CN105687323A - Externally-used gel preparation for treating erythromelalgia and preparation method of externally-used gel preparation - Google Patents
Externally-used gel preparation for treating erythromelalgia and preparation method of externally-used gel preparation Download PDFInfo
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Abstract
The invention discloses an externally-used gel preparation for treating erythromelalgia and a preparation method of the externally-used preparation. The externally-used gel preparation is mainly prepared from components in parts by weight as follows: 2-4 parts of promethazine hydrochloride, 1.1-1.5 parts of paeonol, 0.3-1.2 parts of diphenhydramine hydrochloride, 0.1-0.42 parts of an alpha adrenergic receptor stimulant, 0.5-1.3 parts of ursolic acid, 0.6-0.7 parts of diclofenac sodium, 1.2-2.0 parts of bergapten, 1.5-3.4 parts of magnesium sulfate, 0.1-0.7 parts of chavicol, 0.12-0.25 parts of naringin, 0.8-2.0 parts of eucalyptol, 20-34 parts of a gel matrix, 0.03-0.06 parts of an antioxidant, 0.02-0.04 parts of a preservative and 0.05-0.1 parts of a solubilizer. The externally-used gel preparation for treating erythromelalgia has the functions of shrinking blood vessels and reducing the vascular permeability, can also relieve pain and resist inflammation and bacteria and can remarkably relieve redness, swelling, heat and pain of lower limbs in a short period of time; the externally-used gel preparation which is locally applied is prepared from the medicines, the absorption and utilization rate of the preparation is high, the safety is also higher, and clinical experiments show that the externally-used gel preparation has a good curative effect.
Description
Technical field
The present invention relates to pharmaceutical technology field, be specifically related to a kind of external-use gel preparation treating erythromelalgia and preparation method thereof。
Background technology
Erythromelalgia (Erythromelalgia) is a kind of agnogenic peripheral vessel systolic and diastolic function obstacle disease, Clinical symptoms be acra skin red, swollen, bitterly, heat, multiple be born in biped。First Mitchell in 1878 reports a kind of disease that red with finger tip skin, swollen, hot, pain is feature called after erythromelalgia。This disease is divided into constitutional and Secondary cases two class by Babb in 1964 etc.。The erythromelalgia that the class occurring mainly in south China has popular feature is defined as idiopathic erythromelalgia by nineteen ninety-five professor Wang Jiaju。
The etiology and pathogenesis of erythromelalgia is not yet clear and definite, it is possible to cause that with cold acra blood capillary systolic and diastolic function obstacle is relevant。Due to acral arteriolar ectasia, blood flow dramatically increases, contrafluxion, and Ink vessel transfusing tension force increases, before oppressing or stimulate tremulous pulse and contiguous teleneuron to produce violent pain。Often catch cold because there's a sudden fall in temperature or long-haul march etc. is brought out。
The drug main treating this disease at present to have: analgesic is aspirin such as, shrink, expand medicine such as medmain antagonistic Desemil, ephedrine, diazepam, isoproterenol, nitroglycerin, sodium nitroprusside, reserpine, chlorpromazine, the rifampicin etc. of blood vessel, and the medicine such as 17-hydroxy-11-dehydrocorticosterone, additionally tcm therapy such as Chinese medicine fumigation and washing, acupuncture, nursing cold compress etc., all can obtain certain curative effect, but effect is notable not。
Summary of the invention
Present invention solves the technical problem that be to provide a kind of can the external-use gel preparation effectively treating erythromelalgia and preparation method thereof。
The technical scheme is that, a kind of external-use gel preparation treating erythromelalgia, component meter by weight, mainly consist of the following composition: promethazine hydrochloride 2-4 part, paeonol 1.1-1.5 part, diphhydramine hydrochloride 0.3-1.2 part, alpha adrenergic receptor agonist 0.1-0.42 part, ursolic acid 0.5-1.3 part, diclofenac sodium 0.6-0.7 part, bergapton 1.2-2.0 part, magnesium sulfate 1.5-3.4 part, chavicol 0.1-0.7 part, naringin 0.12-0.25 part, eucalyptol 0.8-2.0 part, gel-type vehicle 20-34 part, antioxidant 0.03-0.06 part, preservative 0.02-0.04 part, solubilizing agent 0.05-0.1 part。
Further, described alpha adrenergic receptor agonist is phenylephrine or norepinephrine, it is possible to α 1 receptor of exciting blood vessel, makes vasoconstriction, mainly makes small artery and venule shrink。
Further, described gel-type vehicle is carbomer, and acid, alkali, alcohol are had certain toleration by carbomer, have good biocompatibility, skin is not stimulated。
Further, described carbomer is Carbopol 941, and its concentration is 0.6-1.0%。
