CN100506273C - Process for preparing concentrated anti-virus oral administration liquid - Google Patents

Process for preparing concentrated anti-virus oral administration liquid Download PDF

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CN100506273C
CN100506273C CNB2006100484113A CN200610048411A CN100506273C CN 100506273 C CN100506273 C CN 100506273C CN B2006100484113 A CNB2006100484113 A CN B2006100484113A CN 200610048411 A CN200610048411 A CN 200610048411A CN 100506273 C CN100506273 C CN 100506273C
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extractum
solution
filtrate
volatile oil
concentrated
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CN1899571A (en
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杨士伟
蔡俊安
王云东
郭鑫慧
张祥俊
鲁张彦
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HENAN BAINIAN KANGXIN PHARMA CO Ltd
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HENAN BAINIAN KANGXIN PHARMA CO Ltd
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Abstract

The concentrated antiviral oral liquid is prepared with isatis root, gypsum, reed rhizome, rehmannia root, curcuma root and other four kinds of Chinese medicinal materials. Its preparation process includes decoction, filtering, concentrating to obtain extractum, collecting volatile oil and emulsion, dissolving the extractum in alcohol solution, filterng, concentrating to obtain extractum again, adding water via stirring, filtering to obtain clear liquid, mixing with the volatile oil and emulsion and seasoning and sterilizing. The present invention has raised concentration and effective component content, convenient taking and carrying and other advantages.

