CN105997954A - Itching-relieving and pain-relieving pollen liniment and preparation method thereof - Google Patents
Itching-relieving and pain-relieving pollen liniment and preparation method thereof Download PDFInfo
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- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
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Abstract
The invention discloses itching-relieving and pain-relieving pollen liniment and a preparation method thereof. The external liniment is mainly prepared from snakegourd roots, dahurian angelica roots, short-pedicel aconite roots, borneol, camphor, frankincense processed with vinegar, myrrh processed with vinegar, peppermint oil, eucalyptus oil and an auxiliary material. The liniment is prepared according to properties of medicines in a formula of itching-relieving and pain-relieving pollen tincture and functions of the medicines in the formula, used matrixes are screened, the use quantity of the matrixes is optimized, and the prepared liniment is applicable to various patients. Besides, a specific preparation process and parameters are improved, effective ingredients in frankincense are promoted to be dissolved out through combination of the matrixes and the preparation process, and particularly, the effective ingredient, namely, AKBA (acetyl-11-keto-beta-boswellic acid), in the frankincense is promoted to be dissolved out. The liniment is better refined, the efficacy is more remarkable, and the clinic efficacy is good.
Description
Technical field
The present invention relates to a kind of pollen dispel Pigmentum agent and preparation method thereof of itching, belong to the field of medicine technology.
Technical background
Traumatic injury is in daily life for some people seemingly homely food, and Chinese traditional treatment traumatic injury has thousand of years go through
History, ancient " traumatic injury " is called the introduction of all wounds, how because of External Force Acting, or overexerts in the case of self fault
And cause.Muscles and bones trauma that the traditional Chinese medical science causes in human body because of External Force Acting all, swelling and pain due to blood stasis, disharmony between QI and blood, blockage of main and collateral channels
So that internal organs are impaired, it is referred to as traumatic injury.Its main pathology is that congestion is stopped up stagnant, and blood is held one's breath resistance, therefore with pain, swelling is
Main performance.Treatment is many with promoting blood circulation to remove obstruction in the collateral, relaxing muscles and tendons and promoting circulation of QI, and reducing swelling and alleviating pain is method, and curative effect is the most obvious.
Pollen itching-dispelling pain-relieving tincture comes from ethnic groups medication among the people, and Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani) has strong analgesic activity, for principal agent, is aided with
The Radix Angelicae Dahuricae, Radix Trichosanthis are ministerial drug, have detumescence, antipruritic effect, help Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani) to play antiinflammatory, analgesic efficacy；Pain is the most not
Logical, the most bitterly, Gu Zuo is to have the Olibanum of blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain, Myrrha for general rule.We have blood circulation promoting and blood stasis dispelling, and detumescence is only
Bitterly, effect of dispelling wind for relieving itching, we are for blood circulation promoting and blood stasis dispelling, and reducing swelling and alleviating pain, dispelling wind for relieving itching, effect is obvious.But due in tincture
Containing substantial amounts of ethanol, the patient of alcohol sensible should not be suitable for by skin, and tincture ethanol during storing is readily volatilized, meeting
Affect the curative effect of medicine.Additionally, applicant further found that, use existing extraction process to make pollen and dispel and itch in analgetic preparation, Olibanum
Effective ingredient be difficult to measure, the content of especially 11-carbonyl-beta-acetyl boswellic acid is difficult to measure.Pollen is dispelled pain relieving of itching
The clinical efficacy of preparation is the most preferable.
Liniment, refers to be dissolved into membrane material and medicine with organic solvent and the exterior-applied formulation made.Used time is applied to affected part.Solvent is waved
After Faing, formation thin film is to protect wound surface, and the most gradually release contained drug plays therapeutical effect.Liniment preparation technology is simple, need not
Framed back material, is not required to special plant equipment, and easy to use, current liniment is more and more higher by attention degree in the world of medicine.
As pollen itching-dispelling pain-relieving tincture is made liniment, will be enlarged by its scope of application, be preferably patient service.
Summary of the invention:
It is an object of the invention to, it is provided that a kind of pollen is dispelled Pigmentum agent and preparation method thereof of itching.The present invention dispels according to pollen and itches
The character of each medicine in analgesic tincture prescription, and the effect that this medicine is played in prescription, be made into liniment, and to used
Substrate is screened, and is optimized substrates quantity, and the liniment made is suitable for all kinds of patient and uses.Meanwhile, to specifically
Processing technology and parameter are improved, and substrate of the present invention and processing technology of the present invention combine, and promote effective ingredient in Olibanum
Dissolution, especially Olibanum effectively become the dissolution of 11-carbonyl-beta-acetyl boswellic acid (AKBA).Make the more refine of this medicine,
Drug effect is more significantly, and clinical efficacy is good.
