CN102614265A - Swelling-diminishing and pain-relieving self-emulsifying ointment - Google Patents
Swelling-diminishing and pain-relieving self-emulsifying ointment Download PDFInfo
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Abstract
The invention relates to a swelling-diminishing and pain-relieving self-emulsifying ointment, which can be used for treating rheumatism and rheumatoid arthritis pain. According to the technical scheme of the invention, the swelling-diminishing and pain-relieving self-emulsifying ointment is prepared by uniformly mixing a swelling-diminishing and pain-relieving paste extract serving as a medicament with a self-emulsifying substrate serving as a medicament carrier. Every gram of the swelling-reducing and pain-relieving self-emulsifying ointment contains 100-400mg of swelling-diminishing and pain-relieving paste extract; the self-emulsifying substrate is prepared from 12-20 percent by weight of an oil phase, 40-60 percent by weight of an emulsifier and 20-40 percent by weight of an auxiliary emulsifying agent; the oil phase consists of refined oil, glycerin monostearate and octadecanol in the weight ratio of 8:2:1; the emulsifier consists of polysorbate 80 and RH40 in the weight ratio of 2:8, or consists of polysorbate 80 and EL in the weight ratio of 6:4; and the auxiliary emulsifying agent is glycerol. The swelling-diminishing and pain-relieving self-emulsifying ointment is prepared by the following steps of: putting the oil phase into a constant-temperature water bath of 80 DEG C for heating and melting; adding the emulsifier, the auxiliary emulsifying agent and the swelling-diminishing and pain-relieving paste extract in sequence; dissolving and stirring uniformly; standing; and cooling for curing. The swelling-diminishing and pain-relieving self-emulsifying ointment has a good curative effect, and is an innovation of a medicament for diminishing swelling and relieving pain.
Description
One, technical field
The present invention relates to medicine, particularly a kind of subduing swelling and relieving pain self emulsifying ointment.
Two, background technology
Contain medicines such as Semen Strychni, Radix Aconiti, Radix Aconiti Kusnezoffii, Olibanum, Myrrha, Radix Angelicae Sinensis, the Radix Angelicae Dahuricae in the clinical proved recipe subduing swelling and relieving pain cream prescription.Former dosage form is processed black plaster and is used in clinical, because of its technology is loaded down with trivial details, and technical sophistication, content of beary metal is high; The quality difficulty or ease factor such as are controlled and have been influenced its curative effect and the scope of application, after with its effective component extracting, process the usual cream agent in clinical use; Though it is convenient than black plaster to use, pollution-free to skin, it is big to have a consumption; Occur when applying massage ointment can not rapid osmotic in skin, the phenomenon that is difficult to rapid absorption, comes off from skin, thus influence the performance of drug effect; If be made into self-emulsifiable preparation, then can overcome above-mentioned many shortcomings, also increased the dissolubility of shipwreck soluble drugs such as Olibanum, Myrrha in the prescription simultaneously; Self-emulsified drug delivery system is one of forward position preparation technique of modern medicinal agents research, and it has the drug loading that improves water solublity and fat-soluble medicine, the oil phase component particle diameter is reached micron to nano grade disperse; The affinity of increasing and skin and mucosa improves the Transdermal absorption speed and the absorbtivity of medicine, and to have processing technology simple for self-emulsifiable preparation in addition; Advantages such as convenient drug administration, and how effectively to treat arthralgia symptoms such as rheumatism, rheumatoid arthritis, be the technical barrier that urgent clinical needs solve.
Three, summary of the invention
To above-mentioned situation, for overcoming the defective of prior art, the present invention's purpose just provides a kind of subduing swelling and relieving pain self emulsifying ointment, can be effective to treat rheumatism, rheumatoid arthritis swells and ache.
