CN1709344A - Injection Chinese medicine first-aid powder injection drug and its preparing method - Google Patents
Injection Chinese medicine first-aid powder injection drug and its preparing method Download PDFInfo
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- CN1709344A CN1709344A CN 200510021149 CN200510021149A CN1709344A CN 1709344 A CN1709344 A CN 1709344A CN 200510021149 CN200510021149 CN 200510021149 CN 200510021149 A CN200510021149 A CN 200510021149A CN 1709344 A CN1709344 A CN 1709344A
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Abstract
The present invention relates to a Chinese medicine first-aid powder injection preparation. Said preparation is made up by using extracts obtained by making the Chinese medicinal materials of musk, curcuma tuber and gardenia fruit undergo the process of supercritical extraction and borneol as effective medicine component and adding auxiliary component acceptable in powder injection preparation. Besides, said invention also provides the concrete steps of its preparation method.
Description
Technical field
What the present invention relates to is powder pin type injectable drug preparation of a kind of natural medicinal ingredients and preparation method thereof.
Background technology
XINGNAOJING ZHUSHEYE is to have listed the Chinese patent medicine preparation that a kind of first aid of ministry of Health of China drug standard is used in, have refreshment relieving convulsion, clearing away heat and cooling blood, promoting flow of QI and blood, the effect of detoxifcation analgesic, be present a kind of key medicine for the treatment of central coma, there is better curative effect the aspects such as stupor, tic, toxic encephalopthy and drug intoxication that cause for disturbance of consciousness, Heavy craniocerebral injury, cerebral hemorrhage, cerebral infarction, epidemic encephalitis type B, hepatic coma, nervous system infection especially.The active drug composition of this medicine is formed jointly for the extract and the Borneolum Syntheticum that are obtained by natural drug raw material Moschus, Fructus Gardeniae, Radix Curcumae, and wherein the active drug composition of Moschus, Fructus Gardeniae and Radix Curcumae is the extract component that adopts the vapor distillation method to obtain.Limit by the water solublity of these active drug compositions, clearly stipulate to need to use as Tweens compositions such as tween 80s during this medicine preparation as cosolvent.Existing bibliographical information uses the Tweens material to carry out can bringing corresponding unfavorable factor in the solubilising in injection.As, Wang Guitian etc. are at " Chinese medicine causes the analysis of untoward reaction factors " (" ChinaPharmacist " 2001,4 (5), 384) though in once be reported in the Chinese medicine add tween 80 for hydrotropy and improve stable essential, but the effect that it also has certain haemolysis simultaneously and changes biofilm structure, the biomembranous lipid barrier of energy corrosion makes biomembrane molecule arrange non-directional, thereby the biomembrane permeability is increased.In addition, also the local inflammatory response due to the tween 80 has been made relevant report in " the pharmacoepidemiology magazine " 1996,5 (4), 245.Therefore,, particularly in traditional medicine Injectio, use the Tweens material, can cause the toxic reaction of systems such as human body cardiovascular and cerebrovascular vessel at ejection preparation.Therefore health ministry clearly is defined in cardiovascular very early and once with adding the Tweens additives in the injectable drug.
At publication number is that Ceng Wenxian discloses a kind of injection XINGNAOJING lyophilized powder and novel preparation method thereof in the Chinese patent of CN1562292A, wherein Fructus Gardeniae, Radix Curcumae, three kinds of compositions of Moschus are adopted certain density ethanol extraction, separating treatment respectively, and adopt HP-that 3-methylcyclopentadecanol extract and Borneolum Syntheticum have been carried out enclose.The result of this preparation method is unsatisfactory, and except that the change because of its extracting method solvent for use has caused the effective ingredient of medicine changes, the impurity level in the resultant extract of this method is more, operates loaded down with trivial detailsly again, also is unfavorable for industrialized great production.