For solving above-mentioned technical problem, the present invention realizes by the following technical solutions: a kind of pollen is dispelled Pigmentum agent of itching, by according to
Radix Trichosanthis 30-60 part of weight portion meter, Radix Angelicae Dahuricae 30-60 part, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani) 20-50 part, Borneolum Syntheticum 1-8 part, Camphora 1-8
Part, Olibanum (processed with vinegar) 10-30 part, Myrrha (processed with vinegar) 10-30 part, and by volume Oleum menthae 5-30 part of part meter, Oleum Eucalypti 1-8 part,
And calculate by weight ethyl cellulose 1-16 part, PVP K-30 1-16 part, olefin(e) acid resin 1-16 part,
Tween 1 1-10 part and zein 5-15 part are made.
Aforesaid pollen is dispelled Pigmentum agent of itching, by Radix Trichosanthis 45 parts in parts by weight, the Radix Angelicae Dahuricae 45 parts, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani)
34 parts, Borneolum Syntheticum 4 parts, Camphora 5 parts, Olibanum (processed with vinegar) 20 parts, Myrrha (processed with vinegar) 20 parts, and the Oleum menthae 10 that by volume part is counted
Part, Oleum Eucalypti 5 parts, and the ethyl cellulose calculated by weight 8 parts, PVP K-30 8 parts, olefin(e) acid resin
8 parts, tween one 80 5 parts and zein 10 parts are made.
A kind of aforesaid pollen is dispelled the manufacture method of Pigmentum agent of itching, and comprises the following steps:
(1) taking Radix Trichosanthis, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani), Myrrha (processed with vinegar), the Radix Angelicae Dahuricae is ground into coarse granule, mixing, adds the infiltration of 75-85% ethanol
20-28 hour, then impregnate in three times with 75-85% ethanol, 2-4 hour for the first time；Second and third time each 1-3 hour, merges
Impregnation liquid, filters, must mix filtrate standby, then take Olibanum (processed with vinegar), adds 6-10 times amount soak by water 1-3 time, each 1-3h,
Filter, merging filtrate, be condensed into concentrated solution, standby；Filtering residue adds the ethanol solution of 6-10 times amount 55-65%, reflux, extract,
2-3 time, each 0.5-3h, filter, merging filtrate, recovery ethanol, to only, obtains alcohol extract, alcohol extract, mixing filtrate
Merge with concentrated solution, obtain A product；
(2) separately take Borneolum Syntheticum, Camphora, Oleum menthae, Oleum Eucalypti add 75-85% ethanol and dissolve, and add in A product, then add 75-85% ethanol
Make into 900-1100ml, mixing, stand 20-28 hour, take supernatant, filter, obtain B product；
(3) B product add ethyl cellulose, olefin(e) acid resin and zein, stir evenly dissolving, obtain C product；
(4) C product add PVP K-30 and tween 80, stir, to obtain final product.
Aforesaid pollen is dispelled the manufacture method of Pigmentum agent of itching, and comprises the following steps:
(1) taking Radix Trichosanthis, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani), Myrrha (processed with vinegar), the Radix Angelicae Dahuricae is ground into coarse granule, mixing, adds 80% ethanol infiltration 24
Hour, then impregnate in three times with 80% ethanol, 3 hours for the first time；Second and third time is each 2 hours, merges 3 impregnation liquid,
Filter, filtrate must be mixed standby, then take Olibanum (processed with vinegar), add 8 times amount soak by water 3 times, each 2h, filter, merging filtrate,
Filtrate reduced in volume becomes relative density under room temperature to be the concentrated solution of 1.10-1.15, standby；Filtering residue adds the ethanol of 8 times amount 60%
Solution, reflux, extract, 3 times, each 2h, filter, merging filtrate, reclaim ethanol to only, obtain alcohol extract, alcohol extract, mixed
Close filtrate to merge with concentrated solution, obtain A product；
(2) separately take Borneolum Syntheticum, Camphora, Oleum menthae, Oleum Eucalypti add 80% ethanol and dissolve, and add in A product, then add 80% ethanol and make into 1000ml,
Mixing, stands 24 hours, takes supernatant, filters, obtains B product；
(3) B product add ethyl cellulose, olefin(e) acid resin and zein, stir evenly dissolving, obtain C product；
(4) C product add PVP K-30 and tween 80, stir, to obtain final product.
In drug prescription of the present invention, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani) has strong analgesic activity, for principal agent, is aided with the Radix Angelicae Dahuricae, Radix Trichosanthis is
Ministerial drug, has detumescence, antipruritic effect, helps antiinflammatory, analgesic efficacy that Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani) plays, and pain is the most obstructed, general rule the most bitterly,
Gu Zuo is to have the Olibanum of blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain, Myrrha.There is blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, effect of dispelling wind for relieving itching.
Applicant has carried out long numerous studies to pollen analgetic preparation, applicant at first with Radix Trichosanthis, the Radix Angelicae Dahuricae, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani),
Borneolum Syntheticum, Camphora, Olibanum (processed with vinegar), Myrrha (processed with vinegar), Oleum menthae and Oleum Eucalypti are that tincture made by raw material, but because tincture is containing substantial amounts of ethanol,
The patient of alcohol sensible should not be suitable for by skin, and tincture ethanol during storing is readily volatilized, can affect the curative effect of medicine.
