CN1565501A - Novel preparation method of - Google Patents

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CN1565501A
CN1565501A CN 03124641 CN03124641A CN1565501A CN 1565501 A CN1565501 A CN 1565501A CN 03124641 CN03124641 CN 03124641 CN 03124641 A CN03124641 A CN 03124641A CN 1565501 A CN1565501 A CN 1565501A
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dihuang
mingmu
extraction
preparation
powder
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毛友昌
毛小敏
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Abstract

The invention discloses a novel preparation method of 'Mingmu Dihuang' and its formulation, characterized by the modification to the preparing process by using the novel medicament preparing technologies, which achieves the beneficial effects of good curative effect, small amount of administration and easiness in carrying. The preparation can be used for treating photophobia and irritated epiphora with warm tear.

Description

Preparation technology that Mingmu-Dihuang is new and preparation thereof
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine, relates in particular to new preparation technology of Mingmu-Dihuang and preparation thereof.
Background technology
Radix Rehmanniae Pilulae for Improving Eyesight side goes out Ming Dynasty's " Wanbing Huichun, Curative Measures for All Diseases ", system adds Fructus Lycii, Flos Chrysanthemi, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Fructus Tribuli, Concha Haliotidis by LIUWEI DIHUANG WAN and forms, be the famous prescription of TCM Ophthalmology, has nourishing kidney, nourishing the liver, the function that makes eye bright, be used for the hepatic and renal YIN deficiency, the puckery photophobia of order, blurred vision, diseases such as epiphora induced by wind are evident in efficacy.The technology of this pill adds an amount of refined honey/mulse for 12 flavor pulverizing medicinal materials in the prescription become fine powder, makes big honeyed pills/water-honeyed pill.Because the whole former powder of prescription Chinese crude drug are used as medicine, so this pill dose is big, 9g of big honeyed pills, water-honeyed pill is once also wanted 6g.
Along with the development of Chinese medicine preparation research, many colleagues of the world of medicine have carried out unremitting research and innovation to its technology, dosage form, pharmacology, clinical etc., now its application forms except that Radix Rehmanniae Pilulae for Improving Eyesight, bright in addition, Mingmu-Dihuang concentrated pill.Its technology of Mingmu-Dihuang concentrated pill (taken in Drug Standard of Ministry of Public Health of the Peoples Republic of China Chinese traditional patent formulation preparation the 9th in) is carried for the Radix Rehmanniae Preparata decocting, is condensed into clear paste; Fructus Corni, Cortex Moutan, the Radix Paeoniae Alba, Flos Chrysanthemi, Radix Angelicae Sinensis (recipe quantity 2/3), Fructus Tribuli, Fructus Lycii are solvent with 70% ethanol, Rhizoma Alismatis with 45% ethanol be solvent respectively percolation extract, reclaim ethanol and be condensed into clear paste; Rhizoma Dioscoreae, Poria, Concha Haliotidis, Radix Angelicae Sinensis (recipe quantity 1/3) are ground into fine powder, with above-mentioned clear paste mixing, make concentrated pill, and drying forms.This concentrated pill is once taken recipe quantity and has been reduced approximately 1/3rd on the basis of pill, and still need take the 8-10 ball at every turn, and volatile ingredient easily loss in the concentrate drying process, simultaneously concentrated pill also have molten loose slow, the deficiency that bioavailability is low.
In sum, existing at present Mingmu-Dihuang preparation can keep prescription Chinese crude drug effective ingredient to guarantee curative effect comprehensively, can accomplish the preparation exquisiteness again, and dose is little, and can demonstrate fully modern we can say of Chinese medicine preparation does not have.And along with the fast development of medical science technology, the continuous application of various new techniques, new equipment, new adjuvant, improving constantly of herbal pharmaceutical industrial technology level is to excavate motherland's medicine treasure-house, strives for the modernization of Chinese medicine, and excellent opportunity is provided.Based on this, we use the modern pharmaceutical technology, technology to Mingmu-Dihuang preparation is improved necessarily, make made Mingmu-Dihuang preparation can fully keep its effective ingredient, have good effect, dose is few, takes plurality of advantages such as easy to carry, this is significant to inheriting and develop motherland's medicine legacy.