Publication number is that the Chinese patent literature of CN1554431A discloses a kind of Xingnaojing powder injection and preparation method thereof, what it also adopted Fructus Gardeniae, Radix Curcumae is certain density ethanol extraction, separating treatment, carry carrying out water again behind the Moschus employing supercritical extraction volatile ingredient, adopt HP-to carry out enclose respectively then equally to Moschus supercritical extraction volatile ingredient with through distillation processing gained Borneolum Syntheticum.The preparation method of the document does not in fact still overcome or avoids problem in the above-mentioned document, the problem includes: same problem.
In addition, publication number is that the Chinese patent literature of CN1616020A also discloses a kind of Xingnaojing powder injection and preparation method thereof, it adopts the method consistent with the medicine required standard to extract Aromatic water to Fructus Gardeniae, Radix Curcumae, Moschus, and then with the HP-of the fragrant water yield 5-30% Aromatic water is carried out preparing XINGNAOJING powder pin behind the enclose.But because the fragrant water yield that obtains of this method is big, the enclose that this Aromatic water is carried out HP-has increased the difficulty that big dirt produces operation again, equally also is unfavorable for industrialized big production.
Summary of the invention
At above-mentioned situation, the present invention is under the prerequisite that the Xing Nao Jing ' injection pharmaceutical preparation effective ingredient that does not change existing national drug standards regulation is formed, a kind of injection XINGNAOJING pharmaceutical preparation of new model is provided, can not only separate satisfactorily and never use the solubilizing agent of Tweens material to guarantee equally even improve this stability of drug, simplify preparation technology simultaneously, help industrialized great production.On this basis, the present invention also will provide the preparation method of this injection XINGNAOJING pharmaceutical preparation.
Injection Chinese medicine first aid of the present invention XINGNAOJING powder injection formulation medicine, be to be the active drug composition, form with the auxiliary element that powder medicine administered by injection thing allows by volatile extract composition and the Borneolum Syntheticum to the Moschus of this medicine regulation material quantity, Radix Curcumae, Fructus Gardeniae in the present national standard.Wherein, Moschus, Radix Curcumae and three kinds of volatile extract compositions of Fructus Gardeniae, all be to adopt the supercritical extraction mode, the extract that the volatile ingredient that for example adopts the supercritical fluid technology extraction to obtain obtains, with Borneolum Syntheticum jointly as the active drug composition, and form jointly with acceptable auxiliary element in powder injection formulation.
On this basis, can adopt existing processing mode, auxiliary element hybrid process each mixing active ingredients thing is common and that powder medicine administered by injection thing allows is handled.For example can be described by aforementioned documents, with HP-the active drug mixture of ingredients is carried out enclose and handle.Wherein, when adopting HP-to carry out the enclose processing, comprise 5～20 times of promising said volatile extract and Borneolum Syntheticum gross weights in the auxiliary element that said powder medicine administered by injection thing allows, more preferably 8～12 times HP-is good.
To the preparation of each effective volatile medicine composition in the above-mentioned powder medicine administered by injection thing of the present invention, can be earlier the powder of medicine material Moschus, Radix Curcumae and the Fructus Gardeniae of medicine ormal weight be put in the supercritical extraction device, under the condition of 15-45Mpa and 30 ℃-40 ℃, use CO
2Supercritical fluid technology extraction mode obtains corresponding volatility extract composition, adds the Borneolum Syntheticum of ormal weight and the ethanol or the aquiferous ethanol of meltage then its dissolving is mixed.HP-with the abundant stirring and dissolving of suitable quantity of water, and is under agitation slowly dropped to the alcoholic solution of hybrid medicine composition in the HP-aqueous solution, ingredient is carried out enclose.This inclusion complex in solution need not to be dried in the usual way the clathrate powder, directly in this inclusion complex in solution, add at least a (wherein the being preferably mannitol) excipient in mannitol, lactose, the glucose etc. and be adjusted to pH value 6.0-6.5, adopt the ultrafiltration mode, or remove pyrogen and dry (as modes such as lyophilization commonly used or spray dryinges) in boiling modes such as adding down the 0.05%-0.2% active carbon, promptly obtain the said injection powder of the present invention medicine administered by injection thing.