Again because liniment is as carrier transdermal administration, having unique advantage compared with other dosage forms, liniment can also medicament curative effect enhancement；
Because 1, liniment of the present invention can form uniform film patch in localized skin surface, the effective ingredient of skin surface can be stoped to volatilize,
On the one hand the effective ingredient that effective ingredient permeates downwards, another aspect is upwards volatilized, due to the stop of film, changes by permeating downwards, therefore
And drug effect can be made to increase.2, liniment of the present invention is close to the continuous action of skin and can fully be improved surrounding tissue circulation, makes affected part week
Marjoram Extract in the normal structure enclosed, blood flow rate is accelerated, and effectively absorbs the congested of impingement tissue and oozes out, eliminates congestive edema.
3, the effective ingredient in liniment of the present invention is slowly release, and persistently penetrate to the skin deep tissues, adds liniment good
Tackness, more promote local organization active ingredient is fully absorbed.So the liniment that the present invention provides can reach to increase
Curative effect.
Therefore, applicant considers to be made into liniment, but after being formed into liniment, substrate accounts for the overwhelming majority of liniment, removes
Outside the effect of excipient, also act as the role of pharmaceutical carrier simultaneously, the quality of liniment is played an important role.For guaranteeing
Liniment quality of the present invention is good, and drug effect is good, and applicant has carried out substantial amounts of research to selection and the consumption thereof of the substrate of liniment,
Applicant draws through lot of experiments, selects ethyl cellulose, PVP K-30, olefin(e) acid resin, tween 1
And corn protein is when being substrate.Dispel Pigmentum agent drug effect of itching of the pollen made is preferable.
Additionally, existing pollen is also dispelled by applicant, the itch processing technology of analgetic preparation is improved, and existing pollen is dispelled pain relieving system of itching
The manufacture method method of agent is: Radix Trichosanthis, the Radix Angelicae Dahuricae, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani), Olibanum, Myrrha are ground into coarse granule, mixing, adds 80%
Ethanol infiltration 24h, then impregnate in three times with 80% ethanol, 3 hours for the first time, second and third each 2h, merge 3 dippings
Liquid, filters, and filtrate is standby；Separately take Borneolum Syntheticum, Camphora, Oleum menthae, Oleum Eucalypti add 80% ethanol and dissolve, and add in above-mentioned filtrate,
Add 80% ethanol again and make into 1000ml, mixing, stand 24h, take supernatant, filter, to obtain final product.But inventor was studying
Finding in journey, adopting the pollen made in this way and dispel and itch in analgetic preparation, the effective ingredient of Olibanum is difficult to measure.Make Olibanum
Clinical efficacy the most preferable.Inventor also finds in technical study, uses the inventive method individually extracted by Olibanum and change
Becoming the extraction process of Olibanum, the pollen so made is dispelled and is itched in analgetic preparation, and the effective ingredient of Olibanum is easily measured, and measure
The effective ingredient of Olibanum is high.This allows for so that the more refine of this medicine, and drug effect is more significantly, and clinical efficacy is good.Applicant is also
Find, use present invention process and coordinate above-mentioned substrate, can better promote the dissolution of effective ingredient, particularly 11-in Olibanum
The dissolution of carbonyl-beta-acetyl boswellic acid, promotees the effect of oozing and becomes apparent from so that pollen is dispelled the 11-carbonyl-β that itches in analgetic preparation-
Acetyl boswellic acid (AKBA) improves, and the boswellic acids (BAs) in Olibanum is the effective ingredient of effect such as its antiinflammatory, antitumor etc.,
Wherein 11-carbonyl-beta-acetyl boswellic acid (AKBA) anti-inflammatory activity is the most notable, therefore, and 11-carbonyl-beta-acetyl boswellic acid (AKBA)
Dissolution improve after, drug effect is more preferable, so that its clinical effectiveness is more preferable.
Compared with prior art, the present invention is according to the character of medicine each in pollen itching-dispelling pain-relieving tincture prescription, and this medicine is at prescription
Played in effect, be made into liniment, and substrate used screened, substrates quantity is optimized, makes
Liniment be suitable for all kinds of patient use., being improved concrete processing technology and parameter, substrate and the present invention make meanwhile
Technique combines, and promotes and effectively becomes 11-carbonyl-beta-acetyl boswellic acid in Olibanum in the dissolution of effective ingredient, especially Olibanum
(AKBA) dissolution.Making the more refine of this medicine, drug effect is more significantly, and clinical efficacy is good.
Applicant carried out following experiments, the provable present invention has effective effect；
Experimental example 1. adjuvant screens
1 experiment material
Substrate of the present invention: Oleum menthae 10ml, Oleum Eucalypti 5ml, ethyl cellulose 8g, PVP K-30 8g, olefin(e) acid
Resin 8g, tween 1 5g and zein 10g.
Contrast media A: Oleum menthae 10ml, Oleum Eucalypti 5ml, polyvinyl butyral resin 4.50g, diethyl phthalate 12.50g,
Tween 80 15.00g, acetone 1.00g.