The technical scheme that the present invention solves is that described subduing swelling and relieving pain self emulsifying ointment is done medicine with subduing swelling and relieving pain cream extract, processes as the pharmaceutical carrier mix homogeneously with self emulsifying substrate; Subduing swelling and relieving pain cream extractive content is 100～400mg in every 1g subduing swelling and relieving pain self emulsifying ointment; Described self emulsifying substrate is by the weight meter: oil phase 12～20%, emulsifying agent 40～60% and co-emulsifier 20～40% are processed, and described oil phase is oil refining, glyceryl monostearate and octadecanol, and its weight ratio is 8: 2: 1; Described emulsifying agent is polyoxyethylene sorbitan monoleate and polyoxyethylene hydrogenated Oleum Ricini (RH40); Its weight ratio is 2: 8, perhaps is polyoxyethylene sorbitan monoleate and polyoxyethylene castor oil (EL), and its weight ratio is 6: 4; Described co-emulsifier is glycerin (glycerol); Described subduing swelling and relieving pain cream extract is processed by Semen Strychni 1000g, Radix Aconiti 150g, Radix Aconiti Kusnezoffii 150g, Radix Angelicae Sinensis 150g, Radix Angelicae Dahuricae 150g, Olibanum 150g, Myrrha 150g, and Semen Strychni, Radix Aconiti, Radix Aconiti Kusnezoffii, Radix Angelicae Sinensis, the Radix Angelicae Dahuricae are ground into coarse powder, and 8 times of amount volumetric concentrations using Semen Strychni, Radix Aconiti, Radix Aconiti Kusnezoffii, Radix Angelicae Sinensis, Radix Angelicae Dahuricae weight are 70% soak with ethanol 1h; Heating and refluxing extraction 1 hour is filtered; 6 times of amount volumetric concentrations that medicinal residues add Semen Strychni, Radix Aconiti, Radix Aconiti Kusnezoffii, Radix Angelicae Sinensis, Radix Angelicae Dahuricae weight again are 70% soak with ethanol 1h, and heating and refluxing extraction 1 hour is filtered; Merging filtrate, kind of the extracting solution of winning, subsequent use; Again Olibanum, Myrrha are ground into fine powder, 8 times of amount volumetric concentrations using Olibanum, Myrrha weight are 70% soak with ethanol 1h, heating for dissolving half an hour in 80 ℃ of water-baths, filter, second kind of extracting solution, subsequent use; Two kinds of extracting solution are merged, decompression recycling ethanol, be concentrated into the thick paste shape that every 1g is equivalent to crude drug 5g, cryopreservation, subsequent use; Wherein, earlier oil phase is placed 80 ℃ of water bath with thermostatic control heating and meltings, and then add emulsifying agent, co-emulsifier and subduing swelling and relieving pain cream extract successively, after dissolving stirs, leave standstill, be cooled to curing, promptly get;
Under the room temperature, the swollen analgesic therapy self emulsifying ointment 1.5～2.0g of cancellation puts in the palm or in the container, adds water 1～2mL, grinds gently, can form the Emulsion that uniform and smooth, particle diameter reach micron level fast.
Abundant raw material of the present invention, be prone to purchase, expense is low, method is simple, be prone to produce, the product good effect, be effective to treat swelling and ache of rheumatism, rheumatoid arthritis, be the innovation on the subduing swelling and relieving pain medicine.
Four, description of drawings
Fig. 1 is the outward appearance of low temperature subduing swelling and relieving pain self emulsifying ointment of the present invention.
Fig. 2 is the outward appearance of room temperature subduing swelling and relieving pain self emulsifying ointment of the present invention.
Fig. 3 is the outward appearance of high temperature subduing swelling and relieving pain self emulsifying ointment of the present invention.
Fig. 4 is the centrifugal back of the blank substrate emulsion of the present invention phenomenon.
Fig. 5 is the centrifugal back of subduing swelling and relieving pain self emulsifying ointment emulsion of the present invention phenomenon.
Fig. 6 is the not rabbit skin part state diagram of administration of the present invention.
Fig. 7 is the rabbit skin part state diagram of drug administration 1h of the present invention.
Fig. 8 is the rabbit skin part state diagram of drug administration 12h of the present invention.
Fig. 9 is the rabbit skin part state diagram of drug administration 24h of the present invention.
Figure 10 is the rabbit skin part state diagram of drug administration 48h of the present invention.
Figure 11 is the rabbit skin part state diagram of drug administration 72h of the present invention.
Figure 12 is subduing swelling and relieving pain self emulsifying ointment particle size distribution figure of the present invention.
Five, the specific embodiment
Do further explain below in conjunction with the accompanying drawing specific embodiments of the invention.
The present invention can be provided by following examples in practical implementation.