When adopting activated carbon to boil the removal pyrogen operation of mode, be preferably in boil after again in 70-90 ℃ of insulation 5-20 minute, remove the pyrogen composition to reach abundant absorption, and then cooling is filtered.Its filtration can adopt the substep mode to carry out, first coarse filtration decarburization, and reuse microporous filter membrane (as 0.22 μ m aperture commonly used) filters.
In above-mentioned preparation method, the water yield of dissolving HP-can be convenient to operation again generally so that it is fully dissolved, and cuts down the consumption of energy, and reaches can make HP-fully carry out enclose to be as the criterion.Test shows, the water consumption during dissolving generally can for HP-weight with 5-20 doubly.
The preparation of above-mentioned enclose solution can adopt the mode of existing at present report and/or use to carry out.For example, one of concrete operation method that can be for reference, be that the volatile ingredient that will be collected by supercritical extraction and Borneolum Syntheticum are dissolved in the arbitrary solvent in ethanol, aquiferous ethanol or the acetone, and then add the HP-of said amount and stir it is fully dissolved, promptly obtain the said volatile ingredient of collecting for the supercritical extraction of the usefulness of making up a prescription and the inclusion complex in solution of Borneolum Syntheticum effective ingredient.
The first aid of the above-mentioned injection Chinese medicine of the present invention is with a remarkable advantage of XINGNAOJING powder injection formulation medicine, is the stable in properties of active drug composition wherein, and is easy to use.On the one hand, the active drug composition in the medicine of the present invention is the volatile effective component in the medicine regulation raw material all, therefore is equivalent to the content of the crude drug amount of national drug prescribed by standard more exactly.On the other hand, result of the test shows, after all volatility active drug composition is used the HP-enclose, also can solve the water solublity problem of volatile ingredient in the XINGNAOJING ZHUSHEYE satisfactorily, has improved stability of drug and drug effect effectively.In addition, when the active drug composition is carried out the enclose processing,, need not to be dried earlier powdered, adopted directly this enclose solution is used for follow-up operation, also simplified the operation of preparation process greatly according to the characteristics of HP-.
The specific embodiment by the following examples is described in further detail foregoing of the present invention again.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.Do not breaking away under the above-mentioned technological thought situation of the present invention, various replacements or change according to ordinary skill knowledge and customary means are made all should comprise within the scope of the invention.
The specific embodiment
Medicinal raw material is chosen satisfactory crude drug Moschus 7.5g, Radix Curcumae 30g and Fructus Gardeniae 30g, Borneolum Syntheticum 1g by the pharmacopeia regulation.
Embodiment 1
The powder of above-mentioned medicinal raw material Moschus, Radix Curcumae and Fructus Gardeniae is put in the supercritical extraction device, and extraction is 2 hours under the extraction temperature of the extracting pressure of 15Mpa and 30 ℃, the extract of Moschus, Radix Curcumae and Fructus Gardeniae.
Get HP-, add in 5 times of water gagings, be put on the agitator, stir.Other gets extract, the Borneolum Syntheticum of Moschus, Radix Curcumae and Fructus Gardeniae, the dissolve with ethanol of weight such as uses, and slowly drops in the HP-aqueous solution, stirred 5 hours, the inclusion complex in solution of active drug composition.
