CN102657841A - Ginger phenols extract preparation and preparation method thereof - Google Patents
Ginger phenols extract preparation and preparation method thereof Download PDFInfo
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- CN102657841A CN102657841A CN2012101873951A CN201210187395A CN102657841A CN 102657841 A CN102657841 A CN 102657841A CN 2012101873951 A CN2012101873951 A CN 2012101873951A CN 201210187395 A CN201210187395 A CN 201210187395A CN 102657841 A CN102657841 A CN 102657841A
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Abstract
The invention relates to a ginger phenols extract preparation, in particular to a ginger phenols extract soft capsule and a preparation method thereof. The content of the soft capsule comprises 3-10 parts of ginger phenols extract and 40-60 parts of oleaginous base by weight part. Preferably, the content of the soft capsule comprises 6 parts of ginger phenols extract and 54 parts of corn oil by weight. The extraction method of the ginger phenols extract in the soft capsule is supercritical carbon dioxide extraction method which has the advantages of high extraction rate and high content of 6-gingerol. Meantime, the ginger phenols extract soft capsule has good stability.
Description
Technical field
The present invention relates to a kind of ginger phenols extract preparation, specifically, relate to a kind of ginger phenols extract soft capsule and preparation method thereof.
Background technology
The economy, culture and the social life that develop rapidly the mankind of the modern means of communication and aerospace industry have been brought into play important facilitation, but also make some people move disease simultaneously.Motion sickness is that the nervous function that causes behind the uncomfortable conditioning that receives in the movement environment is lacked of proper care, and mainly shows as the autonomic nervous system dysfunction.Symptom is usually carries out sexual development, uncomfortable by the gastric area, feel sick, salivation increase, pale complexion, be in a cold sweat, dizzy, headache, and then develop into retch, vomiting, drowsiness, indifferent.The vomiting severe patient in addition can dewater, depletion.It betides people when taking simulation of car, ship, aircraft, recreation facility or navigation, Aeronautics and Astronautics and actual job.Different because of residing movement environment, motion sickness has different titles again, like carsick, airsick (motion sickness), seasick (navigation motion sickness or sea are dizzy), space motion sickness (space flight is sick), simulator sickness etc.The motion sickness sickness rate is higher, and is also bigger with the different variations of movement environment.
The pathogenesis of motion sickness: the motion sickness Study on Pathogenesis is familiar with according to many Chinese and overseas scholars for many years; Can think that abnormal motion stimulates sensigenous conflict in the central nervous system; Cause many transmitter in central nervous system systemic-function loss of equilibrium; Endocrine function, cerebral cortex functional disorder, not normal to the regulating and controlling effect of brain stem autonomic center, cause vestibular sensations to reach the autonomic nervous dysfunction unusually.The motion sickness resistant medicament of clinical practice at present mainly contains following several types: anticholinergic agent, antihistaminic, dopamine-receptor antagonist, 5-hydroxytryptamine receptor antagonist, sympatheticomimetic etc.But these side effects of pharmaceutical drugs are all very big, and anticholinergic agent can suppress the central nervous system, cause drowsinessly, also can make the dimness of vision, xerostomia, impair one's memory etc., should not be used for carrying out the personnel of operation.The antihistaminic kind is more, and is the most commonly used with dimenhydrinate (generally claiming dimenhydrinate, dimenhydrinate), and the side effect that also has maincenter to suppress can cause drowsinessly, when especially increasing consumption for stiffening effect, thereby can not be used for carrying out the personnel of operation.In a word, mostly the motion sickness resistant medicament of clinical practice at present is cholinolytic and antihistaminic medicine, acts on stronger; But side effect is also more; It is little to press for toxic and side effects, does not influence normal operation, goes sightseeing, the motion sickness resistant medicament of operation, space flight operation etc. such as particularly sail across a sea.
The Chinese medicine Rhizoma Zingiberis Recens is the bright rhizome of zingiber (Zingiber officinale Rosc), and nature and flavor are hot, warm, return lung, spleen, stomach warp, have effects such as the cold expelling of inducing sweat, warming middle-JIAO to stop vomiting, preventing phlegm from forming and stopping coughing, cures mainly anemofrigid cold, gastrofrigid vomiting, cold-phlegm cough.