Contrast media B: Oleum menthae 10ml, Oleum Eucalypti 5ml, polyvinyl formal-acetal 6.50g, dimethyl phthalate 10.00g,
Arlacel-80 5.50g, concentration are the ethanol 6.0g of 85%.
Contrast media C: Oleum menthae 10ml, Oleum Eucalypti 5ml, collodion 4.00g, dibutyl phthalate 12.50g, Semen Ricini
Oil 6.00g, tween 80 5.50g, acetone 10.05g, glycerol 5.10g, triethanolamine 1.00g.
Contrast media D: Oleum menthae 10ml, Oleum Eucalypti 5ml, polyvinyl formal-acetal 10.00g, diacetyl monoglyceride 9.01g,
Acetylated monoglyceride 11.00g, Arlacel-80 5.60g, glycerol 6.00g, tween 80 2.50g.
2 assay methods and result
Taking above-mentioned substrate, be measured viscosity, stability, film formation time, adhesive force and pliability, measurement result sees below
Table.
Table 1 viscosity, stability, film formation time, adhesive force and pliability measurement result
| Substrate | Viscosity | Stability | Film formation time | Adhesive force | Pliability |
| Substrate of the present invention | Thick | Well | Within 1min | Well | Good |
| Substrate A | Shang Ke | Well | 7-9min | Shang Ke | Have |
| Substrate B | Moderate | It is layered after 10 days, has oil droplet | 5-6min | Shang Ke | Typically |
| Substrate C | Moderate | Good | 10-12min | Shang Ke | Well |
As seen from table, in liniment group of the present invention, viscosity, stability, film formation time, adhesive force and pliability are the most excellent.
Experimental example 2: pharmacodynamic study
Applicant has carried out Pharmacodynamics research to the present invention, by experimental data, beneficial effects of the present invention is described.
1, analgesic test
1.1 Experimental agents
Liniment the most of the present invention: make by embodiment 1；
1.1.2 former tincture:
Prescription: Radix Trichosanthis 45g, Radix Angelicae Dahuricae 45g, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani) 34g, Borneolum Syntheticum 4g, Camphora 5g, Olibanum (vinegar system) 20g, do not have
Medicine (vinegar system) 20g, Oleum menthae 10ml, Oleum Eucalypti 5ml；
Technique: first take Radix Trichosanthis, the Radix Angelicae Dahuricae, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani), Olibanum (vinegar system), Myrrha (vinegar system) pulverizing, mixing, add
80% ethanol infiltration 24h, then impregnate in three times with 80% ethanol, 3h for the first time, second and third each 2h, merge 3 dippings
Liquid, filters, and filtrate is standby；Separately take Borneolum Syntheticum, Camphora, Oleum menthae, Oleum Eucalypti add 80% ethanol and dissolve, and add in above-mentioned filtrate,
Add 80% ethanol again and make into 1000ml, mixing, stand 24h, take supernatant, filter, make tincture.
1.2 experimental technique
Take healthy Kunming mouse 48, male and female half and half, be randomly divided into 3 groups, i.e. blank group, liniment group of the present invention (is pressed
Method according to the embodiment of the present invention 1 makes) and former tincture group, often group 16.Dosage is respectively blank group (0.5g/kg
Excipient), of the present invention group (0.5g/kg liniment of the present invention group), former tincture group (0.5g/kg).Mice buttocks back is taken off
Hair, smears corresponding tested material, smears 2h, be administered once daily, successive administration 3 days.In last after medicine 12h, each mice abdomen
0.8% white vinegar acid solution 0.2ml/ is injected only in chamber, and in observed and recorded 15min, the number of times of writhing response occurs in every mice, calculates all
Number and standard deviation, compare group difference.
1.3 result
Each administration group all can resist the pain reaction caused by white vinegar acid stimulation, makes mouse writhing number of times significantly reduce (being shown in Table 2).
The table 2 impact (n=12, x ± s) on mouse writhing number of times
Note: compare with former tincture group*P ＜ 0.05；
Compare with blank group#P ＜ 0.05,##P ＜ 0.01.
1.4 conclusion
Above experimental studies results shows, liniment group of the present invention and former tincture group all can resist the pain caused by white vinegar acid stimulation
Reaction (P ＜ 0.01), but liniment group of the present invention is better than former tincture group (P ＜ 0.05).
2, antiinflammatory experiment
2.1 Experimental agents
Liniment the most of the present invention: make by embodiment 1；
2.2.2 former tincture:
Prescription: Radix Trichosanthis 45g, Radix Angelicae Dahuricae 45g, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani) 34g, Borneolum Syntheticum 4g, Camphora 5g, Olibanum (vinegar system) 20g, do not have
Medicine (vinegar system) 20g, Oleum menthae 10ml, Oleum Eucalypti 5ml；
Technique: first take Radix Trichosanthis, the Radix Angelicae Dahuricae, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani), Olibanum (vinegar system), Myrrha (vinegar system) pulverizing, mixing, add
80% ethanol infiltration 24h, then impregnate in three times with 80% ethanol, 3h for the first time, second and third each 2h, merge 3 dippings
Liquid, filters, and filtrate is standby；Separately take Borneolum Syntheticum, Camphora, Oleum menthae, Oleum Eucalypti add 80% ethanol and dissolve, and add in above-mentioned filtrate,
Add 80% ethanol again and make into 1000ml, mixing, stand 24h, take supernatant, filter, make tincture.
