CN1284562C - A kind of production process of applying activated carbon column chromatography to prepare traditional Chinese medicine extract for intravenous injection - Google Patents
A kind of production process of applying activated carbon column chromatography to prepare traditional Chinese medicine extract for intravenous injection Download PDFInfo
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- 238000010253 intravenous injection Methods 0.000 title claims abstract description 18
- 238000004440 column chromatography Methods 0.000 title claims description 4
- 238000004519 manufacturing process Methods 0.000 title description 6
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 25
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- 238000002360 preparation method Methods 0.000 claims abstract description 17
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 57
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- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
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Abstract
Description
发明领域field of invention
本发明涉及静脉注射剂用中药提取物的制备方法，特别是中药栀子(Gardenia jasminoides Eills)静脉注射剂用提取物的生产工艺。The invention relates to a preparation method of a traditional Chinese medicine extract for intravenous injection, in particular to a production process of an extract of the traditional Chinese medicine Gardenia jasminoides Eills for intravenous injection.
背景技术Background technique
在现有技术中，在静脉注射剂用中药提取物制备方法的文献报道中已有运用回流法、渗漉法、大孔树脂柱层析等制备静脉注射剂用中药提取物的方法。中药注射剂药效迅速，其药物不受消化液和食物的影响；中药注射剂适用于急救，并适用于不能口服给药或患有消化系统障碍者。In the prior art, in the literature reports on the preparation methods of Chinese medicine extracts for intravenous injections, there have been methods for preparing Chinese medicine extracts for intravenous injections by using the reflux method, percolation method, and macroporous resin column chromatography. Chinese medicine injections are quick in action, and their medicines are not affected by digestive juices and food; Chinese medicine injections are suitable for first aid, and are suitable for those who cannot be administered orally or suffer from digestive system disorders.
发明内容Contents of the invention
本发明的目的是提供一种静脉注射剂用中药提取物的制备方法，该方法包括将中药粗提取，回收溶剂至清膏，得到中药粗提物，将中药粗提物放入活性炭柱，先用蒸馏水洗脱，再用有机溶剂洗脱，收集洗脱液，减压回收该有机溶剂，干燥，得到中药提取物，将该中药提取物制成注射制剂。The object of the present invention is to provide a kind of preparation method of Chinese medicine extract for intravenous injection, this method comprises that Chinese medicine is crudely extracted, reclaims solvent to clear ointment, obtains Chinese medicine crude extract, and Chinese medicine crude extract is put into activated carbon column, first uses Eluting with distilled water and then using an organic solvent, collecting the eluate, recovering the organic solvent under reduced pressure, drying to obtain a Chinese medicine extract, which is prepared into an injection preparation.
中药粗提取可以用本领域的常规方法进行，例如回流法、渗漉法、浸渍法、超声波法等。The crude extraction of traditional Chinese medicine can be carried out by conventional methods in this field, such as reflux method, percolation method, maceration method, ultrasonic method and the like.
例如所述的渗漉法可以是将中药粉末在常温常压下装入渗漉器中，不断添加新溶剂，使溶剂始终保持浸过中药粉末，并使其渗透过中药粉末，自上而下从渗漉器下部以1～10毫升/分钟的流速流出渗漉液，收集渗出液，回收溶剂至相对密度为1.05-1.15的清膏即可得到中药粗提物。For example, the percolation method can be to put the Chinese medicine powder into a percolator at normal temperature and pressure, and continuously add new solvents to keep the solvent soaked in the Chinese medicine powder and make it permeate the Chinese medicine powder, from top to bottom The percolation liquid flows out from the lower part of the percolator at a flow rate of 1-10 ml/min, the percolation liquid is collected, and the solvent is recovered to a clear paste with a relative density of 1.05-1.15 to obtain the crude extract of traditional Chinese medicine.
