150
75 Radix Paeoniae Alba of cortex albiziae, 75 Angelica sinensis, 150 radix astragali 150
75 white pepper of honey-fried licorice root, 75 fruit of glossy privet, 150 stir-baked FRUCTUS GARDENIAE 150;
Preparation method is same as above.
Embodiment 3
The present invention be made active ingredient parts by weight composition be:
80 Poria cocos of polygala, 160 vine of multiflower knotweed, 80 spina date seed 160
80 Radix Paeoniae Alba of cortex albiziae, 80 Angelica sinensis, 160 radix astragali 160
80 white pepper of honey-fried licorice root, 80 fruit of glossy privet, 160 stir-baked FRUCTUS GARDENIAE 160;
Preparation method is same as above.
Embodiment 4
The present invention be made active ingredient weight composition be:Polygala 75g, Poria cocos 150g, vine of multiflower knotweed 75g, spina date seed 150g, silk tree
Skin 75g, Radix Paeoniae Alba 75g, Angelica sinensis 150g, radix astragali 150g, honey-fried licorice root 75g, white pepper 75g, 150 g of the fruit of glossy privet, stir-baked FRUCTUS GARDENIAE 150g;
Preparation method is same as above.
We's card is become estranged for negative and positive, and sun does not enter caused by the moon.Eating and drinking without temperance, abnormal emotion, work and rest imbalance cause deficiency of the spleen causing weakness of QI, fortune
Change is not good for, the biochemical weary source of qi and blood, it is impossible to which life is given in the heart, supports and has a sleepless night so that the mind is lost.This disease and the heart, the close phase of liver,spleen,kidney
Close, control should tranquilizing and allaying excitement, and need nourishing qi and blood.
Fang Zhong:Chinese medical discrimination of having a sleepless night belongs to the overabundance of yang in outer more, and the deficiency of Yin is in interior, and sun does not enter the moon.Therefore Radix Paeoniae Alba picric acid enters liver and spleen blood
Point, cape jasmine purge the green and pacify spleen and lung, Polygonum multiflower knotweed and blood vessels and receive cloudy gas, three medicines, which share, holds back yang-energy, and cloudy gas is received, and it is clear to float fire.It is yellow
Stilbene QI invigorating, Angelica sinensis and blood, two medicine phases 5 strengthen taste to help source of generating QI and blood.Spina date seed is sweet in flavor, and energy nourishing heart is cloudy, it is milk-livered, beneficial to treat
Liver blood and have the effect calmed the nerves.For the key medicine of mental-tranquilization.And polygala, cortex albiziae property be apt to lead off it is sensible can happily gas and calming heart is pacified
God, Poria cocos can lead to kidney qi and strong will is not forgotten, and be restoring normal coordination between heart and kidney, tranquilizing the mind, the good merchantable brand of the strong knowledge of intelligence development.Again with the pungent white Hu dissipated
Green pepper, pungent sweet radix glycyrrhizae and all tonic phases 5, can be such that it mends without stagnant.All medicines share, plays tranquilizing and allaying excitement, nourishing qi and blood, reconciliation altogether
The effect of negative and positive.It is mainly used for the symptoms such as the dreaming often and waking easily, dysphoria, dizzy weak, palpitation and amnesia of insomnia initiation.
Function is with curing mainly:Tranquilizing and allaying excitement, nourishing qi and blood, adjustment negative and positive.For treat it is various insomnia trigger insomnia and dreamful sleep,
The diseases such as dysphoria, dizzy weak, palpitation and amnesia.
【Preparation title】
Adopted name:Tranquilizing and allaying excitement particle
The Chinese phonetic alphabet:Zhenjing Anshen Keli
【Composition】Polygala, Poria cocos, the vine of multiflower knotweed, spina date seed, cortex albiziae, Radix Paeoniae Alba, Angelica sinensis, radix astragali, honey-fried licorice root, white pepper, the fruit of glossy privet,
Stir-baked FRUCTUS GARDENIAE.
【Character】This product is particle of the lark to taupe brown;It is sweet in flavor.
【Major function】Tranquilizing and allaying excitement, nourishing qi and blood, adjustment negative and positive.For treat it is various insomnia trigger insomnia and dreamful sleep,
The diseases such as dysphoria, dizzy weak, palpitation and amnesia.
