CN101239138A - 'Zishuiqinggan'oral preparation and preparation thereof - Google Patents
'Zishuiqinggan'oral preparation and preparation thereof Download PDFInfo
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- CN101239138A CN101239138A CNA2008100841158A CN200810084115A CN101239138A CN 101239138 A CN101239138 A CN 101239138A CN A2008100841158 A CNA2008100841158 A CN A2008100841158A CN 200810084115 A CN200810084115 A CN 200810084115A CN 101239138 A CN101239138 A CN 101239138A
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Abstract
The present invention relates to a zishuiqinggan oral liquid preparation which is prepared from 11 Chinese traditional medicines including rehmanniae vaporata etc., and a method for preparing the same. The preparation is prepared from mixed extract (including extractum or dry powder and volatile oil) including rehmanniae vaporata, angelica, zaoren, cornus officinalis, tuckahoe, yarm, bupleurum, capejasmine, cortex moutan, americanwater plantain as raw materials, and acceptable carrier or excipient as substrate in medicine by conventional process. The preparation has good property of nourishing yin and blood, dispersing stagnant liver and clearing away heat for treating yin deficiency and liver depression, hypochondrial distending pain, gastric cavity pain, dry throat with a bitter taste, red tongue and less tongue coating, pulse deficiency and wiry or thin soft. The medicine preparation is used for treating chronic hepatitis, neurasthenia, climacteric syndrome, neurosis, masculine sterility and hypertension in clinical.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of deficiency of YIN stagnation of liver-QI that cures mainly, distending pain over the hypochondrium, oral formulations of gastralgia and preparation method thereof, particularly the extract with Zi Shuiqinggan Chinese medicine prescription is the oral formulations of active constituents of medicine.
Background technology
" Zi Shuiqinggan drink " comes from " doctor ancestor own duty is compiled ", form by Radix Bupleuri, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Fructus Gardeniae, Fructus Corni, Poria, Rhizoma Dioscoreae, Cortex Moutan, Rhizoma Alismatis, Radix Rehmanniae Preparata etc., from prescription, closing the Danzhi Xiaoyao San plus-minus by LIUWEI DIHUANG WAN forms, effect with nourishing YIN and benefiting blood, soothing the liver heat clearing away, be used for the treatment of deficiency of YIN stagnation of liver-QI, distending pain over the hypochondrium, gastralgia, dry mouth and throat, the few tongue of red tongue, deficient and stringy pulse or soft card, be commonly used to treat chronic hepatitis, neurasthenia, menopausal syndrome, neurosis, masculine sterility, hypertension clinically.
The Zi Shuiqinggan drink has better therapeutic effect to hypertension, and particularly dialectical genus deficiency of YIN liver energy stagnation type curative effect is better.In recent years, someone thinks, the essence of yin deficiency syndrome may be interleukin-1 (IL-1), the enhancing of tumor necrosis factor cytokines such as (TNF), also there is simultaneously the scholar to propose the relation that cyclic adenosine monophosphate (cAMP), this a pair of mutual antagonistic substance of cyclic guanosine monophosphate (cGMP) have embodied traditional Chinese medical science YIN declining when YANG growing, be embodied in yin defiency patient blood plasma and preponderate, cAMP/cGMP raises, and yang deficiency patient in contrast.Experimental studies results such as Yang Shi show, Zi Shuiqinggan can be to 2KIC-RHR rat model serum il-1 and the effective antagonism of TNF ascendant trend, and can adjust cAMP/cGMP ratio.Proved that from microcosmic angle we belong to the effectiveness of type of deficiency of YIN leading to hyper activity of YANG to the hypertension disease.
Clinical observation result shows, on conventional Western medicine processing basis, add the Zi Shuiqinggan drink, at obvious effective rate, doing well,improving, bring high blood pressure down, aspect such as hemorheology property improvement all obviously is better than matched group, follows up a case by regular visits to through half a year simultaneously and do not find blood pressure bounce-back ascensionist, obtains late result preferably.
