CN102218061A - Application of penehyclidine hydrochloride in preparation of medicine for treating motion sickness - Google Patents
Application of penehyclidine hydrochloride in preparation of medicine for treating motion sickness Download PDFInfo
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- CN102218061A CN102218061A CN 201110110776 CN201110110776A CN102218061A CN 102218061 A CN102218061 A CN 102218061A CN 201110110776 CN201110110776 CN 201110110776 CN 201110110776 A CN201110110776 A CN 201110110776A CN 102218061 A CN102218061 A CN 102218061A
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- motion sickness
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- ether hydrochloride
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Abstract
The invention discloses application of penehyclidine hydrochloride in preparation of a medicine for treating motion sickness; motion sickness is a joint name of train sickness, sea sickness, aviation sickness and other sickness caused by swinging, bumping, rotation, deceleration movement and the like due to various reasons. The medicine for treating motion sickness is tablets, granules, capsules or patches and other pharmaceutical preparations which are prepared by adopting the penehyclidine hydrochloride composition as a main component and adding pharmaceutically acceptable auxiliary components, wherein the weight ratio of the penehyclidine hydrochloride to the auxiliary components is 1: 1-1:400. According to the invention, the application field of the penehyclidine hydrochloride is widened, a novel medicine is provided for special group with motion sickness, the untoward effects and uncomfortableness brought to people by taking the conventional medicine for treating motion sickness are avoided; furthermore, the medicine is long in effective time, rapid in taking effect and smaller in dosage, and not only troubles caused by taking the medicine are reduced, but also the incidence of the untoward effects are also greatly reduced.
Description
Technical field
The invention belongs to medicine field, be specifically related to the application in preparation treatment motion sickness disease medicament of the pharmaceutic usage of chemical compound amyl ethyl quin ether hydrochloride, particularly amyl ethyl quin ether hydrochloride.
Background technology
Motion sickness be motion sickness, motion sickness, air-sickness and because waving of causing of a variety of causes, jolt, the general designation of associated diseases such as rotation, accelerated motion, often by by bus, by ship, take aircraft and cause.People begin one's study to the pathogeny of motion sickness disease very early, but up to now, still do not find and cure way completely, generally can only select suitable anti-motion sickness medicine, alleviate the cinetosis symptom.
Prior art (Peng Lijun, Yu Hanhua. anti-motion sickness medicine pharmacological research progress, 2004 the 24th the 2nd phases of volume of Chinese Hospitals pharmaceutical journal) studies show that anticholinergic agent can effectively be alleviated the cinetosis symptom, scopolamine wherein just has curative effect preferably to the cinetosis symptom.
Prior art shows: act on different receptor subtype (M1, M2, M3, M4, M5) anticholinergic agent has different curative effects to motion sickness, the receptor-selective difference, very big to motion sickness effect difference, the anticholinergic agent that has has very good curative effect, have then without any curative effect, for example: scopolamine just can be blocked 5 kinds of subtype acceptor (M1, M2, M3, M4, M5), motion sickness there is curative effect preferably, idaverine (idaverine) can be blocked M1 and M2 receptor, to not effect of motion sickness, zamifenacin (Zamafenacin) can be blocked M3 and M5 receptor subtype, and motion sickness is had preferably curative effect and do not produce untoward reaction such as calmness.
Scopolamine since to receptor subtype without any selectivity, act on whole 5 kinds of receptor subtypes, though effective to alleviating motion sickness, when using the scopolamine medicine, xerostomia appears easily also, sticking expectorant is difficult for untoward reaction such as expectoration, blurred vision, abdominal distention, urine retention, dysphoria.Drowsiness weak, side effect such as memory is impaired is also arranged, also the drug withdrawal rebound phenomena can occur.