Further, described antioxidant is di-t-butyl carboxymethyl benzene, and antioxidant effect is good。
Further, described preservative is selected from any one in sodium benzoate, methyl hydroxybenzoate, imidazolidinyl urea。
Further, described solubilizing agent is tween 80, and tween 80 solubilizing effect is good, and zest is little, can be used for various gel。
The preparation method of a kind of external-use gel preparation treating erythromelalgia is:
(1) promethazine hydrochloride of formula ratio, paeonol, diphhydramine hydrochloride, alpha adrenergic receptor agonist, ursolic acid, diclofenac sodium, bergapton, magnesium sulfate, chavicol, naringin are taken, join in 40 parts of alcoholic solution, stirring, obtains component A；
(2) take 2 parts of glycerol and 0.8 part of propylene glycol, be dissolved in 5-6 part purified water, obtain component B；
(3) gel-type vehicle of formula ratio is taken, the component A obtained and component B is joined in gel-type vehicle successively under stirring, it is further continued for adding the eucalyptol of formula ratio, antioxidant, preservative, solubilizing agent, stir, regulating its pH value is 5.0-6.0, obtains water white topical agent。
The invention has the beneficial effects as follows: the present invention treats the external-use gel preparation of erythromelalgia and has vasoconstrictive, reduce the function of vascular permeability, can also ease pain, antiinflammatory, antibacterial, can significantly improve in a short time lower limb red, swollen, hot, pain symptom, medicine being prepared into external-use gel preparation with topical, drug absorption availability is high, and safety is also higher, through clinical verification, show fabulous curative effect。
Detailed description of the invention
Embodiment 1: a kind of external-use gel preparation treating erythromelalgia, component meter by weight, mainly consists of the following composition: promethazine hydrochloride 2 parts, paeonol 1.1 parts, diphhydramine hydrochloride 0.3 part, alpha adrenergic receptor agonist 0.1 part, ursolic acid 0.5 part, diclofenac sodium 0.6 part, bergapton 1.2 parts, 1.5 parts of magnesium sulfate, chavicol 0.1 part, naringin 0.12 part, eucalyptol 0.8 part, gel-type vehicle 20 parts, antioxidant 0.03 part, preservative 0.02 part, solubilizing agent 0.05 part。
Wherein, described alpha adrenergic receptor agonist is phenylephrine or norepinephrine, it is possible to α 1 receptor of exciting blood vessel, makes vasoconstriction, mainly makes small artery and venule shrink。Described gel-type vehicle is carbomer, and acid, alkali, alcohol are had certain toleration by carbomer, have good biocompatibility, skin is not stimulated；Described carbomer is Carbopol 941, and its concentration is 0.6%。Described antioxidant is di-t-butyl carboxymethyl benzene, and antioxidant effect is good。Described preservative is selected from any one in sodium benzoate, methyl hydroxybenzoate, imidazolidinyl urea。Described solubilizing agent is tween 80, and tween 80 solubilizing effect is good, and zest is little, can be used for various gel。
The preparation method of the external-use gel preparation of this treatment erythromelalgia is:
(1) promethazine hydrochloride of formula ratio, paeonol, diphhydramine hydrochloride, alpha adrenergic receptor agonist, ursolic acid, diclofenac sodium, bergapton, magnesium sulfate, chavicol, naringin are taken, join in 40 parts of alcoholic solution, stirring, obtains component A；
(2) take 2 parts of glycerol and 0.8 part of propylene glycol, be dissolved in 5 parts of purified water, obtain component B；
(3) gel-type vehicle of formula ratio is taken, the component A obtained and component B is joined in gel-type vehicle successively under stirring, is further continued for adding the eucalyptol of formula ratio, antioxidant, preservative, solubilizing agent, stirs, regulating its pH value is 5.0, obtains water white topical agent。
Embodiment 2: a kind of external-use gel preparation treating erythromelalgia, component meter by weight, mainly consists of the following composition: promethazine hydrochloride 3 parts, paeonol 1.3 parts, diphhydramine hydrochloride 0.75 part, alpha adrenergic receptor agonist 0.26 part, ursolic acid 0.9 part, diclofenac sodium 0.65 part, bergapton 1.6 parts, 2.45 parts of magnesium sulfate, chavicol 0.4 part, naringin 0.185 part, eucalyptol 1.4 parts, gel-type vehicle 27 parts, antioxidant 0.045 part, preservative 0.03 part, solubilizing agent 0.075 part。