Summary of the invention
The purpose of this invention is to provide new preparation technology of a kind of Mingmu-Dihuang and preparation thereof, improve the quality of products and curative effect, increase the stability of product, has good effect, dosage is little, takes advantages such as easy to carry, further satisfies and ensured people's medication demand.
The objective of the invention is such realization:
Preparation technology and preparation thereof that Mingmu-Dihuang is new comprise the steps:
1, the prescription of Mingmu-Dihuang preparation is formed
The prescription of Mingmu-Dihuang preparation series is made up of Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Fructus Corni, Rhizoma Alismatis, Poria, Cortex Moutan, Fructus Lycii, Flos Chrysanthemi, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Fructus Tribuli, Concha Haliotidis 12 flavor medicines.
Per 100 times dose of made Mingmu-Dihuang preparation is:
Radix Rehmanniae Preparata 40-150 Rhizoma Dioscoreae 20-75 Fructus Corni 20-75 Cortex Moutan 15-60
Poria 15-60 Rhizoma Alismatis 15-60 Fructus Lycii 15-60 Flos Chrysanthemi 15-60
Radix Angelicae Sinensis 15-60 Radix Paeoniae Alba 15-60 Fructus Tribuli 15-60 Concha Haliotidis 20-75
Per 100 suboptimum doses are:
Radix Rehmanniae Preparata 80-90 Rhizoma Dioscoreae 40-50 Fructus Corni 40-50 Cortex Moutan 30-40
Poria 30-40 Rhizoma Alismatis 30-40 Fructus Lycii 30-40 Flos Chrysanthemi 30-40
Radix Angelicae Sinensis 30-40 Radix Paeoniae Alba 30-40 Fructus Tribuli 30-40 Concha Haliotidis 40-50
2, preparation technology that Mingmu-Dihuang is new and preparation thereof
2.1 Radix Rehmanniae Preparata, Rhizoma Alismatis adopt water boiling and extraction or the first alcohol extraction medicinal residues method that water is carried or other is suitable again to extract in the prescription.The condition that decocting boils is: decoct 2-3 time, amount of water is doubly measured for the 6-15 of dose for the first time, and second and third time doubly measured for the 4-12 of dose, and each 0.5-4 hour, the medicinal residues of all the other flavour of a drug added when frying in shallow oil together, can add when second fries in shallow oil.The condition of alcohol extraction is: with 60-95% ethanol is solvent, can adopt heating reflux method or percolation or other suitable method to extract.
2.2 Rhizoma Dioscoreae, Concha Haliotidis are adopted water boiling and extraction or part to beat powder part decocting or all beat powder or method extraction that other is suitable in the prescription.
2.3 Fructus Corni, Fructus Lycii, the Radix Paeoniae Alba, Fructus Tribuli adopt alcohol extraction or water is carried or the first alcohol extraction medicinal residues method that water is carried or other is suitable is again extracted in the prescription.
2.4 in the prescription Poria can adopt water boiling and extraction or flooding or first lixiviate to fry in shallow oil again to carry or first alcohol extraction again water carry or enzymolysis and extraction or supersound extraction or extracting section are partly beaten powder or all beaten powder or method that other is suitable is extracted.Decocting boils and can decoct with water with Radix Rehmanniae Preparata etc.; The condition of flooding is: add 4-15 times of water gaging of dose, warm macerating (50-90 ℃)/boil the back warm macerating 2-4 time, each 1-3 hour; Be preferably add 8 times of water gagings and boil after, 80 ℃ of warm macerating 3 times, each 1.5 hours.Enzymolysis and extraction can adopt papain or other suitable enzyme.
2.5 Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis extract volatile ingredient or extract the volatile ingredient medicinal residues method put forward of water or extract volatile ingredient medicinal residues reuse alcohol and water earlier and respectively put forward method once or adopt to close with other medical material and collect the method for distillate when frying in shallow oil or all beat powder or method extraction that other is suitable more earlier in the prescription.The extraction of volatile ingredient can be adopted atmospheric steam distillation or reduced steam distillation or supercritical extraction or other suitable method extraction.
Can independent/merging make clathrate with suitable enclose material enclose 2.6 extract the volatile ingredient of gained in the technology, also available The suitable solvent dissolving back is sprayed and is added.The enclose material can adopt beta-schardinger dextrin-or hydroxypropyl or other suitable material.