Description

The preparation method of concentrated anti-virus oral administration liquid
One, technical field
The present invention relates to the method for production Chinese medicine oral liquid in the field of medicaments, particularly is a kind of preparation method that is used to produce concentrated anti-virus oral administration liquid.
Two, background technology
Antivirus oral liquid is a Chinese medicine preparation, has clearing heat and expelling damp, the removing pathogenic heat from blood and toxic substance from the body effect.Be widely used in the treatment of anemopyretic cold and influenza, good inspecting bed effect is arranged, liked by the patient.But this product processes is limit by technological level in one's early years, is simple water extract-alcohol precipitation process for refining route, and impurity is many, and the extraction and application rate is low.Active constituent content is low in product, causes each dose many, is unfavorable for that especially the child and the patient of the difficulty of taking medicine take, and carry also inconvenient.On production technology, there is serious drawback.
Three, summary of the invention
The objective of the invention is the deficiency that exists in the above-mentioned existing product production technology, adopt that Modern High-Speed is centrifugal, the membrance separation purification techniques provides a kind of and can effectively improve oral liquid concentration and active constituent content, take and carry the preparation method that is used to produce concentrated anti-virus oral administration liquid more convenient, better effects if, concentrated anti-virus oral administration liquid of the present invention is achieved through the following technical solutions:
By by weight percentage: Radix Isatidis 28-35%, Gypsum Fibrosum 11-16%, Rhizoma Phragmitis 13-16%, Radix Rehmanniae 6-9%, Radix Curcumae 4-9%, Rhizoma Anemarrhenae 5-10%, Rhizoma Acori Graminei 3-7%, Herba Pogostemonis 5-8%, Fructus Forsythiae 8-12% does raw material, make according to the following steps:
1, the water that at first 6-12 of its total amount of adding doubly measures in Radix Isatidis, Gypsum Fibrosum, Rhizoma Phragmitis, Radix Rehmanniae, Radix Curcumae, the Rhizoma Anemarrhenae, Rhizoma Acori Graminei, Herba Pogostemonis, Fructus Forsythiae nine flavor Chinese medicines, decoct secondary, the each decoction 1-2 hour, filter, merge filtrate twice, concentrated filtrate is the extractum of 1.1-1.4 (measuring under 50-80 ℃ of condition) to density, when decocting, collect volatile oil and volatile oil emulsion, standby;
2, adding mass concentration again in above-mentioned extractum is the ethanol of 80-95%, make to contain alcohol amount in its solution and reach 60-70%, stir evenly the back and placed 24-48 hour, draw supernatant and filter, reclaim ethanol in the filtrate, continue to be concentrated into the extractum that density is 1.1-1.4 (measuring) under 50-80 ℃ of condition;
3, the water that the 4-6 of adding extractum weight doubly measures in above-mentioned extractum, stir evenly after high speed centrifuge separate clear liquid, clear liquid is through ultrafiltration, selecting molecular cut off for use is the ultrafilter membrane of 40000-80000,10-45 ℃ of ultra-filtration process temperature, operating pressure is 0.1-0.3Mpa, gets filtrate and be transported in the material-compound tank to prepare burden;
4, last, in above-mentioned filtrate, be added in the volatile oil and volatile oil emulsion and an amount of flavoring agent that are extracted when decocting earlier, supply water to total amount, stir, sterilization, fill or fill, sterilization promptly.
Above-mentioned said flavoring agent is glycyrrhizin solution or stevioside solution or cyclamate solution or syrup solution etc., said each Chinese medicinal components, be the decoction pieces that cooks by the Chinese medicine processing requirement, that is to say, each Chinese medicinal components, all be meant the Chinese crude drug raw material that has cooked by the Chinese medicine requirement, because of Chinese medicine processing is a known technology, so no longer repeat.
The present invention and prior preparation method are relatively, its advantage is: adopt the centrifugal and membrane separation technique of Modern High-Speed, removed invalid impurity, make medicine in unit volume, valid density to double, content of effective is the twice of original same dose, because concentration and active constituent content improve, oral dose is reduced, given full play to the effect of effective ingredient, be half of original dose, and saved raw material, packaging material greatly, reduced production cost, take and carry more convenient, be particularly suitable for the child and the patient of the difficulty of taking medicine uses.
Four, specific embodiments
Below in conjunction with example the specific embodiment of the present invention is described further.
Example 1
1, gets Radix Isatidis 90kg, Gypsum Fibrosum 40kg, Rhizoma Phragmitis 42.5kg, Radix Rehmanniae 22.5kg, Radix Curcumae 17.5kg, Rhizoma Anemarrhenae 17.5kg, Rhizoma Acori Graminei 17.5kg, Herba Pogostemonis 20kg, Fructus Forsythiae 32.5kg puts in the multi-function extractor, adds water 2400kg, boiled 1.5 hours, extracting solution is through filtering, and filtrate for later use adds water 1800kg in the medicinal residues, boiled 1 hour 20 minutes, extracting solution filters, and merges secondary filtrate, and being concentrated to density is the extractum of 1.25 (measuring under 50 ℃ of conditions), when decocting, collect volatile oil and volatile oil emulsion;
2, adding mass concentration again in above-mentioned extractum is 95% ethanol, makes its solution contain the alcohol amount and reaches 70%, stirs 30 minutes, leaves standstill 48 hours, draw supernatant and filter, and recovery filtrate ethanol, and continue to be concentrated under 50 ℃ of conditions, density is 1.30 extractum;
3, adding 5 times of water of extractum amount at above-mentioned extractum stirs evenly, is centrifugalize under the 15000r/min through channel separator at rotating speed, clear liquid and being transported in the fluid reservoir of hollow-fibre membrane ultrafiltration apparatus, operating pressure 0.2Mpa, the ultra-filtration process temperature is less than 45 ℃, by molecular cut off is 50000 ultrafilter membrane, collects the filtrate that sees through ultrafilter membrane.