The mannitol of usual amounts (or lactose, glucose) is added stirring and dissolving in the inclusion complex in solution of active drug composition, regulate pH value to 6.0-6.5 with NaOH, 0.1% active carbon boils the back can first coarse filtration decarburization after 5-20 minute activated carbon treatment of 70-90 ℃ of insulation, the filtering with microporous membrane of reuse 0.22 μ m.Be sub-packed in the 2ml ampoule, be cooled to-30 ℃～-40 ℃ after, place rapidly in the freeze drying box, kept 1～2 hour, freeze drying box is carried out application of vacuum, making the vacuum in the case is 0.2～0.4Pa, carries out lyophilization.Heating up and being strict controlled in below the eutectic point-2 ℃ kept 12 hours, was warming up to 40 ℃ at last, put into aseptic filtration gas, and the water content of control preparation is generally 2% 1～5%, seals sealing rapidly and gets final product.
Embodiment 2
Above-mentioned medicinal raw material Moschus, Radix Curcumae and Cape Jasmine Fruit are put in the supercritical extraction device, and extraction is 2 hours under the extraction temperature of the extracting pressure of 45Mpa and 40 ℃, the extract of Moschus, Radix Curcumae and Fructus Gardeniae.
Get HP-, add in 10 times of water gagings, be put on the agitator, stir.Other gets extract, the Borneolum Syntheticum of Moschus, Radix Curcumae and Fructus Gardeniae, the dissolve with ethanol of the moisture 5-30% of weight such as uses, and slowly drops in the HP-aqueous solution, stirred 2 hours, the inclusion complex in solution of active drug composition.
The inclusion complex in solution stirring and dissolving that the mannitol of usual amounts is added the active drug composition, regulate pH value to 6.0-6.5 with NaOH, after ultrafiltration removes thermal source, control filtrate down after carrying out spray drying under the suitable flow velocity at inlet temperature 100-150 ℃, aseptic subpackaged, promptly.
Above-mentioned lyophilized injectable powder of the present invention has been carried out relevant pharmacodynamics contrast test with the XINGNAOJING ZHUSHEYE of using at present.Because of this medicine belongs to a kind of first aid medication of Chinese medicine preparation form, so the two short effect of waking up to mice has been investigated in this test.
1, reagent and experimental animal
Experimental animal: healthy Kunming mouse, body weight 20 ± 2g (institute of antibiotics, Sichuan Province provides).
XINGNAOJING ZHUSHEYE, Wuxi Shanhe Medicine Industry Co., Ltd, lot number: 040608;
Powder is used in the pentobarbital sodium experiment, and French import is by the packing of Beijing chemical reagents corporation, lot number: 020219;
Injection caffeine and sodium benzoate raw material, Shanghai the 14 pharmaceutical factory;
Injection XINGNAOJING freeze-dried powder of the present invention.
2, experimental technique and result
2.1 XINGNAOJING ZHUSHEYE and injection of the present invention are ' Xingnaojing ' freeze dried to the free active influence test of mice
Get 30 of mices, body weight 20 ± 2g, male and female half and half, be divided into ' Xingnaojing ' freeze dried group of normal saline blank group, XINGNAOJING ZHUSHEYE matched group, injection of the present invention at random, measure movable number of times in each Mus 5min before the administration respectively, through comparing, the activity indifference opposite sex of three groups of mices has comparability.Each medicine all proportionately people's consumption calculate the every Mus in dilution back all with the dosage ip administration of 0.2ml/10g.Measure the interior free movable number of times of each Mus 5min with the free activity inventory instrument of the multi-functional mice of YLS-2LA behind the administration 30min, calculate the average and the standard deviation of each group, check with t, the result is as shown in table 1, demonstrate with the blank group of normal saline significant difference is relatively arranged, the ' Xingnaojing ' freeze dried free movable number of times that can obviously improve mice of XINGNAOJING ZHUSHEYE and injection of the present invention is described, has a better effect but injection of the present invention is ' Xingnaojing ' freeze dried.