【Specification】Per packed 10g(Equivalent to medicine materical crude slice 13.5g)
【Usage and dosage】Boiling water is taken after mixing it with water.Once 2 bags, 3 times a day.
【Adverse reaction】It is still not clear
【Taboo】Pregnant woman disables.
【Points for attention】1st, raw and cold and greasy heavy food is eaten less.
2nd, to keep mood optimistic during taking medicine, it is never angry angry.
3rd, hypertension, heart disease, hepatopathy, nephrosis chronic diseases severe patient are taken in the case where doctor instructs.
4th, please be stop using when this product character changes.
5th, other medicines are such as used, are please used under physician guidance.
Rational technology Journal of Sex Research
(1) selection of formulation
This prescription is that the Empirical formula come is summed up on Clinical Basis, is had a better effect, and clinically application is decoction, existing
In some formulations, only mixture and granule can meet the requirement of preparation, since mixture is liquid preparation, is storing, transport, taking
Band etc. is there are problem, and granule is solid dosage forms in contrast, has not only kept decoction to absorb the characteristics of fast, effective rapid, but also
With property stablize, easy to store, transport, carry, it is convenient to take, it is sweet agreeable to the taste the characteristics of, therefore select granule be this preparation
Formulation.
(2) identification and pre-treatment of bulk pharmaceutical chemicals
1st, polygala:This product is milk wort polygala Polygala tenuifolia Willd. or ovum leaf polygala Polygala
The dry root of sibirica L..Main product in Shanxi, Shaanxi, Hebei, Henan, Shandong, the Inner Mongol, Anhui, meet《The Chinese people
Republic's pharmacopeia》(Version in 2015)Pertinent regulations under one medicinal material item of page 156.
2nd, Poria cocos:This product is the dry sclerotia of On Polyporaceae Poria cocos Poria cocos (Schw.) Wolf.Main product in
The ground such as Hebei, Henan, Shandong, Anhui, Zhejiang, Fujian, Guangdong, Guangxi, Hunan, Hubei, Sichuan, Guizhou, Yunnan, Shanxi.Symbol
Close《Pharmacopoeia of People's Republic of China》(Version in 2015)Pertinent regulations under one medicinal material item of page 240.
3rd, the vine of multiflower knotweed(Polygonum multiflower knotweed):This product is the dry of polygonum multiflorum thunb Polygonum multiflorum Thunb.
Dry rattan.Autumn, two season of winter tap, and remove residual leaf, are bundled into or take advantage of fresh-cut section, dry.Main product is in Henan, Hubei, Guangxi, wide
The provinces and regions such as east, Guizhou, Sichuan, Shaanxi, Jiangsu.Meet《Pharmacopoeia of People's Republic of China》(Version in 2015)One page 265 should
Pertinent regulations under medicinal material item.
4th, spina date seed:This product is rhamnaceae plant wild jujube Ziziphus jujuba Mill. var. spinosa
(Bunge) dry mature seed of Hu ex H.F.Chou.Main product in In Eastern Gansu, Shaanxi, North of Shanxi, the Henan northwestward,
Middle of Hebei province, Chifeng periphery, Liaoning west and south, Shandong are local.Meet《Pharmacopoeia of People's Republic of China》(Version in 2015)
Pertinent regulations under one medicinal material item of page 366.
5th, cortex albiziae:This product is the dry bark of legume silk tree Albizia julibrissin Durazz..Main product
In Hubei, Jiangsu, Zhejiang.Meet《Pharmacopoeia of People's Republic of China》(Version in 2015)It is related under one medicinal material item of page 143
Regulation.
6th, Radix Paeoniae Alba:This product is the dry root of ranunculaceae plant Chinese herbaceous peony Paeonia lactiflora Pall..Main product is in peace
The ground such as emblem, Heilungkiang, Jilin, Liaoning, Hebei, Henan, Shandong, Shanxi, Shaanxi, the Inner Mongol.Meet《People's Republic of China's medicine
Allusion quotation》(Version in 2015)Pertinent regulations under one medicinal material item of page 105.