Wherein, described alpha adrenergic receptor agonist is phenylephrine or norepinephrine, it is possible to α 1 receptor of exciting blood vessel, makes vasoconstriction, mainly makes small artery and venule shrink。Described gel-type vehicle is carbomer, and acid, alkali, alcohol are had certain toleration by carbomer, have good biocompatibility, skin is not stimulated；Described carbomer is Carbopol 941, and its concentration is 0.8%。Described antioxidant is di-t-butyl carboxymethyl benzene, and antioxidant effect is good。Described preservative is selected from any one in sodium benzoate, methyl hydroxybenzoate, imidazolidinyl urea。Described solubilizing agent is tween 80, and tween 80 solubilizing effect is good, and zest is little, can be used for various gel。
The preparation method of the external-use gel preparation of this treatment erythromelalgia is:
(1) promethazine hydrochloride of formula ratio, paeonol, diphhydramine hydrochloride, alpha adrenergic receptor agonist, ursolic acid, diclofenac sodium, bergapton, magnesium sulfate, chavicol, naringin are taken, join in 40 parts of alcoholic solution, stirring, obtains component A；
(2) take 2 parts of glycerol and 0.8 part of propylene glycol, be dissolved in 5-6 part purified water, obtain component B；
(3) gel-type vehicle of formula ratio is taken, the component A obtained and component B is joined in gel-type vehicle successively under stirring, is further continued for adding the eucalyptol of formula ratio, antioxidant, preservative, solubilizing agent, stirs, regulating its pH value is 5.5, obtains water white topical agent。
Embodiment 3: a kind of external-use gel preparation treating erythromelalgia, component meter by weight, mainly consists of the following composition: promethazine hydrochloride 4 parts, paeonol 1.5 parts, diphhydramine hydrochloride 1.2 parts, alpha adrenergic receptor agonist 0.42 part, ursolic acid 1.3 parts, diclofenac sodium 0.7 part, bergapton 2.0 parts, 3.4 parts of magnesium sulfate, chavicol 0.7 part, naringin 0.25 part, eucalyptol 2.0 parts, gel-type vehicle 34 parts, antioxidant 0.06 part, preservative 0.04 part, solubilizing agent 0.1 part。
Wherein, described alpha adrenergic receptor agonist is phenylephrine or norepinephrine, it is possible to α 1 receptor of exciting blood vessel, makes vasoconstriction, mainly makes small artery and venule shrink。Described gel-type vehicle is carbomer, and acid, alkali, alcohol are had certain toleration by carbomer, have good biocompatibility, skin is not stimulated；Described carbomer is Carbopol 941, and its concentration is 1.0%。Described antioxidant is di-t-butyl carboxymethyl benzene, and antioxidant effect is good。Described preservative is selected from any one in sodium benzoate, methyl hydroxybenzoate, imidazolidinyl urea。Described solubilizing agent is tween 80, and tween 80 solubilizing effect is good, and zest is little, can be used for various gel。
The preparation method of the external-use gel preparation of this treatment erythromelalgia is:
(1) promethazine hydrochloride of formula ratio, paeonol, diphhydramine hydrochloride, alpha adrenergic receptor agonist, ursolic acid, diclofenac sodium, bergapton, magnesium sulfate, chavicol, naringin are taken, join in 40 parts of alcoholic solution, stirring, obtains component A；
(2) take 2 parts of glycerol and 0.8 part of propylene glycol, be dissolved in 6 parts of purified water, obtain component B；
(3) gel-type vehicle of formula ratio is taken, the component A obtained and component B is joined in gel-type vehicle successively under stirring, is further continued for adding the eucalyptol of formula ratio, antioxidant, preservative, solubilizing agent, stirs, regulating its pH value is 6.0, obtains water white topical agent。
Curative effect:
Case selection: patient 402 example choosing erythromelalgia through outpatient service is divided equally into two groups at random, often organizes 201 people, respectively treatment group and matched group, and two group memberships are absent from biased and significant difference。
Therapeutic Method: the oral medmain antagonistic of matched group and aspirin, treatment group uses the external-use gel preparation of the embodiment of the present invention 2 preparation。Within 5th, it is a course for the treatment of, 3 courses for the treatment of of treatment altogether。
Efficacy determination: adopt 4 grade standards
Recovery from illness clinical improvements rate >=95%；Effective clinical improvements rate < 95%, >=60%；Effective clinical improvement rate < 60%, >=20%；Invalid clinical improvements rate < 20%；
Therapeutic outcome: in Table 1
| Group | Recovery from illness (example %) | Effective (example %) | Effectively (example %) | Invalid (example %) | Total effective rate (%) |
| Treatment group | 158(78.6) | 31(15.4) | 9(4.48) | 3(0.15) | 198(98.5) |
| Experimental group | 32(15.9) | 40(19.8) | 58(28.9) | 71(35.3) | 130(64.7) |
Interpretation of result: matched group total effective rate is 64.7%, the total effective rate of external-use gel preparation of the present invention is 98.5%, (p < 0.01), illustrates that external-use gel preparation total effective rate of the present invention is significantly higher than the total effective rate of matched group。