The report that a large amount of Rhizoma Zingiberis Recens treatment vomitings are arranged in the traditional Chinese medical science classical literature.Physician Li Gao claims " Rhizoma Zingiberis Recens is the patient suffering from habitual vomiting panacea ".Tao Hongjing: " the rheumatism cold and heat are told, removed to the Rhizoma Zingiberis Recens preventing or arresting vomiting." property of medicine opinion " record Rhizoma Zingiberis Recens preventing or arresting vomiting can not be told any more food." Bencao Congxin " record: Roast Rhizoma Zingiberis Recens and middle emesis." dietitian's heart mirror " record " stopping vomiting is told, and hundred medicines are not poor: Rhizoma Zingiberis Recens one or two, and cut like Semen phaseoli radiati and close with vinegar slurry seven greatly, take four in silverware and close, empty stomach and dregs are revolved and are sipped it "." Medical Treasures of the Golden Chamber " Rhizoma Zingiberis Recens Rhizoma Pinelliae soup people that cures the disease seemingly breathes heavily in the heart, seemingly vomits, like vomiting muddled right helpless person in the heart." Medical Treasures of the Golden Chamber " Zingiberis-Ginseng-Pinelliae Pill controls incesant vomiting during pregnancy.
Five, the sixties, China has developed a series of Chinese herb compounds in the Chinese herbal medicine motion, like anti-corona clever sheet; Form by 10 flavor Chinese medicines such as Rhizoma Zingiberis Recens, Caulis Perillae, anti-corona, form by Flos Daturae, Rhizoma Zingiberis, Pericarpium Zanthoxyli etc.; The Rhizoma Zingiberis Recens mixture is made up of 6 flavor Chinese medicines such as Rhizoma Zingiberis Recens, the Rhizoma Pinelliae, is used to prevent and treat motion sickness; Effect is strong than dimenhydrinate, and side effect is not obvious.The report that a large amount of Rhizoma Zingiberis Recens anti-kinetosis are arranged in recent ten years both at home and abroad.
The Rhizoma Zingiberis Recens section is spread on Neiguan acupoint, can prevent carsickness, try out in 39 routine carsick persons, carsick phenomenon does not take place in 38 examples, and being used to treat the serious symptom vomiting has good effect, Rhizoma Zingiberis Recens is mashed like the mud shape spread on the effect that Neiguan acupoint also has the prevention carsickness.
Rhizoma Zingiberis Recens juice all has significant inhibitory effect to the gastric emptying of Canis familiaris L. due to the cisplatin rat stomach emptying sluggishness sluggish and that 1,2,3,-thrihydroxy-benzene causes, and its effect is better than ondansetron.To CuSO
4Due to pigeon vomiting, but the Rhizoma Zingiberis Recens juice significant prolongation occur vomiting incubation period, reduce the vomiting number of times, tell intensity and reach 85% in the town.
With the Rhizoma Zingiberis Recens airing; Wear into fine powder and be loaded in the capsule orally, at random, the double blinding clinical trial shows: Rhizoma Zingiberis Recens powder can suppress vomiting and be in a cold sweat, and has that significant prevention is seasick, carsickness acts on; Effect is superior to dimenhydrinate; Do not find any tangible untoward reaction, but preparation is unstable, places the effect of two weeks and promptly greatly reduce.Rhizoma Zingiberis Recens powder can significantly alleviate the nausea and vomiting that multiple operation back occurs, and acts on quite with metoclopramide, and has no side effect.5 months randomized controlled result of the test of 70 routine women is remarkable, the vomiting that Rhizoma Zingiberis Recens powder gestation causes, and inhibitory action and metoclopramide are suitable, and have no side effect.Rhizoma Zingiberis Recens powder dizzyly has a significant inhibitory effect to what thermostimulation caused.
12 routine volunteer's result of the tests show that Rhizoma Zingiberis Recens extract significantly strengthens harmonization of the stomach duodenum intestinal motive force.The effect and the metoclopramide of oral Rhizoma Zingiberis Recens acetone extract enhance gastrointestinal power are suitable.Rhizoma Zingiberis Recens acetone and ethanol extraction all have significant inhibitory effect to the gastric emptying of Canis familiaris L. due to the cisplatin gastric emptying sluggishness sluggish and that 1,2,3,-thrihydroxy-benzene causes, and the effect of acetone extract is better than ethanol extraction, and suitable with ondansetron.To CuSO
4Due to pigeon vomiting, but gingerade decoct significant prolongation occur vomiting incubation period, reduce vomiting number of times and vomiting number of elements.The ethanol of Rhizoma Zingiberis Recens and acetone extract have significant inhibitory effect to the vomiting of the Canis familiaris L. due to the chemotherapy such as cisplatin.
