CN101033197A - Pharmaceutical for preventing and treating fever and preparation thereof - Google Patents
Pharmaceutical for preventing and treating fever and preparation thereof Download PDFInfo
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- CN101033197A CN101033197A CN 200710097231 CN200710097231A CN101033197A CN 101033197 A CN101033197 A CN 101033197A CN 200710097231 CN200710097231 CN 200710097231 CN 200710097231 A CN200710097231 A CN 200710097231A CN 101033197 A CN101033197 A CN 101033197A
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Abstract
This invention relates to a capsicum alkali substance and its new usage mainly referring to antipyretic action of the substance used in preventing and curing fever, and the substance can cure fever caused by various diseases and the effect is obvious and swiftly with little side effect.
Description
Technical field
The present invention relates to composition is the clinical new role of capsicine material, specifically, relate to the capsicine material refrigeration function, can be used for preventing and treating the new application of fever and clinical acceptable various preparations prepared therefrom.
Background technology
The capsicine material is to extract the vanilla amide alkaloid that obtains from capsicum.Capsicine has another name called capsaicine, is a kind of pungent vanilla amide alkaloid of extreme of phenolic hydroxy group.Chemical name is δ-methyl-N-[(4-hydroxy 3-methoxybenzene base)-methyl]-(instead)-6-nonene base acid amides.Molecular formula is C
18H
27O
3N.Be from the natural phant capsicum, to refine and get, also can synthetic, pure product are white crystal, 65 ℃-66 ℃ of fusing points.Be soluble in methyl alcohol, ethanol, acetone, chloroform and the ether, also dissolve in the alkaline aqueous solution.
The capsicine material comprises capsicine, Dihydrocapsaicin and other capsicine compounds of group.A kind of capsicine material of regulation in the American Pharmacopeia (USP29), it contains capsicine must not be less than 55%, contains Dihydrocapsaicin and the capsicine summation must not be less than 75%, contains other capsicine compositions (or claiming capsicine compounds of group) and must not cross 15%.The capsicine compounds of group comprises Dihydrocapsaicin, homocpsaicin, Homodihydrocapsaicin I, homodihydrocapsaicin I, norhydrocapsaicin, Nordihydrocapsaicin, suitable capsicine, nonivamide, olvanil, NE-21610, N-oleyl-homovanillamide, Dong-APharmaceutical, resin toxin.Capsicine and Dihydrocapsaicin are the main components in the capsicum, utilize its anti-inflammatory analgesic action, the existing capsicine ointment of having developed.Be mainly used in rheumatoid arthritis, the pain that arthrosis causes, intramuscular pain, backache, motion sprain with banded spore rash after the neuropathy left over.
Just there is detailed argumentation in the pharmacological action China of capsicum as far back as the Ming Dynasty, and " evil that exorcises evil spirits is killed all poison of gas of waking up for the place food that disappears, the gas that unhitches, appetizing mouth to be loaded with capsicum in " the food book on Chinese herbal medicine " of the Ming Dynasty." saying, and claim its " warming spleen and stomach for dispelling cold removes the wind sweating and goes cold addiction, and row phlegm is by wet " in " property of medicine is examined ".Because the backwardness of idea and technology causes China that the understanding of capsicum is rested on traditional theory of traditional Chinese medical science level, fails further deeply to develop always.Present application also only limits to the production of external preparation.China's capsicine compound is that capsicine is to alleviating the research of local pain and analgesic activity in main developing trend pharmaceutically.As capsicine ointment, can alleviate the muscle and the arthralgia that cause by rheumatism, and back pain and sprain, pull the pain that causes.Studies show that, use capsicine ointment tid or qid and can fully exhaust the P material that suppress its synthetic and transportation and reach better analgesic activity, 1 week is with regard to onset when treatment arthrodynia; Treatment neurodynia then needs just can make in 2～4 weeks pain to be eased.
China be the earliest with capsicum as one of country of drug use, in medical capsicum treatment stomach cold, diseases such as rheumatism.Studies show that after capsicine is to zoster and lose neuropathy, diabetes, neuropathy, rheumatic arthritis, osteoarthritis, psoriasis, baldnesses etc. have significant curative effect.