所述的回流法可以采用回流装置，将中药粉末装入回流装置，保持溶剂温度在30～80℃，提取和回收溶剂同时进行，至相对密度为1.05-1.15(60℃测定)的清膏，得到中药粗提物。The reflux method can use a reflux device, put the Chinese medicine powder into the reflux device, keep the solvent temperature at 30-80°C, extract and recover the solvent at the same time, until the clear paste has a relative density of 1.05-1.15 (measured at 60°C), Obtain the crude extract of traditional Chinese medicine.
所述的浸渍法可以采用浸渍装置，将中药粉末置于有盖的容器内，将规定量的溶剂加入后，加盖密封，时时振摇或搅拌，在常温或温热(30～80℃)情况下，置暗处浸渍3-5日或至规定时间；过滤，收取滤液；然后药渣再加入新溶剂，如此重复2-4次，最后用压榨器压榨药渣，取压榨液过滤；合并滤液，回收溶剂至相对密度为1.05-1.15的清膏即可得到中药粗提物。The impregnation method can use an impregnation device, place the Chinese medicine powder in a container with a cover, add a specified amount of solvent, cover and seal, shake or stir from time to time, at room temperature or warm (30-80°C) Under normal circumstances, soak in the dark for 3-5 days or until the specified time; filter and collect the filtrate; then add new solvent to the medicinal residues, repeat this 2-4 times, and finally squeeze the medicinal residues with a squeezer, and filter the squeezed liquid; combine The filtrate is recovered to a clear paste with a relative density of 1.05-1.15 to obtain the crude extract of the traditional Chinese medicine.
所述的超声波提取法例如可以是将中药粉末装入容器，加入规定量的溶剂，置于超声波提取器中，超声处理10-30分钟，过滤，收取滤液；然后药渣再加入新溶剂，如此重复2-4次，合并滤液，回收溶剂至相对密度为1.05-1.15的清膏即可得到中药粗提物。The ultrasonic extraction method can be, for example, putting Chinese medicine powder into a container, adding a specified amount of solvent, placing it in an ultrasonic extractor, ultrasonically treating it for 10-30 minutes, filtering, and collecting the filtrate; then adding a new solvent to the medicinal residue, so Repeat 2-4 times, combine the filtrates, recover the solvent to a clear paste with a relative density of 1.05-1.15 to obtain the crude extract of the traditional Chinese medicine.
在以上各种方法中，溶剂是通常用于中药提取的那些溶剂，例如水性溶剂，醇类、醚类、酮类等溶剂，如乙醇，甲醇，丙酮等。它可以根据具体的中药或中药活性成分来选择。In the above various methods, the solvents are those commonly used in the extraction of traditional Chinese medicines, such as aqueous solvents, solvents such as alcohols, ethers, and ketones, such as ethanol, methanol, and acetone. It can be selected according to the specific traditional Chinese medicine or active ingredients of traditional Chinese medicine.
优选回收溶剂至相对密度为1.05-1.15(60℃测定)的清膏。Preferably the solvent is recovered to a clear paste with a relative density of 1.05-1.15 (measured at 60°C).
所述洗脱用有机溶剂可以是本领域常用的那些，例如二氯甲烷，乙醇，甲醇，丙酮，己烷等。这可以根据具体的中药或中药活性成分来决定。所述洗脱优选用8-20倍量的有机溶剂来进行。The organic solvent for elution may be those commonly used in the art, such as dichloromethane, ethanol, methanol, acetone, hexane, and the like. This can be determined according to the specific Chinese medicine or the active ingredient of Chinese medicine. The elution is preferably carried out with 8-20 times the amount of organic solvent.
所述柱层析的过程可以是：常温常压下，加入固定相活性炭，其上加入中药粗提物，然后先加入洗脱液蒸馏水，打开层析柱的下口，使洗脱液蒸馏水缓缓流出，弃去；再加入8-20倍量洗脱溶剂如60％-90％乙醇、丙酮或甲醇洗脱，收集洗脱液，加热回收溶剂并浓缩，干燥，得到中药提取物。The process of the column chromatography can be: under normal temperature and pressure, add stationary phase activated carbon, add Chinese medicine crude extract on it, then first add eluent distilled water, open the lower port of the chromatographic column, make the eluent distilled water slowly Slowly flow out and discard; then add 8-20 times the amount of eluting solvent such as 60%-90% ethanol, acetone or methanol to elute, collect the eluate, heat to recover the solvent, concentrate, and dry to obtain the Chinese medicine extract.