The source of the Chinese crude drug of " Zi Shuiqinggan drink " is as follows:
Radix Rehmanniae Preparata: Radix Rehmanniae Preparata: be the processed product of the tuber of scrophulariaceae rehmannia glutinosa plant.Heart tonifying, diuresis, blood sugar lowering and rising peripheral leukocytes are arranged, effects such as raise immunity.
Radix Angelicae Sinensis: be the root of umbelliferae angelica.Enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, the effect of loosening bowel to relieve constipation.
The Radix Paeoniae Alba: be the root of ranunculaceae plant Radix Paeoniae.The suppressing the hyperactive liver pain relieving is arranged, nourishing blood for regulating menstruation, the effect of astringing YIN to stop sweating.
Semen Ziziphi Spinosae: be the seed of Rhamnaceae plant Ziziphi Spinosae.Nourish heart, calm the nerves, the effect of arresting sweating.
Fructus Corni: be the drying and ripening sarcocarp of Cornaceae plant Fructus Corni.Liver and kidney tonifying is arranged, the effect of essence astringing and desertion stemming.
Poria: be the dry sclerotia of Polyporaceae fungus Poria.Multiparasitization is on tree roots such as pinaceae plant Pinus densiflora or Pinus massoniana Lamb.Has the promoting diuresis to eliminate damp pathogen effect.
Rhizoma Dioscoreae: be Dioscoreaceae plant Rhizoma Dioscoreae rhizome.The spleen reinforcing nourishing the stomach is arranged, the lung benefiting that promotes the production of body fluid, the effect of the kidney invigorating arresting seminal emission.
Radix Bupleuri: be the root of umbelliferae bupleurum.Have to evacuate and bring down a fever the effect of yang invigorating soothing liver-QI.
Fructus Gardeniae: originating is the fruit of Maguireothamnus speciosus Fructus Gardeniae.The pathogenic fire purging relieving restlessness is arranged, clearing away heat and promoting diuresis, the effect of removing pathogenic heat from blood and toxic substance from the body.
Cortex Moutan: be the rough bark of cohosh Paeonia suffruticosa.Clearing away heat and cooling blood is arranged, the effect of blood circulation promoting competent silt.
Rhizoma Alismatis: be the tuber of Alismataceae plant Rhizoma Alismatis.Diuresis is arranged, the effect of heat clearing away.
We card is because kidney yin is then considered its cloudy blood and more hindered, so gas is more stagnant. to nourish kidney yin, join the GUISHAO Semen Ziziphi Spinosae by Six-element, thereby YIN nourishing is with soothing the liver and use like this with nourishing blood to suppress the hyperactive liver. and reach kidney water foot, liver blood fills, the body fluid profit, irritability is easypro, the purpose that the stagnation of QI is removed certainly.
" Zi Shuiqinggan " in ancient times has only decoction, decoct behind the needs purchase decoction pieces and take, carry take all very inconvenient, we quantitatively control by index components and make the modern Chinese medicine oral formulations through studying, and product dosage is accurate, steady quality, conveniently take, be applicable to the big production of commercialization, overcome that the Chinese medicine decoction consumption is big, consumption is inaccurate, carry take inconvenience, can't commercialization etc. shortcoming, the needs that make things convenient for clinical treatment and family to use.
Summary of the invention
The objective of the invention is to preparation method according to modern Chinese medicine, quantitatively control by index components and to make the modern Chinese medicine oral formulations, with Zi Shuiqinggan be developed to product dosage accurately, steady quality, conveniently take, be applicable to the Chinese patent medicine of the big production of commercialization, make things convenient for clinical treatment and family to use.