The treatment on, capsaicine as analgesic use in clinical.The method that is used for synthetic capsaicin and analogue thereof has many pieces of patent reports, and (patent No. is respectively: 02134386.1,03109061.3,200480015966.7,200610044810.2), capsaicine is prepared into the also existing patent report (patent No.: 200410064972.3), also be useful on the anti-Alzheimer disease (patent No.: 200510027292.9) of gel.
According to statistics, because heating causes death, the annual whole world has at least more than 2,000,000, what especially upper respiratory tract infection and influenza caused is high hot, having a strong impact on the healthy of people, the expense that is used for the treatment of every year is up to tens yuan, therefore, the outer wind-heat that infects of control effectively is the arduous and urgent task of medical worker.The reason that causes high heat has many, as viral infection, and bacterial infection, mycoplasma infection, parasitic infection etc., the wherein high heat that causes of virus or bacterial infection commonly.
Exogenous high fever disease is many because of evil poison invasion causes, " poison is gone into heresy, and heat is that poison is given birth to." controlling should be clearing heat and detoxicating.Modern medicine proves, all because of infecting due to certain bacterium or the virus, heating can make physical demands to the exogenous high fever disease, causes headache, insomnia, even faint from fear, excessive heat (more than 41 ℃) or lasting heating also can cause permanent brain damage even death.Therefore treatment is based on anti-infective, analgesic.But it is necessary that heating more than the moderate is suitably used febrifugee.
Summary of the invention
Purpose of the present invention mainly is further development and utilization capsicine material, makes the medicine that contains the capsicine material give full play to its due pharmaceutical use clinical, and be applied to by corresponding preparations clinical, thereby finish the present invention.
The contriver discovers that by experiment the capsicine material has tangible refrigeration function, can be used for preparing the medicine of prevention or treatment fever.The invention technical scheme is as follows:
The chemical structural formula of capsicine is as follows:
The invention provides a kind of application of capsicine material, it is characterized in that being used to prepare medicine with refrigeration function.
The present invention also provides a kind of concrete clinical application of capsicine material, it is characterized in that being used to prepare the medicine of prevention or treatment fever.
Above-mentioned described capsicine material is to extract the vanilla amide alkaloid that obtains from capsicum.It comprises in capsicine, Dihydrocapsaicin or their derivatives (also claiming the capsicine compounds of group) one or more.Wherein, preferred described capsicine material contains capsicine and is not less than 55%, contains Dihydrocapsaicin and the capsicine summation is no less than 75%, contains other capsicine compositions (or claiming capsicine compounds of group) and is no more than 15%.Wherein said capsicine compounds of group is selected from one or more in homocpsaicin, Homodihydrocapsaicin I, homodihydrocapsaicin I, norhydrocapsaicin, Nordihydrocapsaicin, suitable capsicine, nonivamide, olvanil, NE-21610, N-oleyl-homovanillamide, Dong-APharmaceutical, the resin toxin.
The above-mentioned described application of the present invention, wherein said medicine can be external preparation, injection or oral preparations.Wherein said external preparation is preferably suppository or liniment, made by capsicine material and suitable auxiliary material, auxiliary material can use for one or more mixing in stearic acid, glyceryl monostearate, paraffin, lanolin, sapn series, animal-plant oil, glycerine, propylene glycol, sorbyl alcohol, polyoxyethylene glycol series, tween series, the sodium lauryl sulphate etc.
Wherein said oral preparations, be preferably tablet, capsule, dripping pill, granule or oral liquid, made by capsicine material and suitable auxiliary material, auxiliary material can use for one or more mixing in sucrose, lactose, starch, dextrin, N.F,USP MANNITOL, Microcrystalline Cellulose, Vltra tears, sodium starch glycolate, polyvinylpolypyrrolidone, polyvidone, rebaudioside, aspartame, soluble saccharin, Magnesium Stearate and nutrition agent or the sanitas etc.
The above-mentioned described medicine of the present invention, its effective constituent is the capsicine material, and content is more than 50%, and it can extract by natural matter and make, and also can prepare by the synthetic approach.