2.2 experimental technique
2.2.1 mice ear experiment takes healthy Kunming mouse 48, male and female half and half, and packet, dosage are with 1.1
Under, successive administration 6 days, every mouse right ear one side was smeared 20 μ L dimethylbenzene in the 7th day, another side smears 10 μ L.30min
Rear execution animal, beats with 8mm card punch and takes left and right ear same position disk, weigh, calculate swelling rate=(auris dextra weight-left ear
Weight)/left ear weight × 100%.The results are shown in Table 3.
2.2.2 rat paw edema experiment takes male Kunming kind rat 48, is randomly divided into 3 groups, and packet is with under 2.2.1 item.
Rat abdomen depilation area is 2.5cm × 2.5cm.Liniment group external application 0.3g/kg of the present invention, smears outside former tincture group
0.3g/kg, blank group external application bare substrate 0.3g/kg, smear 2h, every day 1 time, successive administration 6 days.With volume
Method surveys normal foot sole of the foot volume (mL) of Rat Right metapedes.After last is administered, Rat Right metapedes plantar subcutaneous injection 1% carrageenin 0.1mL
Cause inflammation, the sufficient sole of the foot volume of 5h same position after survey cause inflammation.Calculating swelling rate=(causing the scorching front foot sole of the foot thickness of scorching metapedes sole of the foot thickness-cause)/
Cause scorching front foot sole of the foot thickness × 100%.The results are shown in Table 4.
Table 3 mice is turned round auricle edema rate and compares (n=12, x ± s)
Note: compare with former tincture group*P ＜ 0.05；
Compare with blank group#P ＜ 0.05,##P ＜ 0.01.
Table 4 is respectively organized rat paw edema rate and is compared (n=12, x ± s)
Note: compare with former tincture group*P ＜ 0.05；
Compare with blank group#P ＜ 0.05,##P ＜ 0.01.
2.3 conclusion
Result shows: liniment group of the present invention and former tincture group all can reduce mice and turn round auricle edema rate and rat paw edema rate.With
Former tincture group compares, and liniment group effect of the present invention is more preferably (P ＜ 0.05).
3, dispel test of itching
3.1 Experimental agents
Liniment the most of the present invention: (making by embodiment 1)；
3.2.2 former tincture:
Prescription: Radix Trichosanthis 45g, Radix Angelicae Dahuricae 45g, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani) 34g, Borneolum Syntheticum 4g, Camphora 5g, Olibanum (vinegar system) 20g,
Myrrha (vinegar system) 20g, Oleum menthae 10ml, Oleum Eucalypti 5ml；
Technique: first take Radix Trichosanthis, the Radix Angelicae Dahuricae, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani), Olibanum (vinegar system), Myrrha (vinegar system) pulverizing, mixing, add
80% ethanol infiltration 24h, then impregnate in three times with 80% ethanol, 3h for the first time, second and third each 2h, merge 3 dippings
Liquid, filters, and filtrate is standby；Separately take Borneolum Syntheticum, Camphora, Oleum menthae, Oleum Eucalypti add 80% ethanol and dissolve, and add in above-mentioned filtrate,
Add 80% ethanol again and make into 1000ml, mixing, stand 24h, take supernatant, filter, make tincture.
3.2 experimental technique
Take Cavia porcellus 50, be divided into blank group (bare substrate), liniment group of the present invention at random；Former tincture group.Respectively organize globefish
Dorsal portion shaving 1.5cm × 1.5cm behind the Mus right side, is uniformly applied to shaving district respectively by tested material, and dosage is each 0.05g cm-2, it is administered area about 1cm2, it being given daily 3 times, medication interval is 1h, is administered the 3rd day, abrades respectively at shaving with coarse sandpaper
To injure epidermis, there is slight oozing of blood for degree.Tested material or tester 1 time it is coated with the most respectively in wound local, after coating 10min, point
At every Cavia porcellus wound surface, do not drip 0.01% histamine phosphate 0.05mL, hereafter every 3min according to 0.01%, 0.02%, 0.03%,
0.04%, 0.05% progressive concentration, only it is 0.05mL/ every time, during until Cavia porcellus occurs later licking metapedes, records every Cavia porcellus
The total amount of given histamine, with this total amount as itch-threshold, and compares the itch-threshold of each treated animal.Result liniment of the present invention and former tincture
Agent all can improve Cavia porcellus itch-threshold, the skin pruritus that suppression is caused by histamine to some extent, and presents good dose-effect dependence pass
It is, and the effect of liniment of the present invention is better than former tincture, has significance (P < 0.05) with blank group comparing difference, is shown in Table 5.
