CN101278986B - Process for preparing compound folium isatidis injection with membrane filter technique - Google Patents
Process for preparing compound folium isatidis injection with membrane filter technique Download PDFInfo
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- CN101278986B CN101278986B CN2008100166266A CN200810016626A CN101278986B CN 101278986 B CN101278986 B CN 101278986B CN 2008100166266 A CN2008100166266 A CN 2008100166266A CN 200810016626 A CN200810016626 A CN 200810016626A CN 101278986 B CN101278986 B CN 101278986B
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Abstract
The invention discloses a process for preparing compound dyers woad leaf injection by membrane filtration technology. The process for preparing the compound dyers woad leaf injection by membrane filtration technology is as follows: according to the prescription of the compound dyers woad leaf injection, medicine materials are decocted; medicine liquid is condensed to three times as much as formula dosage, centrifuged, filtrated directly by the membrane with large pore size, filtrated by an ultrafiltration membrane and condensed by a nanofiltration membrane, thus extracting the compound dyers woad leaf injection. The process for preparing the compound dyers woad leaf injection has following characteristics: 1. heating process is reduced to decrease the loss of effective components; 2. the process is carried out at normal temperature to prevent phase transition and pollution; 3. the ethanol extraction process in conventional technology is replaced, so cost is saved and production is kept clean; 4. extraction period is shortened and pollution sections are reduced, thus offering technological insurance for the quality of products; 4. compared with content produced by prior art, the content is increased by over two times.
Description
(1) technical field
The present invention relates to a kind of preparation technology of medicine, particularly a kind of membrane filtration technique prepares the technology of compound indigowoad leaf injection.
(2) background technology
Because of modern industrial fast development, the thing followed is warming of global climate and increasing the weight of of polluting, particularly some developed regions, and sickness rate such as viral infection, innominate high fever have the trend that rises year by year.Especially the SARS in 03 year allows people remember clearly, and the compound indigowoad leaf injection has been made very big contribution period at SARS.The compound indigowoad leaf injection is clinical antipyretic and antidotal type Chinese patent medicine commonly used, is mainly used in the treatment of influenza and innominate high fever.Clinical experience shows this product determined curative effect, few side effects for many years.Also have broad-spectrum antibacterial action, not only gram positive bacteria is had stronger bacteriostasis, and some fungus is also had stronger bacteriostasis; The compound indigowoad leaf injection also has stronger antiendotoxin activity.The Chinese medicine injection of influenza in 2006, antivirus action whole nation income from sales is 30.52 hundred million yuan according to statistics, and the compound indigowoad leaf injection is number five, and accounts for 5.3% of sales quota; The Chinese medicine injection whole nation income from sales of antivirus action in 2007 is 41.38 hundred million yuan, and the compound indigowoad leaf injection is number three, and accounts for 7.1% of sales quota, is ascendant trend year by year.Expectation will reach influenza, more than 10% of anti virus herb injection sales quota in 2008 along with the progressively raising of people to Chinese medicine and Green Product consciousness.
Existing compound indigowoad leaf injection is included on the second ten fens volumes of ministry standard Chinese traditional patent formulation preparation, and standard is numbered: WS3-B-3901-98.The method for making of the compound indigowoad leaf injection that this standard is included: get Folium Isatidis 1000g, Flos Lonicerae 500g, Rhizoma Et Radix Notopterygii 250g, Rhizoma Bistortae 250g, Radix Et Rhizoma Rhei 250g decocts with water three times, each 1 hour, collecting decoction filters, and filtrate is concentrated into relative density and is about 1.20 (80 ℃), add ethanol and make and contain alcohol amount and reach 60%, cold preservation makes precipitation, filters, filtrate is concentrated into relative density and is about 1.20 (80 ℃), adds suitable quantity of water and makes dilution, and cold preservation makes precipitation, filter, filtrate is concentrated into relative density and is about 1.20 (80 ℃), adds ethanol and makes and contain the alcohol amount and reach 85%, cold preservation makes precipitation, filters, and filtrate is reclaimed ethanol to the greatest extent, add an amount of water for injection, cold preservation makes precipitation, filters, filtrate transfers pH value to 7.9-8.2 with 10% sodium hydroxide solution, adds anhydrous sodium sulfite and makes concentration reach 2%, boils 1 hour, put coldly, add active carbon 5g, stir evenly, leave standstill, cold preservation filters, and adds benzyl alcohol 20ml in the filtrate, stir evenly, filter to clear and bright, add the injection water to 1000ml, embedding, 100 ℃ of sterilizations 30 minutes, promptly.