The medicine of oral formulations involved in the present invention is by Radix Rehmanniae Preparata, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Semen Ziziphi Spinosae, Fructus Corni, Poria, Rhizoma Dioscoreae, Radix Bupleuri, Fructus Gardeniae, Cortex Moutan, the mixed extract of Rhizoma Alismatis (comprising water extract or volatile oil, extractum or dry powder) is a raw material, with as the pharmaceutically acceptable carrier of substrate or excipient routinely prepared form, because it is slightly different to record " Zi Shuiqinggan " recipe quantity in the different medical books, each flavour of a drug and weight fraction (unit is g or kg) are in preparation the present invention prescription:
Radix Rehmanniae Preparata 5-20 part, Radix Angelicae Sinensis 3-15 part, Radix Paeoniae Alba 5-20 part, Semen Ziziphi Spinosae 3-15 part, Fructus Corni 5-20 part, Poria 3-15 part, Rhizoma Dioscoreae 5-20 part, Radix Bupleuri 3-15 part, Fructus Gardeniae 3-15 part, Cortex Moutan 3-15 part, Rhizoma Alismatis 3-15 part.
Each flavour of a drug and weight fraction (unit is g or kg) are in the best optimizing prescriptions:
15 parts in Radix Rehmanniae Preparata, 9 parts of Radix Angelicae Sinensis, 12 parts of the Radix Paeoniae Albas, 9 parts of Semen Ziziphi Spinosaes, Fructus Corni 12,9 parts in Poria, 12 parts of Rhizoma Dioscoreaes, 9 parts of Radix Bupleuri, 9 parts of Fructus Gardeniae, 9 parts of Cortex Moutans, 9 parts of Rhizoma Alismatis.
Substrate: the common medicinal supplementary material in the medicament book in preparation oral administration solid and the liquid preparation;
Proportioning: extract (comprise water extract and volatile oil: extractum or dry powder): substrate=9: 1~1: 9.
The extraction process of the present invention's " Zi Shuiqinggan " mixed extract (water extract and volatile oil) is as follows:
(1) each flavor medical material is cleaned, take by weighing each medical material and add 6-20 times of water gaging by best deal and soaked 2-12 hour, heating extraction 2-3 time, extracting solution merges, and reclaims volatile oil;
(1) aqueous extract left standstill 12-48 hour, crossed the leaching supernatant, and concentrating under reduced pressure gets extractum or spray drying, and to get dry powder be water extract;
(2) " Zi Shuiqinggan " extract (water extract and volatile oil) and pharmaceutically acceptable carrier or excipient composition routinely technology make various oral administration solids or liquid preparation, wherein said carrier or excipient pharmaceutically selected according to different dosage forms, and these used carriers or excipient can determine for the those of ordinary skill of pharmaceutical field.
The extracting method of the present invention's " Zi Shuiqinggan " extract is a lot, has only provided a kind of method here, but is not limited to this kind method.
Medicine of the present invention, wherein dosage form comprises oral solid formulation and oral liquid, wherein oral solid formulation comprises: tablet, hard capsule, liquid type capsule, granule, soft capsule, drop pill, pill, pellet, slow releasing preparation; Oral liquid comprises: oral liquid, syrup, medicated wine; Granule wherein, oral liquid, hard capsule and additive of tablet are selected from starch, sodium bicarbonate, Icing Sugar, lactose, amylum pregelatinisatum, microcrystalline Cellulose, inorganic salts mainly is some inorganic calcium salts, as calcium sulfate, citric acid, calcium hydrogen phosphate and medicinal calcium carbonate, mannitol, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methylcellulose and ethyl cellulose, hydroxypropyl emthylcellulose, hypromellose, other binding agent, dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, polyethylene compares pyrrolidone, cross-linking sodium carboxymethyl cellulose, magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, in polyethylene glycols (Macrogol 2000-6000) and month pure magnesium sulfate of extension and the xylitol one or more; Wherein the adjuvant of soft capsule, liquid type capsule and drop pill is selected from Polyethylene Glycol (Macrogol 200-6000), propylene glycol, Cera Flava, Lac, polyoxyethylene monostearate, glycerol, ethanol, (polysorbas20,40,60,65,80), spans (span 20,40,60,65,80), soybean oil, Oleum Camelliae, safflower oil, Radix Oenotherae erythrosepalae oil, olive oil, C
5-C
14Triglyceride, in the ethyl oleate one or more, can also dose antioxidant, be selected from alpha-tocopherol, ascorbyl palmitate, Butylated hydroxyanisole (BHA), the dibenzylatiooluene (BHT) one or more.