Embodiment 1
The present invention is in practical implementation, and described subduing swelling and relieving pain self emulsifying ointment is done medicine with subduing swelling and relieving pain cream extract, processes as the pharmaceutical carrier mix homogeneously with self emulsifying substrate; Subduing swelling and relieving pain cream extractive content is 100～400mg in every 1g subduing swelling and relieving pain self emulsifying ointment, and described self emulsifying substrate is by the weight meter: oil phase 12%, emulsifying agent 48% and co-emulsifier 40% are processed, and described oil phase is oil refining, glyceryl monostearate and octadecanol; Its weight ratio is 8: 2: 1, and described emulsifying agent is polyoxyethylene sorbitan monoleate and polyoxyethylene hydrogenated Oleum Ricini (RH40), and its weight ratio is 2: 8; Perhaps be polyoxyethylene sorbitan monoleate and polyoxyethylene castor oil (EL), its weight ratio is 6: 4, and described co-emulsifier is glycerin (glycerol); Wherein, earlier oil phase is placed 80 ℃ of water bath with thermostatic control heating and meltings, and then add emulsifying agent, co-emulsifier and subduing swelling and relieving pain cream extract successively; After dissolving stirs; Leave standstill, be cooled to curing, promptly get;
Under the room temperature, the swollen analgesic therapy self emulsifying ointment 1.5～2.0g of cancellation puts in the palm or in the container, adds water 1～2mL, grinds gently, can form the Emulsion that uniform and smooth, particle diameter reach micron level fast.
Embodiment 2
The present invention is in practical implementation, and described subduing swelling and relieving pain self emulsifying ointment is done medicine with subduing swelling and relieving pain cream extract, processes as the pharmaceutical carrier mix homogeneously with self emulsifying substrate; Subduing swelling and relieving pain cream extractive content is 100～400mg in every 1g subduing swelling and relieving pain self emulsifying ointment, and described self emulsifying substrate is by the weight meter: oil phase 15%, emulsifying agent 50% and co-emulsifier 35% are processed, and described oil phase is oil refining, glyceryl monostearate and octadecanol; Its weight ratio is 8: 2: 1, and described emulsifying agent is polyoxyethylene sorbitan monoleate and polyoxyethylene hydrogenated Oleum Ricini (RH40), and its weight ratio is 2: 8; Perhaps be polyoxyethylene sorbitan monoleate and polyoxyethylene castor oil (EL), its weight ratio is 6: 4, and described co-emulsifier is glycerin (glycerol); Wherein, earlier oil phase is placed 80 ℃ of water bath with thermostatic control heating and meltings, and then add emulsifying agent, co-emulsifier and subduing swelling and relieving pain cream extract successively; After dissolving stirs; Leave standstill, be cooled to curing, promptly get;
Under the room temperature, the swollen analgesic therapy self emulsifying ointment 1.5～2.0g of cancellation puts in the palm or in the container, adds water 1～2mL, grinds gently, can form the Emulsion that uniform and smooth, particle diameter reach micron level fast.
Embodiment 3
The present invention is in practical implementation, and described subduing swelling and relieving pain self emulsifying ointment is done medicine with subduing swelling and relieving pain cream extract, processes as the pharmaceutical carrier mix homogeneously with self emulsifying substrate; Subduing swelling and relieving pain cream extractive content is 100～400mg in every 1g subduing swelling and relieving pain self emulsifying ointment, and described self emulsifying substrate is by the weight meter: oil phase 18%, emulsifying agent 52% and co-emulsifier 30% are processed, and described oil phase is oil refining, glyceryl monostearate and octadecanol; Its weight ratio is 8: 2: 1, and described emulsifying agent is polyoxyethylene sorbitan monoleate and polyoxyethylene hydrogenated Oleum Ricini (RH40), and its weight ratio is 2: 8; Perhaps be polyoxyethylene sorbitan monoleate and polyoxyethylene castor oil (EL), its weight ratio is 6: 4, and described co-emulsifier is glycerin (glycerol); Wherein, earlier oil phase is placed 80 ℃ of water bath with thermostatic control heating and meltings, and then add emulsifying agent, co-emulsifier and subduing swelling and relieving pain cream extract successively; After dissolving stirs; Leave standstill, be cooled to curing, promptly get;
Under the room temperature, the swollen analgesic therapy self emulsifying ointment 1.5～2.0g of cancellation puts in the palm or in the container, adds water 1～2mL, grinds gently, can form the Emulsion that uniform and smooth, particle diameter reach micron level fast.