Because the compound indigowoad leaf injection is a compound preparation, complicated component, the quality shakiness shows as clinical quality shakiness, poor controllability, the probability that untoward reaction takes place strengthens, and is difficult to adapt to Chinese medicine injection modernization and international requirement.
The composition of compound indigowoad leaf injection non-quantitation accounts for very big ratio at present, and some macromole impurity are difficult to remove, and particularly the more difficulty of the tannin in the Radix Et Rhizoma Rhei is removed, and tannin phenomenons such as variable color, muddiness, precipitation can occur than length standing time.Tannin is the main cause that influences clarity of injection, and it can generate precipitation with the metal ion effect in alkaloid, protein, the medicine, therefore must remove the tannin in the injection.In general tannin enters in the body and can cause jaundice, hepatic necrosis, intramuscular injection meeting generation local pain, scleroma, and tannin is generally the polyatomic phenol material, the promptly water-soluble alcohol that is dissolved in again.And the protein in the compound indigowoad leaf is also more, must remove from injection, otherwise can produce precipitation.
In the existing ministry standard, it is relatively poor that ethanol precipitation twice removes the tannin effect, and it is qualified that products obtained therefrom is difficult to, and poor selectivity.And a large amount of ethanol of precipitate with ethanol consumption, increasing cost, ethanol is organic solvent, increases to pollute.Ethanol precipitation twice, twice water precipitating makes loss of effective components serious, is difficult to reach standard-required.Existing technology comprises that also water alcohol method, heat treatment refrigeration, glue alcohol method, polyamide method etc. remove the tannin method, and wherein water alcohol method tannin-removing effect is better, but a large amount of effective ingredient is removed, and loses very big.Some method is also introduced other impurity, and end product quality is reduced.
Membrane separation technique as 21 century the most promising separation technology use at field of medicaments the history in more than 30 year arranged.Its application at the field of Chinese medicines sees Japan the earliest, Japan in 20th century six the seventies with application of membrane separation technology refining in the Chinese prescription preparation.The research of internal membrane isolation technics in Chinese medicine preparation starts from late 1970s, takes the lead in launching in this respect research by officina of Beijing Hospital of the Chinese People's Liberation Army.Nineteen eighty-two, the technical study that ultrafiltration prepares Chinese medicine is tested and appraised, and domestic relevant pharmacy expert thinks: it is an important breakthrough that improves the Chinese medicine quality that ultrafiltration prepares Chinese medicine.After this, constantly have and adopt hyperfiltration technique to prepare Chinese medicine and oral liquid, and the research report of pharmaceutically active ingredient and refining Chinese medical concrete in the separation and purification, mainly be the applied research of organic high molecular layer ultra-filtration process.