4, last, in above-mentioned filtrate, add volatile oil and volatile oil emulsion, add filtered mass concentration and be 10% glycyrrhizin solution 5kg, add water to 350L, stir, pour into the PVC bottle after sterilizing by the ultraviolet steriliser, promptly.
Example 2
1, gets Radix Isatidis 90kg, Gypsum Fibrosum 40kg, Rhizoma Phragmitis 42.5kg, Radix Rehmanniae 22.5kg, Radix Curcumae 17.5kg, Rhizoma Anemarrhenae 17.5kg, Rhizoma Acori Graminei 17.5kg, Herba Pogostemonis 20kg, Fructus Forsythiae 32.5kg puts in the multi-function extractor, adds water 2400kg, boiled 1.5 hours, extracting solution is through filtering, and filtrate for later use adds water 1800kg in the medicinal residues, boiled 1 hour 20 minutes, extracting solution filters, and merges secondary filtrate, is concentrated to the extractum of density 1.25 (measuring under 50 ℃ of conditions), when decocting, collect volatile oil and volatile oil emulsion;
2, adding mass concentration again in above-mentioned extractum is 95% ethanol, makes its solution contain the alcohol amount and reaches 70%, stirs 30 minutes, leaves standstill 48 hours.The absorption supernatant filters, and reclaims filtrate ethanol, and to continue to be concentrated under 50 ℃ of conditions density measurement be 1.30 extractum;
3, adding 5 times of water of extractum amount at above-mentioned extractum again stirs evenly, is centrifugalize under the 15000r/min through channel separator at rotating speed, clear liquid and being transported in the fluid reservoir of hollow-fibre membrane ultrafiltration apparatus, operating pressure 0.2Mpa, the ultra-filtration process temperature is less than 45 ℃, by molecular cut off is 50000 ultrafilter membrane, collects the filtrate that sees through ultrafilter membrane.
4, last, in above-mentioned filtrate, add volatile oil and volatile oil emulsion, add filtered mass concentration and be 10% glycyrrhizin solution 5kg, amount of water stirs to 350L, is filled in the vial, through sterilizing, promptly.
Example 3
1, gets Radix Isatidis 90kg, Gypsum Fibrosum 40kg, Rhizoma Phragmitis 42.5kg, Radix Rehmanniae 22.5kg, Radix Curcumae 17.5kg, Rhizoma Anemarrhenae 17.5kg, Rhizoma Acori Graminei 17.5kg, Herba Pogostemonis 20kg, Fructus Forsythiae 32.5kg puts in the multi-function extractor, adds water 2400kg, boils 1.5 hours, extracting solution is through filtering, and filtrate for later use adds water 1800kg in the medicinal residues, boiled 1 hour 20 minutes, extracting solution filters, and merges secondary filtrate, be concentrated to extractum, when decocting, collect volatile oil and volatile oil emulsion 50 ℃ of condition lower densities 1.25;
2, adding mass concentration at above-mentioned extractum is 95% ethanol, makes its solution contain the alcohol amount and reaches 70%, stirs 30 minutes, leaves standstill 48 hours, draw supernatant and filter, and recovery filtrate ethanol, and to continue to be concentrated under 50 ℃ of conditions density measurement be 1.30 extractum;
3, adding 5 times of water of extractum amount again in above-mentioned extractum stirs evenly, is centrifugalize under the 15000r/min through channel separator at rotating speed, clear liquid and being transported in the fluid reservoir of hollow-fibre membrane ultrafiltration apparatus, operating pressure 0.2Mpa, the ultra-filtration process temperature is less than 45 ℃, by molecular cut off is 50000 ultrafilter membrane, collects the filtrate that sees through ultrafilter membrane.
4, last, in above-mentioned filtrate, add volatile oil and volatile oil emulsion, add filtered mass concentration and be 10% stevioside solution 5kg, fill up the water yield to 350L, stir, be filled in the vial, through sterilization, promptly.
Oral liquid of the present invention is compared with existing oral liquid, and its quality and effect all increase significantly, and relevant clinical data is as follows:
One, case is selected
Be diagnosed as wind-warm lung-heat disease (acute pneumonia, peribronchitis etc.) patient, totally 75 people, test group 42 people, matched group 33 people.
Two, diagnostic criteria
Onset is anxious, fever with chills, or hyperpyrexia shiver with cold, and the cough chest pain is coughed up yellow sputum or band blood, yellow fur, rapid pulse.Thirsty hypohidrosis, uncomfortable in chest, out of breath.Or chest X-ray pulmonary has inflammatory to change.Leukocyte or neutrality increase.
Three, therapeutic scheme
Adopt the method for random packet, double blind control.
Test group (A): oral concentrated anti-virus oral administration liquid of the present invention, obey 5ml at every turn, obey every day 3 times.
Matched group (B): oral common antivirus oral liquid, obey 10ml at every turn, obey every day 3 times.
Before taking medicine and take medicine after a week, check symptom, Chest X-rays or X-ray film, blood, urine, just routine etc. respectively.
Four, treatment criterion
Clinical every observation index calculates the score value of treatment front and back all by " new Chinese medicine clinical research guideline " rank scores standard, calculates after the treatment again and the preceding ratio of treatment, does and judges evaluation.
Recovery from illness: ratio≤0.2
Produce effects: 0.2<ratio≤0.5
Effectively: 0.5<ratio≤0.8
Invalid: ratio〉0.8
Five, clinical observation situation
Concentrated type (A) and plain edition (B) antivirus oral liquid clinical observation situation:
Figure C200610048411D00081
Six, conclusion
From the above, concentrated anti-virus oral administration liquid total effective rate of the present invention is suitable with the plain edition antivirus oral liquid.But, the cure rate of concentrated type and obvious effective rate all are higher than plain edition, illustrate through behind the impurity removal and purification, the medicine inherent quality increases, the quality and the curative effect that show the concentrated anti-virus oral administration liquid that the present invention prepares all are better than the oral liquid that former preparation technology prepares, be the innovation greatly on the preparation oral liquid method, huge economic and social benefit is arranged.