The capsicine material is mixed with the auxiliary material that pharmaceutically can accept and use, and handle, can prepare corresponding pharmaceutical preparation, as tablet, capsule, granule and oral liquid etc. according to the corresponding preparation mode.Pharmacodynamic experiment is the result show, the above-mentioned medicinal preparations refrigeration function of the present invention is evident in efficacy, and effect is satisfied.
Show that by analgesic test-results capsicine material of the present invention can be used for the treatment flu, the heating of influenza and malaria etc., particularly make oral preparations after, by oral administration, have easy to usely, the patient is acceptant, acts on advantages such as rapid.Capsicine material of the present invention proves through pharmacological evaluation, has good refrigeration function.The capsicine material all has tangible refrigeration function in the scope of 0.1～10.0mg/kg dosage.
Febrifuge commonly used clinically now is chemical medicine mostly, and main component has: paracetamol (PCl), acetylsalicylic acid (ASA), Phenacetin, pyramidon, Sedatine etc.It is more to contain toxic or blood system is had remarkable untoward reaction, has caused domestic and international expert's attention, particularly is applied to the clinical treatment of children's heating.And in the above pharmaceutical preparation mouthfeel bitter taste is arranged, also generally do not accepted by the patient entirely.Therefore, the new efficient febrifuge of exploitation has wide prospect.The invention provides a kind of medicine that has refrigeration function, can be used for preventing or treating fever, its effective constituent is the capsicine material, and its consumption is little, and produce effects is fast, and toxic side effect is little, has better to separate thermal effect.
The capsicine material is prepared into have refrigeration function, the various preparations of prevention or treatment fever, pharmaceutical preparation of the present invention in the preparation, with reference to the Pharmacopoeia of the People's Republic of China, by standard under the different dosage form item and requirement, add suitable auxiliary material, make the preparation of corresponding formulation, as external preparation, injection and oral preparations.Wherein external preparation relates to suppository, liniment; Oral preparations relates to tablet, capsule, granule, oral liquid etc.
Embodiment
Below by embodiment the present invention is described in further detail.
Refrigeration function embodiment 1:
1 material and method
1.1 the preparation of soup:
2, the preparation of 4-dinitrophenol solution: precision takes by weighing 2, and 4-dinitrophenol (chemical pure) 150mg places 80ml left and right sides NS, and Dropwise 5 mol/LNaOH solution constantly stirs, and treats the clear and bright glassy yellow that becomes of soup, adds NS to 100ml again.Can not add too much NaOH and make solution alkalescence bigger than normal, the interference experiment result.
Aspirin tablet grinds among the CMC-Na of back adding 1%.
Taking by weighing an amount of capsicine is suspended among 1% the CMC-Na.
1.2 animal: male rat, body weight 150-200g, the SPF level is provided by Guangdong Province's Experimental Animal Center.2 surveys every day body temperature.Choosing body temperature change is not higher than 0.3 ℃ of person and experimentizes.
1.3 method:
To 2,2, 4-dinitrophenol causes the influence of rat fever: rat prediction body temperature 3 days, experiment day mensuration rat basal body temperature, screening body temperature fluctuates little person for qualified rat, every mouse dorsal part subcutaneous injection 2,4-dinitrophenol NaOH liquid 20mg/kg pyrogenicity selects heating to reach that the person is divided into 5 groups, gastric infusion at random more than 1 ℃ behind the 1h, after the administration 30,60,90,120,180min surveys rat temperature, measures the anus temperature 1 time in 0.5,1.0,1.5,2.0,3.0,4.0,6.0 hour after administration.Every mouse back subcutaneous injection 2,4-dinitrophenol 1ml/100g (15mg/kg).
Dosage: press 1ml/100g body weight gastric infusion.
2 results: different time is measured the body temperature of rat, result such as table 1 before the medication and after the medication.