Benzene ring nonyl ester (it is happy to fly match) (Li Geng etc. the anti-animal motion sickness of benzene ring nonyl ester levo form and optical isomer pharmacodynamic study, CAL aerospace medicine magazine the 17th the 2nd phase of volume of June in 2006) clinically also as anti-motion sickness drug use, because dosage is bigger than normal, there is not receptor-selective simultaneously, observed clinically side effect is many, as xerostomia, quickening heart rate etc.
Amyl ethyl quin ether hydrochloride, English name Penehyclidine Hydrochloride, chemical name 3-(2-cyclopenta-2-hydroxyl-2-phenyl ethoxy) quinuclidine hydrochloride, molecular formula C
20H
29NO
2HCl, molecular weight 351.92.
Amyl ethyl quin ether hydrochloride is a kind of novel anticholinergic agent, has selectivity M
1, M
3And N
1, N
2Receptor antagonism all has very strong cholinolytic effect to maincenter and periphery, and to M
2Receptor does not have obvious effect, at present clinically about the pharmaceutical applications of amyl ethyl quin ether hydrochloride mainly concentrate on premedication, fields such as medication, shock are rescued in organophosphate poisoning, yet there are no amyl ethyl quin ether hydrochloride and be applied to prepare anti-motion sickness drug world.
Summary of the invention
One of purpose of the present invention is to provide a kind of pharmaceutic usage of chemical compound amyl ethyl quin ether hydrochloride, widens the application of chemical compound amyl ethyl quin ether hydrochloride.
Another object of the present invention is to provide a kind of and be different from existingly, have the cholinolytic class medicine new product of alleviating the cinetosis symptom, for the specific crowd with cinetosis symptom provides a kind of novel alternative medicine.
The pharmacodynamics test that amyl ethyl quin ether hydrochloride of the present invention is used in preparation treatment motion sickness medicine is confirmed by the clinical trial that the reverse syndrome model test of turn-taking of rabbit reaches the particular patient crowd.
Enforcement of the present invention is that to adopt pharmaceutically common process for preparing medicine be that the product of various dosage forms is tested with the amyl ethyl quin ether hydrochloride compound, concrete pharmaceutical formulation combination, and preparation method is described in an embodiment.
The medicine of treatment motion sickness of the present invention is to be main component with the amyl ethyl quin ether hydrochloride chemical compound, adds pharmaceutically acceptable auxiliary element, the pharmaceutical preparatioies such as tablet, granule, capsule or patch that the preparation process by routine is prepared into.
Described pharmaceutically acceptable auxiliary element comprises filler, bonding agent, disintegrating agent, lubricant, coloring agent or correctives.
Described filler is meant the weight or volume that is used for filling tablet, thereby is convenient to the auxiliary element of tabletting, as starch, Icing Sugar, dextrin, lactose, microcrystalline Cellulose, mannitol or inorganic calcium salt.
Described bonding agent is meant the auxiliary element that drug powder is combined, the binding agent of adhesive effect and the wetting agent of a wetting action have been comprised, as distilled water, ethanol, starch slurry, sodium carboxymethyl cellulose, methylcellulose, ethyl cellulose, hydroxypropyl emthylcellulose, 5%～20% aqueous gelatin solution, 50%～70% aqueous sucrose solution, 3%～5% polyvinylpyrrolidone aqueous solution.
Described disintegrating agent is meant the material that is fragmented into fine particle in gastrointestinal solution rapidly, has very strong imbibition, can disintegrate the adhesion of tablet, as dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone or cross-linking sodium carboxymethyl cellulose.
Described lubricant is meant the generalized concept with the anti-stick effect of fluidizer, thereby or rise to reduce the fluidizer that frictional force between the granule is improved powder flowbility, or prevent that supplementary material is adhered to the material of die surface, as magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, polyethylene glycols or magnesium laurylsulfate.
The amyl ethyl quin ether hydrochloride chemical compound in the treatment motion sickness disease medicament of the present invention and the weight ratio of auxiliary element are: 1:1～1:400, preferred 1:50～1:200.