Pharmaceutical preparation of the present invention, wherein tablet specifically refers to common compressed tablet, coated tablet, coated tablet, Film coated tablets, enteric coated tablet, effervescent tablet, chewable tablet, multilayer tablet, dispersible tablet, Sublingual tablet, buccal tablet.
Pharmaceutical preparation of the present invention wherein can also contain aromatic and antiseptic, and wherein aromatic comprises one or more in Fructus Citri tangerinae essence, flavoring banana essence, strawberry essence, the cream flavour, and antiseptic comprises one or more in parabens, the benzoic acids.
" Zi Shuiqinggan " method for preparing extractive is as follows:
Prescription: Radix Rehmanniae Preparata 5-20 part, Radix Angelicae Sinensis 3-15 part, Radix Paeoniae Alba 5-20 part, Semen Ziziphi Spinosae 3-15 part, Fructus Corni 5-20 part, Poria 3-15 part, Rhizoma Dioscoreae 5-20 part, Radix Bupleuri 3-15 part, Fructus Gardeniae 3-15 part, Cortex Moutan 3-15 part, Rhizoma Alismatis 3-15 part.
Method for making: the medical material of respectively distinguishing the flavor of of will writing out a prescription cleans, and take by weighing each medical material of recipe quantity and add 6-20 times of water gaging and soaked 2-12 hour, heating extraction 2-3 time, extracting solution merges, collection volatile oil; Aqueous extract left standstill 12-48 hour, crossed the leaching supernatant, and concentrating under reduced pressure gets extractum or spray drying is that dry powder is that water extract is standby.
Preparation " Zi Shuiqinggan " oral liquid and syrup
" Zi Shuiqinggan " extract and correctives, antiseptic and water are made oral liquid, and wherein correctives is selected from one or more in sucrose, saccharin sodium, sodium cyclamate, stevioside, aspartoyl aminotoluene acid methyl ester, the Oleum menthae (alcohol); Antiseptic is selected from sorbic acid methyl ester, benzoic acids, you moor in golden class etc. one or more.
The preparation method of oral liquid and syrup is as follows: " Zi Shuiqinggan " extract adds water to be adjusted to preparation amount, adds correctives, antiseptic mix homogeneously, through technologies such as sterilization, fill, check, packings, promptly gets Zi Shuiqinggankoufu liquid and syrup.
Wherein the weight percent content of Jia Ruing is: " Zi Shuiqinggan " extract 5-80%, correctives 0.05-5%, antiseptic 0.001-2%, water 10-90%.
Preparation " Zi Shuiqinggan " granule, pill, pellet, capsule, tablet
Granule, pill, pellet, capsule, and tablet are made the used adjuvant of concentrated granule or pill or tablet and are comprised diluent, binding agent, lubricant; Diluent is selected from one or more of starch, lactose, dextrin, microcrystalline Cellulose kind; Binding agent comprise water, macromolecular material and alcoholic acid one or more; Lubricant comprises one or more in magnesium stearate, Pulvis Talci, the stearic acid.
Granule, pill, pellet, capsule, and the preparation method of tablet as follows:
With " Zi Shuiqinggan " extract and an amount of pharmaceutic adjuvant mixing, adding binding agent etc. is made soft material, makes granule with granulator, and dry, granulate promptly gets granule, or the general pill of making, or makes capsule through capsule filling machine, or makes tablet through tabletting.