7th, Angelica sinensis:This product is the dry root of umbelliferae angelica Angelica sinensis (Oliv.) Diels..It is main
Originate in the ground such as Gansu, Yunnan, Sichuan, Qinghai, Shaanxi, Hunan, Hubei, Guizhou.Meet《Pharmacopoeia of People's Republic of China》(2015
Year version)Pertinent regulations under one medicinal material item of page 133.
8th, radix astragali:This product is legume astragalus mongolicus Astragalus membranaceus (Fisch.)
Bge.var.mongholicus (Bge.) Hsiao or Astragalus membranacus Astragalus membranaceus (Fisch.) Bge.
Dry root.Main product is in the Inner Mongol of China, Shanxi, Heilungkiang and other places.Meet《Pharmacopoeia of People's Republic of China》(2015
Version)Pertinent regulations under one medicinal material item of page 302.
9th, honey-fried licorice root:This product is glycyrrhizic legume Glycyrrhiza uralensis Fisch., swollen fruit Radix
The dry root and rhizome of Glycyrrhiza inflata Bat. or glycyrrhiza glabra Glycyrrhiza glabra L..Spring, autumn two
Season excavates, and removes fibrous root, dries.This product is the Preparation process product of radix glycyrrhizae.Main product is in northeast, Hebei, Shanxi Yanchi County, ningxia, sweet
The ground such as the respectful, Inner Mongol, Qinghai, Shaanxi, Xinjiang.Meet《Pharmacopoeia of People's Republic of China》(Version in 2015)One medicine of page 87
Pertinent regulations under material item.
10th, white pepper:The ripe peeling fruit that this product is Piperaceae plant pepper Piper nigrum L..Main product is in wide
The ground such as east, Guangxi and Yunnan.Meet《Pharmacopoeia of People's Republic of China》(Version in 1963)Pertinent regulations under the medicinal material item of page 88.
11st, the fruit of glossy privet:This product is the dry mature fruit of Oleaceae plants glossy privet Ligustrum lucidum Ait..It is main
Originate in Zhejiang, Jiangsu.Meet《Pharmacopoeia of People's Republic of China》(Version in 2015)Pertinent regulations under one medicinal material item of page 45.
12nd, stir-baked FRUCTUS GARDENIAE:This product is the drying and ripening fruit of madder wort cape jasmine Gardenia jasminoides Ellis
It is real.Main product is saved in Shandong, Zhejiang, Jiangxi, Fujian, Taiwan etc..Meet《Pharmacopoeia of People's Republic of China》(Version in 2015)One
Pertinent regulations under the medicinal material item of page 248.
Pre-treatment:Each taste medicine is chosen to miscellaneous, elution, drying, dispensing.
Three) medicinal material extract technical study
1. the chemical composition general introduction of Chinese medicine in prescription
(1)Polygala:Mainly containing components such as polygalic acids.
(2)Poria cocos:Mainly contain the component such as pachymic acid, pachymic acid methyl esters.
(3)The vine of multiflower knotweed(Polygonum multiflower knotweed):Predominantly Chrysophanol, rheum emodin, are secondly the components such as Rhein.
(4)Spina date seed:Mainly containing components such as Saponin A, B.
(5)Cortex albiziae:The main component such as lactone containing acacic acid, Acacia sapogenin.
(6)Radix Paeoniae Alba:Mainly containing components such as Paeoniflorin, hydroxypaeoniflorin, Albiflorin, benzoylpaeoniflorins.
(7)Angelica sinensis:Mainly containing components such as forulic acid, succinic acid, vanillic acids.
(8)Radix astragali:Mainly containing components such as calycosin, astragalus saponins.
(9)Honey-fried licorice root:Mainly containing components such as glycyrrhizic acids.
(10)White pepper:Mainly containing components such as pipering and volatile oil.
(11)The fruit of glossy privet:Mainly contain the component such as oleanolic acid, acetyloleanolic acid, ursolic acid.
(12)Stir-baked FRUCTUS GARDENIAE:Mainly contain the component such as gardenoside, cape jasmine ketone glucoside.
2. the design of extraction process route
This prescription is that the Empirical formula come is summed up on Clinical Basis, and clinically application is decoction, is had a better effect, in order to
Ensure curative effect, the method still decocted using water is extracted.