The content of active component is respectively in hydrochloric amyl ethyl quin ether in the described pharmaceutical preparation: 0.5mg, 1.0mg, 1.5mg, 2.0mg, 2.5mg or 3.0mg/ sheet, perhaps 0.5mg, 1.0mg, 1.5mg, 2.0mg, 2.5mg or 3.0mg/ bag, perhaps 0.5mg, 1.0mg, 1.5mg, 2.0mg, 2.5mg or 3.0mg/ grain, perhaps 0.5mg, 1.0mg, 1.5mg, 2.0mg, 2.5mg or 3.0mg/ subsides.
The traditional preparation process of pharmaceutical preparation employing of the present invention forms through dissolving, mixing, granulation, drying, filling or compacting.
With respect to prior art, advantage of the present invention shows:
1, the amyl ethyl quin ether hydrochloride alternative acts on M1, the M3 receptor subtype, show by clinical trial, amyl ethyl quin ether hydrochloride has very tangible anti-cinetosis symptom, simultaneously, because to the not effect of M2 receptor, so can overcome the effect of the inherent quickening heart rate of other anticholinergic agents that do not have receptor-selective, as scopolamine, atropine etc. can cause user's heart rate to be accelerated, dysphoria, particularly to the old people, child and other cardiovascular and cerebrovascular diseases patient are useful, can not cause having palpitation, cardiopalmus is for this class crowd provides more wide medicament selection space.
Produce effects was fast when 2, amyl ethyl quin ether hydrochloride resisted motion sickness, and longer duration by studies show that, is taken amyl ethyl quin ether hydrochloride and can be detected in blood after 5 minutes, and visible produce effects is very fast; The half-life of amyl ethyl quin ether hydrochloride is 10.35 hours simultaneously, longer duration for the crowd of long-distance travel or lasting riding public transportation means, does not need to reuse, a slice, one, one are pasted promptly can last very long, has reduced this crowd's the trouble of taking.
When 3, amyl ethyl quin ether hydrochloride resisted motion sickness, consumption was less, and 1mg is following or still less promptly can reach the effect of alleviating the cinetosis symptom, and the adverse reaction rate that brings thus greatly reduces.
4, the test later stage observes, and does not see that also the drug withdrawal rebound phenomenon takes place.
The specific embodiment
Below in conjunction with embodiment foregoing of the present invention is described in further detail again, but this should be interpreted as technical solution of the present invention only limits to following examples.
The anti-animal motion sickness of embodiment 1 amyl ethyl quin ether hydrochloride pharmacodynamics test
1 summary purpose is estimated amyl ethyl quin ether hydrochloride with animal experiment motion sickness is had preventive and therapeutic effect.The reverse syndrome of turn-taking of rabbit that method adopts the reversibility cholinesterase inhibitor to cause.The anti-motion sickness effect of conclusion amyl ethyl quin ether hydrochloride is obvious, and effective dose is significantly less than benzene ring nonyl ester.
2 materials
2.1 be subjected to the reagent thing
It is synthetic that amyl ethyl quin ether hydrochloride is thought special medicine share by Chengdu power, purity 99.5%, and paraoxon, different dipropylene glycol are available from Acros company, and purity is all more than 99%, and procaine is available from Yongkang, Beijing pharmaceutcal corporation, Ltd.
Control drug
Benzene ring nonyl ester (benzene ring nonyl ester sheet, Beijing Walsall Pharmaceutical Co., Ltd, lot number 10082316) is got 1000 pulverizing, and effective component extracting is also refining repeatedly, and purity is more than 99.0% after testing.
Reagent
Paraoxon purity 99% is made into 3.8% solution with 100% different dipropylene glycol; Amyl ethyl quin ether hydrochloride is configured to the solution of 1mg/ml with distilled water; Benzene ring nonyl ester is configured to the solution of 1mg/ml with distilled water;
2.3 experimental animal
112 of Japan large ear rabbits, body weight 1.6～2.5kg, male and female are not limit, and the one-level animal (quality certification: the SCXK(river) 2004-14) is provided by plant of Sichuan Province's laboratory animal special commission.