Granule, pill, pellet, capsule, and tablet, wherein every gram granule is equivalent to contain the crude drug amount of 0.1-10 gram.
Preparation " Zi Shuiqinggan " soft capsule
With " Zi Shuiqinggan " extract and adjuvant diluent, antioxidant, antiseptic, suspending agent, wherein diluent is selected from one or more in Polyethylene Glycol, propylene glycol, vegetable oil, the mineral oil; Antioxidant is selected from that glycine, vitamin E and derivant thereof, ascorbic acid, pyrosulfurous acid are received, in the potassium metabisulfite one or more; Antiseptic comprises sorbic acid methyl ester, benzoic acids, you moor in golden class etc. one or more; Suspending agent is selected from one or more in chitin, cellulose family, agar, the Cera Flava.
Preparation method is as follows: " Zi Shuiqinggan " extract 5-50%, add an amount of diluent, antioxidant, antiseptic, suspending agent mix homogeneously, prepared forms routinely, and wherein every gram soft capsule is equivalent to contain the crude drug amount of 0.1-10 gram.
Specific embodiment
Embodiment one: " Zi Shuiqinggan " extract 1 (extractum and volatile oil) preparation method
Prescription: Radix Rehmanniae Preparata 15g, Radix Angelicae Sinensis 9g, Radix Paeoniae Alba 10g, Semen Ziziphi Spinosae 10g, Fructus Corni 10g, Poria 9g, Rhizoma Dioscoreae 12g, Radix Bupleuri 9g, Fructus Gardeniae 9g, Cortex Moutan 9g, Rhizoma Alismatis 9g.
Method for making: the medical material of respectively distinguishing the flavor of of will writing out a prescription cleans, and takes by weighing each medical material by recipe quantity, adds 6 ~ 15 times of water gagings and soaks 2-10 hour, heat little boiling and extracts 2-3 time, and volatile oil is collected in the extracting solution merging; Aqueous extract left standstill 12-48 hour, crossed the leaching supernatant, and it is the about 22.2g of water extract that concentrating under reduced pressure gets extractum, the about 0.03g of volatile oil.
Embodiment two: " Zi Shuiqinggan " extract 2 (dry powder and volatile oil) preparation method
Prescription: Radix Rehmanniae Preparata 15g, Radix Angelicae Sinensis 9g, Radix Paeoniae Alba 12g, Semen Ziziphi Spinosae 9g, Fructus Corni 9g, Poria 9g, Rhizoma Dioscoreae 12g, Radix Bupleuri 9g, Fructus Gardeniae 9g, Cortex Moutan 9g, Rhizoma Alismatis 9g.
Method for making: the medical material of respectively distinguishing the flavor of of will writing out a prescription cleans, and takes by weighing each medical material by recipe quantity, adds 8 ~ 10 times of water gagings and soaks 2-8 hour, and being heated to boils extracts 2-3 time, and volatile oil is collected in the extracting solution merging; Aqueous extract left standstill 12-48 hour, crossed the leaching supernatant, concentrating under reduced pressure, and it is the about 24.2g of water extract that spray drying gets dry powder; The about 0.03g of volatile oil.
Embodiment three: " Zi Shuiqinggan " oral solid formulation preparation method
(1) preparation " Zi Shuiqinggan " granule
Prescription:
" Zi Shuiqinggan " extract 1 10-90%
Starch 5.0-70%
Dextrin 2.0-20%
Xylitol 5.0-20%
Sorbic acid methyl ester 0.001-2.0%
Optimizing prescriptions:
" Zi Shuiqinggan " extract 1 22.2g
Starch 10.0g
Dextrin 3.0g
Xylitol 2.0g
Sorbic acid methyl ester 0.002g
Method for making: press method preparation " Zi Shuiqinggan " extract among the embodiment one, add the recipe quantity adjuvant and make granule according to a conventional method, an amount of dissolve with ethanol of volatile oil evenly is sprayed on the granule, cold drying, and packing is made three bags, every bag of 10.1g.