The anti-kinetosis mechanism of Rhizoma Zingiberis Recens is also not clear and definite fully at present.Most researchs think that the anti-kinetosis effect of Rhizoma Zingiberis Recens mainly is through the direct influence to gastronintestinal system, improve digestive tract power.Jiang Zhenglin etc. discover; The anti-kinetosis effect of Rhizoma Zingiberis Recens is similar with the anticholinergic agent scopolamine; The lumbar injection Rhizoma Zingiberis Recens juice is better than gastric infusion to the effect of the anti-kinetosis of rat; The effect of prompting Rhizoma Zingiberis Recens anti-kinetosis possibly also have other mechanism of action except that outside the Pass directly effect has to gastrointestinal with it.The research of Qian Dongsheng etc. is thought; Rhizoma Zingiberis Recens plays the anti-kinetosis effect through maincenter and periphery cholinolytic and antihistamine; The process of inhibition of Rhizoma Zingiberis Recens juice cerebral cortex is strengthened; Preceding stimulation impulsion for bringing out is inhibited to corticocerebral conductive process, thereby can alleviate dizzy and nauseating reaction.
Comprehensive above data can find out that Rhizoma Zingiberis Recens has anti-kinetosis effect definitely and significantly and do not have obvious toxic and side effects, is comparatively ideal motion sickness resistant medicament.Europe and American Pharmacopeia are classified Rhizoma Zingiberis Recens as anti-dizzy antiemetic.But different method for preparinies are bigger to the anti-kinetosis function influence of Rhizoma Zingiberis Recens; Wherein the anti-dizzy antiemetic effect of Rhizoma Zingiberis Recens juice is the strongest; Significantly be superior to dimenhydrinate etc., medicines such as the effect of dried Rhizoma Zingiberis Recens powder and dimenhydrinate, metoclopramide and scopolamine are suitable, and the anti-kinetosis effect of Rhizoma Zingiberis Recens acetone extract and dimenhydrinate etc. are quite or slightly; The effect of Rhizoma Zingiberis Recens ethanol extraction and water extract is less, even not anti-dizzy antiemetic effect.But Rhizoma Zingiberis Recens juice and Rhizoma Zingiberis powder are all unstable, are difficult to be prepared into stable, dosage form easily.Use organic solvent extraction, when reclaiming solvent, be prone to make a part of composition to lose or destroy.According to phenolic constituents such as the gingerol in the Rhizoma Zingiberis Recens, shogaols is its anti-dizzy antiemetic main component, and we select supercritical CO through systematic research
2The fluid extraction method, the preparation ginger phenols extract, and prepare further that the anti-kinetosis effect is strong, side effect is little, the Jiang Su soft gelatin capsule that dosage form is stable.
Summary of the invention
Primary goal of the invention of the present invention is to provide a kind of ginger phenols extract soft capsule;
Second goal of the invention of the present invention is to provide this ginger phenols extract preparation of soft capsule method.
In order to accomplish the object of the invention, the technical scheme of employing is:
A kind of ginger phenols extract soft capsule, the consisting of of described soft capsule content: ginger phenols extract 3～10 weight portions, oleaginous base 40～60 weight portions; Be preferably: ginger phenols extract 4～8 weight portions, oleaginous base 50～56 weight portions; More preferably: ginger phenols extract 6 weight portions, oleaginous base 52～56 weight portions.
First optimal technical scheme of the present invention is: described oleaginous base is selected from least a in Semen Maydis oil, Oleum Arachidis hypogaeae semen, soybean oil, the olive oil.
Second optimal technical scheme of the present invention is: the consisting of of described soft capsule content: ginger phenols extract 6 weight portions, Semen Maydis oil 54 weight portions.
The 3rd optimal technical scheme of the present invention is: the consisting of of described soft capsule rubber: gelatin 25～40 weight portions, glycerol 10～20 weight portions, water 30～48 weight portions; Be preferably gelatin 30～36 weight portions, glycerol 12～18 weight portions, water 36～42 weight portions.
The 4th optimal technical scheme of the present invention is: the method for distilling of ginger phenols extract is in the described soft capsule:
(1) Rhizoma Zingiberis Recens is cut into 2～5mm thin slice, 40～45 ℃ of aeration-drying to water content were pulverized 40 mesh sieves less than 10%, got Rhizoma Zingiberis Recens powder;
(2) with the Rhizoma Zingiberis Recens powder supercritical CO of packing into
2In the extraction equipment, be that 40～55 ℃, pressure are 20～30Mpa, CO in temperature
2Flow velocity is to extract under the condition of 10kg/h.kg raw material, and the extraction time is 1～3 hour, is that the separating still of 10Mpa is collected ginger phenols extract in pressure then.
The 5th optimal technical scheme of the present invention is: the ultra CO of supercritical
2Extraction conditions, temperature are 53～55 ℃, preferred 55 ℃.
The 6th optimal technical scheme of the present invention is: the ultra CO of supercritical
2Extraction conditions, pressure are 28～30Mpa, preferred 30Mpa.