Claims (3)

1, a kind of preparation method of concentrated anti-virus oral administration liquid, it is characterized in that being, by weight percentage: Radix Isatidis 28-35%, Gypsum Fibrosum 11-16%, Rhizoma Phragmitis 13-16%, Radix Rehmanniae 6-9%, Radix Curcumae 4-9%, Rhizoma Anemarrhenae 5-10%, Rhizoma Acori Graminei 3-7%, Herba Pogostemonis 5-8%, Fructus Forsythiae 8-12% does raw material, makes according to the following steps:
(1), the water that at first 6-12 of its total amount of adding doubly measures in Radix Isatidis, Gypsum Fibrosum, Rhizoma Phragmitis, Radix Rehmanniae, Radix Curcumae, the Rhizoma Anemarrhenae, Rhizoma Acori Graminei, Herba Pogostemonis, Fructus Forsythiae nine flavor Chinese medicines, decoct secondary, the each decoction 1-2 hour, filter, merge twice filtrate and concentrate, concentrated solution density measurement under 50-80 ℃ of condition is 1.1-1.4 extractum, when decocting, collect volatile oil and volatile oil emulsion, standby;
(2), adding mass concentration again in above-mentioned extractum is the ethanol of 80-95%, make the alcohol amount of containing in its solution reach 60-70%, stirring evenly the back placed 24-48 hour, the absorption supernatant filters, reclaim ethanol in the filtrate, continue to concentrate, concentrated solution density measurement under 50-80 ℃ of condition is 1.1-1.4 extractum;
(3), the water that the 4-6 of adding extractum weight doubly measures in above-mentioned extractum, stir evenly after high speed centrifuge separate clear liquid, clear liquid is through ultrafiltration, selecting molecular cut off for use is the ultrafilter membrane of 40000-80000,10-45 ℃ of ultra-filtration process temperature, operating pressure is 0.1-0.3Mpa, gets filtrate and be transported in the material-compound tank to prepare burden;
(4), in above-mentioned filtrate, be added in the volatile oil and volatile oil emulsion and an amount of flavoring agent that are extracted when decocting earlier, supply water to total amount, stir, sterilize.
2, the preparation method of concentrated anti-virus oral administration liquid according to claim 1 is characterized in that, said flavoring agent is glycyrrhizin solution or stevioside solution or cyclamate solution or syrup solution.
3, the preparation method of concentrated anti-virus oral administration liquid according to claim 1 is characterized in that, (1), get Radix Isatidis 90kg, Gypsum Fibrosum 40kg, Rhizoma Phragmitis 42.5kg, Radix Rehmanniae 22.5kg, Radix Curcumae 17.5kg, Rhizoma Anemarrhenae 17.5kg, Rhizoma Acori Graminei 17.5kg, Herba Pogostemonis 20kg, Fructus Forsythiae 32.5kg puts in the multi-function extractor, adds water 2400kg, boiled 1.5 hours, extracting solution is through filtering, and filtrate for later use adds water 1800kg in the medicinal residues, boiled 1 hour 20 minutes, extracting solution filters, and merges secondary filtrate, is concentrated under 50 ℃ of conditions density measurement and is 1.25 extractum, when decocting, collect volatile oil and volatile oil emulsion;
(2), again in above-mentioned extractum, add mass concentration and be 95% ethanol, make its solution contain the alcohol amount and reach 70%, stirred 30 minutes, left standstill 48 hours, and drew supernatant and filter, reclaim filtrate ethanol, and continue to be concentrated under 50 ℃ of conditions, density is 1.30 extractum;
(3), adding 5 times of water of extractum amount at above-mentioned extractum stirs evenly, is centrifugalize under the 15000r/min through channel separator at rotating speed, clear liquid and being transported in the fluid reservoir of hollow-fibre membrane ultrafiltration apparatus, operating pressure 0.2Mpa, the ultra-filtration process temperature is less than 45 ℃, by molecular cut off is 50000 ultrafilter membrane, collects the filtrate that sees through ultrafilter membrane.
(4), last, in above-mentioned filtrate, add volatile oil and volatile oil emulsion, add filtered mass concentration and be 10% glycyrrhizin solution or stevioside solution or cyclamate solution or syrup solution 5kg, add water to 350L, stir, by pouring into the PVC bottle after the sterilization of ultraviolet steriliser, promptly.
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CN102579632A (en) * 2012-04-09 2012-07-18 河南百年康鑫药业有限公司 Preparation method of concentrated heat-clearing and cough-relieving oral solution for children
CN102988896A (en) * 2012-12-06 2013-03-27 青岛文创科技有限公司 Traditional Chinese medicine oral liquid for treating wind-heat type common cold

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* Cited by examiner, † Cited by third party
Title
中药成方制剂第11分册. 药典委员会,89,药典委员会. 1996
中药成方制剂第11分册. 药典委员会,89,药典委员会. 1996 *

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