3. the research of extracting factor
(1)The measure of medicinal material water absorption rate
Polygala 10g, Poria cocos 20g, Polygonum multiflower knotweed 10g, spina date seed 20g, cortex albiziae 10g, Radix Paeoniae Alba 10g, Angelica sinensis are taken in prescription ratio
20g, radix astragali 20g, honey-fried licorice root 10g, white pepper 10g, fruit of glossy privet 20g, stir-baked FRUCTUS GARDENIAE 20g.(Medicinal material 180g altogether)Add water 2000ml
Immersion, situation about being once impregnated with was observed every 30 minutes, until medicinal material is all impregnated with, time 2 h, filters out and do not absorbed all
Aqueous, it is 211% to try to achieve mixing medicinal material water absorption rate.Determine that 2 times of water measured need to be added when extracting for the first time.
The measure of 1 medicinal material water absorption rate of table
。
(2)Water decocts the investigation of process conditions
For water decoction, the factor for influencing extraction effect mainly has 3, i.e.,:Amount of water, decoct number, decocting time, uses
Orthogonal arrage L9(34) experiment is arranged, each factor have selected three levels, be shown in Table 2:
The factor level table that 2 water of table decocts
。
Inspection target:Evaluation to extraction process, uses dry extract paste-forming rate, alcohol extract as inspection target.
1) orthogonal test methods:Polygala 10g, Poria cocos 20g, Polygonum multiflower knotweed 10g, spina date seed 20g, cortex albiziae are weighed respectively
9 parts of the medicinal materials such as 10g, Radix Paeoniae Alba 10g, Angelica sinensis 20g, radix astragali 20g, honey-fried licorice root 10g, white pepper 10g, fruit of glossy privet 20g, stir-baked FRUCTUS GARDENIAE 20g,
Every part of 180g, is tested according to the condition of factor level table, and filtration, merges extracting solution, be concentrated under reduced pressure, be dried under reduced pressure, weigh,
Dry extract weight and paste-forming rate are calculated, orthogonal experiments are calculated with dry extract weight, are shown in Table 3, table 4, table 5:
2)The assay method of alcohol extract:With reference to《Chinese Pharmacopoeia》The measure of hot dipping under ethanol soluble extractives determination method item.Take
Test sample(Cross No. 2 sieves)About 2g, it is accurately weighed, put in 150ml conical flasks, accurate absolute ethyl alcohol 50ml, close plug, weighed weight,
Stand 1 it is small when after, connect condenser pipe, when being heated to reflux to boiling, and keeping slightly boiling 1 small.After letting cool, conical flask is removed, close plug,
Weighed weight again, the weight of less loss is supplied with absolute ethyl alcohol, is shaken up, and is filtered with dry filter, precision measures filtrate 25ml, puts
It is dry after being evaporated in water-bath, when 105 DEG C of dryings 3 are small, to put in drier and cool down 30 minutes into the evaporating dish of constant weight, it is fast
The accurately weighed weight of speed.The content of ethanol soluble extractives in test sample is calculated with dry product.Test data is shown in Table 3, table 4, table 5:
3)Comprehensive grading
Experimental result accounts for 30% with paste-forming rate, and the amount of ethanol soluble extractives accounts for 70% and is weighted, and calculates orthogonal experiments, is shown in Table
3rd, table 4, table 5:
3 orthogonal experiment data of table and comprehensive grading
4)Orthogonal experiments
Analyzed using alcohol extract content in paste volume, medicinal material and comprehensive grading as index, the results are shown in Table 4, table 5.
4 orthogonal test [L of table9(34)] and result
。
5 the results of analysis of variance table of table
。
Tranquilizing and allaying excitement particle F0.05(2,2)= 19 F0.01(2,2)= 99.
From variance result, the change of B factor levels has result of the test pole significant impact, with reference to analysis directly perceived,
Decocting method condition is preferably A1B3C1, i.e.,:Add 4 times amount water, decoct 3 times, every time 1 it is small when.
5)Checking test:
According to orthogonal experiments, to decocting condition A preferably out1B3C13 groups of checking tests have been carried out, have been separately added into 6,4,4
Times amount water, decoct three times, every time 1 it is small when, it is as a result as follows:
The checking test of 6 water boiling and extraction of table
。
Proving test the result shows that, the RSD of alcohol extract recovery rate is respectively in the paste-forming rate and medicinal material of three batches of samples
2.54%% and 1.89%, reappearance is good, therefore determines A1B3C1For optimum extraction process.