The 7th optimal technical scheme of the present invention is: described preparation of soft capsule method is:
(1) preparation of content: take by weighing ginger phenols extract and oleaginous base by weight, fully stir in 55～65 ℃ and make whole dissolvings; Put common filter paper filtration under diminished pressure in the buchner funnel, filtrating is filtered through the G3 sintered glass funnel again, gets clear and bright solution;
(1) preparation of glue: take by weighing water and glycerol by weight, be heated to 70～80 ℃, mix homogeneously adds gelatin by weight, stirs, and fusion is incubated 1～2 hour, leaves standstill, and treats to remove after the foam come-up, filters heat preservation for standby use;
(2) the preparation soft gelatin capsule places 21～24 ℃ of relative humidity 20～30%, temperature with the soft gelatin capsule of processing, and carries out drying under the air blast condition, and making glue shell water content is 6～10%.
Further explain in the face of technical scheme of the present invention down:
The present invention proposes a kind of soft capsule of ginger phenols extract,, be difficult to make solid preparation because the crude drug of preparation of the present invention is a semifluid; If process tablet etc.; Not only need add a large amount of adjuvants, and because the pungent abnormal smells from the patient of crude drug, make the compliance variation of medicine.And because ginger phenols extract of the present invention is soluble in vegetable oil, and because it has acid, oral back local concentration may produce stimulation to gastrointestinal when higher, after the vegetable oil dilution, delays its release, reduces local excitation.Therefore, ginger phenols extract is prepared into soft capsule, can overcomes above-mentioned defective.Simultaneously,, can also prevent volatilization, increase stability because the ginger phenols extract less stable behind vegetable oil dissolving preparation soft gelatin capsule, suppresses its oxidation thereby reduce with contacting of oxygen.Simultaneously, because Semen Maydis oil does not almost have influence to blood fat, and the large-scale production of medicinal Semen Maydis oil, resource is sufficient, steady quality, can reach medicinal standard, and price is lower.The results showed that the Semen Maydis oil solution of ginger phenols extract still keeps clear and bright state through long-time place (2～3 years), do not have deposition, metachromatism, assay is stablized constant.So the present invention preferably adopts Semen Maydis oil and ginger phenols extract to prepare soft capsule, find that through contrast test the stability of ginger phenols extract of the present invention in Semen Maydis oil is higher than other oleaginous bases.Can know that through stability test the stability of the soft capsule of formulation of the present invention is good.And find that through stability test adopt ginger phenols extract: Semen Maydis oil is the ratio of 1:9, the stability of the soft capsule that obtains is best, is superior to other ratios.
The method preparation of supercritical carbon dioxide extraction has been adopted in the preparation of the ginger phenols extract in the soft capsule of the present invention, and this method has simple to operate, extraction ratio advantages of higher with respect to other organic solvent extracting access method.The present invention improves this method:
At first, Rhizoma Zingiberis Recens is dry, and under lower temperature conditions, aeration-drying prevents the volatilization of effective ingredient; And find that through the influence experiment of extraction ratio and the dried water content of Rhizoma Zingiberis Recens water content is bigger to the productive rate influence of extract between 10～20% the time, and that water content changes less than 10% productive rate is little, is lower than 10% so selection is dried to water content.Simultaneously, the granularity of material has double influence to extraction ratio, and on the one hand, material attenuates has increased mass transfer area, has reduced mass transfer distance and resistance to mass tranfer, is beneficial to extraction; On the other hand, material is too thin, is prone to be compacted under the high pressure, has increased resistance to mass tranfer, is unfavorable for extraction.The present invention finds Rhizoma Zingiberis powder is prepared into 40 purpose granularities through experiment, and extraction yield is best.
Then, with the Rhizoma Zingiberis Recens powder supercritical CO of packing into
2In the extraction equipment, be that 50～55 ℃, pressure are 25～30Mpa, CO in temperature
2Flow velocity is to extract under the condition of 10kg/h.kg raw material, and the extraction time is 2～3 hours; Preferred condition is that temperature is that 55 ℃, pressure are 30Mpa, CO
2Flow velocity is 10kg/h.kg; Be the separating still collection ginger phenols extract of 10Mpa then in pressure.Carrying out supercritical CO
2Find in the extraction process, when the pressure of adjustment separator I is 50 ℃ of 10Mpa, temperature, can obtain oleoresin shape thing, promptly what obtain then is grease at separator II (pressure is 6.5Mpa).The GC-MS analysis result shows, contains compositions such as monoterpene, sesquiterpene among the extract II, is mainly volatile oil.Extract I mainly contains phenols component, therefore is called ginger phenols extract.And learn through further pharmacodynamic experiment, the extract of the ginger phenols that just prepares with extraction method for preparing of the present invention, its drug effect is best; And extraction conditions of the present invention, its productive rate can reach 3～12.0%, and the content of 6-gingerol can reach 22.5～28.5% in the prepared ginger phenols extract that obtains.
