CN1453290A - Prepn of curcumol and oral medicine containing curcumol - Google Patents
Prepn of curcumol and oral medicine containing curcumol Download PDFInfo
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- CN1453290A CN1453290A CN 03108036 CN03108036A CN1453290A CN 1453290 A CN1453290 A CN 1453290A CN 03108036 CN03108036 CN 03108036 CN 03108036 A CN03108036 A CN 03108036A CN 1453290 A CN1453290 A CN 1453290A
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- yellow ginger
- liquid
- medicament
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- steroidal saponin
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- 239000003814 drug Substances 0.000 title abstract description 33
- QRMPRVXWPCLVNI-YYFQZIEXSA-N Curcumol Chemical compound C1C(=C)[C@@H]2CC[C@H](C)[C@@]22C[C@@H](C(C)C)[C@]1(O)O2 QRMPRVXWPCLVNI-YYFQZIEXSA-N 0.000 title abstract 6
- QRMPRVXWPCLVNI-UHFFFAOYSA-N Curcumenol Natural products C1C(=C)C2CCC(C)C22CC(C(C)C)C1(O)O2 QRMPRVXWPCLVNI-UHFFFAOYSA-N 0.000 title abstract 3
- VFLDPWHFBUODDF-FCXRPNKRSA-N curcumin Chemical compound C1=C(O)C(OC)=CC(\C=C\C(=O)CC(=O)\C=C\C=2C=C(OC)C(O)=CC=2)=C1 VFLDPWHFBUODDF-FCXRPNKRSA-N 0.000 abstract description 74
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 abstract description 36
- 239000007788 liquid Substances 0.000 abstract description 14
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- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Chinese medicine material curcuma is water decocted or ethanol reflux extracted with the extracted liquid being water diluted; the extracted liquid is then water eluted and ethanol eluted in macro porous resin column; and the elutent liquid is collected and concentrated into paste while ethanol being recovered. The paste is decompression dried, crushed, sieved and packed. Curcumol is mixed with solid or liquid medicine excipient and the mixture is produced into orally taken solid or liquid medicine.
Description
Technical field
The invention belongs to the medicinal preparation technical field of the reaction product that contains raw material or itself and not clear structure, be specifically related to derive from the material of plant.
Background technology
Cardiovascular diseases belongs to organic disease, and the elderly's sickness rate is the highest, and treatment cycle is long, adopts operation or western medicine for acute attack, and is general or supportive treatment takes traditional Chinese medicine or Chinese patent medicine.
The Chinese patent medicine that is used for the treatment of at present cardiovascular diseases clinically has FUFANG DANSHEN DIWAN, step-length NAOXINTONG, puerarin, puerarin sheet, Herba Erigerontis tablet, Diaoxinxuekang etc.These medicines have certain therapeutic action clinically, but curative effect is not fairly obvious, some medicine material obtains comparatively difficulty, in the Chinese medicine material proportioning as the step-length NAOXINTONG, some are arranged is animal drugs, used Dioscorea panthaica Prain et Burkill is the species of frequently endangering in the Chinese medicine material proportioning of Diaoxinxuekang, and the root of kudzu vine is to forbid the plant of gathering.
The yellow ginger element is the total saponins constituents that extracts from the yellow ginger dry root, with the content of the new glycosides colorimetric estimation of yellow ginger total steroidal saponin more than 60%.
The former plant of yellow ginger is a Rhizome of Peltate Yam, is the exclusive kind that is grown in China, and its suitable habitat is area, China Ankang, in Hubei and Sichuan growth is arranged also, is the main raw material that extracts saponin, and from the content analysis of saponin, yellow ginger content is the highest, is generally 4%.
Summary of the invention
A technical problem to be solved by this invention is to provide a kind of preparation method of yellow ginger element.
Another technical problem to be solved by this invention is to overcome the shortcoming of said medicine, and a kind of oral pharmaceutical that cardiovascular diseases contains the yellow ginger element for the treatment of are provided.
Solving the problems of the technologies described above a technical scheme that is adopted and be with the Chinese medicine yellow ginger is that raw material is made according to following step:
The decocting of getting Chinese medicinal materials yellow ginger weight ratio and be 8～10 times boils, or is that 3～5 times alcohol reflux, extracting solution received alcohol back thin up with weight ratio.Last macroporous resin column is used the water lotion identical with yellow ginger weight washing, is 50%～70% ethanol elution of yellow ginger 1/2 with weight again, collects 50%～70% ethanol eluate, reclaims ethanol, is condensed into rare cream, and drying under reduced pressure is pulverized, and sieves, and packs.