(2) preparation " Zi Shuiqinggan " tablet:
(1) ordinary tablet prescription:
" Zi Shuiqinggan " extract 2 5.0-90%
Starch 5.0-50%
Dextrin 2.0-20%
Microcrystalline Cellulose 5.0-20%
Pulvis Talci 0.5-5.0%
Magnesium stearate 0.1-5.0%
Optimizing prescriptions:
" Zi Shuiqinggan " extract 2 24.2g
Starch 14g
Dextrin 3g
Microcrystalline Cellulose 2g
Pulvis Talci 0.2g
Magnesium stearate 0.1g
Method for making: press method preparation " Zi Shuiqinggan " extract among the embodiment two, add the recipe quantity adjuvant and make granule according to a conventional method, an amount of dissolve with ethanol of volatile oil evenly is sprayed on the granule, cold drying, and tabletting is promptly.
(2) effervescent tablet is write out a prescription and is prepared as follows:
Prescription: " Zi Shuiqinggan " extract 2 24.2g
Starch 5g
Dextrin 8g
Microcrystalline Cellulose 10g
Pulvis Talci 0.1g
Magnesium stearate 0.1g
Anhydrous citric acid 1.0g
Sodium bicarbonate 1.0g
Lactose 0.5g
Water is an amount of
Method for making: press method preparation " Zi Shuiqinggan " extract among the embodiment two, add the recipe quantity adjuvant and make granule according to a conventional method, an amount of dissolve with ethanol of volatile oil evenly is sprayed on the granule, cold drying, and tabletting is promptly.
(3) buccal tablet is write out a prescription and is prepared as follows:
Prescription: " Zi Shuiqinggan " extract 2 24.2g
Starch 2g
Dextrin 3g
Microcrystalline Cellulose 10g
Pulvis Talci 0.1g
Magnesium stearate 0.1g
Citric acid 0.1g
Aspartame 0.02g
Water is an amount of
Method for making: press method preparation " Zi Shuiqinggan " extract among the embodiment two, add the recipe quantity adjuvant and make granule according to a conventional method, an amount of dissolve with ethanol of volatile oil evenly is sprayed on the granule, cold drying, and tabletting is promptly.
(4) coated tablet is write out a prescription and is prepared as follows:
Prescription: " Zi Shuiqinggan " extract 2 24.2g
Starch 13g
Dextrin 2g
Microcrystalline Cellulose 2g
Pulvis Talci 0.1g
Magnesium stearate 0.1g
Method for making: press method preparation " Zi Shuiqinggan " extract among the embodiment two, add the recipe quantity adjuvant and make granule according to a conventional method, the an amount of dissolve with ethanol of volatile oil, evenly be sprayed on the granule, cold drying, tabletting is made coating material according to conventional method, with coating machine coating promptly, the difference according to coating material can be bundled into sugar-coat and film-coat.
(3) preparation " Zi Shuiqinggan " pill
Prescription:
" Zi Shuiqinggan " extract 2 24.2g
Starch 3g
Magnesium stearate 0.1g
Dextrin 3g
Water is an amount of
Method for making: press method preparation " Zi Shuiqinggan " extract among the embodiment two, add the recipe quantity adjuvant and make granule according to a conventional method, an amount of dissolve with ethanol of volatile oil evenly is sprayed on the granule, cold drying, and pelleting is promptly.
(4) preparation " Zi Shuiqinggan " soft capsule
The content prescription:
" Zi Shuiqinggan " extract 2 24.2g
Vegetable oil 10g
Ethylparaben 0.01g
Cera Flava 2g
Method for making: press method preparation " Zi Shuiqinggan " extract among the embodiment two, add vegetable oil, the Cera Flava of optimizing prescriptions percentage amounts, ethylparaben prepared routinely forms.
