CN104288194A - Preparation method for compound radix isatidis granules - Google Patents
Preparation method for compound radix isatidis granules Download PDFInfo
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- CN104288194A CN104288194A CN201410596822.0A CN201410596822A CN104288194A CN 104288194 A CN104288194 A CN 104288194A CN 201410596822 A CN201410596822 A CN 201410596822A CN 104288194 A CN104288194 A CN 104288194A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/19—Acanthaceae (Acanthus family)
- A61K36/195—Strobilanthes
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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)
- A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
- A61K36/315—Isatis, e.g. Dyer's woad
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/19—Preparation or pretreatment of starting material involving fermentation using yeast, bacteria or both; enzymatic treatment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
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Abstract
The invention discloses a preparation method for compound radix isatidis granules. The preparation method comprises the steps as follows: firstly, adding water in radix isatidis raw and decocting twice with the first time and the second time being 2 hours and one hour respectively, merging the decocted soup and filtering the soup; secondly, concentrating the filtered soup with the relative density being 1.10, at 45 DEG C, adding complex enzyme consisting of pectinase, cellulase and pectate lyase for enzymolysis, wherein the weight ratio of the pectinase to the cellulase to the pectate lyase is 5 to 3 to 2, and the addition amount of the complex enzyme is 0.5-1.0% of the weight of the concentrated filtered soup; thirdly, concentrating continuously till the relative density being 1.20, at 45 DEG C, filtering, cooling, adding 95% ethyl alcohol so as to enable the alcohol content to be 30%, leaving to stand for sedimentation, and extracting supernatant liquid; fourthly, recycling ethyl alcohol, concentrating the liquid with the relative density being 1.20 at the temperature of 70 DEG C; fifthly, adding regular amount of cane sugar and dextrin, preparing granules, and drying the granules. According to the preparation method provided by the invention, through adopting the enzymolysis technology additionally, the ethanol concentration during ethanol sedimentation is reduced, and the cost is lowered.
Description
Technical field
The present invention relates to a kind of preparation method of medicine, be specifically related to a kind of preparation method of compound isatis root granules.
Background technology
Radix Isatidis (conventional another name: indigo-blue, Isatis indigotica Fort (Indigofera tinctoria L, Baphicanthus cusia (nees) Brem. Polygonum tinctorium Ait) root, Radix Clerodenri Cyrtophylli) be a kind of Chinese crude drug.All produce all over China.Radix Isatidis is divided into northern Radix Isatidis and Rhizoma Et Radix Baphicacanthis Cusiae, and northern Radix Isatidis source is the root of cruciferae isatis (Isatis tinctoria L.) and careless Folium Isatidis (I.indigotica Fort.); Rhizoma Et Radix Baphicacanthis Cusiae is rhizome and the root of acanthaceous vegetable acanthaceous indigo (Baphicacanthus cusia (Nees) Brem.), has effect of heat-clearing and toxic substances removing, preventing cold, sore-throat relieving.Cure mainly: maculae caused by violent heat pathogen, the headache of high heat, major part pestilence, crimson tongue purple dark, scarlet fever, erysipelas, mumps, sore throat, skin ulcer swell, carbuncle, chickenpox, measles, hepatitis, influenza, epidemic encephalitis, encephalitis b, pneumonia, coma tell nosebleed, pharyngeal swelling, acute catarrhal conjunctivitis, skin ulcer rash; Epidemic encephalitis type B, acute, chronic hepatitis, mumps, osteomyelitis can be prevented and treated.
Compound isatis root granules, main component is Radix Isatidis, and adjuvant is sucrose, dextrin, is brown or tan granule; Taste is sweet, micro-hardship.Mainly contain sugar-containing type and Sugarless type two kinds.Compound isatis root granules, heat-clearing and toxic substances removing, removing heat from blood, for anemopyretic cold, laryngopharynx swelling and pain.Take Radix Isatidis during flu, be conducive to strengthening immunity, kill body inner virus and pathogenic bacterium, be conducive to rehabilitation; Take Radix Isatidis during influenza He during viral disease, be conducive to building up resistance, keep off infection.For the laryngopharynx swelling and pain caused by exuberant lung-stomach heat, pharyngoxerosis, acute tonsillitis.