Solving the problems of the technologies described above another technical scheme that is adopted is: the yellow ginger element in total steroidal saponin, by 1: 0.25～11.5 weight ratios and the solid mixed with excipients of conventional medicine, is made the Peroral solid dosage form medicament with conventional formulation technology.The yellow ginger element in total steroidal saponin, is mixed with the conventional medicine liquid excipient by 1: 10～50 weight ratios, make the liquid oral medicament with conventional formulation technology.
Peroral solid dosage form medicament of the present invention is tablet, granule, capsule, soft capsule.Liquid oral medicament of the present invention is an oral liquid.
The optimum ratio of oral pharmaceutical of the present invention is:
The yellow ginger element by 1: 1～10 weight ratios and the solid mixed with excipients of conventional medicine, is made Peroral solid dosage form medicament with conventional formulation technology in total steroidal saponin.The yellow ginger element mixes with the conventional medicine liquid excipient by 1: 20～40 weight ratios in total steroidal saponin, makes the liquid oral medicament with conventional formulation technology.
The best proportioning of oral pharmaceutical of the present invention is:
The yellow ginger element is in total steroidal saponin, consolidates mixed with excipients by 1: 7 weight ratio with conventional medicine, makes the Peroral solid dosage form medicament with conventional formulation technology.The yellow ginger element mixes with the conventional medicine liquid excipient by 1: 20 weight ratio in total steroidal saponin, makes the liquid oral medicament with conventional formulation technology.
The preparation method of yellow ginger element of the present invention has that raw material is easy to get, technology is easy, yield is than advantages such as height, and yield can reach more than 70%, can be used for the extraction of yellow ginger element.
The medicinal ingredients yellow ginger of oral pharmaceutical of the present invention is plain through acute toxicity test, and test-results shows that the plain mouse administration of yellow ginger can not ask LD
50, maximum dosage-feeding is 24.0g/kg, is equivalent to 1440 times of people's daily dosage portion.Oral pharmaceutical yellow ginger cellulose capsule of the present invention is through the pharmacological effect test, after test-results shows that oral pharmaceutical yellow ginger cellulose capsule of the present invention is the mouse stomach administration according to the dosage of 75mg/kg, 150mg/kg, 300mg/kg, general situations such as the spirit of animal, activity there is not obvious influence.The vetanarcol inducing mouse there is not tangible influence the length of one's sleep; After being the anesthetized dog duodenal administration by the dosage of 25mg/kg, 50mg/kg, 100mg/kg, breathing, blood pressure (systolic pressure, diastolic pressure peace is pulse pressure all) and the electrocardiogram(ECG of animal there is not tangible influence.
Oral pharmaceutical of the present invention enter the clinic observation test through State Food and Drug Administration's approval.
Embodiment
The present invention is described in more detail below in conjunction with embodiment, but the invention is not restricted to these embodiment.
Embodiment 1
Get yellow ginger 100kg, be cut into the thick thin slice in the 15mm left and right sides, add the 500kg decocting and boil 3 times, each 1 hour, merge decoction liquor, to filter, filtrate is that 20kg, column length are the D of 2m by the weight of having handled well
101Macroporous resin column with the water lotion washing of 100kg, is used 50% ethanol 50kg wash-out behind the upward intact sample again, collects 50% ethanol eluate, reclaims ethanol, is condensed into rare cream, and drying under reduced pressure is pulverized, and sieves packing.
Embodiment 2
Get yellow ginger 100kg, be cut into the thick thin slice in the 15mm left and right sides, or be ground into meal, the ethanol 500kg refluxing extraction with 70% 2 times, each 2 hours, merge alcohol extract, reclaim ethanol, add water 400kg to there not being the alcohol flavor, stir evenly, placed 12 hours, and filtered, filtrate is that 20kg, column length are the D of 2m by the weight of having handled well
101Macroporous resin column with the water lotion washing of 100kg, is used 70% ethanol 50kg wash-out behind the upward intact sample again, collects 70% ethanol eluate, reclaims ethanol, is condensed into rare cream, and drying under reduced pressure is pulverized, and sieves packing.
Embodiment 3
With 1000 in production product tablet of the present invention is that the used raw material of example and auxiliary material and proportioning thereof are:
The plain 167g of yellow ginger
Starch 100g
Dextrin 80g
Sucrose 15g
Talcum powder 15g
Magnesium Stearate 3g
Contain activeconstituents total steroidal saponin 100g among the plain 167g of the yellow ginger of said ratio.
Its preparation method is: get yellow ginger element, starch, dextrin, sucrose mixing, add talcum powder and Magnesium Stearate, mixing is pressed into 1000, and sugar coating or film-coat get product.Raw material that sugar coating or film-coat are used and proportioning thereof are chosen by conventional sugar coating of technology of pharmaceutics or used raw material and the proportioning thereof of film-coat, and every contains total steroidal saponin 100mg.