(5) preparation " Zi Shuiqinggan " capsule
Prescription:
" Zi Shuiqinggan " extract 2 10-95%
Starch 5-55%
Magnesium stearate 0.1-5%
Optimizing prescriptions:
" Zi Shuiqinggan " extract 2 24.2g
Starch 5g
Magnesium stearate 0.5g
Method for making: press method preparation " Zi Shuiqinggan " extract among the embodiment two, add the recipe quantity adjuvant and make granule according to a conventional method, an amount of dissolve with ethanol of volatile oil evenly is sprayed on the granule, and cold drying, fill are promptly.
Embodiment four: " Zi Shuiqinggan " oral liquid preparation method
Prescription: " Zi Shuiqinggan " extract 1 5-80%
Sucrose 5.0-50%
Sodium cyclamate 5.0-40%
Sorbic acid methyl ester 0.001-2%
Distilled water 10-90%.
Optimizing prescriptions:
" Zi Shuiqinggan " extract 1 22.2g
Sucrose 5.0g
Sodium cyclamate 0.5g
Sorbic acid methyl ester 0.002g
Distilled water is settled to 50ml.
Method for making: press method preparation " Zi Shuiqinggan " extract among the embodiment one, add each adjuvant of prescription and distilled water, again through the ultrafilter ultrafiltration, the ultrafiltrate fill, sterilization, promptly.
Claims (7)
1, a kind of by 11 flavor Chinese medicines preparations such as Radix Rehmanniae Preparata Zi Shuiqinggankoufu preparation and preparation method thereof, said preparation is with Radix Rehmanniae Preparata, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Semen Ziziphi Spinosae, Fructus Corni, Poria, Rhizoma Dioscoreae, Radix Bupleuri, Fructus Gardeniae, Cortex Moutan, the mixed extract of Rhizoma Alismatis (extractum or dry powder and volatile oil) is a raw material, with as the pharmaceutically acceptable carrier of substrate or excipient routinely prepared form, wherein:
1.1 Radix Rehmanniae Preparata 5-20 part, Radix Angelicae Sinensis 3-15 part, Radix Paeoniae Alba 5-20 part, Semen Ziziphi Spinosae 3-15 part, Fructus Corni 5-20 part, Poria 3-15 part, Rhizoma Dioscoreae 5-20 part, Radix Bupleuri 3-15 part, Fructus Gardeniae 3-15 part, Cortex Moutan 3-15 part, Rhizoma Alismatis 3-15 part.
Each flavour of a drug and weight fraction (unit is g or kg) are in the best optimizing prescriptions:
15 parts in Radix Rehmanniae Preparata, 9 parts of Radix Angelicae Sinensis, 12 parts of the Radix Paeoniae Albas, 9 parts of Semen Ziziphi Spinosaes, Fructus Corni 12,9 parts in Poria, 12 parts of Rhizoma Dioscoreaes, 9 parts of Radix Bupleuri, 9 parts of Fructus Gardeniae, 9 parts of Cortex Moutans, 9 parts of Rhizoma Alismatis.
1.2 substrate: the common medicinal supplementary material in the medicament book in preparation oral administration solid and the liquid preparation;
1.3 proportioning: extract (comprise water extract: extractum or dry powder and volatile oil): substrate=9: 1~1: 9.
2, according to the Zi Shuiqinggan extract in the claim 1, its preparation technology is as follows:
1.1 each flavor medical material is cleaned, take by weighing each medical material and add 6~20 times of water gagings by best deal and soaked 2-12 hour, heating extraction 2-3 time, extracting solution merges, and collects volatile oil;
1.2 aqueous extract left standstill 12-48 hour, crossed the leaching supernatant, concentrating under reduced pressure gets extractum or spray drying, and to get dry powder be water extract;
1.3 Zi Shuiqinggan water extract and volatile oil and carrier pharmaceutically or adjuvant root make up routinely technology and make various oral administration solids or liquid preparation, these wherein used carriers or excipient can determine for the those of ordinary skill of pharmaceutical field.