6)The preparation of lab scale sample
Lab scale is carried out by 15 times of amounts of recipe quantity, weighs medicinal material:Polygala 150g, Poria cocos 300g, Polygonum multiflower knotweed 150g, spina date seed
300g, cortex albiziae 150g, Radix Paeoniae Alba 150g, Angelica sinensis 300g, radix astragali 300g, honey-fried licorice root 150g, white pepper 150g, fruit of glossy privet 300g,
Stir-baked FRUCTUS GARDENIAE 300g.(Medicinal material 2700g altogether), 12 taste of the above, be separately added into 6,4,4 times amount water, decoct three times, every time 1 it is small when,
Collecting decoction, filtration, filtrate are concentrated into relative density 1.20(80℃), weigh:1330g, is dried under reduced pressure(Less than 80 DEG C), do leaching
Cream is weighed:621.53g, paste-forming rate 23.02% are close with proving test result.
(Four)Separation, the research of method for concentration
1. separation
During water boiling and extraction, the separation of the dregs of a decoction and extracting solution belongs to crude separation, use 100 mesh nylon screens for filter material into
Row filtration.
2. concentration
Liquid after extraction, filtering is using being concentrated under reduced pressure, and thickening temperature is no more than 80 DEG C, and the solution after extraction, filtering needs to subtract
Pressure is concentrated into the medicinal extract of certain relative density, in order to make pellet, is generally concentrated into relative density 1.15~1.25(80℃),
Grope by many experiments, this preparation Decoction is concentrated into relative density 1.20~1.25(80℃).
(Five)Preparations shaping Journal of Sex Research
Due to extracting medicinal extract, there is very strong hygroscopicity, be directly prepared into particle has certain difficulty in preparation and storage process,
Appropriate amount of auxiliary materials need to be added to meet preparation process and formulation requirements, generally by medicinal extract:Auxiliary material=1:0.5~5 ratio adds auxiliary
Material.
Pelleting method has dry granulation and wet granulation, this experimental selection wet granulation.
1. selection and the dosage of auxiliary material
The common auxiliary material of pelleting has:Sucrose, dextrin, soluble starch, superfine silica gel powder(Silica)Etc. a variety of, this experiment selection
Above-mentioned auxiliary material has carried out pelleting research.
2. the selection of wetting agent
The ethanol of various concentrations is common wetting agent.This experiment uses 50~75% ethanol as wetting agent, adjusts the dry of softwood
Humidity.
3. the investigation of the method for pelleting
1) sucrose pelleting research
Medicinal extract:Sucrose=1:5, particle can be made.
2) dextrin pelleting research
Medicinal extract:Dextrin=1:3, particle is not made.
3) soluble starch pelleting research
Medicinal extract:Soluble starch=1:2, particle can be made.
4) superfine silica gel powder pelleting research
Medicinal extract:Superfine silica gel powder=1:0.2, particle can be made.
Since superfine silica gel powder has extremely strong dilution, and stream effect is helped, added in right amount, remaining auxiliary material adds soluble shallow lake
Total amount is made in powder adjustment, can be made into sugar type granules.
5) superfine silica gel powder and soluble starch pelleting research
Take medicinal extract appropriate, add superfine silica gel powder and soluble starch to carry out pelleting research, the results are shown in Table 7:
7 medicinal extract of table adds superfine silica gel powder and soluble starch pelleting result
。
According to the above results, it is supplementary product consumptions of the 70g as this preparation to determine auxiliary material total amount, according to above-mentioned lab scale(Altogether
Medicinal material 2700g)As a result(Dry extract weight:621.53g, goes out dry extract rate 23.02%,)Calculate, add superfine silica gel powder, soluble starch
In right amount(1379g), can be made into particle 2000g.
4. preparation specification and usage and dosage determine
According to above-mentioned experimental result, selection is made the particle of 1.35 crude drug g/ particles g, calculates prescription, preparation method, specification, usage
Dosage:
【Prescription】
。
【Preparation method】
12 taste of the above, be separately added into 6,4,4 times amount water, decoct three times, every time 1 it is small when, collecting decoction, filtration, filtrate concentration
To relative density 1.20~1.25(80℃), add superfine silica gel powder, appropriate soluble starch, mix, particle is made, it is dry, it is made
1000g, to obtain the final product.