将中药提取物制成注射用制剂例如可以用以下方法来进行：取中药提取物用适量注射用水溶解，滤过，滤液灌装进入安瓿，灭菌，即得中药静脉注射剂。The preparation of Chinese medicine extracts into injection preparations can be carried out, for example, by the following method: take Chinese medicine extracts, dissolve them in an appropriate amount of water for injection, filter, fill the filtrate into ampoules, and sterilize to obtain Chinese medicine intravenous injections.
本发明的方法既适用于单味中药原料的注射制剂的制备，也适用于多味中药原料组成的组方的注射制剂的制备。多味中药原料例如可以分别进行粗提取，过活性炭柱和洗脱，再合并提取物，制成注射用制剂。The method of the invention is not only applicable to the preparation of injection preparations of single Chinese medicine raw materials, but also suitable for the preparation of injection preparations composed of multi-taste Chinese medicine raw materials. For example, raw materials of various traditional Chinese medicines can be crudely extracted, passed through an activated carbon column and eluted, and then the extracts can be combined to make preparations for injection.
更特定地，本发明提供了一种中药栀子(Gardenia jasminoides Eills)静脉注射剂用提取物的生产工艺。More specifically, the present invention provides a production process for the extract of the traditional Chinese medicine Gardenia jasminoides Eills for intravenous injection.
本发明所提供的中药栀子(Gardenia jasminoides Eills)静脉注射剂用提取物的生产工艺包括取中药栀子，粉碎，加入乙醇溶剂渗漉，收集渗漉液，回收乙醇，浓缩至相对密度为1.05-1.15的清膏，得到中药栀子粗提物。将中药栀子粗提物放入活性炭柱，先用蒸馏水洗脱至洗脱液无色，再用8-12倍量60-80％乙醇洗脱，收集洗脱液，回收乙醇并浓缩，干燥，得到栀子提取物。取栀子提取物用适量注射用水溶解，滤过，滤液灌装进入安瓿，灭菌，即得中药栀子静脉注射剂。The production process of the Chinese medicine Gardenia jasminoides Eills (Gardenia jasminoides Eills) intravenous injection extract provided by the present invention includes taking the Chinese medicine Gardenia jasminoides Eills, pulverizing it, adding ethanol solvent for percolation, collecting the percolation liquid, reclaiming ethanol, and concentrating to a relative density of 1.05- 1.15 of the clear ointment to obtain the crude extract of the traditional Chinese medicine Gardenia. Put the crude extract of Gardenia jasminoides into the activated carbon column, first elute with distilled water until the eluent is colorless, then elute with 8-12 times the amount of 60-80% ethanol, collect the eluent, recover the ethanol and concentrate, dry , to obtain Gardenia extract. The gardenia extract is dissolved in an appropriate amount of water for injection, filtered, the filtrate is filled into ampoules, and sterilized to obtain the traditional Chinese medicine gardenia intravenous injection.
其中，所述中药栀子的粉碎，可以是将中药栀子粉碎成粒度为10-20目的粉末，在上述粒度范围之外也是可行的。Wherein, the pulverization of the traditional Chinese medicine Fructus Gardeniae can be pulverizing the traditional Chinese medicine Fructus Fructus Gardeniae into a powder with a particle size of 10-20 mesh, and it is also feasible to use a particle size outside the above-mentioned range.
所述溶剂可以是60％-90％的乙醇、丙酮或甲醇溶剂。The solvent may be 60%-90% ethanol, acetone or methanol solvent.