2.7 the extraction process fit applications of above-mentioned each medicine, through being prepared from the various novel Mingmu-Dihuang preparation that shows the new technology characteristic, as Mingmu-Dihuang sheet, Mingmu-Dihuang dispersible tablet, Mingmu-Dihuang chewable tablet, Radix Rehmanniae Pilulae for Improving Eyesight, Mingmu-Dihuang micropill, Mingmu-Dihuang drop pill, Mingmu-Dihuang capsule, Mingmu-Dihuang oral liquid etc.
2.8 the pulverizing medicinal materials of need extracting in the technology becomes coarse powder/be cut into decoction pieces to extract, and is generally 5-60 purpose coarse powder/be cut into decoction pieces, is preferably 30-50 order coarse powder; The medical material that need be ground into fine powder in the technology was ground into 80-160 purpose fine powder usually, and the best is standby for superfine powder is broken into 200-300 purpose fine powder.
2.9 drying can adopt vacuum drying or spray drying or lyophilization or other suitable method in the technology.The vacuum drying temperature is controlled at 50-90 ℃, and the best is 60-70 ℃.Spray drying is for to be condensed into the concentrated solution that relative density is 1.03-1.25 (60 ℃) with extracting solution, and spray drying, inlet temperature are 100-200 ℃, and leaving air temp is 50-150 ℃.Best relative density is 1.05-1.15 (60 ℃), and inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.
Adopt concentrating under reduced pressure/thin film concentration/vacuum film to concentrate or other proper method 2.10 concentrate in the technology.
2.11 filterable method has a direct impact the size of preparation dose in the technology, can adopt conventional the filtration, and is centrifugal, ultrafiltration adds filtrations/centrifugal/ultrafiltration or other method that suits behind the clarifier.
2.12 used adjuvant can be sucrose, lactose, dextrin, starch, beta-schardinger dextrin-, HP-, microcrystalline Cellulose, micropowder silica gel, hydroxypropyl cellulose, carboxymethylstach sodium, polyvinylpolypyrrolidone, Aspartane, stevioside, essence, mannitol, sorbitol, 30 POVIDONE K 30 BP/USP in the technology 30Or other suitable adjuvant one or more be used.
2.13 the capsular content of prepared Mingmu-Dihuang can be powder/granule/micropill, the Chinese crude drug of promptly writing out a prescription adopt suitable prepared powdered encapsulated/make encapsulated behind the granule/make behind the micropill encapsulated.
2.14 prepared Mingmu-Dihuang tablet can be used suitable coating material coating, one or more are used as stomach dissolution type film-coat pre-mixing agent (Opadry), hydroxypropyl cellulose or other suitable material; According to the difference of used adjuvant, can or have the Mingmu-Dihuang dispersible tablet that speed collapses ability for common Mingmu-Dihuang sheet and maybe can chew Mingmu-Dihuang chewable tablet or other the suitable Mingmu-Dihuang tablet of taking.
2.15 prepared Radix Rehmanniae Pilulae for Improving Eyesight can be various types of balls; Prepared ball can be used suitable coating material coating.
2.16 prepared Mingmu-Dihuang oral liquid can be for having sugared type or Sugarless type according to the difference of used adjuvant.
This invention is compared with prior art: production technology more becomes to improving rationally, adopt the prepared Mingmu-Dihuang preparation of the present invention can fully keep its effective ingredient, have good effect, dose is little, take advantages such as easy to carry, further satisfy and ensured people's medication needs.
The specific embodiment
Following embodiment can be for reference in order to further specify the present invention, but do not limit the scope of the invention thus.
Embodiment 1: the capsular preparation of Mingmu-Dihuang
12 flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; It is standby that Concha Haliotidis is ground into fine powder; All the other ten Herba indigoferae Pseudotinctoriae pulverize separately become coarse powder standby; Get Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis and add the water distillation respectively, extract volatile ingredient, standby with an amount of anhydrous alcohol solution; Aqueous solution ultrafiltration after the distillation is standby; Fructus Corni, Fructus Lycii, the Radix Paeoniae Alba, Fructus Tribuli be with 70% ethanol extraction 2 times, merge extractive liquid,, and ultrafiltration, filtrate recycling ethanol is standby; Poria adds water temperature and soaks 2 times, and leachate merges, ultrafiltration, filtrate for later use; Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Rhizoma Alismatis decoct with water 3 times, first and second time each 2 hours, 1 hour for the third time, the medicinal residues of above-mentioned Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis, Fructus Lycii, Fructus Corni, the Radix Paeoniae Alba, Fructus Tribuli, Poria add when second fries in shallow oil with frying in shallow oil, collecting decoction, ultrafiltration, aqueous solution, Poria leachates such as the alcohol extract behind recovery such as filtrate and the above-mentioned Fructus Corni ethanol, Cortex Moutan merge, and vacuum film is condensed into thick paste, with above-mentioned Concha Haliotidis fine powder and appropriate amount of auxiliary materials mixing, granulate, drying, spray adds above-mentioned ethanol solution, mixing, encapsulated, promptly.