Embodiment 4
The present invention is in practical implementation, and described subduing swelling and relieving pain self emulsifying ointment is done medicine with subduing swelling and relieving pain cream extract, processes as the pharmaceutical carrier mix homogeneously with self emulsifying substrate; Subduing swelling and relieving pain cream extractive content is 100～400mg in every 1g subduing swelling and relieving pain self emulsifying ointment, and described self emulsifying substrate is by the weight meter: oil phase 20%, emulsifying agent 60% and co-emulsifier 20% are processed, and described oil phase is oil refining, glyceryl monostearate and octadecanol; Its weight ratio is 8: 2: 1, and described emulsifying agent is polyoxyethylene sorbitan monoleate and polyoxyethylene hydrogenated Oleum Ricini (RH40), and its weight ratio is 2: 8; Perhaps be polyoxyethylene sorbitan monoleate and polyoxyethylene castor oil (EL), its weight ratio is 6: 4, and described co-emulsifier is glycerin (glycerol); Wherein, earlier oil phase is placed 80 ℃ of water bath with thermostatic control heating and meltings, and then add emulsifying agent, co-emulsifier and subduing swelling and relieving pain cream extract successively; After dissolving stirs; Leave standstill, be cooled to curing, promptly get;
Under the room temperature, the swollen analgesic therapy self emulsifying ointment 1.5～2.0g of cancellation puts in the palm or in the container, adds water 1～2mL, grinds gently, can form the Emulsion that uniform and smooth, particle diameter reach micron level fast.
The present invention's stability is strong, and to the skin nonirritant, infiltration rate is fast; Contained medicine can be rapidly by skin absorbs utilization, instant effect, good effect; Be effective to treat rheumatism, rheumatoid arthritis swells and ache, and through experiment with on probation obtained sufficient proof, interrelated data is following:
1 instrument and reagent
1.1 instrument AL204 analytical balance: Mettler-Toledo Instrument (Shanghai) Co., Ltd.; TG165 table model high speed centrifuge: Beijing Orient peace promise biochemical technology company limited; Rise-2002 type laser particle size analyzer: the Science and Technology Ltd. of Jinan profit.752S UV, visible light beam split photometry: Prism Optical Technology Co.
1.2 reagent and material Oleum Arachidis hypogaeae semen (20100818 Henan Province's Milky Way oils and fats company limiteies.Use preceding refining: get Oleum Arachidis hypogaeae semen 500, be heated to 320 ℃, drip into pearl, subsequent use); Octadecanol (analytical pure 20110427 Tianjin Jinnan District salt water are bought the industrial park); Glyceryl monostearate (analytical pure 20110423 China Medicine (Group) Shanghai Chemical Reagent Co.); Polyoxyethylene sorbitan monoleate (analytical pure 20100826 Tianjin sky over the river chemical industry company limiteies); Polyoxyethylene hydrogenated Oleum Ricini (RH40) (201004 lot number 13405656PO go up the grand chemical industry pharmaceutical adjunct technology of sea-freight company limited); Polyoxyethylene castor oil (EL) (201004 lot number 79816675L0 go up the grand chemical industry pharmaceutical adjunct technology of sea-freight company limited), glycerin (analytical pure 20100308 Tianjin Fengchuan Chemical Reagent Science & Technology Co., Ltd.); Depilatory cream (the magical painless safe depilatory cream of flower piperazine G20090645 Guangzhou 100 refined cosmetics company limiteies).20110320), (lot number: 20101020) effluent south wind damp disease hospital provides the subduing swelling and relieving pain emulsifiable paste subduing swelling and relieving pain cream extract (lot number:.