At present, the manufacture method of compound isatis root granules is: by Radix Isatidis 1400g, decoct with water secondary, 2 hours first times, second time 1 hour, collecting decoction, filter, it is 1.20 (50 DEG C) that filtrate is concentrated into relative density, adding ethanol makes alcohol content be 60%, leave standstill and make precipitation, get supernatant, reclaim ethanol and be concentrated into appropriate.Get thick paste, add appropriate sucrose and dextrin, make granule, dry, make 1000g; Or get thick paste, and add appropriate dextrin and sweeting agent, make granule, dry, make 600g (Sugarless type), to obtain final product.Such manufacture method comes with some shortcomings, drop to room temperature just can add ethanol as medicinal liquid must be placed to temperature, but due to the gelatinization of starch, medicinal liquid becomes g., jelly-like, now be difficult to make ethanol enter g., jelly-like thing inside and dissolve effective ingredient, simultaneously the precipitated gelatinized starch got off has wrapped up effective ingredient, has that ethanol consumption is large, effective ingredient is easily wrapped the shortcoming precipitating and cause yield to reduce.
In sum, necessary to the optimization of the preparation method of existing compound isatis root granules.
Summary of the invention
The technical problem to be solved in the present invention is for the deficiencies in the prior art, is optimized, enhances productivity to the preparation method of compound isatis root granules, reduces cost.
For solving the problems of the technologies described above, the technical solution used in the present invention is:
1) by Radix Isatidis raw material, decoct with water secondary, 2 hours first times, second time 1 hour, collecting decoction, filter;
2) filtrate is concentrated into relative density is 1.10, temperature 45 C, add pectase, cellulase, pectin lyase the compound enzyme of composition carry out enzymolysis, the weight ratio of pectase, cellulase, pectin lyase is 5:3:2, and compound enzyme addition is the 0.5-1.0% of concentrated rear filtrate weight;
3) continuing to be concentrated into relative density is 1.20, temperature 45 C, filters, and cooling, adds 95% ethanol and make alcohol content be 30%, quiescent setting, extracts supernatant;
4) reclaim ethanol, being concentrated into relative density when temperature is 70 DEG C is 1.20;
5) add sucrose and the dextrin of conventional amount used, make granule, dry.
Decoction of the present invention, adopts prior art common process.
Compared with prior art, the present invention has the following advantages:
1, decoction and alcohol sedimentation technique is Hydrolysis kinetics method conventional during Chinese medicine preparation is produced.During precipitate with ethanol, concentration of alcohol has material impact to solid preparation of Chinese medicine curative effect, taking dose, dosage form selection, preparations shaping, product stability etc., and during choose reasonable precipitate with ethanol, concentration of alcohol is one of key link in solid preparation of Chinese medicine process.But, at present in the research of decoction and alcohol sedimentation technique alcohol precipitation process, general main examination precipitate with ethanol process influence factor, as Chinese medicine extraction concentrated liquor relative density, precipitate with ethanol temperature, precipitate with ethanol time and add the impact on Chinese medicinal ointment index components content, yield of extract such as alcohol mode, during little research precipitate with ethanol, ethanol consumption is on the impact of whole production process etc., and normal follow-up production process and the preparation stability given brings problem.The present invention, by adding enzymolysis process, can reduce concentration of alcohol during precipitate with ethanol, reduce costs.
2, prior art has research to adopt during leaching process to add amylase, but is far longer than diastatic deactivation speed from the infiltration-dissolving-diffusion process of medical material organization internal due to starch, causes effect not control.Somebody studies employing 80 DEG C of soak extraction Radix Isatidis extractums, although greatly reduce the leaching of starch, also greatly reduces the leaching of effective ingredient simultaneously, causes the waste of herb resource.Main containing the compound such as saccharide (polysaccharide, oligosaccharide), adenosine, organic acid, amino acids, alkaloids in Radix Isatidis, and the present invention is by the application to compound enzyme, compare single enzyme, work targetedly, better can decompose polysaccharose substance, avoid above drawback, successful.