Domestic less relatively to the research of Inorganic Ceramic Membranes in Chinese medicine preparation.Inorganic ceramic film is a kind of solid film, it is the semipermeable membrane of being made by the inorganic material pottery, it mainly is according to " screening " theory, according to the material molecule diameter difference of in certain membrane aperture scope, permeating permeability difference then, utilize pressure differential to be motive force, small-molecule substance can be passed through, and macromolecular substances then is trapped, thereby realizes the separation between them.Substrate is mainly inorganic material such as zirconium oxide, aluminium oxide to inorganic ceramic film and special architectural feature has following advantage because of it constitutes: 1. high temperature resistant, and be applicable to and handle high temperature, high viscosity fluid; 2. the mechanical strength height has good wear-resisting, abrasion resistance energy, can the high pressure recoil make film regeneration; 3. chemical stability is good, acid and alkali-resistance, antimicrobial degraded; 4. long service life, general available 3～5 years, even 8～10 years.These advantages are compared with organic high molecular layer, make it that potential application advantage be arranged in many aspects, become the isolating important new technique of secondary filter under the harsh conditions, now be widely used in fields such as food industry, biological engineering, environmental project, chemical industry, petrochemical industry, metallurgical industry.Inorganic ceramic film is particularly suitable for the refining of decocting for Chinese herbal medicine liquid.Wherein the aperture is that the micro-filtration membrane of 0.2 μ m can be used for removing float such as microgranule in the medicinal liquid, micelle, and the aperture is the staged care that 0.1,0.05 μ m and littler ultrafilter membrane then can be used for the different molecular weight composition.Present domestic most Chinese medicine producer boils with decocting and is basic extraction process, thereby Inorganic Ceramic Membranes has the general suitability in China's Chinese medicine industry.
In sum, the method for making of existing compound indigowoad leaf injection production technology is unreasonable, and loss of effective components is serious; Tannin is removed not thorough, influences clarity, pain during injection.Consume a large amount of organic solvents, increase and pollute, have a strong impact on the quality of product.In view of the major defect that existing compound indigowoad leaf injection preparation exists, can not adapt to the quality controllable and effective requirement of clinical drug safety to the compound indigowoad leaf injection at present far away.
(3) summary of the invention
The present invention provides a kind of and has saved cost, reduced the technology that the membrane filtration technique that pollutes, improves the quality of products prepares the compound indigowoad leaf injection in order to remedy the deficiencies in the prior art.
The present invention is achieved through the following technical solutions:
A kind of membrane filtration technique prepares the technology of compound indigowoad leaf injection, and its special character is: may further comprise the steps:
(1) decoct: get Folium Isatidis 1000g, Flos Lonicerae 500g, Rhizoma Et Radix Notopterygii 250g, Rhizoma Bistortae 250g, Radix Et Rhizoma Rhei 250g, add decocting and boil three times, amount of water is respectively 8,6,6 times, decocts 1 hour at every turn, merges decoction liquor, filters;
(2) concentrate: filtrate is lower than the 3 times amounts of 80 ℃ of concentrating under reduced pressure to the Folium Isatidis medical material, cooling;
(3) centrifugal: concentrated solution is centrifugal with high speed centrifuge, filter;
(4) large aperture membrane filtration: with centrifugal liquid large aperture membrane filtration, filtrate is heated to 80 ℃, transfers pH value to 8.0 with alkali, is chilled to room temperature;
(5) ultrafiltration:, use ultrafiltration membrance filter with above-mentioned membrane filtration liquid;
(6) nanofiltration: ultrafiltrate is arrived 1000ml with filtering and concentrating under the NF membrane room temperature;
(7) preparation: nanofiltration liquid carries out intermediate after the assay was approved, and taking liquid transfers pH value to 7.9-8.2 with 40%NaOH, adds 0.2% anhydrous sodium sulfite of amount of preparation, stir evenly, heated and boiled is after 40 minutes, after adding active carbon 5g and boiling 20 minutes again, filtered while hot, filtrate add medicinal benzene methanol 20ml, stir evenly, filter adds the injection water to 1000ml to clarification, stirs evenly, embedding, towards nitrogen, 100 ℃, 30 minutes, sterilization, promptly.
What the present invention was different with traditional compound indigowoad leaf process for preparing injection liquid is that the whole technical process heating process of the present invention reduces, replace the pure extraction process by water of carrying twice twice with membrane filtration technique, instead of ethanol is extracted, and saves cost, cut down the consumption of energy, increase content of effective.
Production craft step of the present invention (4), (5), (6) used film are inorganic ceramic film or hollow-fibre membrane.
Production craft step of the present invention (4) retaining molecular weight is 100,000-200,000 molecular weight; Step (5) retaining molecular weight is the 5000-10000 molecular weight; It is 150nm-300nm that step (6) film is held back the aperture.