Usage and dosage: once oral 2,3 times on the one, one after each meal.
Embodiment 4
With 1000 of production product soft capsules of the present invention is that the used raw material of example and auxiliary material and proportioning thereof are:
The plain 167g of yellow ginger
Maize germ 500g
Beeswax 8g
Contain activeconstituents total steroidal saponin 100g among the plain 167g of the yellow ginger of said ratio.
Its preparation method is: get the yellow ginger element and pulverized 120 mesh sieves, make the plain fine powder of yellow ginger, add maize germ, beeswax, stirring and evenly mixing is made capsulation solution, is pressed into soft capsule, and drying gets product.Every contains total steroidal saponin 100mg.
Usage and dosage: once oral 2,3 times on the one, one after each meal.
Embodiment 5
With 1000 of production product capsules of the present invention is that the raw material in example institute river and auxiliary material and proportioning thereof are:
The plain 167g of yellow ginger
Starch 33g
Contain activeconstituents total steroidal saponin 100g among the plain 167g of the yellow ginger of said ratio.
Its preparation method is: gets the yellow ginger element, adds starch, mix, make softwood for mixing humectant with 85% ethanol, and cryodrying, 1000 capsules of packing into after the granulation get product.Every heavy 0.2g contains total steroidal saponin 100mg.
Usage and dosage: once oral 2,3 times on the one, one after each meal.
Embodiment 6
With production product granule 1000g of the present invention is that the used raw material of example and auxiliary material and proportioning thereof are:
The plain 167g of yellow ginger
Starch 600g
Sucrose 183g
Dextrin 50g
Contain activeconstituents total steroidal saponin 100g among the plain 167g of the yellow ginger of said ratio.
Its preparation method is: get yellow ginger element, starch, dextrin, sucrose mixing, add 85% ethanol and make particle, drying is made 1000g, gets product.Every gram contains total steroidal saponin 100mg.
Usage and dosage: once oral 2g, 3 times on the one, one after each meal.
Embodiment 7
With production product oral liquid of the present invention 1000mL is that the used raw material of example and auxiliary material and proportioning thereof are:
The plain 167g of yellow ginger
Sweet close plain 10g
Purified water adds to 1000mL
Contain activeconstituents total steroidal saponin 100g among the plain 167g of the yellow ginger of said ratio.
Its preparation method is: get the plain 500mL of adding of yellow ginger purified water and make its dissolving, filter, filtrate adds sweet close element makes its dissolving, adds purified water to 1000mL, divides in the ampoule of packing into, gets product.Every bottle of 10mL, every milliliter contains total steroidal saponin 10mg.
Usage and dosage: once oral 20mL, 3 times on the one, one after each meal.
In order to verify beneficial effect of the present invention, committee of contriver unit one belongs to drags test unit that yellow ginger element of the present invention has been carried out acute toxicity test, and product capsule of the present invention has been carried out the pharmacological effect test, and various test situation are as follows;
One, the plain acute toxicity test in mice of yellow ginger
Test objective: observe plain acute toxic reaction and the death condition that produced behind the gastric infusion in 1st of yellow ginger.
Be subjected to the reagent thing: yellow ginger is plain to be that greatly western-Yonghe County's biological medicine science and technology laboratory provides lot number: 20020108 (containing total steroidal saponin 60%), the aterrimus powder is crossed 120 mesh sieves with medicinal powder, is made into 20% concentration with distilled water.
Animal subject: the ICR mouse, body weight 18～22g, male and female half and half are provided by zooscopy chamber, Traditional Chinese Medicine Research Institute, Shanxi Province.
Animal subject conformity certification number: the moving card of doctor word 08-24 number.
Test method: get 12 of ICR mouse, male and female half and half, every group 4, totally 3 groups, after the fasting 12 hours, organize mouse stomach administration 20%0.40mL/10g (once), 20%0.80mL/10g (secondary), 20%1.20mL/10g (three times) respectively to each in one day, pre-test result, three treated animals are all survived.So test as maximum dosage-feeding according to 1.20mL/10g (three times).
Other gets 20 of ICR mouse, male and female half and half, fasting are after 12 hours, are administered three times in one day each mouse stomach, each 3 hours at interval, each 0.40mL/10g, animal is raised with particulate material, freely drinks water, natural lighting 12 hours/12 hours, 20～24 ℃ of room temperatures, humidity 60%, table 1 is observed general activity situation and the survival condition of animal in the week after the administration.
Test-results: movable normal after the mouse administration, there is not excited, uneasy performance, animal does not have convulsions, does not have perpendicular hair, sheds tears, hydrostomia, protruding eye, diarrhoea, writhing response.Apnea is rapid, and lip and afterbody do not have the cyanosis phenomenon.Do not have 1 animal dead in 7 days, put to death the back of weighing in the 8th day.Dissect and find gastric filling, intestines do not have flatulence, dissect, and the visual inspection heart, liver, spleen, lung, kidney, suprarenal gland, thymus gland, ovary, uterus, seminal vesicle, prostate gland, testis, stomach, intestines and thoracic cavity, abdominal cavity, each organ is all no abnormal.