Table 1 XINGNAOJING injectable powder is to the free active influence of mice (n=10, x ± s)
| Group | The movable number (inferior) of mice in the 5min | Raising rate (%) |
| Normal saline blank group XINGNAOJING ZHUSHEYE group XINGNAOJING powder of the present invention pin group | ????187.3±22.4 ????247.7±4.5 ※????????264.2±5.4 ※ | ????- ????32.2 ????41.1 |
Compare ※ P＜0.01 with the blank group of normal saline
2.2 the ' Xingnaojing ' freeze dried influence of XINGNAOJING ZHUSHEYE and injection of the present invention to mouse sleep time
Get 40 of mices, body weight 20 ± 2g, male and female half and half are divided into ' Xingnaojing ' freeze dried group of normal saline blank group, caffeine and sodium benzoate normal saline solution (2mg/ml), XINGNAOJING ZHUSHEYE matched group, injection of the present invention at random.Each medicine all proportionately people's consumption calculate the every Mus in dilution back all with the dosage ip administration of 0.2ml/10g, each Mus while ip0.2% pentobarbital sodium 0.2ml/10g behind the 40min, the record righting reflex loss time is to the time of recovering, calculate the average and the standard deviation of each group, check with t, the result is as shown in table 2, demonstrate with normal saline blank group significant difference is relatively arranged, illustrate that the ' Xingnaojing ' freeze dried hypnosis time of occurrence to pentobarbital sodium in mice of XINGNAOJING ZHUSHEYE and injection of the present invention has obvious prolongation effect, have a better effect but injection of the present invention is ' Xingnaojing ' freeze dried.
2.3 the ' Xingnaojing ' freeze dried influence test (writhing method) of XINGNAOJING ZHUSHEYE and injection of the present invention to the mice analgesic activity
Get 30 of mices, body weight 20 ± 2g, male and female half and half are divided into ' Xingnaojing ' freeze dried group of normal saline blank group, XINGNAOJING ZHUSHEYE matched group, injection of the present invention at random.Each medicine all proportionately people's consumption calculate the every Mus in dilution back all with the dosage ip administration of 0.2mL/10g, each Mus ip 0.6% glacial acetic acid solution 0.3ml/ only behind the 30min, the writhing response number of times of each Mus in the record 15min, calculate the average and the standard deviation of each group, carry out the t check, the result is as shown in table 3, demonstrate with normal saline blank group significant difference is relatively arranged, illustrate that the ' Xingnaojing ' freeze dried glacial acetic acid that can obviously reduce of XINGNAOJING ZHUSHEYE and injection of the present invention causes the mouse writhing reaction times, significant analgesic activity is arranged, have a better effect but injection of the present invention is ' Xingnaojing ' freeze dried.
Table 2 XINGNAOJING injectable powder is to the influence of mice hypnosis time of occurrence (n=10, x ± s)
| Group | Dosage (dilution back) | The length of one's sleep (min) |
| Physiological saline blank group caffeine sodium benzoate physiological saline group XINGNAOJING ZHUSHEYE group Xingnaojing powder of the present invention pin group CN1554431A powder pin group CN1562292A powder pin group | ??0.4ml ??2mg/kg ??20ml/kg ??20ml/kg ??20ml/kg ??20ml/kg | ??29.5±5.3 ??9.3±4.7 ??14.9±4.4 ※????11.2±5.2 ※????12.6±5.8 ※????11.3±5.2 ※ |
Compare with the blank group of normal saline: ※ P＜0.01 (test data of CN1554431A powder pin, CN1562292A powder pin draws from corresponding data in literature)
Table 3 XINGNAOJING injectable powder causes influence (n=10, the x ± s) of pain effect to mice
| Group | The movable number (inferior) of mice in the 5min | Analgesia rate (%) |
| Normal saline blank group XINGNAOJING ZHUSHEYE group XINGNAOJING powder of the present invention pin group | ??38.02±2.5 ??23.06±2.1 ※????21.32±2.2 ※ | ??- ??39.03 ??43.92 |
Compare ※ P＜0.01 with the blank group of normal saline
Claims (9)
1. injection Chinese medicine first-aid powder medicine administered by injection thing, volatile extract composition and Borneolum Syntheticum by the Moschus of medicine regulation material quantity, Radix Curcumae, Fructus Gardeniae are the active drug composition, form with the auxiliary element that powder medicine administered by injection thing allows, the extract of volatile extract composition that it is characterized in that Moschus, Radix Curcumae and Fructus Gardeniae for adopting the supercritical extraction mode to obtain, with Borneolum Syntheticum be the active drug composition, form jointly with acceptable auxiliary element in powder injection formulation.