Production craft step of the present invention (3) high speed centrifuge rotating speed is 10000r/min-18000r/min.
The used alkali of production craft step of the present invention (4) is selected from a kind of in sodium hydroxide, sodium carbonate, sodium citrate, ammonia, sodium hydrogen phosphate, the sodium tartrate.
We by the analysis to multiple Folium Isatidis injection process characteristic of compound recipe and quality control, use multistage membrane filtration technique through unremitting effort, have removed the most of impurity in the injection, and maximum has kept effective ingredient, makes retention rate 〉=80%.And use membrane filtration technique, no phase transformation at normal temperatures; Instead of ethanol is extracted, and reduces cost, and improves content.
The present invention is according to the prescription decocting herbs of compound indigowoad leaf injection, and medicinal liquid is concentrated to 3 times of recipe quantity, and is centrifugal, directly extracts the technology of compound indigowoad leaf injection by technology such as large aperture membrane filtration, ultrafiltration membrance filter, NF membrane concentrate.And have following characteristics simultaneously: 1, reduce heating process, reduce loss of effective components; 2, normal-temperature operation, no phase transformation, pollution-free; 3, the alcohol extraction process in the alternative traditional handicraft is saved cost, cleaner production; 4, shorten extracting cycle, reduce pollution section, provide technology to guarantee for guaranteeing product quality.5, content can more former technology improve more than 2 times.
(4) description of drawings
The present invention is further illustrated below in conjunction with accompanying drawing.
Accompanying drawing is a process flow diagram of the present invention.
(5) specific embodiment
Embodiment 1:
Get Folium Isatidis 1000g, Flos Lonicerae 500g, Rhizoma Et Radix Notopterygii 250g, Rhizoma Bistortae 250g, Radix Et Rhizoma Rhei 250g five tastes medical material, add decocting and boil three times, amount of water is respectively 8,6, and 6 times, each 1h merges decoction liquor, filters, and filtrate is concentrated to 3 times of amounts of Folium Isatidis medical material.With medicinal liquid high speed centrifugation (rotating speed is 18000r/min), ceramic membrane filter with 200,000 molecular weight, filtrate is heated to 80 ℃, transfers pH value to 8.0 with 1% sodium hydroxide, is chilled to room temperature, the ceramic super-filtering film of reuse 10,000 molecular weight filters, to the 1 times of amount that is about Folium Isatidis, impurity such as detection level, resin, tannin, protein are qualified, do lab scale with the NF membrane filtering and concentrating of 200nm for ultrafiltrate, detect again undue toxicity, endotoxin qualified after, prepare embedding as reserve liquid.
Finished product process for preparation: get reserve liquid and filter, transfer pH value to 7.9-8.2, add 0.2% anhydrous sodium sulfite of amount of preparation with 40%NaOH, stir evenly, heated and boiled is after 40 minutes, after adding active carbon 5g and boiling 20 minutes again, filtered while hot, filtrate add medicinal benzene methanol 20ml, stir evenly, filter adds the injection water to recipe quantity to clarification, stirs evenly, embedding, the pure nitrogen gas of leaping high (〉=99.99%), 100 ℃, 30 minutes, sterilization, promptly.
Embodiment 2:
Get Folium Isatidis 1000g, Flos Lonicerae 500g, Rhizoma Et Radix Notopterygii 250g, Rhizoma Bistortae 250g, Radix Et Rhizoma Rhei 250g five tastes medical material, add decocting and boil three times, amount of water is respectively 8,6, and 6 times, each 1h merges decoction liquor, filters, and filtrate is concentrated to 3 times of amounts of Folium Isatidis medical material.With medicinal liquid high speed centrifugation (rotating speed is 15000r/min), doughnut membrane filtration with 150,000 molecular weight, filtrate is heated to 80 ℃, transfers pH value to 8.0 with 1% sodium hydroxide, is chilled to room temperature, the hollow fiber ultrafiltration membrane of reuse 10,000 molecular weight is filtered, to the 1 times of amount that is about Folium Isatidis, impurity such as detection level, resin, tannin, protein are qualified, do lab scale with the NF membrane filtering and concentrating of 300nm for ultrafiltrate, detect again undue toxicity, endotoxin qualified after, prepare embedding as reserve liquid.