The mouse body weight is 18.67 ± 2.56g before the administration, and the 8th day body weight is 22.27 ± 2.10g after the administration.
Table 1 animal acute toxicity test is observed table
Observation item performance and symptom
Spontaneous activity increases, minimizing, play, tired crouch motionless
Muscular movement is trembled, tic, paralysis, ataxia
Muscular tension strengthens, weakens, myotony, muscle relaxation
React nervous, slow in reacting
The perpendicular hair of vegetative nerve, shed tears, hydrostomia, protruding eye, diarrhoea, writhing response
Respiration inhibition, rapid, depleted
Skin color is pale, cyanosis, hyperemia
Death time is anxious dead, slow dead
Dead symptom struggle, opisthotonus, spit out white foams
Conclusion (of pressure testing): the plain mouse administration of yellow ginger can not asked LD
50, maximum dosage-feeding is 24.0g/kg, is equivalent to 1440 times of people's daily dosage portion.
Method of calculation: 0.40mL/10g * 3 time * 100 * 20g/100mL=24.0g/kg;
Adult consumption: 600mg is calculated as 10mg/kg by adult 60kg;
24.0g/kg * 60% ÷ 10mg/kg=1440 doubly.
Two, the pharmacological effect of yellow ginger cellulose capsule test
Test objective: the main pharmacodynamics of observing the yellow ginger cellulose capsule is made evaluation objectively to its selectively acting, for clinical trial provides test basis with other pharmacological actions widely.
Be subjected to the reagent thing: yellow ginger cellulose capsule content is the black crystalline powder, lot number: 20020310, by the west big-Yonghe County's thing gives birth to the medical sci-tech laboratory and provides.
Be subjected to reagent thing compound method:
Dog: facing the time spent is made into the suspension of 10mg% with this product with physiological saline, gives through duodenum according to required dosage;
Mouse: with concentration (heavy dose) be 30mg/mL, other respectively organize medication by doubling dilution to desired concn, the filling stomach give.
Animal subject: hybrid dog, male and female half and half, body weight 12.50 ± 1.97kg.ICR strain small white mouse, male and female half and half, body weight 20 ± 1g provides by Xian Medical Univ's Experimental Animal Center, and the moving card of doctor word is 08-004 number.Small white mouse is supplied solid feed and tap water, the drinking-water of freely ingesting, the branch sex is raised in cages.26 ℃ of room temperatures, relative humidity 72%.
1, to animal spirit, active influence
Test method: get 40 of ICR strain small white mouses during test, ♀ ♂ half and half, body weight 20.0 ± 1.0g is divided into 4 groups at random, and each 5 of every group of ♀ ♂ are divided into normal physiological saline control group and large, medium and small dosed administration group.The administration treated animal is irritated stomach respectively and is given yellow ginger cellulose capsule normal saline solution 0.1mL/10g (75mg/kg, 150mg/kg, 300mg/kg), and the physiological saline control animals gives 10mL/kg physiological saline.Successive administration 3 days, the general situation such as expression, hair, activity, pupil, mouth and nose discharge of eye, stool and urine of observing animal simultaneously.Last administration 30 minutes, 60 minutes, 120 minutes is with the many movable number of times (inferior/10 minute) of measuring animal with instrument of YSD-4 type physiological and pharmacological.
Test-results: test-results sees Table 2.
Table 2 yellow ginger cellulose capsule is to the influence (x ± s of mouse mobility; x
2-test)
Dosage number of animals animal activity counting (inferior/10 minute)
Group
(mg/kg) (n) 30 minutes 60 minutes 120 minutes
Saline control group-10 21.21 ± 1.55 25.90 ± 8.23 26.70 ± 9.92
Small dose group 75.0 10 21.32 ± 1.51 27.50 ± 8.48 25.10 ± 7.99
Middle dosage group 150.0 10 20.80 ± 2.15 28.80 ± 9.50 25.80 ± 6.21
Heavy dose of group 300.0 10 20.60 ± 1.51 25.20 ± 5.18 26.50 ± 6.12
Conclusion (of pressure testing): the result shows in the table 2, and the activity count of each administration treated animal and saline control group relatively find no obvious significant difference (P＞0.01), and prompting yellow ginger cellulose capsule does not have obvious influence to the activity of animal.When observing during administration simultaneously, also do not find that the expression, spirit, hair, activity, stool and urine etc. of animal have obviously unusual performance, prompting yellow ginger cellulose capsule does not have obvious influence to the neural system of animal.