Embodiment 2: the capsular preparation of Mingmu-Dihuang
12 flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; 12 flavor medicine pulverize separately become coarse powder standby in will writing out a prescription; Get Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis and add the water distillation respectively, extract volatile ingredient, make-cyclodextrin clathrate is standby; Aqueous solution ultrafiltration after the distillation is standby; Medicinal residues and Radix Rehmanniae Preparata, Rhizoma Alismatis, Fructus Corni, Fructus Lycii, the Radix Paeoniae Alba, Fructus Tribuli, Rhizoma Alismatis be with 90% ethanol extraction 2 times, merge extractive liquid,, and ultrafiltration, filtrate recycling ethanol is standby; Poria adds water temperature and soaks 2 times, and leachate merges, ultrafiltration, filtrate for later use; Rhizoma Dioscoreae decocts with water 3 times, first and second time each 2 hours, 1 hour for the third time, medicinal residues after medicinal residues after the alcohol extractions such as above-mentioned Radix Rehmanniae Preparata, the Poria lixiviate add when second fries in shallow oil with frying in shallow oil, collecting decoction, ultrafiltration, aqueous solution, Poria leachates such as the alcohol extract behind recovery such as filtrate and the above-mentioned Radix Rehmanniae Preparata ethanol, Cortex Moutan merge, and are concentrated into an amount of; Concha Haliotidis decocts with water 3 times, and each 1 hour, collecting decoction filtered, and filtrate is concentrated in right amount, and with concentrated solution mixing such as above-mentioned Rhizoma Dioscoreae, spray drying, the collection dried cream powder is standby; Above-mentioned dried cream powder and above-mentioned paeonol clathrate, volatile oil clathrate compound and appropriate amount of auxiliary materials mixing are made micropill, and be encapsulated, promptly.
Embodiment 3: the preparation of Mingmu-Dihuang sheet
12 flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; It is standby that Concha Haliotidis is ground into fine powder; All the other ten Herba indigoferae Pseudotinctoriae pulverize separately become coarse powder standby; Get Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis and add the water distilling under reduced pressure respectively, extract volatile ingredient, standby with an amount of anhydrous alcohol solution; Aqueous solution after the distillation filters standby; The medicinal residues of Fructus Corni, Fructus Lycii, the Radix Paeoniae Alba, Fructus Tribuli and above-mentioned Cortex Moutan, Flos Chrysanthemi are with 90% ethanol extraction 2 times, and merge extractive liquid, filters, and filtrate recycling ethanol is standby; Poria adds water temperature and soaks 2 times, and leachate filters, filtrate for later use; Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Rhizoma Alismatis decoct with water 3 times, first and second time each 2 hours, 1 hour for the third time, medicinal residues after above-mentioned Fructus Lycii, Fructus Corni, the Radix Paeoniae Alba, Fructus Tribuli, Cortex Moutan, the Flos Chrysanthemi alcohol extraction, the medicinal residues after the Poria lixiviate add when second fries in shallow oil with frying in shallow oil, and collecting decoction filters, aqueous solution, Poria leachates such as the alcohol extract behind recovery such as filtrate and the above-mentioned Fructus Corni ethanol, Cortex Moutan merge, being concentrated into relative density is 1.05, spray drying, and it is standby to collect dried cream powder; Above-mentioned dried cream powder and above-mentioned Concha Haliotidis fine powder and appropriate amount of auxiliary materials mixing are granulated, and spray adds above-mentioned ethanol solution, mixing, and tabletting, coating, promptly.