The finished product process for preparation is identical with embodiment 1.
Embodiment 3:
Get Folium Isatidis 1000g, Flos Lonicerae 500g, Rhizoma Et Radix Notopterygii 250g, Rhizoma Bistortae 250g, Radix Et Rhizoma Rhei 250g five tastes medical material, add decocting and boil three times, amount of water is respectively 8,6, and 6 times, each 1h merges decoction liquor, filters, and filtrate is concentrated to 3 times of amounts of Folium Isatidis medical material.With medicinal liquid high speed centrifugation (rotating speed is 10000r/min), ceramic membrane filter with 100,000 molecular weight, filtrate is heated to 80 ℃, transfers pH value to 8.0 with 10% sodium carbonate, is chilled to room temperature, the ceramic super-filtering film of reuse 5000 molecular weight filters, to the 1 times of amount that is about Folium Isatidis, impurity such as detection level, resin, tannin, protein are qualified, do lab scale with the NF membrane filtering and concentrating of 150nm for ultrafiltrate, detect again undue toxicity, endotoxin qualified after, prepare embedding as reserve liquid.
The finished product process for preparation is identical with embodiment 1.
Embodiment 4:
Get Folium Isatidis 1000g, Flos Lonicerae 500g, Rhizoma Et Radix Notopterygii 250g, Rhizoma Bistortae 250g, Radix Et Rhizoma Rhei 250g five tastes medical material, add decocting and boil three times, amount of water is respectively 8,6, and 6 times, each 1h merges decoction liquor, filters, and filtrate is concentrated to 3 times of amounts of Folium Isatidis medical material.With medicinal liquid high speed centrifugation (rotating speed is 15000r/min), ceramic membrane filter with 100,000 molecular weight, filtrate is heated to 80 ℃, transfers pH value to 8.0 with 10% sodium hydrogen phosphate, is chilled to room temperature, the hollow fiber ultrafiltration membrane of reuse 8000 molecular weight is filtered, to the 1 times of amount that is about Folium Isatidis, impurity such as detection level, resin, tannin, protein are qualified, do lab scale with the NF membrane filtering and concentrating of 300nm for ultrafiltrate, detect again undue toxicity, endotoxin qualified after, prepare embedding as reserve liquid.
The finished product process for preparation is identical with embodiment 1.
Embodiment 5:
Get Folium Isatidis 1000g, Flos Lonicerae 500g, Rhizoma Et Radix Notopterygii 250g, Rhizoma Bistortae 250g, Radix Et Rhizoma Rhei 250g five tastes medical material, add decocting and boil three times, amount of water is respectively 8,6, and 6 times, each 1h merges decoction liquor, filters, and filtrate is concentrated to 3 times of amounts of Folium Isatidis medical material.With medicinal liquid high speed centrifugation (rotating speed is 18000r/min), doughnut membrane filtration with 100,000 molecular weight, filtrate is heated to 80 ℃, transfers pH value to 8.0 with 10% sodium citrate, is chilled to room temperature, the hollow fiber ultrafiltration membrane of reuse 10,000 molecular weight is filtered, to the 1 times of amount that is about Folium Isatidis, impurity such as detection level, resin, tannin, protein are qualified, do lab scale with the NF membrane filtering and concentrating of 300nm for ultrafiltrate, detect again undue toxicity, endotoxin qualified after, prepare embedding as reserve liquid.
The finished product process for preparation is identical with embodiment 1.
The present invention's concrete technical scheme required for protection is not limited to the concrete combination of the expressed technical scheme of the foregoing description, comprises the assembled scheme that they are all.