2, to the influence of the length of one's sleep of vetanarcol inducing mouse
(1) influence of dosage vetanarcol inducing mouse length of one's sleep above threshold
Test method: get 40 of ICR strain small white mouses, ♀ ♂ half and half, body weight 20.0 ± 1.0g is divided into 4 groups at random, and each 5 of every group of ♀ ♂ are divided into normal physiological saline control group, large, medium and small dosed administration group and positive controls.The administration treated animal is irritated stomach respectively and is given yellow ginger cellulose capsule normal saline solution 0.1mL/10g (75mg/kg, 150mg/kg, 300mg/kg), the physiological saline control animals gives 10ml/kg physiological saline, logotype 3 days, after the last administration 30 minutes, each treated animal is abdominal injection vetanarcol 40mg/kg respectively, with after the administration to the time of areflexia is the latent period of sleeping anyway; With areflexia anyway to the time of recovering be the length of one's sleep.
Test-results: test-results sees Table 3.
Table 3 yellow ginger cellulose capsule is to the vetanarcol inducing mouse influence of the length of one's sleep (x ± s)
The dosage group length of one's sleep in latent period
(mg/kg) (branch) (branch)
Saline control group-16.60 ± 5.10 26.60 ± 5.34
Small dose group 75.0 19.30 ± 5.72 26.20 ± 6.55
Middle dosage group 150.0 16.76 ± 5.37 27.10 ± 5.51
Heavy dose of group 300.0 15.48 ± 6.04 25.10 ± 6.71
Conclusion (of pressure testing): the result in the table 3 shows that the sleep latent period of each administration treated animal and the length of one's sleep and saline control group do not have tangible significant difference (P＞0.05).Illustrate that the yellow ginger cellulose capsule does not have tangible influence the length of one's sleep to dosage vetanarcol inducing mouse above threshold.
(2) to the influence of the length of one's sleep of sub-threshold dose vetanarcol inducing mouse
Test method: test method is with 1, and each treated animal is abdominal injection vetanarcol 30mg/kg respectively.
Test-results: test-results sees Table 4.
Table 4 yellow ginger cellulose capsule is to the vetanarcol inducing mouse influence of the length of one's sleep (x ± s)
Dosage length of one's sleep in latent period
Group
(mg/kg) (branch) (branch)
Saline control group-16.60 ± 5.10 26.60 ± 5.34
Small dose group 75.0 19.30 ± 5.72 26.20 ± 6.55
Middle dosage group 150.0 16.76 ± 5.37 27.10 ± 5.51
Heavy dose of group 300.0 15.48 ± 6.04 25.10 ± 6.71
Conclusion (of pressure testing): table 4 result shows that the sleep latent period of each administration treated animal and the length of one's sleep and saline control group do not have tangible significant difference (P＞0.05).Illustrate that the yellow ginger cellulose capsule does not have tangible influence the length of one's sleep to sub-threshold dose vetanarcol inducing mouse.
Result in table 3, the table 4 illustrates simultaneously, and the yellow ginger cellulose capsule does not have tangible influence the length of one's sleep to the vetanarcol inducing mouse.
3, to the influence of anesthetized dog breathing/cardiovascular systems
Test method: during test with 24 healthy hybrid dogs, ♀ ♂ half and half, body weight 14.5 ± 1.97kg is divided into 4 groups at random, 6 every group, is divided into physiological saline control group and large, medium and small dosed administration group.The administration treated animal gives yellow ginger cellulose capsule 25mg/kg, 50mg/kg, 100mg/kg through duodenum respectively, and the normal control group gives the physiological saline of equivalent.During experiment, respectively with animal with 3% vetanarcol (30mg/kg) anesthesia, dorsal position is fixed, and cuts skin of neck, exposes tracheae, inserts tracheae and is connected with the respiration energy converting device.Separate a side arteria carotis communis, insert the conduit that is full of heparin-physiological saline, be connected with pressure transducer.Connect standard I I lead electrocardiogram electrode; Simultaneously breathing, electrocardiogram(ECG and blood pressure signal are imported RM600 type polygraph (Japanese photoelectricity company product), breathing, blood pressure and the electrocardiogram(ECG of record animal.Separate a side femoral vein, insert conduit, be connected intravenous drip physiological saline with the physiological saline drop bottle.Art finishes, and stablizes about 30 minutes, and behind the various normal index of record animal, various physical signs such as 15 minutes, 30 minutes, 60 minutes, 90 minutes, the breathings of 120 timesharing animals, blood pressure, electrocardiogram(ECG are observed after the administration in the beginning administration.
Test-results: test-results sees Table 5, table 6, table 7, table 8, table 9, table 10.