The refrigeration function of table 1 capsicine (℃, x ± s, n=7)
| Group | Dosage (mg/kg) | Before the medication | Different time after the medication (min) | |||||
| 30 | 60 | 90 | 120 | 180 | 300 | |||
| Physiological saline group model group acetylsalicylic acid group capsicine group | 100.0 0.1 1.0 | 37.16±0.53 37.26±0.18 37.30±0.25 37.22±0.31 37.18±0.38 | 37.18± 0.34# 37.90± 0.25 * 36.94± 0.35## 36.80± 0.85 **## 36.06± 0.84 **## | 37.22± 0.61## 38.24± 0.25 ** 36.50± 0.43 **## 36.58± 0.72 **## 35.54± 0.51 **## | 37.12± 0.41# 37.78± 0.41 36.74± 0.43# 36.72± 0.40# 35.94± 0.58 **## | 37.00± 0.47 37.36± 0.42 36.76± 0.38# 36.98± 0.54 36.18± 0.49 *# | 37.18±0.57 36.90±0.76 36.26±0.44 36.72± 0.60 36.76± 0.38 | 36.92± 0.34 36.88± 0.31 36.32± 0.56 36.14± 0.26 36.22 ±0.40 |
| 10.0 | 37.30±0.25 | 36.34± 0.90 **## | 35.96± 0.96 **## | 36.16± 0.83 *# | 36.20± 0.50 *# | 36.12± 0.37 | 36.20 ±0.66 | |
Compare with the physiological saline group:
*P＜0.05,
*P＜0.01; Compare with model group: #p＜0.05, ##p＜0.01
As shown in Table 1, in injection 2,60min behind the 4-dinitrophenol solution, rat temperature reaches the climax, continues 2h.Compare with model group, the capsicine of 0.1～10.0mg/kg all has significantly in 30～90min after medication or extremely significant significant difference (p＜0.05 or p＜0.01); During 120min, capsicine still has significant refrigeration function when middle and high dosage.
Conclusion: capsicine all has tangible refrigeration function in the scope of 0.1～10.0mg/kg dosage.
Refrigeration function embodiment 2:
According to the identical method of refrigeration function embodiment 1, take by weighing an amount of Dihydrocapsaicin and be suspended among 1% the CMC-Na.Press 1ml/100g body weight gastric infusion.
Different time is measured the body temperature of rat, result such as table 2 before the medication and after the medication.
The refrigeration function of table 2 Dihydrocapsaicin (℃, x ± s, n=7)
| Group | Dosage (mg/kg) | Before the medication | Different time after the medication (min) | |||||
| 30 | 60 | 90 | 120 | 180 | 300 | |||
| Physiological saline group model group aspirin group dihydrocapsaicin group | 100.0 0.1 1.0 | 37.16±0.53 37.26±0.18 37.30±0.25 37.41±0.42 37.22±0.36 | 37.18± 0.34# 37.90± 0.25 * 36.94± 0.35## 36.76± 0.74 **## 36.21± 0.77 **## | 37.22± 0.61## 38.24± 0.25 ** 36.50± 0.43 **## 36.63± 0.81 **## 36.01± 0.65 **## | 37.12± 0.41# 37.78± 0.41 36.74± 0.43# 36.55± 0.46# 35.83± 0.67 **## | 37.00± 0.47 37.36± 0.42 36.76± 0.38# 36.87± 0.63 36.23± 0.56 *# | 37.18±0.57 36.90±0.76 36.26±0.44 36.64±0.55 36.81±0.51 | 36.92± 0.34 36.88± 0.31 36.32± 0.56 36.09± 0.26 36.42± 0.51 |
| 10.0 | 37.35±0.31 | 36.15± 0.87 **## | 35.84± 0.84 **## | 36.02± 0.86 *# | 36.46± 0.61 *# | 36.23±0.43 | 36.33± 0.71 | |
Compare with the physiological saline group:
*P＜0.05,
*P＜0.01; Compare with model group: #p＜0.05, ##p＜0.01
As shown in Table 2, compare with model group, the Dihydrocapsaicin of 0.1～10.0mg/kg all has significantly in 30～90min after medication or extremely significant significant difference (p＜0.05 or p＜0.01); During 120min, Dihydrocapsaicin still has significant refrigeration function when middle and high dosage.
Above-mentioned test-results explanation, capsicine material of the present invention has tangible refrigeration function, thereby can be used for preparing the medicine of prevention or treatment heating or fever.