Embodiment 4: the preparation of Mingmu-Dihuang chewable tablet
12 flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; 12 flavor medicine pulverize separately become coarse powder standby in will writing out a prescription; Get Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis and add the water distillation respectively, extract volatile ingredient, standby with an amount of anhydrous alcohol solution; Aqueous solution ultrafiltration after the distillation is standby; Radix Rehmanniae Preparata, Rhizoma Alismatis, Fructus Corni, Fructus Lycii, the Radix Paeoniae Alba, Fructus Tribuli, Rhizoma Alismatis be with 90% ethanol extraction 2 times, merge extractive liquid,, and ultrafiltration, filtrate recycling ethanol is standby; Poria adds water temperature and soaks 2 times, and leachate merges, ultrafiltration, filtrate for later use; Rhizoma Dioscoreae decocts with water 3 times, first and second time each 2 hours, 1 hour for the third time, the medicinal residues of above-mentioned Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis, Fructus Lycii, Radix Rehmanniae Preparata, Rhizoma Alismatis, Fructus Corni, the Radix Paeoniae Alba, Fructus Tribuli, Poria add when second fries in shallow oil with frying in shallow oil, collecting decoction, add the clarifier ultrafiltration, aqueous solution, Poria leachates such as the alcohol extract behind recovery such as filtrate and the above-mentioned Radix Rehmanniae Preparata ethanol, Cortex Moutan merge, and are concentrated into an amount of; Concha Haliotidis decocts with water 3 times, and each 1 hour, collecting decoction filtered, and filtrate is concentrated in right amount, and with concentrated solution mixing such as above-mentioned Rhizoma Dioscoreae, spray drying, the collection dried cream powder is standby; Above-mentioned dried cream powder and an amount of chewable tablet auxiliary materials and mixing are granulated, drying, and spray adds above-mentioned ethanol solution, and mixing is pressed into chewable tablet, coating, promptly.
Embodiment 5: the preparation of Mingmu-Dihuang dispersible tablet
12 flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; 12 flavor medicine pulverize separately become coarse powder standby in will writing out a prescription; Get Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis and add the water distilling under reduced pressure respectively, extract volatile ingredient, standby with an amount of anhydrous alcohol solution; Aqueous solution ultrafiltration after the distillation is standby; Radix Rehmanniae Preparata, Rhizoma Alismatis, Fructus Corni, Fructus Lycii, the Radix Paeoniae Alba, Fructus Tribuli, Rhizoma Alismatis be with 90% ethanol extraction 2 times, merge extractive liquid,, and ultrafiltration, filtrate recycling ethanol is standby; Poria, Rhizoma Dioscoreae decoct with water 3 times, first and second time each 2 hours, 1 hour for the third time, the medicinal residues of above-mentioned Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis, Fructus Lycii, Radix Rehmanniae Preparata, Rhizoma Alismatis, Fructus Corni, the Radix Paeoniae Alba, Fructus Tribuli, Poria add when second fries in shallow oil with frying in shallow oil, collecting decoction, add the clarifier ultrafiltration, aqueous solutions such as the alcohol extract behind recovery such as filtrate and the above-mentioned Radix Rehmanniae Preparata ethanol, Cortex Moutan merge, and are concentrated into an amount of; Concha Haliotidis decocts with water 3 times, and each 1 hour, collecting decoction filtered, and filtrate is concentrated in right amount, and with concentrated solution mixing such as above-mentioned Rhizoma Dioscoreae, spray drying, the collection dried cream powder is standby; Above-mentioned dried cream powder and an amount of dispersible tablet auxiliary materials and mixing are granulated, drying, and spray adds above-mentioned ethanol solution, and mixing is pressed into dispersible tablet, coating, promptly.