Description of drawings:
Fig. 1 is the high-efficient liquid phase chromatogram of the ginger phenols extract for preparing among the embodiment;
Fig. 2 be in the experimental example 2 the Rhizoma Zingiberis Recens powder water content to the influence curve of extraction yield.
The specific embodiment of the present invention only limits to content of the present invention is done further explanation and explanation, content of the present invention is not enough become restriction.
The specific embodiment
Embodiment 1 preparation ginger phenols extract soft capsule
1. prescription is:
2 preparation technologies
2.1 supercritical carbon dioxide extraction ginger phenols extract thing:
(1) Rhizoma Zingiberis Recens is cut into 2～5mm thin slice, 45 ℃ of aeration-drying to water content were pulverized 40 mesh sieves less than 10%, got Rhizoma Zingiberis Recens powder;
(2) with the Rhizoma Zingiberis Recens powder supercritical CO of packing into
2In the extraction equipment, be that 55 ℃, pressure are 30Mpa, CO in temperature
2Flow velocity is to extract under the condition of 10kg/h.kg raw material, and the extraction time is 2 hours, is that the separating still of 10Mpa is collected and obtained ginger phenols extract in pressure then, and its high-efficient liquid phase chromatogram is as shown in Figure 1.
2.2 solution preparation
The preparation of content solution: accurately take by weighing ginger phenols extract 600g, add medicinal Semen Maydis oil 5400g, fully stir in 60 ℃ and make whole dissolvings; Put common filter paper filtration under diminished pressure in the buchner funnel, filtrating is filtered through the G3 sintered glass funnel again, gets clear and bright solution.
The preparation of glue: by formulation weight, take by weighing gelatin, G & W, first G & W mixing post-heating to 70～80 ℃ adds gelatin by prescription, stirs, and fusion is incubated 1～2 hour, leaves standstill, and treats to remove after the foam come-up, filters heat preservation for standby use.
2.3 soft gelatin capsule preparation
Adopt RJWJ-1 type soft capsule system capsule mechanism to be equipped with the Jiang Su soft gelatin capsule; The soft gelatin capsule of processing is spread out and put in tray, put into drying alley, at 20～30% relative humiditys, 21～24 ℃ of temperature are carried out drying under the air blast condition, make glue shell water content in 6～10% scopes; Every ball soft gelatin capsule weighs 0.3 gram, includes the 30mg ginger phenols extract.
Embodiment 2～6 preparation ginger phenols extract soft capsules
It is as shown in table 1 to fill a prescription:
Table 1:
Method for preparing is with embodiment 1.
Embodiment 7～12: preparation ginger phenols extract soft capsule
It is as shown in table 2 to fill a prescription:
Table 2:
All the other compositions and method for preparing are with embodiment 1.
Experimental example 1: the extraction of ginger phenols extract
Adopt the method for embodiment 1, Rhizoma Zingiberis Recens is carried out supercritical carbon dioxide extraction, wherein, the baking temperature of Rhizoma Zingiberis Recens is carried out grouping experiment, be divided into 4 groups: 30 ℃ of groups, 40 ℃ of groups, 60 ℃ are organized and 80 ℃ of groups; Make the fresh ginger sheet be dried to water content below 10% respectively at 30,40,60 and 80 ℃, all the other conditions are with embodiment 1.Get the dried Rhizoma Zingiberis Recens powder of 200g respectively and carry out supercritical CO
2Extraction is measured extract content and 6-gingerol content, result such as table 3.
The influence of table 3. Rhizoma Zingiberis Recens powder baking temperature to extracting
Experimental result shows, baking temperature to the extraction influence of 6-gingerol obviously, when temperature was 60～80 ℃, the content that extracts 6-gingerol in the product reduced, so the present invention is chosen in 40～45 ℃ and under ventilation condition, carries out drying.The factor that influences under the Rhizoma Zingiberis Recens powder step extraction effect possibly be since temperature too Gao Zehui make a part of composition lose or destroys, therefore must control baking temperature.
Experimental example 2
Adopt the method for embodiment 1, Rhizoma Zingiberis Recens is carried out supercritical carbon dioxide extraction, wherein, water content in the Rhizoma Zingiberis Recens powder is carried out grouping experiment, its experimental result is as shown in table 4, and all the other conditions are with embodiment 1.See accompanying drawing 2.