Instrument
The Sartorius electronic analytical balance, West Germany, d=0.01mg.
T-1000 type electronic balance, d=0.1g, two outstanding brother's (group) company limiteies of the U.S..
The foundation of the reverse syndrome model of turn-taking of 3 rabbits
Lie on the back Japanese white big ear rabbit fixing, expose cervical region fully, procaine local anaesthesia with 2%, isolate the about 1.5cm of right common carotid artery, (10mm * 5mm), masking foil separates itself and surrounding tissue to the artery segment of peeling off out with 3 layers of lens paper parcel on the artery segment pad that is wrapped, the paraoxon of drawing 10 μ l 3.8% with 10 μ l liquid chromatograph injectors slowly drips on the lens paper, wrap masking foil, sewed up wound, it is free movable that animal is put on the floor.Observe to give the mandatory reverse number of turn-taking that animal occurs in the paraoxon 2 hours, be the positive sign of the reverse syndrome of turn-taking more than the 3 circle/min.
Irritate stomach gave normal saline to the matched group rabbit on an empty stomach in 20 minutes in advance, and experimental group was irritated the stomach trial drug in 20 minutes in advance on an empty stomach, and the common carotid artery part sticks paraoxon then.
Result and analysis in table 1
Table 1 amyl ethyl quin ether hydrochloride is to the effect analysis of the reverse syndrome of turn-taking of prevention rabbit
Annotate: ED is an effective dose, and CL is a confidence limit
8 rabbit of paraoxon group give paraoxon and all occur reverse turn-taking after 10 minutes, illustrate that animal model is successful.In the reverse syndrome model of turn-taking of rabbit, 8 animals of the blank group of paraoxon all do not occur turn-taking symptom and other are unusual, and therefore can get rid of different dipropylene glycol causes the probability of turn-taking.
Benzene ring nonyl ester group and amyl ethyl quin ether hydrochloride group are all effective to rabbit motion sickness model due to the strong cholinesterase inhibitor paraoxon, and comparatively speaking, the dosage of amyl ethyl quin ether hydrochloride group is littler, acts on more obvious.
Embodiment 2 amyl ethyl quin ether hydrochloride sheets treatment motion sickness 60 examples
Select to have repeatedly carsick seasick passing medical history at random, through health check-ups, patient's 60 examples that do not have symptoms such as conscience lung and hematological abnormalities and regular headache and insomnia, be divided into three groups, be respectively amyl ethyl quin ether hydrochloride sheet group (1mg/ sheet), benzene ring nonyl fat sheet group (2 mg/ sheet), vitamin B1 sheet (100 mg/ sheet) group, ride to take medicine in preceding 30 minutes, observe the patient and taking medicine 2～4 hours back 0.5～1 hour, 6～8 hours, (the dizziness of cinetosis symptom appears, feel sick, vomiting) probability is observed untoward reaction such as xerostomia simultaneously, the situation that nervous cardiopalmus occurs, the result sees Table 2 respectively, table 3:
Table 2 amyl ethyl quin ether hydrochloride and matched group are alleviated cinetosis symptom total effective rate comparison sheet
As can be seen from Table 2: amyl ethyl quin ether hydrochloride group and benzene ring pelargonate group show that all the cinetosis symptom is had good effect, the amyl ethyl quin ether hydrochloride sheet is the 1mg/ sheet, the benzene ring nonyl ester sheet is the 2mg/ sheet, under the essentially identical situation of total effective rate, amyl ethyl quin ether hydrochloride obviously reduces than the consumption of benzene ring nonyl ester;
A situation arises and continue the produce effects information slip for table 3 amyl ethyl quin ether hydrochloride and matched group untoward reaction
Annotate: it is effective to continue the produce effects situation, the cinetosis symptom do not occur after referring to take medicine, continue not occur the cinetosis symptom more by bus always, if then be considered as invalid.