The preparation of example of formulations 1 capsicine tablet
Tablet formulation (1000)
Capsicine material 0.1g～100g
Weighting agent 100g～300g
Disintegrating agent 0～20g
Tackiness agent 0～100g
Solubility promoter 0～3.0g
Lubricant 1～5g
The preparation method: by prescription take by weighing capsicine material and weighting agent, disintegrating agent is an amount of, cross 80 mesh sieves, mix with the equivalent incremental method, with an amount of tackiness agent system softwood, crossing 18～24 mesh sieves granulates, in 30～40 ℃ of drying under reduced pressure, whole grain adds behind the lubricant of formula ratio according to the ordinary method compressing tablet promptly.
Wherein, weighting agent can be various auxiliary materials such as pregelatinized Starch, lactose, N.F,USP MANNITOL, Microcrystalline Cellulose sodium, hydroxypropylcellulose, lime carbonate, Calcium hydrogen carbonate, yellow soda ash, secondary calcium phosphate, tackiness agent is the PVP alcohol or the aqueous solution, starch slurry, hydroxypropylcellulose etc.Disintegrating agent is that in carboxymethylstach sodium, low-substituted hydroxypropyl cellulose, the polyvinylpolypyrrolidone one or more mix.Solubility promoter is alkaline salts such as Calcium hydrogen carbonate, sodium bicarbonate, sodium lauryl sulphate, lime carbonate.
Add in disintegrating agent adopts separately or in the method that adds.
The preparation of example of formulations 2 capsicine oral liquids
Oral liquid prescription (1000ml)
Capsicine material 20mg～20g
Ethanol 0～20ml
Distilled water 800～1000ml
Sanitas is an amount of
Solubility promoter is an amount of
The preparation method: take by weighing the capsicine material by formula ratio, add ethanol, stir and make dissolving, add sanitas, use the distilled water constant volume, solution is according to every bottle of 2ml, 5ml, and 10ml, packing such as 20ml, promptly.Wherein sanitas can be phenylformic acid and salt thereof, and Sorbic Acid and salt thereof, solubility promoter are ethanol, glycerine, propylene glycol, sodium bicarbonate, saleratus, lime carbonate etc.
The capsular preparation of example of formulations 3 capsicines
Capsule prescription (1000)
Capsicine material 0.1g～100g
Weighting agent 100g～300g
Tackiness agent 0～100g
Solubility promoter 0～3.0g
Lubricant 1～5g
The preparation method: by prescription take by weighing the capsicine material and weighting agent an amount of, cross 80 mesh sieves, mix with the equivalent incremental method, with an amount of tackiness agent system softwood, crossing 18～24 mesh sieves granulates, in 30～40 ℃ of drying under reduced pressure, whole grain adds behind the lubricant of formula ratio according to ordinary method can capsule promptly.
Wherein, weighting agent can be various auxiliary materials such as pregelatinized Starch, lactose, N.F,USP MANNITOL, Microcrystalline Cellulose sodium, hydroxypropylcellulose, lime carbonate, Calcium hydrogen carbonate, yellow soda ash, secondary calcium phosphate, tackiness agent is the PVP alcohol or the aqueous solution, starch slurry, hydroxypropylcellulose etc.Solubility promoter is alkaline salts such as Calcium hydrogen carbonate, sodium bicarbonate, sodium lauryl sulphate, lime carbonate.
The preparation of example of formulations 4 capsicine particulate
Granule prescription (1000g)
Capsicine material 0.1g～10g
Weighting agent 100g～300g
Tackiness agent 0～100g
Solubility promoter 0～3.0g
Lubricant 1～5g
The preparation method: by prescription take by weighing capsicine material and weighting agent, lubricant is an amount of, crosses 80 mesh sieves, mix with the equivalent incremental method, with an amount of tackiness agent system softwood, cross 18～24 mesh sieves and granulate, in 30～40 ℃ of drying under reduced pressure, whole grain, according to the ordinary method packing promptly.