The influence of table 4. Rhizoma Zingiberis Recens powder water content to extracting
From accompanying drawing 1, can find out, water content between 10～20% the time productive rate influence to extract bigger, and that water content changes less than 10% productive rate is little, is lower than 10% so selection is dried to water content.
Experimental example 3
Adopt the method for embodiment 1, Rhizoma Zingiberis Recens is carried out supercritical carbon dioxide extraction, wherein, the condition of supercritical carbon dioxide extraction is carried out grouping experiment, and its experimental result is as shown in table 5, and all the other conditions are with embodiment 1.
Table 5:
Can know that according to above-mentioned contrast test adopt the temperature and pressure condition among the embodiment 1, the productive rate of prepared ginger phenols extract is the highest, the content of 6-gingerol is the highest.Therefore the condition in the preferred embodiment of the present invention 1 is an extraction conditions, carries out large-scale production.
Experimental example 4: stability test
1 sample source
Get 3 batches (0101,0102,0103) of the ginger phenols extract soft capsule of embodiment 1 preparation.
2 test apparatuses
Tianjin, island UV-2501PC ultraviolet spectrophotometer;
High pressure liquid chromatograph, Waters 600 pumps, 996 diode array detectors, 717 automatic samplers, 2010 chromatographic work stations.
3 contents of the test
Get 3 batches (0101,0102,0103) of the ginger phenols extract soft capsule of embodiment 1 preparation, deposited 18 months at normal temperature, observe, measure content respectively at sampling in 1,2,3,6,9,12,18 month with listing packing (plastic-aluminum bubble-cap).
4 investigation projects and method: measure according to officinal relevant rules:
Appearance character: direct observation.
Differentiate: thin layer chromatography.
Disintegration time, the ball method of double differences are different: pertinent regulations under the capsule item.
Every of total phenol content contains 15 ~ 24mg: ultraviolet spectrophotometry, make blank with Semen Maydis oil, and adopt dual wavelength to measure.
6-gingerol content: HPLC.
5. investigation result
Investigate the result like table 10-12.This preparation was through 18 months investigation, and its physicochemical property and assay are not all seen significant change, explain that the investigation of said preparation preliminarily stabilised property meets the requirements.
Table 10. Jiang Su soft gelatin capsule preliminarily stabilised property experimental result
Table 11. Jiang Su soft gelatin capsule preliminarily stabilised property experimental result
Table 12. Jiang Su soft gelatin capsule preliminarily stabilised property experimental result
Embodiment 5: pharmacodynamic experiment
1. the preparation of medicine:
1.1 extract ginger phenols extract according to the method among the embodiment 1;
1.2 extract ginger phenols extract according to the method in the Comparative Examples 1;
1.3 extract ginger phenols extract according to the method in the Comparative Examples 3;
1.4 extract ginger phenols extract according to the method in the Comparative Examples 5;
1.5 extract ginger phenols extract according to the method in the Comparative Examples 6.
2. pharmacodynamic experiment:
2.1: the prevention experiment that guinea pig eye trembles:
Cavia porcellus is divided into 6 groups at random, 20 of every treated animals; Body weight 300 ~ 400 grams, ♀
dual-purpose.
Matched group only gives Semen Maydis oil 05ml/; All the other 5 groups of dosages are 20mg/kg;
Medication and time are gastric infusion one time, and administration time is the preceding 30min of test.
Experimental technique
In darkroom with sound insulation and lucifuge, clear-headed Cavia porcellus is placed in the special fixed bin, two the place aheads at eye level, as positive and negative electrode, the auris dextra outer rim is a reference electrode at the subcutaneous insertion of right and left eyes outer canthus 3/8# medical suture needle.Put into Cavia porcellus external auditory meatus edge with a transfusion plastic tube and connect syringe, draw 4 ℃ of cold water of 5ml, in 30s, inject fast and finish with syringe.Lead physiograph with RM-6000 more, be equipped with nystagmus that preposition biological amplifier AB-600G traces level that 4 ℃ of cold water stimulating Cavia porcellus external auditory meatuss bring out or the vertical direction continuously ripple that quivers.The instrument record condition is time constant 2, sensitivity 0.02mV/DIV, filtering 30Hz, chart drive speed 10mm/s, 1 °=1mm of calibration.Be normal eye movement ripple writing time, and 30s, 1min nystagmus involve the nystagmus ripple concluding time after irritating cold water.
Observation index
The nystagmus incidence rate (%) of quivering: after observing cold water stimulating Cavia porcellus external auditory meatus, the animal that occurs 5 same directions (to the left or to the right) sawtooth like wave and certain time continuously is the nystagmus positive person (+) that quivers.