To sum up, by the analysis to two groups, it can be deduced that conclusion, the effect of Chinese medicine decoction of the present invention treatment erythromelalgia is significantly higher than Western medicine medmain antagonistic and aspirin, has significant therapeutic effect。
Model case:
Case 1, single certain, sex: female, the age: 41 years old。Cardinal symptom: left foot local red and swollen heat pain, in burning sensation, with acupuncture sample pain, hospital diagnosis is erythromelalgia。The external-use gel preparation using embodiment 1 preparation is treated, and smears every day 3 times, and 3 courses for the treatment of cure, and follow up a case by regular visits to and do not recur。
Case 2, sternly certain, sex: man, 30 years old age。Cardinal symptom: two toes (toe) first thickens, amyotrophy, numb, night, pain was obvious, and instep is scorching hot rubescent or blue, and with pain, hospital diagnosis is erythromelalgia。The external-use gel preparation using embodiment 2 preparation is treated, and smears every day 3 times, and 3 courses for the treatment of cure, and follow up a case by regular visits to and do not recur。
Case 3 Wang, sex: female。Age: 22 years old。Cardinal symptom: biped skin rubefaction, Pi Wengao, with swelling, pain, perspiration symptom, hospital diagnosis is erythromelalgia。The external-use gel preparation using embodiment 3 preparation is treated, and smears every day 3 times, and 3 courses for the treatment of cure, and follow up a case by regular visits to and do not recur。
With the above-mentioned desirable embodiment according to the present invention for enlightenment, by above-mentioned description, relevant staff in the scope not necessarily departing from this invention technological thought, can carry out various change and amendment completely。The technical scope of this invention is not limited to the content in description, it is necessary to determine its technical scope according to right。
Claims (8)
1. the external-use gel preparation treating erythromelalgia, it is characterized in that, component meter by weight, mainly consist of the following composition: promethazine hydrochloride 2-4 part, paeonol 1.1-1.5 part, diphhydramine hydrochloride 0.3-1.2 part, alpha adrenergic receptor agonist 0.1-0.42 part, ursolic acid 0.5-1.3 part, diclofenac sodium 0.6-0.7 part, bergapton 1.2-2.0 part, magnesium sulfate 1.5-3.4 part, chavicol 0.1-0.7 part, naringin 0.12-0.25 part, eucalyptol 0.8-2.0 part, gel-type vehicle 20-34 part, antioxidant 0.03-0.06 part, preservative 0.02-0.04 part, solubilizing agent 0.05-0.1 part。
2. a kind of external-use gel preparation treating erythromelalgia as claimed in claim 1, it is characterised in that described alpha adrenergic receptor agonist is phenylephrine or norepinephrine。
3. a kind of external-use gel preparation treating erythromelalgia as claimed in claim 1, it is characterised in that described gel-type vehicle is carbomer。
4. a kind of external-use gel preparation treating erythromelalgia as claimed in claim 1, it is characterised in that described carbomer is Carbopol 941, and its concentration is 0.6-1.0%。
5. a kind of external-use gel preparation treating erythromelalgia as claimed in claim 1, it is characterised in that described antioxidant is di-t-butyl carboxymethyl benzene。
6. a kind of external-use gel preparation treating erythromelalgia as claimed in claim 1, it is characterised in that any one in sodium benzoate, methyl hydroxybenzoate, imidazolidinyl urea of described preservative。
7. a kind of external-use gel preparation treating erythromelalgia as claimed in claim 1, it is characterised in that described solubilizing agent is tween 80。Tween 80 solubilizing effect is good, and zest is little, can be used for various gel。
8. a kind of external-use gel preparation treating erythromelalgia as described in claim 1-7, it is characterised in that preparation method is:
(1) promethazine hydrochloride of formula ratio, paeonol, diphhydramine hydrochloride, alpha adrenergic receptor agonist, ursolic acid, diclofenac sodium, bergapton, magnesium sulfate, chavicol, naringin are taken, join in 40 parts of alcoholic solution, stirring, obtains component A。
(2) take 2 parts of glycerol and 0.8 part of propylene glycol, be dissolved in 5-6 part purified water, obtain component B。
(3) gel-type vehicle of formula ratio is taken, the component A obtained and component B is joined in gel-type vehicle successively under stirring, it is further continued for adding the eucalyptol of formula ratio, antioxidant, preservative, solubilizing agent, stirs, obtain water white topical agent。
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| CN105147760A (en) * | 2015-09-28 | 2015-12-16 | 成都倍加特生物科技有限公司 | Externally-used soak liquor capable of treating erythromelalgia and preparation method |
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