Wherein, weighting agent can be various auxiliary materials such as pregelatinized Starch, lactose, N.F,USP MANNITOL, Microcrystalline Cellulose sodium, hydroxypropylcellulose, lime carbonate, Calcium hydrogen carbonate, yellow soda ash, secondary calcium phosphate, tackiness agent is the PVP alcohol or the aqueous solution, starch slurry, hydroxypropylcellulose etc.Solubility promoter is alkaline salts such as Calcium hydrogen carbonate, sodium bicarbonate, sodium lauryl sulphate, lime carbonate.
The preparation of example of formulations 5 capsicine suppositorys
Suppository prescription (1000g)
Capsicine material 0.1g～10g
Poly(oxyethylene glycol) 400 200g
Polyethylene glycol 1500 400g
Macrogol 4000 400g
Preparation method: earlier by the amount of used bolt mould and the recipe quantity of main ingredient, calculate the amount of required matrix, the polyethylene glycol composition of calculated amount is put 70 ℃ of heating in water bath and is stirred to whole dissolvings according to displacement value; The capsicine material that adds recipe quantity fully stirs, and is chilled to slightly behind the mixing about 50 ℃, and in the bolt mould of rapid impouring cleaning, refrigeration is taken out while hot, the redundance of pruning, and opening mold is released suppository, and packing is promptly.
The present invention is described according to preferred embodiment.Should be understood that the description of front and embodiment are just to illustrating the present invention.Under prerequisite without departing from the spirit and scope of the present invention, those skilled in the art can design multiple alternative of the present invention and improvement project, and it all should be understood to be within protection scope of the present invention.
Claims (10)
1, a kind of capsicine compound of following formula structure:
2, the application of capsicine material is characterized in that being used to prepare the medicine with refrigeration function.
3, the application of capsicine material is characterized in that the medicine that is used to prepare prevention or treats fever.
4, according to the described application of claim 2-3, wherein said capsicine material is to extract the vanilla amide alkaloid that obtains from capsicum.
5, according to the described application of claim 2-4, wherein said capsicine material comprises one or more in capsicine, the Dihydrocapsaicin or derivatives thereof.
6, according to the described application of claim 2-5, wherein said capsicine material contains capsicine and is not less than 55%, contains Dihydrocapsaicin and the capsicine summation is no less than 75%, contains other capsicine compositions and is no more than 15%.
7, application according to claim 6, wherein said other capsicine compositions are selected from one or more in homocpsaicin, Homodihydrocapsaicin I, Nordihydrocapsaicin, suitable capsicine, the resin toxin.
8, according to the described application of claim 2-7, wherein said medicine is external preparation, injection or oral preparations.
9, application according to claim 8, wherein said external preparation is suppository or liniment, made by capsicine material and suitable auxiliary material, auxiliary material can use for one or more mixing in stearic acid, glyceryl monostearate, paraffin, lanolin, sapn series, animal-plant oil, glycerine, propylene glycol, sorbyl alcohol, polyoxyethylene glycol series, tween series, the sodium lauryl sulphate etc.
10, application according to claim 8, wherein said oral preparations is tablet, capsule, dripping pill, granule or oral liquid, made by capsicine material and suitable auxiliary material, auxiliary material can use for one or more mixing in sucrose, lactose, starch, dextrin, N.F,USP MANNITOL, Microcrystalline Cellulose, Vltra tears, sodium starch glycolate, polyvinylpolypyrrolidone, polyvidone, rebaudioside, aspartame, soluble saccharin, Magnesium Stearate and nutrition agent or the sanitas etc.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200710097231 CN101033197A (en) | 2007-04-29 | 2007-04-29 | Pharmaceutical for preventing and treating fever and preparation thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200710097231 CN101033197A (en) | 2007-04-29 | 2007-04-29 | Pharmaceutical for preventing and treating fever and preparation thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101033197A true CN101033197A (en) | 2007-09-12 |
Family
ID=38729964
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200710097231 Pending CN101033197A (en) | 2007-04-29 | 2007-04-29 | Pharmaceutical for preventing and treating fever and preparation thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101033197A (en) |
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2007
- 2007-04-29 CN CN 200710097231 patent/CN101033197A/en active Pending
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Open date: 20070912 |