本发明的制备静脉注射剂用中药提取物的方法技术先进，结果可靠，操作方便，有利于制备中药注射剂。中药注射剂药效迅速，作用可靠；适用于不宜口服给药的药物；可使某些药物定向或定位给药；可以穴位注射发挥特有的疗效；能够较好地控制所用药物的质量；并可适用于不宜口服给药的患者。The method for preparing the traditional Chinese medicine extract for intravenous injection of the present invention has advanced technology, reliable results, convenient operation and is beneficial to the preparation of traditional Chinese medicine injection. Traditional Chinese medicine injections have rapid and reliable effects; they are suitable for drugs that are not suitable for oral administration; they can make certain drugs be administered orally; they can be injected at acupoints to exert their unique curative effect; For patients who are not suitable for oral administration.
本发明的中药栀子(Gardenia jasminoides Eills)静脉注射剂用提取物的生产工艺合理，稳定，安全，可靠，适合工业生产。应用此工艺生产的静脉注射剂符合质量标准规定，制剂稳定，安全有效。The production process of the traditional Chinese medicine Gardenia jasminoides Eills (Gardenia jasminoides Eills) intravenous injection extract is reasonable, stable, safe and reliable, and is suitable for industrial production. The intravenous injection produced by this process meets the quality standard, and the preparation is stable, safe and effective.
具体实施例specific embodiment
下面通过实施例进一步描述本发明，应该指出的是，这些实施例仅用于说明的目的，决不对本发明构成任何限制。本领域的技术人员清楚，在不偏离本发明的精神和范围的情况下，可以做出一些变化和修改，它们均被包括在本发明范畴内。The present invention will be further described by the following examples. It should be noted that these examples are only for the purpose of illustration, and in no way constitute any limitation to the present invention. It is clear to those skilled in the art that some changes and modifications can be made without departing from the spirit and scope of the present invention, and they are all included in the scope of the present invention.
实施例1Example 1
本发明的上述中药栀子(Gardenia jasminoides Eills)静脉注射剂用提取物的生产工艺包括取处方量的中药栀子，粉碎成10目的粉末，在常温常压下装入渗漉器中，不断添加新溶剂70％乙醇，使溶剂始终保持浸过中药栀子粉末，并使其渗透过中药栀子粉末，自上而下从渗漉器下部以6毫升/分钟的流速流出渗漉液，收集渗出液，回收溶剂至相对密度为1.10的清膏，得到中药栀子粗提物。取中药栀子粗提物进行进一步精制操作如下：The production process of the above-mentioned traditional Chinese medicine gardenia (Gardenia jasminoides Eills) extract for intravenous injection of the present invention comprises taking the traditional Chinese medicine Gardenia jasminoides Eills of the prescription amount, pulverizing into 10 mesh powder, putting it into a percolator at normal temperature and pressure, and constantly adding new The solvent is 70% ethanol, so that the solvent is always soaked in the traditional Chinese medicine Gardenia powder, and makes it penetrate through the traditional Chinese medicine Gardenia powder, and the percolation liquid flows out from the bottom of the percolator at a flow rate of 6 ml/min from top to bottom, and the percolation is collected. liquid, recover the solvent to a clear paste with a relative density of 1.10, and obtain the crude extract of the traditional Chinese medicine Gardenia jasminoides. The crude extract of the traditional Chinese medicine Gardenia jasminoides is further refined as follows:
A、取不锈钢层析柱，常温常压下，加入固定相活性炭，其上加入中药栀子粗提物，然后先加入洗脱液蒸馏水，打开层析柱的下口，使洗脱液蒸馏水缓缓流出，收集蒸馏水洗脱液，至洗脱液无色，弃去；A. Take a stainless steel chromatographic column, add stationary phase activated carbon under normal temperature and pressure, add the crude extract of gardenia jasminoides on it, then add the eluent distilled water first, open the lower port of the chromatographic column, and make the eluent distilled water slowly Slowly flow out, collect distilled water eluate until the eluate is colorless, discard;
B、再加入10倍量70％乙醇洗脱，收集洗脱液，减压回收乙醇并浓缩，干燥，得到栀子提取物。B. Then add 10 times the amount of 70% ethanol to elute, collect the eluate, recover the ethanol under reduced pressure, concentrate, and dry to obtain the Gardenia jasmine extract.