As seen from Table 3, the situation of nervous cardiopalmus does not all appear in the amyl ethyl quin ether hydrochloride group, and 6～8 hours continuous and effective, and the later stage observes, and does not see that a routine drug withdrawal rebound phenomenon takes place.
Embodiment 3 amyl ethyl quin ether hydrochloride patches are used to alleviate the test of cinetosis symptom
Select to have repeatedly carsick seasick passing medical history at random, through health check-ups, patient's 20 examples that do not have symptoms such as conscience lung and hematological abnormalities and regular headache and insomnia, male's 10 examples, women's 10 examples, riding preceding 1 hour in patient's Neiguan acupoint respectively, amyl ethyl quin ether hydrochloride patch (10mg/ sheet), observe the patient after pasting medicine 0.5～1 hour, 2～4 hours, 6～8 hours, the probability of cinetosis symptom (dizzy, feel sick, vomiting) appears, observe the situation of untoward reaction such as xerostomia, nervous cardiopalmus appearance simultaneously, the results are shown in Table 4:
Table 4 amyl ethyl quin ether hydrochloride patch is alleviated cinetosis symptom total effective rate table
As seen, the amyl ethyl quin ether hydrochloride patch has very excellent curative to alleviating the cinetosis symptom equally.
Embodiment 4 amyl ethyl quin ether hydrochloride sheets: get lactose 88.8g, Icing Sugar 38.0g, 17% starch slurry is an amount of, prepares blank granule (30 orders are following), the 1.0g amyl ethyl quin ether hydrochloride is dissolved in being prepared as 1% alcoholic solution in the ethanol then, mix in the blank granule fine powder of part, after crossing 10 mesh sieve secondaries, in 40 ℃ dry once 50-60 minute, again in remaining blank granule and magnesium stearate mix homogeneously, compacting gets 1000.
Embodiment 5 amyl ethyl quin ether hydrochloride granules: get lactose 88.8g, Icing Sugar 38.0g, 17% starch slurry is an amount of, prepare blank granule (30 orders following), the 1.0g amyl ethyl quin ether hydrochloride is dissolved in is prepared as 1% alcoholic solution in the ethanol then, mix in whole blank granule fine powders, after crossing 10 mesh sieve secondaries, in 40 ℃ dry once 50-60 minute, the pack, granule.
Embodiment 6 amyl ethyl quin ether hydrochloride capsules: get lactose 88.8g, Icing Sugar 38.0g, 17% starch slurry is an amount of, prepares blank granule (30 orders are following), the 1.0g amyl ethyl quin ether hydrochloride is dissolved in being prepared as 1% alcoholic solution in the ethanol then, mix in whole blank granule fine powders, after crossing 10 mesh sieve secondaries, in 40 ℃ dry once 50-60 minute, the pack, capsule is filled, and gets capsule.
Embodiment 7 amyl ethyl quin ether hydrochloride patches: get amyl ethyl quin ether hydrochloride 10g, be dissolved in the pressure sensitive adhesive solution, evenly coat on the backing film, heating, drying is removed the organic solvent in the pressure sensitive adhesive solution, is covered with protecting film, makes 1000 and puts up agent.
Claims (10)
1. the application of amyl ethyl quin ether hydrochloride in preparation treatment motion sickness disease medicament.
2. the application of amyl ethyl quin ether hydrochloride according to claim 1 in preparation treatment motion sickness disease medicament, it is characterized in that: the medicine of described treatment motion sickness disease is to be main component with the amyl ethyl quin ether hydrochloride chemical compound, add pharmaceutically the auxiliary element of accepting, the pharmaceutical preparation of tablet, granule, capsule or patch that the preparation process by routine is prepared into.