Embodiment 6: the preparation of Radix Rehmanniae Pilulae for Improving Eyesight
12 flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; It is standby that Concha Haliotidis is ground into fine powder; All the other ten Herba indigoferae Pseudotinctoriae pulverize separately become coarse powder standby; Get Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis and add the water distillation respectively, extract volatile ingredient, it is standby to make cyclodextrin clathrate; Aqueous solution after the distillation filters standby; Radix Rehmanniae Preparata, the Radix Paeoniae Alba, Fructus Corni, Fructus Lycii, Fructus Tribuli, Rhizoma Alismatis are with 95% ethanol extraction 2 times, and merge extractive liquid, filters, and filtrate recycling ethanol is standby; Poria added behind the water boil warm macerating 3 hours, and leachate filters, filtrate for later use; Rhizoma Dioscoreae decocts with water 3 times, first and second time each 2 hours, 1 hour for the third time, the medicinal residues of above-mentioned Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis, Radix Rehmanniae Preparata, the Radix Paeoniae Alba, Fructus Lycii, Fructus Corni, Fructus Tribuli, Rhizoma Alismatis, Poria add when second fries in shallow oil with frying in shallow oil, collecting decoction, filter, aqueous solution, Poria leachates such as the alcohol extract behind recovery such as filtrate and the above-mentioned Fructus Corni ethanol, Cortex Moutan merge, concentrating under reduced pressure becomes thick paste, with above-mentioned Concha Haliotidis fine powder, cyclodextrin clathrate and appropriate amount of auxiliary materials mixing, pill, vacuum drying, coating, promptly.
Embodiment 7: the preparation of Mingmu-Dihuang micropill
12 flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; It is standby that Concha Haliotidis is ground into fine powder; All the other ten Herba indigoferae Pseudotinctoriae pulverize separately become coarse powder standby; Get Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis and add the water distilling under reduced pressure respectively, extract paeonol and volatile oil, it is standby to make cyclodextrin clathrate; Aqueous solution after the distillation filters standby; Fructus Corni, Fructus Lycii, the Radix Paeoniae Alba, Fructus Tribuli are with 70% ethanol extraction 2 times, and merge extractive liquid, filters, and filtrate recycling ethanol is standby; Poria adds water temperature and soaks 2 times, and leachate filters, filtrate for later use; Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Rhizoma Alismatis decoct with water 3 times, first and second time each 2 hours, 1 hour for the third time, the medicinal residues of above-mentioned Cortex Moutan, Flos Chrysanthemi, Fructus Lycii, Fructus Corni, Poria add when second fries in shallow oil with frying in shallow oil, and collecting decoction filters, aqueous solution, Poria leachates such as the alcohol extract behind recovery such as filtrate and the above-mentioned Fructus Corni ethanol, Cortex Moutan merge, being concentrated into relative density is 1.08, spray drying, and it is standby to collect dried cream powder; Above-mentioned dried cream powder and above-mentioned Concha Haliotidis fine powder, cyclodextrin clathrate and appropriate amount of auxiliary materials mixing are made micropill, vacuum drying, promptly.
Embodiment 8: the preparation of Mingmu-Dihuang micropill
12 flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Become coarse powder standby 12 flavor medicine pulverize separately; Get Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis and add the water distilling under reduced pressure respectively, extract paeonol and volatile oil, it is standby to make cyclodextrin clathrate; Aqueous solution after the distillation filters standby; Medicinal residues and Fructus Corni, Fructus Lycii, the Radix Paeoniae Alba, Fructus Tribuli are with 90% ethanol extraction 2 times, and merge extractive liquid, filters, and filtrate recycling ethanol is standby; Poria adds water temperature and soaks 2 times, and leachate filters, filtrate for later use; Concha Haliotidis decocts with water 3 times, and each 1 hour, collecting decoction filtered, and filtrate is concentrated into standby in right amount; Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Rhizoma Alismatis decoct with water 3 times, first and second time each 2 hours, 1 hour for the third time, medicinal residues after medicinal residues after the alcohol extractions such as above-mentioned Fructus Corni, the Poria lixiviate add when second fries in shallow oil with frying in shallow oil, and collecting decoction filters, aqueous solution, Poria leachates such as the alcohol extract behind recovery such as filtrate and the above-mentioned Fructus Corni ethanol, Cortex Moutan merge, be concentrated in right amount, with above-mentioned Concha Haliotidis concentrated solution mixing, being condensed into thick paste/concentrate drying, to make dried cream powder standby; Volatile oil such as above-mentioned thick paste/dried cream powder, paeonol, Radix Angelicae Sinensis and suitable drop pill substrate mixing are made drop pill, promptly.