2. injection Chinese medicine first-aid powder medicine administered by injection thing as claimed in claim 1 is characterized in that comprising in the auxiliary element that said powder medicine administered by injection thing allows 5～20 times HP-of promising said volatile extract and Borneolum Syntheticum gross weight.
3. injection Chinese medicine first-aid powder medicine administered by injection thing as claimed in claim 2 is characterized in that said active drug composition is that the mixture of whole extract and Borneolum Syntheticum is jointly by the form of HP-enclose.
4. the preparation method of injection Chinese medicine first-aid powder medicine administered by injection thing, it is characterized in that the powder of medicine material Moschus, Radix Curcumae and the Fructus Gardeniae of medicine ormal weight is put in the supercritical extraction device, under the temperature of the pressure of 15-45Mpa and 30-40 ℃, obtain corresponding volatility extract composition, add the Borneolum Syntheticum of ormal weight and the ethanol or the aquiferous ethanol of meltage dissolving is mixed; The HP-water fully dissolved stir, and under agitation the alcoholic solution of hybrid medicine composition is slowly dropped in the HP-aqueous solution, ingredient is carried out enclose, excipient is added enclose liquid and is adjusted to pH value 6.0-6.5, remove the pyrogen after drying and obtain injection powder medicine administered by injection thing.
5. preparation method as claimed in claim 4 is characterized in that 5-20 that the said water yield that is used to dissolve HP-is a HP-weight doubly.
6. preparation method as claimed in claim 4 is characterized in that it is to add activated carbon under the condition of boiling that said enclose liquid is removed the mode of pyrogen, refilters processing in 70-90 ℃ of insulation after 5-20 minute then.
7. preparation method as claimed in claim 4 is characterized in that the enclose liquid after the said filtration adopts the freezing mode drying to obtain the freeze-dried powder injectable drug.
8. preparation method as claimed in claim 4 is characterized in that said filtrate filtered adopts the spray drying mode to obtain powder pin injectable drug.
9. as the described preparation method of one of claim 4 to 8, it is characterized in that said excipient can be at least a in mannitol, lactose, the glucose.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101897929A (en) * | 2010-07-07 | 2010-12-01 | 广州安健实业发展有限公司 | Improved composition as well as preparation method and application thereof |
| CN102293984A (en) * | 2010-06-28 | 2011-12-28 | 江西济民可信集团有限公司 | Xingnaojing freeze-drying quick release preparation and preparation method and application thereof |
| CN102406890A (en) * | 2010-07-07 | 2012-04-11 | 西安安健药业有限公司 | Modified composition, preparation method and application thereof |
-
2005
- 2005-06-23 CN CN 200510021149 patent/CN1709344A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102293984A (en) * | 2010-06-28 | 2011-12-28 | 江西济民可信集团有限公司 | Xingnaojing freeze-drying quick release preparation and preparation method and application thereof |
| CN102293984B (en) * | 2010-06-28 | 2015-07-22 | 江西济民可信集团有限公司 | Xingnaojing freeze-drying quick release preparation and preparation method and application thereof |
| CN101897929A (en) * | 2010-07-07 | 2010-12-01 | 广州安健实业发展有限公司 | Improved composition as well as preparation method and application thereof |
| CN102406890A (en) * | 2010-07-07 | 2012-04-11 | 西安安健药业有限公司 | Modified composition, preparation method and application thereof |
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