Experimental result is as shown in Tble 15:
The preventive effect that each extract of table 15. Rhizoma Zingiberis Recens trembles to guinea pig eye
2.2 histamine phosphate brings out the antagonism experiment that the Cavia porcellus pipe smooth muscle shrinks:
Test is established six groups, matched group, 1 group of embodiment, 1 group of experimental example, 3 groups of experimental examples, 5 groups of experimental examples, 6 groups of experimental examples altogether.
Animal: 36 of Cavia porcelluss; Body weight 300 ~ 400 grams, ♀
dual-purpose.Every group 6.
Method: Cavia porcellus tapped the head with blunt causes dusk, gets stomach rapidly, cuts stomach bottom after taking out stomach; Cut off stomach along lesser gastric curvature and remove mucosa (cut-out ring muscle), flesh bar at the bottom of the stomach that is cut into 3mm along the parallel intersection of longitudinal muscle direction is fixed on an end of long 2cm BIAO and BEN on the L type pipe portion hook; The other end is connected on the tension pick-up, places Tyrode ' s liquid, and Tyrode ' s liquid is formed (NaCl137mM; KCl 2.7mM, CaCl
20.2mM, MgCl
20.1mM, NaH
2PO
20.05mM, NaHCO
31.0mM, glucose 1.0mM), pH 7.4, and 37 ℃ of constant temperature, volume are 15ml, feed to contain 95%O
2And 5%CO
2Mist, predetermined tension is 1g, balance 1h writes down stomach, smooth muscle contraction amplitude through tension pick-up with balance recorder.Add His 1 * 10 in advance
-4Mg/ml brings out the contraction of Cavia porcellus stomach and reaches ceiling effect.After washing 3 times, add and to receive reagent back balance 10min, add isodose His again, observe and add the following stomach shrinkage curve of respectively organizing behind the medicine.Experimental result is shown in table 16:
Each extract of table 16. Rhizoma Zingiberis Recens brings out the antagonism that the Cavia porcellus pipe smooth muscle shrinks to histamine phosphate
Compare * * P＜0.01 with matched group, * P＜0.05.
2.3: acetylcholine is brought out the antagonism experiment that the Cavia porcellus pipe smooth muscle shrinks
Test is established six groups, matched group, 1 group of embodiment, 1 group of experimental example, 3 groups of experimental examples, 5 groups of experimental examples, 6 groups of experimental examples altogether.
Animal: 36 of Cavia porcelluss; Body weight 300 ~ 400 grams, ♀
dual-purpose.Every group 6.
Method: Cavia porcellus tapped the head with blunt causes dusk, gets stomach rapidly, cuts stomach bottom after taking out stomach; Cut off stomach along lesser gastric curvature and remove mucosa (cut-out ring muscle), flesh bar at the bottom of the stomach that is cut into 3mm along the parallel intersection of longitudinal muscle direction is fixed on an end of long 2cm BIAO and BEN on the L type pipe portion hook; The other end is connected on the tension pick-up, places Tyrode ' s liquid, and Tyrode ' s liquid is formed (NaCl137mM; KCl 2.7mM, CaCl
20.2mM, MgCl
20.1mM, NaH
2PO
20.05mM, NaHCO
31.0mM, glucose 1.0mM), pH 7.4, and 37 ℃ of constant temperature, volume are 15ml, feed to contain 95%O
2And 5%CO
2Mist, predetermined tension is 1g, balance 1h writes down stomach, smooth muscle contraction amplitude through tension pick-up with balance recorder.Add Ach 1 * 10 in advance
-5Mg/ml brings out the contraction of Cavia porcellus stomach and reaches ceiling effect.After washing 3 times, adding receives reagent back balance 10min, adds isodose Ach again, and observation adds the stomach shrinkage curve behind the agonist.
Each extract of table 17. Rhizoma Zingiberis Recens brings out the antagonism (drug dose is 0.18mg/ml) that the Cavia porcellus pipe smooth muscle shrinks to acetylcholine
Compare * * P＜0.01 with matched group, * P＜0.05.
2.4 preventive effect experiment to Canis familiaris L. vomiting due to the morphine hydrochloride:
Experimental animal: area, Hebei domesticated dog, body weight 13 ~ 17kg, male and female dual-purpose.
Dosage is provided with and divides into groups
Test is established six groups, matched group, 1 group of embodiment, 1 group of experimental example, 3 groups of experimental examples, 5 groups of experimental examples, 6 groups of experimental examples altogether.Matched group gives 2ml/ Semen Maydis oil only, and it is 0.36mg/kg that all the other each groups give dosage.Several 4 of every treated animal.