Result in table 5, table 6, the table 7 shows, relatively, finds no obvious significant difference (P＞0.05) before and after the systolic pressure of each administration treated animal, diastolic pressure and the mean arterial pressure administration.Compare with the physiological saline control group, also do not have obvious significant difference (P＞0.05) between the numerical value in each time period before the administration and after the administration.The yellow ginger cellulose capsule does not have obvious influence to the blood pressure of anesthetized dog.
Result in the table 8 shows, in 2 hours, breathe steadily after the administration of normal control treated animal, frequency of respiration/minute and amplitude of respiration, no significant difference relatively before and after the administration.Each dosed administration treated animal of yellow ginger cellulose capsule also shows as same result.The yellow ginger cellulose capsule does not have tangible influence (P＞0.05) to the respiratory system of anesthetized dog.
Result in the table 9 shows that the heart rate of each administration treated animal is the same with normal physiological saline control group before and after the administration, does not have significantly influence (P＞0.05), and heart rate is steady, numerical value basically identical before and after the administration.Show behind the yellow ginger cellulose capsule duodenal administration that the heart rate to anesthetized dog does not have obvious influence in 2 hours, the vetanarcol inducing mouse is not had tangible influence the length of one's sleep.
The result shows in the table 10, and animal electrocardiogram(ECG parameter before and after the administration comprises P-R interval, QRS complex wave interval, T wave height and S-T interval, each administration group and physiological saline control group no significant difference (P＞0.05).The result of table 7 and table 8 illustrates that simultaneously the yellow ginger cellulose capsule does not have obvious influence (P＞0.05) to the anesthetized dog electrocardiogram(ECG.
The pharmacological effect conclusion (of pressure testing) of oral pharmaceutical yellow ginger cellulose capsule of the present invention: after being the mouse stomach administration according to the dosage of 75mg/kg, 150mg/kg, 300mg/kg, general situations such as the spirit of animal, activity are not had obvious influence; The vetanarcol inducing mouse there is not tangible influence the length of one's sleep.After being the anesthetized dog duodenal administration by the dosage of 25mg/kg, 50mg/kg, 100mg/kg, breathing, blood pressure (systolic pressure, diastolic pressure peace is pulse pressure all) and the electrocardiogram(ECG of animal there is not tangible influence.
Table 5 yellow ginger cellulose capsule is to the influence of anesthetized dog systolic pressure (x ± s)
After the preceding administration of group dosage number of animals administration (kpa)
Not other (mg/kg) (n) (kpa) 15min 30min 60min 90min 120min saline control group-6 19.39 19.71 19.47 19.23 19.14 19.00
± 1.22 ± 1.09 ± 0.97 ± 1.12 ± 1.15 ± 1.23 (changing %)-(0.98 (0.11 (1.75 (1.99 (2.48
± 3.17) ± 3.69) ± 3.28) ± 3.09) ± 2.28) small dose group 25.0 6 19.54 18.96 18.78 18.60 18.36 18.12
± 1.95 ± 1.63 ± 1.68 ± 1.75 ± 2.01 ± 1.88 (changing %)-(1.83 (3.61 (2.27 (5.94 (5.94
± 2.40) dosage group 50.0 6 19.4 19.36 19.36 18.96 18.87 18.60 ± 2.56) ± 5.56) ± 3.60) ± 3.60)
± 1.83 ± 1.83 ± 1.83 ± 1.70 ± 0.13 ± 1.42 (changing %)-(0.23 (0.23 (2.19 (2.75 (1.17
± 0.56) ± 0.56) ± 1.42) ± 1.16) ± 4.98) heavy dose of group 100.0 6 18.91 18.96 18.78 18.69 18.47 18.38
± 2.19 ± 2.20 ± 2.12 ± 2.07 ± 2.09 ± 2.04 (changing %)-(0.19 (0.21 (0.33 (1.28 (2.21
±2.10) ±3.21) ±2.31) ±3.12) ±3.32)
Table 6 yellow ginger cellulose capsule is to the influence of anesthetized dog diastolic pressure (x ± s)