C、取栀子提取物用适量注射用水溶解，滤过，滤液灌装进入安瓿，灭菌，即得中药栀子静脉注射剂。C. Take the gardenia extract and dissolve it with an appropriate amount of water for injection, filter, fill the filtrate into ampoules, and sterilize to obtain the traditional Chinese medicine gardenia intravenous injection.
实施例2Example 2
取中药铃兰，粉碎成10-20目的粉末，加入丙酮回流提取。将铃兰粉末装入回流装置，保持溶剂温度在30～50℃，回流提取，减压回收溶剂，过滤，收取滤液；然后药渣再加入新溶剂，如此重复2-4次；合并滤液，回收溶剂至相对密度为1.05-1.15的清膏即可得到铃兰粗提物。Take Lily of the Valley traditional Chinese medicine, crush it into 10-20 mesh powder, add acetone to reflux and extract. Put the lily of the valley powder into the reflux device, keep the solvent temperature at 30-50°C, reflux extraction, recover the solvent under reduced pressure, filter, and collect the filtrate; then add new solvent to the medicinal residue, repeat this 2-4 times; combine the filtrate, recover The crude lily-of-the-valley extract can be obtained by removing the solvent to a clear paste with a relative density of 1.05-1.15.
取铃兰粗提物进行进一步精制操作如下：Get lily of the valley crude extract and carry out further refining operation as follows:
A、取不锈钢层析柱，常温常压下，加入固定相活性炭，其上加入铃兰粗提物，然后先加入洗脱液蒸馏水，打开层析柱的下口，使洗脱液蒸馏水缓缓流出，弃去。A. Take a stainless steel chromatography column, add stationary phase activated carbon under normal temperature and pressure, add lily of the valley crude extract on it, then add eluent distilled water first, open the lower port of the chromatography column, make the eluent distilled water slowly Outflow, discard.
B、再加入12倍量丙酮洗脱，收集洗脱液，减压回收丙酮并浓缩，干燥，得到铃兰提取物。B. Then add 12 times of acetone for elution, collect the eluate, recover the acetone under reduced pressure and concentrate, dry to obtain lily of the valley extract.
C、取铃兰提取物用适量注射用水溶解，滤过，滤液灌装进入安瓿，灭菌，即得铃兰注射剂。C. Dissolve the lily of the valley extract with an appropriate amount of water for injection, filter, fill the filtrate into ampoules, and sterilize to obtain the lily of the valley injection.
实施例3Example 3
取中药人参，粉碎成10-20目的粉末，加入乙醇回流提取，减压回收溶剂，过滤，收取滤液；然后药渣再加入新溶剂，如此重复2-4次；合并滤液，回收溶剂至相对密度为1.05-1.15的清膏即可得到人参粗提物。Take traditional Chinese medicine ginseng, crush it into 10-20 mesh powder, add ethanol to reflux for extraction, recover the solvent under reduced pressure, filter, and collect the filtrate; then add new solvent to the dregs, repeat this 2-4 times; combine the filtrate, recover the solvent to the relative density 1.05-1.15 clear ointment can get ginseng crude extract.
取人参粗提物进行进一步精制操作如下：Get the ginseng crude extract and carry out further refining operation as follows:
A、取不锈钢层析柱，常温常压下，加入固定相活性炭，其上加入人参粗提物，然后先加入洗脱液蒸馏水，打开层析柱的下口，使洗脱液蒸馏水缓缓流出，弃去。A. Take a stainless steel chromatography column, add stationary phase activated carbon under normal temperature and pressure, add ginseng crude extract on it, then add eluent distilled water first, open the lower port of the chromatography column, and let the eluent distilled water flow out slowly , discarded.