Test method
Select the dog of relatively cooperating for use, and it is relatively more responsive that the subcutaneous injection morphine hydrochloride is caused vomiting, can use repeatedly in 1 week at interval.Fasting is 18 hours before the experiment, presses heavily administration of animal body during test, and ginger phenols extract is filled in the back pharyngeal of dog, gives a small amount of beef simultaneously, lets animal obey voluntarily down.The back 30min that takes medicine begins subcutaneous injection morphine hydrochloride 0.1mg/kg.At once observe time started, vomiting number of times that abdomen (feeling sick), vomiting appear taking out in animal after the injection, be 30min observing time.Experimental result is shown in table 18.
Table 18. Rhizoma Zingiberis Recens extract is to the preventive effect of Canis familiaris L. vomiting due to the morphine hydrochloride
Claims (8)
1. a ginger phenols extract soft capsule is characterized in that, the consisting of of described soft capsule content: ginger phenols extract 3～10 weight portions, oleaginous base 40～60 weight portions; Be preferably: ginger phenols extract 4～8 weight portions, oleaginous base 50～56 weight portions; More preferably: ginger phenols extract 6 weight portions, oleaginous base 52～56 weight portions.
2. ginger phenols extract soft capsule according to claim 1 is characterized in that, described oleaginous base is selected from least a in Semen Maydis oil, Oleum Arachidis hypogaeae semen, soybean oil, the olive oil.
3. ginger phenols extract soft capsule according to claim 1 is characterized in that, the consisting of of described soft capsule content: ginger phenols extract 6 weight portions, Semen Maydis oil 54 weight portions.
4.. ginger phenols extract soft capsule according to claim 1 is characterized in that, the consisting of of described soft capsule rubber: gelatin 25～40 weight portions, glycerol 10～20 weight portions, water 30～48 weight portions; Be preferably gelatin 30～36 weight portions, glycerol 12～18 weight portions, water 36～42 weight portions.
5. ginger phenols extract soft capsule according to claim 1 is characterized in that, the method for distilling of ginger phenols extract is in the described soft capsule:
(1) Rhizoma Zingiberis Recens is cut into 2～5mm thin slice, 40～45 ℃ of aeration-drying to water content were pulverized 40 mesh sieves less than 10%, got Rhizoma Zingiberis Recens powder;
(2) with the Rhizoma Zingiberis Recens powder supercritical CO of packing into
2In the extraction equipment, be that 40～55 ℃, pressure are 20～30Mpa, CO in temperature
2Flow velocity is to extract under the condition of 10kg/h.kg raw material, and the extraction time is 1～3 hour, is that the separating still of 10Mpa is collected ginger phenols extract in pressure then.
6. ginger phenols extract soft capsule according to claim 5 is characterized in that, the ultra CO of supercritical
2Extraction conditions, temperature are 53～55 ℃, preferred 55 ℃.
7. ginger phenols extract soft capsule according to claim 6 is characterized in that, the ultra CO of supercritical
2Extraction conditions, pressure are 28～30Mpa, preferred 30Mpa.
8. according to the described ginger phenols extract soft capsule of the arbitrary claim of claim 1～7, it is characterized in that described preparation of soft capsule method is:
(1) preparation of content: take by weighing ginger phenols extract and oleaginous base by weight, fully stir in 55～65 ℃ and make whole dissolvings; Put common filter paper filtration under diminished pressure in the buchner funnel, filtrating is filtered through the G3 sintered glass funnel again, gets clear and bright solution;
(1) preparation of glue: take by weighing water and glycerol by weight, be heated to 70～80 ℃, mix homogeneously adds gelatin by weight, stirs, and fusion is incubated 1～2 hour, leaves standstill, and treats to remove after the foam come-up, filters heat preservation for standby use;
(2) the preparation soft gelatin capsule places 21～24 ℃ of relative humidity 20～30%, temperature with the soft gelatin capsule of processing, and carries out drying under the air blast condition, and making glue shell water content is 6～10%.
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| CN104489434A (en) * | 2014-12-18 | 2015-04-08 | 东华大学 | Jelly for preventing carsickness and preparation method thereof |
| CN104784659A (en) * | 2015-04-08 | 2015-07-22 | 湖南科技学院 | Traditional Chinese medicine tablet for treating hyperlipidemia and preparation method thereof |
| CN105188400A (en) * | 2013-03-15 | 2015-12-23 | 爱默思公司 | Composition and method for preventing, reducing, alleviating, or treating idiopathic vomiting |
| CN105963705A (en) * | 2016-06-13 | 2016-09-28 | 湖北文理学院 | Compound stabilizer for preserving gingerol and use method of compound stabilizer |
| US11419912B2 (en) | 2013-03-15 | 2022-08-23 | Mars, Incorporated | Dietary composition for preventing, reducing, alleviating or treating idiopathic vomiting |
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