After the preceding administration of group dosage number of animals administration (kpa)
Not other (mg/kg) (n) (kpa) 15min 30min 60min 90min 120min saline control group-6 12.88 12.88 12.65 12.43 12.34 12.21
± 1.69 ± 1.46 ± 1.29 ± 1.18 ± 1.16 ± 0.82 (changing %)-(2.08 (1.38 (2.03 (2.38 (4.54
± 3.45) ± 5.26) ± 1.87) ± 2.06) ± 6.22) small dose group 25.0 6 13.59 13.41 13.08 12.88 12.77 12.45
± 2.32 ± 2.36 ± 0.13 ± 2.53 ± 2.45 ± 2.32 (changing %)-(1.36 (3.48 (5.53 (6.31 (6.31
± 2.67) dosage group 50.0 6 13.98 13.05 13.05 12.72 12.63 12.43 ± 4.07) ± 3.04) ± 3.39) ± 3.39)
± 2.41 ± 2.42 ± 2.42 ± 2.33 ± 2.31 ± 2.16 (changing %)-(0.35 (0.35 (3.05 (3.55 (1.17
± 0.85) ± 0.85) ± 2.52) ± 1.10) ± 5.62) heavy dose of group 100.0 6 13.05 13.10 12.57 12.48 12.17 12.03
± 2.66 ± 2.69 ± 2.77 ± 2.48 ± 2.66 ± 2.50 (changing %)-(0.38 (0.68 (3.12 (3.42 (2.74
±3.26) ±2.10) ±4.24) ±2.76) ±1.78)
Table 7 yellow ginger cellulose capsule is to the influence of anesthetized dog mean arterial pressure (x ± s)
After the preceding administration of group dosage number of animals administration (kpa)
Not other (mg/kg) (n) (kpa) 15min 30min 60min 90min 120min saline control group-6 15.09 15.17 14.68 14.70 14.61 14.47
± 1.51 ± 1.28 ± 0.58 ± 1.11 ± 1.11 ± 0.92 (changing %)-(0.73 (0.01 (2.26 (3.05 (3.64
± 3.22) ± 1.79) ± 2.60) ± 2.33) ± 3.65) small dose group 25.0 6 15.571 15.30 14.88 14.81 14.67 14.34
± 2.19 ± 2.13 ± 2.40 ± 2.292.53 ± 2.31 ± 2.15 (changing %)-(1.95 (4.64 (4.99 (5.96 (5.96
± 1.93) dosage group 50.0 6 15.20 15.16 15.16 14.80 14.71 14.52 ± 3.06) ± 2.46) ± 3.40) ± 3.40)
± 2.20 ± 2.21 ± 2.21 ± 2.11 ± 2.13 ± 1.86 (changing %)-(0.30 (0.30 (1.67 (2.22 (1.74
± 0.73) ± 0.73) ± 2.77) ± 1.63) ± 1.84) heavy dose of group 100.0 6 15.00 15.10 14.64 14.58 14.46 14.30
± 2.48 ± 2.46 ± 2.53 ± 2.52 ± 2.53 ± 2.42 (changing %)-(0.62 (1.12 (2.67 (2.78 (2.14
±3.24) ±4.10) ±3.22) ±2.47) ±3.32)
Table 8 yellow ginger cellulose capsule is to the influence of anesthetized dog respiratory system (x ± s)
After the preceding administration of group dosage number of animals administration
Not (mg/kg) (n) (kpa) 15f divide 30 minutes 60 minutes 90 minutes 120 minutes saline control group-6 respiratory rates (inferior/minute) 19.33 19.33 19.18 19.09 19.18 19.18
± 3.27 ± 3.27 ± 3.25 ± 3.20 ± 3.36 ± 3.36 amplitude of respiration (mm) 41.67 41.67 42.83 42.33 44.17 45.00
± 5.35 ± 4.89 ± 5.42 ± 4.84 ± 5.91 ± 6.99 small dose group 25 6 respiratory rates (inferior/minute) 20.00 20.17 20.17 20.17 20.17 20.17
± 2.37 ± 2.32 ± 2.32 ± 2.32 ± 2.32 ± 2.32 amplitude of respiration (mm) 38.83 38.83 38.83 38.83 40.00 40.50
Dosage group 50 6 respiratory rates in ± 6.52 ± 6.52 ± 6.52 ± 6.52 ± 7.13 ± 7.04 (inferior/minute) 20.00 20.00 20.00 20.42 20.58 20.42
± 2.10 ± 2.10 ± 2.10 ± 2.04 ± 2.40 ± 2.04 amplitude of respiration (mm) 37.83 37.83 37.83 36.83 37.83 37.83
± 7.17 ± 7.17 ± 7.17 ± 7.17 ± 7.17 ± 7.17 heavy dose of group 100 6 respiratory rates (inferior/minute) 20.50 20.50 20.58 20.58 20.58 20.58
± 2.07 ± 2.07 ± 2.11 ± 2.11 ± 2.11 ± 2.11 amplitude of respiration (mm) 36.50 36.50 36.50 36.50 36.50 36.50
±8.67 ±8.67 ±8.67 ±8.67 ±8.67 ±8.67
Table 9 yellow ginger cellulose capsule is to the influence of anesthetized dog heart rate (x ± s)
After the preceding administration of group dosage number of animals administration (bpm)
Not other (mg/kg) (n) (bpm) 15 minutes 30 minutes 60 minutes 90 minutes 120 minutes saline control groups-6 178.18 176.22 177.24 179.46 178.26 177.26
± 19.34 ± 18.24 ± 16.23 ± 19.54 ± 14.56 ± 15.68 small dose group 25 6 179.00 179.82 177.34 176.58 178.09 175.67
Dosage group 50 6 169.67 167.59 168.92 166.59 168.52 165.23 in ± 13.13 ± 12.25 ± 14.43 ± 14.87 ± 12.23 ± 10.62
± 49.15 ± 42.03 ± 44.59 ± 42.31 ± 47.20 ± 40.56 heavy dose of groups 100 6 176.83 175.62 175.72 176.23 176.42 177.02
±46.28 ±44.28 ±44.98 ±40.56 ±44.68 ±48.01