Embodiment 9: the preparation of Mingmu-Dihuang oral liquid
12 flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Become coarse powder standby 12 flavor medicine pulverize separately; Get Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis and add the water distillation respectively, it is standby in right amount to collect distillate; Poria added behind the water boil warm macerating 3 hours, leachate ultrafiltration, filtrate for later use; Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Fructus Corni, Fructus Lycii, the Radix Paeoniae Alba, Fructus Tribuli, Rhizoma Alismatis, Concha Haliotidis decoct with water 3 times, first and second time each 2 hours, 1 hour for the third time, the medicinal residues of above-mentioned Cortex Moutan, Flos Chrysanthemi, Poria add when second fries in shallow oil with frying in shallow oil, and collecting decoction filters, filtrate is concentrated in right amount, merge with distillate such as above-mentioned Cortex Moutan, Poria leachate, add the clarifier ultrafiltration, add an amount of flavoring agent, antiseptic, add water to ormal weight, stir evenly, embedding, promptly.

Claims (7)

1, preparation method that a kind of Mingmu-Dihuang is new and preparation thereof is characterized in that:
(1) in the prescription Radix Rehmanniae Preparata, Rhizoma Alismatis adopt water boiling and extraction/first alcohol extraction medicinal residues again the method carried of water extract.
(2) Rhizoma Dioscoreae, Concha Haliotidis adopt water boiling and extraction/part to play powder part decocting/all the beat method extraction of powder in the prescription.
(3) in the prescription Fructus Corni, Fructus Lycii, the Radix Paeoniae Alba, Fructus Tribuli adopt alcohol extraction/water carry/first alcohol extraction medicinal residues again the method carried of water extract.
(4) in the prescription Poria can adopt water boiling and extraction/flooding/first lixiviate fry in shallow oil again and carry/first alcohol extraction medicinal residues again water carry/enzymolysis and extraction/supersound extraction/part plays the method extraction that powder was carried/all beaten to powder part water.
(5) in the prescription Cortex Moutan, Flos Chrysanthemi, Radix Angelicae Sinensis extract volatile ingredient/elder generation extract the volatile ingredient medicinal residues again method/elder generation of carrying of water extract volatile ingredient medicinal residues reuse alcohol and water and respectively propose once method/employings and the method extraction of closing collection distillate when frying in shallow oil of other medical material; The extraction of volatile ingredient can adopt the method for atmospheric steam distillation/reduced steam distillation/supercritical extraction to extract; Extract the volatile ingredient of gained and can independent/merging make clathrate with enclose material enclose, also the spray of useable solvents dissolving back adds, and the enclose material can adopt beta-schardinger dextrin-or hydroxypropyl.
(6) the extraction process fit applications of warp (1), (2), (3), (4), (5) each medicine, add different adjuvants, be prepared from Mingmu-Dihuang sheet, Mingmu-Dihuang dispersible tablet, Mingmu-Dihuang chewable tablet, Radix Rehmanniae Pilulae for Improving Eyesight, Mingmu-Dihuang micropill, Mingmu-Dihuang drop pill, Mingmu-Dihuang capsule, Mingmu-Dihuang oral liquid.
2, preparation technology that Mingmu-Dihuang according to claim 1 is new and preparation thereof is characterized in that:
(1) the capsular content of prepared Mingmu-Dihuang can be powder/granule/micropill, that the Chinese crude drug adopting process of promptly writing out a prescription is prepared into powder is encapsulated/make encapsulated behind the granule/make behind the micropill encapsulated.
(2) prepared Mingmu-Dihuang tablet can adopt the coating material coating, as stomach dissolution type film-coat pre-mixing agent (Opadry), hydroxypropyl cellulose a kind of/multiple being used, according to the difference of used adjuvant, can make the Mingmu-Dihuang dispersible tablet that novel common Mingmu-Dihuang sheet/have speed collapses ability/can chew the Mingmu-Dihuang chewable tablet of taking.
(3) prepared Radix Rehmanniae Pilulae for Improving Eyesight can be made micropill, honeyed pill, water pill, and prepared ball can be used the coating material coating.
(4) prepared Mingmu-Dihuang oral liquid can be for there being sugared type/Sugarless type according to the difference of used adjuvant.
3, preparation technology that Mingmu-Dihuang according to claim 1 is new and preparation thereof is characterized in that: the pulverizing medicinal materials of need extracting in the technology becomes coarse powder/be cut into decoction pieces to extract, and is generally 5-60 purpose coarse powder/be cut into decoction pieces, and the best was a 30-50 order coarse powder; The medical material that need be ground into fine powder in the technology was ground into 80-160 purpose fine powder usually, and the best is standby for superfine powder is broken into 200-300 purpose fine powder.