Table 5 causes, on Cavia porcellus histamine phosphate, the impact reacted of itching
Note: compare with blank group#P < 0.05,##P<0.01。
Compare with former tincture group,+P ＜ 0.05.
Experimental example 3 11-carbonyl-beta-acetyl boswellic acid (AKBA) assay
1 instrument and reagent
Waters 2695 high performance liquid chromatograph (2996PDA detector), AKBA reference substance (China's pharmaceutical biological product
Calibrating institute, lot number: 111760-200601), acetonitrile (chromatographically pure, JT Baker), glacial acetic acid, methanol (analytical pure, Beijing chemical industry
Factory), experimental water is prepared by Milli-Q system.Liniment of the present invention (with experimental example 2)；Former tincture (with experimental example 2).
2 methods and result
2.1 chromatographic conditions and system suitability
Chromatographic column: Agilent TC-C18 (4.6mm × 250mm, 5 μm)；Flowing phase: acetonitrile-0.1% glacial acetic acid solution (80: 20)；
Column temperature: 30 DEG C；Flow velocity: 1mL min-1；Detection wavelength: 250nm；Sample size: 10 μ L.AKBA is the lowest with adjacent chromatographic peak separating degree
In 1.5, number of theoretical plate is 17000.
The preparation of 2.2 reference substance storing solutions
Precision weighs AKBA reference substance 6.14mg and puts in 10mL measuring bottle, adds methanol to scale, shakes up, to obtain final product.
The preparation of 2.3 need testing solutions
The preparation of need testing solution 1: take liniment of the present invention (being prepared by embodiment 1) about 0.2g, accurately weighed, put rope
In family name's extractor, add methanol 80ml, reflux, extract, 9h, wash and be settled to 100ml with methanol, filter, to obtain final product.
The preparation of need testing solution 2: take former tincture (with experimental example 2) about 0.2gg, accurately weighed, put in apparatus,Soxhlet's,
Add methanol 80ml, reflux, extract, 9h, wash and be settled to 100ml with methanol, filter, to obtain final product.
2.4 linear relationship precisions measure reference substance storing solution 0.25,0.5,1.0,2.0,4.0mL put 10mL amount respectively
In Ping, add methanol to scale, shake up.Precision measures each 10 μ L of above 5 parts of solution and injects chromatograph of liquid, with sample introduction
Amount (μ g) is abscissa, and peak area is vertical coordinate, draws standard curve, obtains regression equation: Y=1.45418 × 106X
+7.42458×103(r=0.99999) show AKBA in 0.1535-2.4560 μ g range linearly.
2.5 precision test
Taking liniment of the present invention, by legal system available test sample solution 1,6 parts below " 2.3 " item, measure, result RSD is 0.67%.
Taking former tincture, by legal system available test sample solution 2,6 parts below " 2.3 " item, measure, result RSD is 0.69%.
2.6 replica tests take liniment of the present invention and former tincture about 0.25g respectively, accurately weighed, by " 2.3 " item
Lower section method makes need testing solution 1 and need testing solution 2, each 6 parts, parallel assay, results averaged, RSD=0.80%
With 0.82%, show that assay method precision is good.
2.7 stability tests by legal system available test sample solution 1 below " 2.3 " item, 0,2,4,8,20h
Sample introduction respectively, measures, RSD is 0.68%, shows that need testing solution 1 is stable in 20h.
By legal system available test sample solution 2 below " 2.3 " item, 0,2,4,8,20h sample introduction respectively, measure,
RSD is 0.70%, shows that need testing solution 2 is stable in 20h.
2.8 recovery tests take liniment 0.1g of the present invention, accurately weighed, put in tool plug conical flask, and the accurate concentration that adds is
0.783mg·mL-1Reference substance solution 5mL, the more accurate methanol 20mL that adds, prepare 6 by method below " 2.3 " item afterwards
Part need testing solution 1, measures, and results averaged, average recovery rate is 97.66%, RSD=1.36%.
Take former tincture 0.1g, accurately weighed, to put in tool plug conical flask, the accurate concentration that adds is 0.783mg mL-1Comparison
Product solution 5mL, the more accurate methanol 20mL that adds, prepare 6 parts of need testing solutions 2 by method below " 2.3 " item afterwards, survey
Fixed, results averaged, average recovery rate is 97.63%, RSD=1.39%.
The mensuration of 2.9 samples precision respectively draws the need testing solution 1 and need testing solution prepared by method below " 2.3 " item
2 each 10ml, by above-mentioned chromatographic condition, according to regression equation calculation AKBA content.It the results are shown in Table 6.
Table 6 AKBA determines result
As seen from table, compared with former tincture, in liniment of the present invention, the content of effective constituents A KBA of Olibanum is higher.
Detailed description of the invention:
Embodiment 1:
Prescription: Radix Trichosanthis 45g, Radix Angelicae Dahuricae 45g, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani) 34g, Borneolum Syntheticum 4g, Camphora 5g, Olibanum (processed with vinegar) 20g, vinegar system
Myrrha 20g, Oleum menthae 10ml, Oleum Eucalypti 5ml, ethyl cellulose 8g, PVP K-30 8g, olefin(e) acid resin 8g,
Tween 1 5g and zein 10g.