B、再加入10倍量乙醇洗脱，收集洗脱液，减压回收乙醇并浓缩，干燥，得到人参提取物。B. Add 10 times the amount of ethanol to elute, collect the eluate, recover the ethanol under reduced pressure and concentrate, dry to obtain the ginseng extract.
取中药五味子，粉碎成10-20目的粉末，加入乙醇回流提取，减压回收溶剂，过滤，收取滤液；然后药渣再加入新溶剂，如此重复2-4次；合并滤液，回收溶剂至相对密度为1.05-1.15的清膏即可得到五味子粗提物。Take the traditional Chinese medicine Schisandra chinensis, crush it into 10-20 mesh powder, add ethanol to reflux extraction, recover the solvent under reduced pressure, filter, and collect the filtrate; then add new solvent to the dregs, repeat this 2-4 times; combine the filtrate, recover the solvent to the relative density The crude extract of Schisandra chinensis can be obtained by clearing the ointment of 1.05-1.15.
取五味子粗提物进行进一步精制操作如下：The crude extract of Schisandra chinensis is further refined as follows:
A、取不锈钢层析柱，常温常压下，加入固定相活性炭，其上加入五味子粗提物，然后先加入洗脱液蒸馏水，打开层析柱的下口，使洗脱液蒸馏水缓缓流出，弃去。A. Take a stainless steel chromatography column, add stationary phase activated carbon under normal temperature and pressure, add the crude extract of Schisandra chinensis on it, then add the distilled water of the eluent first, open the lower port of the chromatography column, and let the distilled water of the eluent flow out slowly , discarded.
B、再加入10倍量五味子洗脱，收集洗脱液，减压回收乙醇并浓缩，干燥，得到五味子提取物。B. Then add 10 times the amount of Schisandra chinensis for eluting, collect the eluate, recover ethanol under reduced pressure, concentrate, and dry to obtain the Schisandra chinensis extract.
取中药麦冬，粉碎成10-20目的粉末，加入乙醇回流提取，减压回收溶剂，过滤，收取滤液；然后药渣再加入新溶剂，如此重复2-4次；合并滤液，回收溶剂至相对密度为1.05-1.15的清膏即可得到麦冬粗提物。Take the traditional Chinese medicine Ophiopogon japonicus, crush it into 10-20 mesh powder, add ethanol to reflux for extraction, recover the solvent under reduced pressure, filter, and collect the filtrate; then add new solvent to the dregs, and repeat this 2-4 times; combine the filtrate, recover the solvent to the relative The crude extract of Ophiopogon japonicus can be obtained from the clear paste with a density of 1.05-1.15.
取麦冬粗提物进行进一步精制操作如下：The Ophiopogon japonicus crude extract is further refined as follows:
A、取不锈钢层析柱，常温常压下，加入固定相活性炭，其上加入麦冬粗提物，然后先加入洗脱液蒸馏水，打开层析柱的下口，使洗脱液蒸馏水缓缓流出，弃去。A. Take a stainless steel chromatography column, add stationary phase activated carbon under normal temperature and pressure, add Ophiopogon japonicus crude extract on it, then add eluent distilled water first, open the lower port of the chromatography column, make the eluent distilled water slowly Outflow, discard.
B、再加入10倍量乙醇洗脱，收集洗脱液，减压回收乙醇并浓缩，干燥，得到麦冬提取物。B. Add 10 times the amount of ethanol to elute, collect the eluate, recover the ethanol under reduced pressure and concentrate, dry to obtain the Ophiopogon japonicus extract.
将上述人参、五味子和麦冬提取物按1∶1∶2的比例用适量注射用水溶解，滤过，滤液灌装进入安瓿，灭菌，即得生脉饮注射剂。Dissolve the above ginseng, schisandra and Ophiopogon japonicus extracts in an appropriate amount of water for injection at a ratio of 1:1:2, filter, fill the filtrate into ampoules, and sterilize to obtain Shengmaiyin injection.
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