4, preparation technology that Mingmu-Dihuang according to claim 1 is new and preparation thereof is characterized in that: drying can adopt vacuum drying/spray drying/lyophilization in the technology; The vacuum drying temperature is controlled at 50-90 ℃, the best is 60-70 ℃, spray drying is for to be condensed into the concentrated solution that relative density is 1.03-1.25 (60 ℃) with extracting solution, spray drying, inlet temperature is 100-200 ℃, and leaving air temp is 50-150 ℃, and best relative density is 1.05-1.15 (60 ℃), inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.
5, preparation technology that Mingmu-Dihuang according to claim 1 is new and preparation thereof is characterized in that: concentrate in the technology and adopt concentrating under reduced pressure/thin film concentration/vacuum film to concentrate.
6, preparation technology that Mingmu-Dihuang according to claim 1 is new and preparation thereof is characterized in that: filter in the technology and can adopt conventional the filtration, centrifugal, ultrafiltration adds filtration/centrifugal/ultrafiltration behind the clarifier.
7, preparation technology that Mingmu-Dihuang according to claim 1 is new and preparation thereof is characterized in that: used adjuvant can be sucrose, lactose, starch, dextrin, microcrystalline Cellulose, micropowder silica gel, hydroxypropyl cellulose, carboxymethylstach sodium, polyvinylpolypyrrolidone, beta-schardinger dextrin-, HP-, Aspartane, stevioside, essence, mannitol, sorbitol, 30 POVIDONE K 30 BP/USP in the technology 30A kind of/multiple being used.
CN 03124641 2003-07-08 2003-07-08 Novel preparation method of Pending CN1565501A (en)

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1899448B (en) * 2006-07-06 2010-09-08 浙江大学 Chinese medicine compound preparation for treating amblyopia and its preparing method
CN101612288B (en) * 2009-07-16 2011-05-18 李怀良 Traditional Chinese medicine for treating diabetic retinopathy
WO2012032209A2 (en) 2010-09-08 2012-03-15 Universidad Miguel Hernández De Elche Pharmaceutical composition for the treatment of dry eye
CN102793848A (en) * 2012-09-07 2012-11-28 黄平县润发药业农民专业合作社 Traditional Chinese medicine powder for treating night blindness
CN103652560A (en) * 2013-12-11 2014-03-26 罗永祺 Radix rehmanniae preparata, fructus corni and rhizoma dioscoreae chewable tablets and preparation method
CN103652557A (en) * 2013-12-11 2014-03-26 罗永祺 Sour pomegranate-sugarcane-Chinese yam chewable tablet and preparation method
CN108245584A (en) * 2018-04-13 2018-07-06 江苏艾兰得营养品有限公司 A kind of traditional Chinese medicine composition for relieving asthenopia and preparation method

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1899448B (en) * 2006-07-06 2010-09-08 浙江大学 Chinese medicine compound preparation for treating amblyopia and its preparing method
CN101612288B (en) * 2009-07-16 2011-05-18 李怀良 Traditional Chinese medicine for treating diabetic retinopathy
WO2012032209A2 (en) 2010-09-08 2012-03-15 Universidad Miguel Hernández De Elche Pharmaceutical composition for the treatment of dry eye
EP4268814A2 (en) 2010-09-08 2023-11-01 Universidad Miguel Hernández De Elche Pharmaceutical composition for the treatment of dry eye
CN102793848A (en) * 2012-09-07 2012-11-28 黄平县润发药业农民专业合作社 Traditional Chinese medicine powder for treating night blindness
CN102793848B (en) * 2012-09-07 2013-12-11 黄平县润发药业农民专业合作社 Traditional Chinese medicine powder for treating night blindness
CN103652560A (en) * 2013-12-11 2014-03-26 罗永祺 Radix rehmanniae preparata, fructus corni and rhizoma dioscoreae chewable tablets and preparation method
CN103652557A (en) * 2013-12-11 2014-03-26 罗永祺 Sour pomegranate-sugarcane-Chinese yam chewable tablet and preparation method
CN108245584A (en) * 2018-04-13 2018-07-06 江苏艾兰得营养品有限公司 A kind of traditional Chinese medicine composition for relieving asthenopia and preparation method

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