Technique:
(1) taking Radix Trichosanthis, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani), Myrrha (processed with vinegar), the Radix Angelicae Dahuricae is ground into coarse granule, mixing, and adding 80% ethanol, to infiltrate 24 little
Time, then impregnate in three times with 80% ethanol, 3 hours for the first time；Second and third time each 2 hours, merges 3 impregnation liquid, filter
Cross, filtrate must be mixed standby, then take Olibanum (processed with vinegar), add 8 times amount soak by water 3 times, each 2h, filter, merging filtrate,
Filtrate reduced in volume becomes relative density under room temperature to be the concentrated solution of 1.10-1.15, standby；Filtering residue adds the ethanol of 8 times amount 60%
Solution, reflux, extract, 3 times, each 2h, filter, merging filtrate, reclaim ethanol to only, obtain alcohol extract, alcohol extract, mixed
Close filtrate to merge with concentrated solution, obtain A product；
(2) separately take Borneolum Syntheticum, Camphora, Oleum menthae, Oleum Eucalypti add 80% ethanol and dissolve, and add in A product, then add 80% ethanol and make into
1000ml, mixing, stand 24 hours, take supernatant, filter, obtain B product；
(3) B product add ethyl cellulose, olefin(e) acid resin and zein, stir evenly dissolving, obtain C product；
(4) C product add PVP K-30 and tween 80, stir, to obtain final product.
Usage and dosage: external, takes and is applied to affected part in right amount, every day 2-3 time.
Embodiment 2:
Formula: Radix Trichosanthis 60g, Radix Angelicae Dahuricae 60g, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani) 50g, Borneolum Syntheticum 8g, Camphora 8g, Olibanum (processed with vinegar) 30g, vinegar system
Myrrha 30g, Oleum menthae 30ml, Oleum Eucalypti 8ml, ethyl cellulose 16g, PVP K-30 16g, olefin(e) acid resin
16g, tween 1 10g and zein 15g.
Technique:
(1) taking Radix Trichosanthis, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani), Myrrha (processed with vinegar), the Radix Angelicae Dahuricae is ground into coarse granule, mixing, adds 85% ethanol infiltration 28
Hour, then impregnate in three times with 85% ethanol, 4 hours for the first time；Second and third time is each 3 hours, merges impregnation liquid, filters,
Filtrate must be mixed standby, then take Olibanum (processed with vinegar), add 10 times amount soak by water 3 times, each 3h, filters, merging filtrate, filter
Liquid concentrating under reduced pressure becomes relative density under room temperature to be the concentrated solution of 1.10-1.15, standby；The ethanol that filtering residue adds 10 times amount 65% is molten
Liquid, reflux, extract, 3 times, each 3h, filter, merging filtrate, reclaim ethanol to only, obtain alcohol extract, alcohol extract, mixed
Close filtrate to merge with concentrated solution, obtain A product；
(2) separately take Borneolum Syntheticum, Camphora, Oleum menthae, Oleum Eucalypti add 75-85% ethanol and dissolve, and add in A product, then add 85% ethanol and make into
1100ml, mixing, stand 28 hours, take supernatant, filter, obtain B product；
(3) B product add ethyl cellulose, olefin(e) acid resin and zein, stir evenly dissolving, obtain C product；
(4) C product add PVP K-30 and tween 80, stir, to obtain final product.
Usage and dosage: external, takes and is applied to affected part in right amount, every day 2-3 time.
Embodiment 3:
Formula: Radix Trichosanthis 30g, Radix Angelicae Dahuricae 30g, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani) 20g, Borneolum Syntheticum 1g, Camphora 1g, Olibanum 10g, Myrrha (processed with vinegar)
10g, Oleum menthae 5ml, Oleum Eucalypti 1ml, ethyl cellulose 1g, PVP K-30 1g, olefin(e) acid resin 1g, tween
One 80 1g and zein 5g.
Technique:
(1) taking Radix Trichosanthis, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani), Myrrha (processed with vinegar), the Radix Angelicae Dahuricae is ground into coarse granule, mixing, adds 75% ethanol infiltration 20
Hour, then impregnate in three times with 75% ethanol, 2 hours for the first time；Second and third time is each 1 hour, merges impregnation liquid, filters,
Must mix filtrate standby, then take Olibanum (processed with vinegar), add 6 times amount soak by water 1h, filter, merging filtrate, filtrate reduced in volume becomes
Under room temperature, relative density is the concentrated solution of 1.10-1.15, standby；Filtering residue adds the ethanol solution of 6 times amount 55%, reflux, extract, 2
Secondary, each 0.5h, filter, merging filtrate, recovery ethanol, to only, obtains alcohol extract, alcohol extract, mixing filtrate and concentration
Liquid merges, and obtains A product；
(2) separately take Borneolum Syntheticum, Camphora, Oleum menthae, Oleum Eucalypti add 75% ethanol and dissolve, and add in A product, then add 75% ethanol and make into
900ml, mixing, stand 20 hours, take supernatant, filter, obtain B product；
(3) B product add ethyl cellulose, olefin(e) acid resin and zein, stir evenly dissolving, obtain C product；
(4) C product add PVP K-30 and tween 80, stir, to obtain final product.