【Usage and dosage】:Warm boiled water.20g, 3 times a day.
【Specification】:Per packed 10g(Equivalent to medicine materical crude slice 13.5g).
This dosage is close with clinical prescription amount.
5. the investigation of wet granular drying temperature
Wet granular is dried, different temperatures has been selected, the results are shown in Table 8:
8 wet granular drying temperature of table tests table
。
According to experimental result, select wet granular drying condition for:80 DEG C of drying temperature.
6. the mobility of particle is investigated
Finished granule measure angle of repose made of taking, investigates the mobility of particle.
Method:Particle is placed in the funnel above the central point for being fixed on culture dish, particle is flowed out from funnel, directly
To particle packing untill being overflowed from plate upper limb, the vertex of the steep heap of circular cone is measured to the height of plate upper limb, measures culture dish
Radius, calculate angle of repose, sample measure three times, be averaged.It is shown in Table 9
The measure at 9 particle angle of repose of table
。
Result above shows:Particle angle of repose is 34.7 degree, shows that mobility of particle is good.
7. the hygroscopicity of finished particle is investigated:
Using the moisture absorption situation when measuring particle in certain relative humidity under the conditions of 25 DEG C, its hygroscopicity, test method are investigated
It is as follows:
1. constant humidity solution is prepared:
MgCl is taken respectively2、K2CO3、NaBr、NaCl、KCl、KNO3Saturated aqueous solution is made at 25 DEG C, puts closed glass drier
Afterwards, it is respectively 33%, 43%, 58%, 75%, 82%, 92% permanent up to relative humidity after being put into when balance 24 is small in 25 DEG C of insulating boxs
Wet solution.
2. the measure of hygroscopic capacity
The measuring cup of constant weight is taken respectively, is added particle about 2g, is gently tiled, make thickness about 3mm or so of medicine, cover bottle cap, essence
It is close weighed, open bottle cap, be respectively placed in the above-mentioned glass desicator for filling constant humidity solution, 24 it is small when after, it is accurately weighed, ask
Go out increased weight, calculated equilibrium water content %, the results are shown in Table 10:It is vertical using equilibrium moisture content % using relative humidity as abscissa
Coordinate is mapped, up to sucting wet curve.
The hygroscopicity of 10 particle of table is investigated
。
From upper table result, when temperature is at 25 DEG C, when relative humidity is below 43%, particle hydroscopicity is relatively low.So
When particle is dispensed and stored, temperature, relative humidity are controlled, sees Fig. 1.
(Six), packaging material selection
Since in finished particle, the large percentage shared by medicinal extract, there is certain hygroscopicity, therefore selected waterproof, humidity resistance are preferable
Composite membrane be inner packaging material, to ensure the stabilization of preparation.
(Seven), three batches of pilot scale sample datas
Three batches of pilot plant tests, feed intake, pilot-scale experiment is shown in Table 11 by 10 times of amounts of recipe quantity.
11 3 batches of pilot product tables of data of table
。
By data above as it can be seen that each item data approaches, stability is preferable, can be used as big working condition foundation.
Claims (2)
- A kind of 1. medicine of tranquilizing and allaying excitement, it is characterised in that:Be made active ingredient parts by weight composition be:70~80 Poria cocos of polygala, 140~160 vine of multiflower knotweed, 70~80 spina date seed 140~16070~80 Radix Paeoniae Alba of cortex albiziae, 70~80 Angelica sinensis, 140~160 radix astragali 140~16070~80 white pepper of honey-fried licorice root, 70~80 fruit of glossy privet, 140~160 stir-baked FRUCTUS GARDENIAE 140~160.
- A kind of 2. medicine of tranquilizing and allaying excitement, it is characterised in that:Be made active ingredient weight composition be:Polygala 75g, Poria cocos 150g, vine of multiflower knotweed 75g, spina date seed 150g, cortex albiziae 75g, Radix Paeoniae Alba 75g, Angelica sinensis 150g, radix astragali 150g, honey-fried licorice root 75g, white Hu Green pepper 75g, 150 g of the fruit of glossy privet, stir-baked FRUCTUS GARDENIAE 150g.
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