Claims (4)
1. a membrane filtration technique prepares the technology of compound indigowoad leaf injection, it is characterized in that: may further comprise the steps:
(1) decoct: get Folium Isatidis 1000g, Flos Lonicerae 500g, Rhizoma Et Radix Notopterygii 250g, Rhizoma Bistortae 250g, Radix Et Rhizoma Rhei 250g, add decocting and boil three times, amount of water is respectively 8,6,6 times, decocts 1 hour at every turn, merges decoction liquor, filters;
(2) concentrate: filtrate is lower than the 3 times amounts of 80 ℃ of concentrating under reduced pressure to the Folium Isatidis medical material, cooling;
(3) centrifugal: concentrated solution is centrifugal with high speed centrifuge, filter;
(4) large aperture membrane filtration: with centrifugal liquid large aperture membrane filtration, filtrate is heated to 80 ℃, transfers pH value to 8.0 with alkali, is chilled to room temperature;
(5) ultrafiltration:, use ultrafiltration membrance filter with above-mentioned membrane filtration liquid;
(6) nanofiltration: ultrafiltrate is arrived 1000ml with filtering and concentrating under the NF membrane room temperature;
(7) preparation: nanofiltration liquid carries out intermediate after the assay was approved, and taking liquid transfers pH value to 7.9-8.2 with 40%NaOH, adds 0.2% anhydrous sodium sulfite of amount of preparation, stir evenly, heated and boiled is after 40 minutes, after adding active carbon 5g and boiling 20 minutes again, filtered while hot, filtrate add medicinal benzene methanol 20ml, stir evenly, filter adds the injection water to 1000ml to clarification, stirs evenly, embedding, towards nitrogen, 100 ℃, 30 minutes, sterilization, promptly;
Described step (4), (5), (6) used film are inorganic ceramic film or hollow-fibre membrane;
Described step (4) retaining molecular weight is 100,000-200,000; Step (5) retaining molecular weight is 5000-10000; It is 150nm-300nm that step (6) film is held back the aperture.
2. the described membrane filtration technique of claim 1 prepares the technology of compound indigowoad leaf injection, it is characterized in that: the rotating speed of the high speed centrifuge that described preparation method step (3) is used is 10000～18000r/min.
3. the described membrane filtration technique of claim 1 prepares the technology of compound indigowoad leaf injection, it is characterized in that: described step (4) transfers the used alkali of pH value to be selected from a kind of in sodium hydroxide, sodium carbonate, ammonia, sodium citrate, sodium tartrate, the sodium hydrogen phosphate with alkali.
4. the described membrane filtration technique of claim 1 prepares the technology of compound indigowoad leaf injection, it is characterized in that: institute's inflated with nitrogen is the highly purified nitrogen of purity 〉=99.99% in the described step (7).
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Families Citing this family (7)
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| CN102988432A (en) * | 2012-12-11 | 2013-03-27 | 广东新峰药业股份有限公司 | Preparation method of traditional Chinese medicine aqueous solution for antibiosis, antiphlogosis and antitumor |
| CN103891784A (en) * | 2013-09-11 | 2014-07-02 | 安徽亿人安有限公司 | Bacteriostatic agent for sterilization and disinfection, skin mucosa disinfection fluid and preparation method thereof |
| CN103931672A (en) * | 2013-09-11 | 2014-07-23 | 安徽亿人安有限公司 | Antibacterial sterilizing skin disinfectant liquid and antibacterial sterilizing antiseptic disinfector and preparation methods thereof |
| CN103494879B (en) * | 2013-10-11 | 2016-02-03 | 湖南永辉医药有限公司 | A kind of ceramic membrane prepares the technique of Salvia Miltiorrhiza Oral Liquid |
| CN105902695B (en) * | 2016-05-24 | 2020-06-19 | 河北天元药业有限公司 | Novel method for preparing Shuangding injection |
| CN106389690A (en) * | 2016-08-31 | 2017-02-15 | 上海新亚药业高邮有限公司 | Ultrafiltration preparation method of compound folium isatidis injection |
| CN108066784A (en) * | 2017-12-25 | 2018-05-25 | 陈益德 | A kind of endotoxic method in removal biomedical product |
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| CN1088818A (en) * | 1992-12-29 | 1994-07-06 | 山东北方制药厂 | Compound Folium Isatidis suppository for treating baby common cold |
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