3, by process optimization of the present invention, to the Radix Isatidis index components adenosine rate of transform, yield of extract, and larger improvement is all brought to drying process with atomizing, extractum dry jet mixing pile, moulding process.
Detailed description of the invention
With embodiment, the invention will be further described below, but the present invention is not limited to these embodiments.
Embodiment 1:
1) by Radix Isatidis raw material, decoct with water secondary, 2 hours first times, second time 1 hour, collecting decoction, filter;
2) filtrate is concentrated into relative density is 1.10, temperature 45 C, add pectase, cellulase, pectin lyase the compound enzyme of composition carry out enzymolysis, the weight ratio of pectase, cellulase, pectin lyase is 5:3:2, compound enzyme addition be concentrated after filtrate weight 0.5%;
3) continuing to be concentrated into relative density is 1.20, temperature 45 C, filters, and cooling, adds 95% ethanol and make alcohol content be 30%, quiescent setting, extracts supernatant;
4) reclaim ethanol, being concentrated into relative density when temperature is 70 DEG C is 1.20;
5) add sucrose and the dextrin of conventional amount used, make granule, dry.
Embodiment 2:
1) by Radix Isatidis raw material, decoct with water secondary, 2 hours first times, second time 1 hour, collecting decoction, filter;
2) filtrate is concentrated into relative density is 1.10, temperature 45 C, add pectase, cellulase, pectin lyase the compound enzyme of composition carry out enzymolysis, the weight ratio of pectase, cellulase, pectin lyase is 5:3:2, compound enzyme addition be concentrated after filtrate weight 1.0%;
3) continuing to be concentrated into relative density is 1.20, temperature 45 C, filters, and cooling, adds 95% ethanol and make alcohol content be 30%, quiescent setting, extracts supernatant;
4) reclaim ethanol, being concentrated into relative density when temperature is 70 DEG C is 1.20;
5) add sucrose and the dextrin of conventional amount used, make granule, dry.
Embodiment 3:
1) by Radix Isatidis raw material, decoct with water secondary, 2 hours first times, second time 1 hour, collecting decoction, filter;
2) filtrate is concentrated into relative density is 1.10, temperature 45 C, add pectase, cellulase, pectin lyase the compound enzyme of composition carry out enzymolysis, the weight ratio of pectase, cellulase, pectin lyase is 5:3:2, compound enzyme addition be concentrated after filtrate weight 0.8%;
3) continuing to be concentrated into relative density is 1.20, temperature 45 C, filters, and cooling, adds 95% ethanol and make alcohol content be 30%, quiescent setting, extracts supernatant;
4) reclaim ethanol, being concentrated into relative density when temperature is 70 DEG C is 1.20;
5) add sucrose and the dextrin of conventional amount used, make granule, dry.
Comparative example 1:
By Radix Isatidis decoction pieces, decoct with water secondary, 2 hours first times, second time 1 hour, collecting decoction, filter, it is 1.20 (50 DEG C) that filtrate is concentrated into relative density, adds ethanol and makes alcohol content be 60%, leave standstill and make precipitation, get supernatant, reclaim ethanol and be concentrated into appropriate.Get thick paste, add appropriate sucrose and dextrin, make granule, dry.
Comparative example 2:
1) by Radix Isatidis raw material, decoct with water secondary, 2 hours first times, second time 1 hour, collecting decoction, filter;
2) filtrate is concentrated into relative density is 1.10, and temperature 45 C, adds amylase, and amylase addition is 0.8% of concentrated rear filtrate weight;
3) continuing to be concentrated into relative density is 1.20, temperature 45 C, filters, and cooling, adds 95% ethanol and make alcohol content be 50%, quiescent setting, extracts supernatant;
4) reclaim ethanol, being concentrated into relative density when temperature is 70 DEG C is 1.20;
5) add sucrose and the dextrin of conventional amount used, make granule, dry.
Table one: embodiment and comparative example data statistics
Conclusion: the present invention by adding compound enzyme in Aqueous extracts concentration process, the consumption of ethanol during precipitate with ethanol can be reduced significantly, to the compound isatis root granules obtained by subsequent technique, all have clear improvement in indexs such as granule yield, granule friability, the long altar on which incense burners are placed rate of transform and spraying dry water content, high-qualityly reduce cost carrying simultaneously.