3, according to the Zi Shuiqinggankoufu pharmaceutical preparation among the claim 1-2, wherein dosage form comprises tablet, hard capsule, granule, soft capsule, liquid type capsule, drop pill and oral liquid, wherein:
1.1 granule, tablet, hard capsule and oral liquid liquid preparation substrate are selected from starch, sodium bicarbonate, Icing Sugar, lactose, amylum pregelatinisatum, microcrystalline Cellulose, inorganic salts (mainly is some inorganic calcium salts, as dredging sour calcium, citric acid, calcium hydrogen phosphate and medicinal calcium carbonate), mannitol, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methylcellulose and ethyl cellulose, hydroxypropyl emthylcellulose, hypromellose, other binding agent, dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross linked polyvinyl pyrrolidone, cross-linking sodium carboxymethyl cellulose, magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, in polyethylene glycols (Macrogol 2000-6000) and month pure magnesium sulfate of extension and the xylitol one or more.
1.2 soft capsule, the capsular substrate of liquid type are selected from Polyethylene Glycol (Macrogol 200-6000), propylene glycol, Cera Flava, Lac, polyoxyethylene monostearate, glycerol, ethanol, (polysorbas20,40,60,65,80), spans (span 20,40,60,65,80), soybean oil, Oleum Camelliae, safflower oil, Radix Oenotherae erythrosepalae oil, olive oil, C
5-C
14Triglyceride, in the ethyl oleate one or more.
4, according to the pharmaceutical preparation among the claim 1-3, wherein tablet specifically refers to common compressed tablet, coated tablet, coated tablet, Film coated tablets, enteric coated tablet, effervescent tablet, chewable tablet, multilayer tablet, dispersible tablet, Sublingual tablet, buccal tablet.
5, according to the pharmaceutical preparation among the claim 1-4, can also dose antioxidant, be selected from alpha-tocopherol, ascorbyl palmitate, Butylated hydroxyanisole (BHA), the dibenzylatiooluene (BHT) one or more.
6, according to the pharmaceutical preparation among the claim 1-5, wherein can also contain aromatic and antiseptic, wherein aromatic comprises one or more in Fructus Citri tangerinae essence, flavoring banana essence, strawberry essence, the cream flavour, and antiseptic comprises one or more in parabens, the benzoic acids.
7, according to the Zi Shuiqinggan drug oral preparation among the claim 1-6, said preparation has the effect of nourishing YIN and benefiting blood, soothing the liver heat clearing away, be used for the treatment of deficiency of YIN stagnation of liver-QI, distending pain over the hypochondrium, gastralgia, dry mouth and throat, the few tongue of red tongue, deficient and stringy pulse or soft card are commonly used to treat chronic hepatitis, neurasthenia, menopausal syndrome, neurosis, masculine sterility, hypertension clinically.
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CN112057542A (en) * | 2020-08-24 | 2020-12-11 | 河北平安健康集团股份有限公司 | A Chinese medicinal composition for treating insomnia, anxiety, depression and climacteric syndrome, and its preparation method |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN112057542A (en) * | 2020-08-24 | 2020-12-11 | 河北平安健康集团股份有限公司 | A Chinese medicinal composition for treating insomnia, anxiety, depression and climacteric syndrome, and its preparation method |
CN112057542B (en) * | 2020-08-24 | 2022-05-10 | 河北平安健康集团股份有限公司 | A Chinese medicinal composition for treating insomnia, anxiety, depression and climacteric syndrome, and its preparation method |
CN114796380A (en) * | 2020-08-24 | 2022-07-29 | 河北平安健康集团股份有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for treating anxiety |
CN114796380B (en) * | 2020-08-24 | 2023-07-21 | 河北平安健康集团股份有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for treating anxiety |
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