Table 10 yellow ginger cellulose capsule is to the influence of each parameter of anesthetized dog electrocardiogram(ECG (x ± s)
After the preceding administration of group dosage number of animals administration (bpm)
Not other (mg/kg) (n) P-R QRS T S-T P-R QRS T S-T
(ms) (ms) (mv) (ms) (ms) (ms) (mv) (ms) heavy dose of group 100 6 73.00 ± 14.95 49.67 ± 9.67 0.18 ± 0.06 73.67 ± 16.37 72.60 ± 12.89 48.56 ± 10.70 0.20 ± 0.06 78.23 ± 17.36 in dosage group 50 6 69.67 ± 11.76 61.33 ± 10.33 0.22 ± 0.06 90.00 ± 20.98 67.89 ± 10.62 60.45 ± 9.78 0.21 ± 0.08 89.09 ± 22.34 in saline control group-6 68.50 ± 8.09 56.50 ± 8.94 0.19 ± 0.13 86.67 ± 14.95 67.89 ± 9.02 57.20 ± 9.84 0.17 ± 0.19 87.78 ± 15.94 small dose group 25 6 69.00 ± 9.86 58.00 ± 16.97 0.24 ± 0.05 80.67 ± 18.14 68.23 ± 8.46 57.57 ± 14.02 0.23 ± 0.07 82.03 ± 17.24
Claims (5)
1, a kind of preparation method of yellow ginger element is characterized in that it is to make with following step:
The decocting of getting Chinese medicinal materials yellow ginger weight ratio and be 8～10 times boils, or is that 3～5 times alcohol reflux, extracting solution received alcohol back thin up with weight ratio; Last macroporous resin column is used the water lotion identical with yellow ginger weight washing, is 50%～70% ethanol elution of yellow ginger 1/2 with weight again, collects 50%～70% ethanol eluate, reclaims ethanol, is condensed into rare cream, and drying under reduced pressure is pulverized, and sieves, and packs.
2, a kind of oral pharmaceutical that contain the yellow ginger element is characterized in that: the yellow ginger element in total steroidal saponin, by 1: 0.25～11.5 weight ratios and the solid mixed with excipients of conventional medicine, is made the Peroral solid dosage form medicament with conventional formulation technology; The yellow ginger element in total steroidal saponin, is mixed with the conventional medicine liquid excipient by 1: 10～50 weight ratios, make the liquid oral medicament with conventional formulation technology.
3, according to the described oral pharmaceutical that contain the yellow ginger element of claim 2, it is characterized in that: said Peroral solid dosage form medicament is tablet, granule, capsule, soft capsule; Said liquid oral medicament is an oral liquid.
4, according to the described oral pharmaceutical that contain the yellow ginger element of claim 2, the yellow ginger element wherein by 1: 1～10 weight ratios and the solid mixed with excipients of conventional medicine, is made the Peroral solid dosage form medicament with conventional formulation technology in total steroidal saponin; The yellow ginger element wherein mixes with the conventional medicine liquid excipient by 1: 20～40 weight ratios in total steroidal saponin, makes the liquid oral medicament with conventional formulation technology.
5, according to the described oral pharmaceutical that contain the yellow ginger element of claim 2, the yellow ginger element is in total steroidal saponin, wherein consolidates mixed with excipients by 1: 7 weight ratio with conventional medicine, makes the Peroral solid dosage form medicament with conventional formulation technology; The yellow ginger element wherein mixes with the conventional medicine liquid excipient by 1: 20 weight ratio in total steroidal saponin, makes the liquid oral medicament with conventional formulation technology.
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| CN102451333A (en) * | 2010-10-20 | 2012-05-16 | 刘光东 | Method for extracting water-soluble saponin from yellow ginger |
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| CN102451333A (en) * | 2010-10-20 | 2012-05-16 | 刘光东 | Method for extracting water-soluble saponin from yellow ginger |
| CN102451333B (en) * | 2010-10-20 | 2014-02-05 | 刘光东 | Method of extracting water-soluble saponin from yellow ginger |
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