Claims (1)
1. a preparation method for compound isatis root granules, is characterized in that comprising the steps:
1) by Radix Isatidis raw material, decoct with water secondary, 2 hours first times, second time 1 hour, collecting decoction, filter;
2) filtrate is concentrated into relative density is 1.10, temperature 45 C, add pectase, cellulase, pectin lyase the compound enzyme of composition carry out enzymolysis, the weight ratio of pectase, cellulase, pectin lyase is 5:3:2, and compound enzyme addition is the 0.5-1.0% of concentrated rear filtrate weight;
3) continuing to be concentrated into relative density is 1.20, temperature 45 C, filters, and cooling, adds 95% ethanol and make alcohol content be 30%, quiescent setting, extracts supernatant;
4) reclaim ethanol, being concentrated into relative density when temperature is 70 DEG C is 1.20;
5) add sucrose and the dextrin of conventional amount used, make granule, dry.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410596822.0A CN104288194B (en) | 2014-10-30 | 2014-10-30 | A kind of preparation method of compound isatis root granules |
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| CN105432899A (en) * | 2015-12-31 | 2016-03-30 | 桂林双象生物科技有限公司 | Preparation method of honeysuckle flower and grosvenor momordica fruit composite tea |
| CN105477347A (en) * | 2015-12-31 | 2016-04-13 | 吉林紫鑫药业股份有限公司 | Method for preparing medicine used for treating liver-stomach disharmony and blood stasis collateral obstruction |
| CN106692490A (en) * | 2016-12-13 | 2017-05-24 | 广西双蚁药业有限公司 | Sucrose-free compound isatis root granules and preparation method thereof |
| CN107349247A (en) * | 2017-05-23 | 2017-11-17 | 回音必集团安徽制药有限公司 | A kind of Radix Isatidis Optimized Extraction Process |
| CN107582600A (en) * | 2017-06-26 | 2018-01-16 | 安徽永生堂药业有限责任公司 | A kind of banlangen granules, banlangen keli and preparation method thereof |
| CN107951910A (en) * | 2017-12-25 | 2018-04-24 | 安徽永生堂药业有限责任公司 | A kind of preparation method of compound isatis root granules electuary |
| CN108969604A (en) * | 2018-08-15 | 2018-12-11 | 康美保宁（四川）制药有限公司 | A kind of pre-treating method and preparation method of compound isatis root granules |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105432899A (en) * | 2015-12-31 | 2016-03-30 | 桂林双象生物科技有限公司 | Preparation method of honeysuckle flower and grosvenor momordica fruit composite tea |
| CN105477347A (en) * | 2015-12-31 | 2016-04-13 | 吉林紫鑫药业股份有限公司 | Method for preparing medicine used for treating liver-stomach disharmony and blood stasis collateral obstruction |
| CN106692490A (en) * | 2016-12-13 | 2017-05-24 | 广西双蚁药业有限公司 | Sucrose-free compound isatis root granules and preparation method thereof |
| CN107349247A (en) * | 2017-05-23 | 2017-11-17 | 回音必集团安徽制药有限公司 | A kind of Radix Isatidis Optimized Extraction Process |
| CN107582600A (en) * | 2017-06-26 | 2018-01-16 | 安徽永生堂药业有限责任公司 | A kind of banlangen granules, banlangen keli and preparation method thereof |
| CN107951910A (en) * | 2017-12-25 | 2018-04-24 | 安徽永生堂药业有限责任公司 | A kind of preparation method of compound isatis root granules electuary |
| CN108969604A (en) * | 2018-08-15 | 2018-12-11 | 康美保宁（四川）制药有限公司 | A kind of pre-treating method and preparation method of compound isatis root granules |
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Denomination of invention: A kind of preparation method of compound isatidis granules Effective date of registration: 20220921 Granted publication date: 20170808 Pledgee: Bohai Bank Co.,Ltd. Zhongshan branch Pledgor: GUANGDONG XIANGSHANTANG PHARMACEUTICAL CO.,LTD. Registration number: Y2022980015849 |