Usage and dosage: external, takes and is applied to affected part in right amount, every day 2-3 time.
Claims (4)
1. a pollen is dispelled Pigmentum agent of itching, it is characterised in that: by Radix Trichosanthis 30-60 part in parts by weight, Radix Angelicae Dahuricae 30-60 part,
Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani) 20-50 part, Borneolum Syntheticum 1-8 part, Camphora 1-8 part, Olibanum (processed with vinegar) 10-30 part, Myrrha (processed with vinegar) 10-30 part,
And by volume Oleum menthae 5-30 part of part meter, Oleum Eucalypti 1-8 part, and ethyl cellulose 1-16 part, poly-calculated by weight
Vinylpyrrolidone K-301-16 part, olefin(e) acid resin 1-16 part, tween one 801-10 part and zein 5-15 part make and
Become.
2. pollen as claimed in claim 1 is dispelled Pigmentum agent of itching, it is characterised in that: by Radix Trichosanthis 45 parts in parts by weight,
The Radix Angelicae Dahuricae 45 parts, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani) 34 parts, Borneolum Syntheticum 4 parts, Camphora 5 parts, Olibanum (processed with vinegar) 20 parts, Myrrha (processed with vinegar) 20 parts, and
The by volume Oleum menthae 10 parts of part meter, Oleum Eucalypti 5 parts, and the ethyl cellulose calculated by weight 8 parts, polyvinylpyrrolidine
Ketone K-308 part, olefin(e) acid resin 8 parts, tween one 805 parts and zein 10 parts are made.
3. a pollen as claimed in claim 1 or 2 is dispelled the manufacture method of Pigmentum agent of itching, it is characterised in that: include following step
Rapid:
(1) taking Radix Trichosanthis, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani), Myrrha (processed with vinegar), the Radix Angelicae Dahuricae is ground into coarse granule, mixing, adds 75-85% ethanol infiltration 20-28
Hour, then impregnate in three times with 75-85% ethanol, 2-4 hour for the first time；Second and third time is each 1-3 hour, merges impregnation liquid,
Filter, filtrate must be mixed standby, then take Olibanum (processed with vinegar), add 6-10 times amount soak by water 1-3 time, each 1-3h, filter,
Merging filtrate, is condensed into concentrated solution, standby；The ethanol solution of filtering residue addition 6-10 times amount 55-65%, reflux, extract, 2-3 time,
0.5-3h every time, filters, merging filtrate, and recovery ethanol, to only, obtains alcohol extract, alcohol extract, mixing filtrate and concentrated solution
Merge, obtain A product；
(2) separately take Borneolum Syntheticum, Camphora, Oleum menthae, Oleum Eucalypti add 75-85% ethanol and dissolve, and add in A product, then add 75-85% ethanol
Make into 900-1100ml, mixing, stand 20-28 hour, take supernatant, filter, obtain B product；
(3) B product add ethyl cellulose, olefin(e) acid resin and zein, stir evenly dissolving, obtain C product；
(4) C product add PVP K-30 and tween 80, stir, to obtain final product.
4. pollen as claimed in claim 3 is dispelled the manufacture method of Pigmentum agent of itching, it is characterised in that: comprise the following steps:
(1) taking Radix Trichosanthis, Radix Aconiti Brachypodi (Radix Aconiti Szechenyiani), Myrrha (processed with vinegar), the Radix Angelicae Dahuricae is ground into coarse granule, mixing, and adding 80% ethanol, to infiltrate 24 little
Time, then impregnate in three times with 80% ethanol, 3 hours for the first time；Second and third time each 2 hours, merges 3 impregnation liquid, filter
Cross, filtrate must be mixed standby, then take Olibanum (processed with vinegar), add 8 times amount soak by water 3 times, each 2h, filter, merging filtrate,
Filtrate reduced in volume becomes relative density under room temperature to be the concentrated solution of 1.10-1.15, standby；Filtering residue adds the ethanol of 8 times amount 60%
Solution, reflux, extract, 3 times, each 2h, filter, merging filtrate, reclaim ethanol to only, obtain alcohol extract, alcohol extract, mixed
Close filtrate to merge with concentrated solution, obtain A product；
(2) separately take Borneolum Syntheticum, Camphora, Oleum menthae, Oleum Eucalypti add 80% ethanol and dissolve, and add in A product, then add 80% ethanol and make into 1000ml,
Mixing, stands 24 hours, takes supernatant, filters, obtains B product；
(3) B product add ethyl cellulose, olefin(e) acid resin and zein, stir evenly dissolving, obtain C product；
(4) C product add PVP K-30 and tween 80, stir, to obtain final product.
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Application publication date: 20161012 |