3. the application of amyl ethyl quin ether hydrochloride according to claim 1 and 2 in preparation treatment motion sickness disease medicament, it is characterized in that: the amyl ethyl quin ether hydrochloride chemical compound in the described treatment motion sickness disease medicament and the weight ratio of auxiliary element are: 1:1～1:400.
4. the application of amyl ethyl quin ether hydrochloride according to claim 2 in preparation treatment motion sickness disease medicament, it is characterized in that: the amyl ethyl quin ether hydrochloride chemical compound in the described treatment motion sickness disease medicament and the weight ratio of auxiliary element are: 1:50～1:200.
5. the application of amyl ethyl quin ether hydrochloride according to claim 3 in preparation treatment motion sickness disease medicament, it is characterized in that: described pharmaceutically acceptable auxiliary element comprises filler, bonding agent, disintegrating agent, lubricant, coloring agent or correctives.
6. the application of amyl ethyl quin ether hydrochloride according to claim 5 in preparation treatment motion sickness disease medicament, it is characterized in that: described filler is meant starch, Icing Sugar, dextrin, lactose, microcrystalline Cellulose, mannitol or inorganic calcium salt.
7. the application of amyl ethyl quin ether hydrochloride according to claim 5 in preparation treatment motion sickness disease medicament is characterized in that: described bonding agent is meant distilled water, ethanol, starch slurry, sodium carboxymethyl cellulose, methylcellulose, ethyl cellulose, hydroxypropyl emthylcellulose, 5%～20% aqueous gelatin solution, 50%～70% aqueous sucrose solution or 3%～5% polyvinylpyrrolidone aqueous solution.
8. the application of amyl ethyl quin ether hydrochloride according to claim 5 in preparation treatment motion sickness disease medicament, it is characterized in that: described disintegrating agent is meant dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone or cross-linking sodium carboxymethyl cellulose.
9. the application of amyl ethyl quin ether hydrochloride according to claim 5 in preparation treatment motion sickness disease medicament, it is characterized in that: described lubricant is meant magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, polyethylene glycols or magnesium laurylsulfate.
10. the application of amyl ethyl quin ether hydrochloride according to claim 2 in preparation treatment motion sickness disease medicament, it is characterized in that: the content of active component is respectively in hydrochloric amyl ethyl quin ether in the described pharmaceutical preparation: 0.5mg, 1.0mg, 1.5mg, 2.0mg, 2.5mg or 3.0mg/ sheet, perhaps 0.5mg, 1.0mg, 1.5mg, 2.0mg, 2.5mg or 3.0mg/ bag, perhaps 0.5mg, 1.0mg, 1.5mg, 2.0mg, 2.5mg or 3.0mg/ grain, perhaps 0.5mg, 1.0mg, 1.5mg, 2.0mg, 2.5mg or 3.0mg/ subsides.
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|---|---|---|---|
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1475214A (en) * | 2002-08-16 | 2004-02-18 | 成都力思特制药有限公司 | Application of amyl ethyl quin ether hydrochloride |
| CN1519239A (en) * | 2003-01-23 | 2004-08-11 | 成都力思特制药股份有限公司 | Ramification of a compound of medication as well as preparation method and application |
| CN1739516A (en) * | 2002-08-16 | 2006-03-01 | 成都力思特制药股份有限公司 | Application of penehyclidine hydrochloride in preparing medicine |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1475214A (en) * | 2002-08-16 | 2004-02-18 | 成都力思特制药有限公司 | Application of amyl ethyl quin ether hydrochloride |
| CN1739516A (en) * | 2002-08-16 | 2006-03-01 | 成都力思特制药股份有限公司 | Application of penehyclidine hydrochloride in preparing medicine |
| CN1519239A (en) * | 2003-01-23 | 2004-08-11 | 成都力思特制药股份有限公司 | Ramification of a compound of medication as well as preparation method and application |
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