The preparation and the method for using of 2 subduing swelling and relieving pain self emulsifying ointment
2.1 subduing swelling and relieving pain cream preparation method of extract
Subduing swelling and relieving pain cream extract prescription is processed by Semen Strychni 1000g, Radix Aconiti 150g, Radix Aconiti Kusnezoffii 150g, Radix Angelicae Sinensis 150g, Radix Angelicae Dahuricae 150g, Olibanum 150g, Myrrha 150g; Semen Strychni, Radix Aconiti, Radix Aconiti Kusnezoffii, Radix Angelicae Sinensis, the Radix Angelicae Dahuricae are ground into coarse powder; 8 times of amount volumetric concentrations using Semen Strychni, Radix Aconiti, Radix Aconiti Kusnezoffii, Radix Angelicae Sinensis, Radix Angelicae Dahuricae weight are 70% soak with ethanol 1h; Heating and refluxing extraction 1 hour is filtered; 6 times of amount volumetric concentrations that medicinal residues add Semen Strychni, Radix Aconiti, Radix Aconiti Kusnezoffii, Radix Angelicae Sinensis, Radix Angelicae Dahuricae weight again are 70% soak with ethanol 1h, and heating and refluxing extraction 1 hour is filtered; Merging filtrate, kind of the extracting solution of winning, subsequent use; Again Olibanum, Myrrha are ground into fine powder, 8 times of amount volumetric concentrations using Olibanum, Myrrha weight are 70% soak with ethanol 1h, heating for dissolving half an hour in 80 ℃ of water-baths, filter, second kind of extracting solution, subsequent use; Two kinds of extracting solution are merged, decompression recycling ethanol, be concentrated into the thick paste shape that every 1g is equivalent to crude drug 5g, cryopreservation, subsequent use.
2.2 it is oil refining, glyceryl monostearate and octadecanol that matrix components and usage ratio are formed oil phase component, three's ratio is 8: 2: 1, accounts for 12.14～20% of substrate mass ratio; Emulsifier component is polyoxyethylene sorbitan monoleate and polyoxyethylene hydrogenated Oleum Ricini (RH40), and the two ratio is 2: 8, perhaps is polyoxyethylene sorbitan monoleate and polyoxyethylene castor oil (EL), and the two ratio is 6: 4, accounts for 40～60% of substrate mass ratio; The co-emulsifier component is glycerin (glycerol), accounts for 20～40% of substrate mass ratio.
2.3 the method for preparing of subduing swelling and relieving pain self emulsifying ointment accurately takes by weighing matrix components in the prescription ratio; Oil phase component oil refining, glyceryl monostearate and octadecanol are placed 80 ℃ of water bath with thermostatic control heating and meltings; Adding emulsifier component polyoxyethylene sorbitan monoleate and RH40 (or EL), co-emulsifier glycerol and subduing swelling and relieving pain cream extract then successively (makes that subduing swelling and relieving pain cream extractive content is 100～400mg) in every 1g ointment, after dissolving, stirring, places; Be cooled to curing, promptly get.
2.4 under the method for using room temperature, the swollen analgesic therapy self emulsifying ointment 1.5～2.0g of cancellation puts in the palm or in the container; Add water 1～2mL, grind gently, can form the Emulsion that uniform and smooth, particle diameter reach micron level fast; Spread upon on the skin, rub a little, can infiltrate skin rapidly and be absorbed and used; Can get an amount of self emulsifying ointment water allotment emulsifying and can use according to the weight of disease location, area size and symptom.
3 subduing swelling and relieving pain self emulsifying ointment stability tests
Ointment is prone to be acted upon by temperature changes, and need do accelerated tests such as heat-resisting, cold-resistant, to observe the stability of ointment.Concrete experimental technique: (1) is observed to have or not and is analysed oily phenomenon after self emulsifying substrate is placed a week respectively at 6 hours ,-15 ℃ constant temperature placements of 55 ℃ of constant temperature placements 24 hours, room temperature; (2) adopt centrifuging, whether with the centrifugal 10min of the emulsion after the water and milkization (3000r/min), observing has separating oil layer phenomenon with ointment.
3.1 low-temperature test is put the 5g subduing swelling and relieving pain self emulsifying ointment that installs in the constant temperature-15 ℃ refrigerator, takes out behind the placement 24h and observes, the ointment after the low-temperature test does not have the oil of analysing as a result, no lamination (see figure 1).
3.2 the room temperature test is observed the 5g subduing swelling and relieving pain self emulsifying ointment that installs in 25 ℃ of environment held, one all backs, ointment did not have the oil of analysing, no lamination (see figure 2) after room temperature was placed a week as a result.
3.3 hot test is taken out the 5g subduing swelling and relieving pain self emulsifying ointment that installs and observed after placing 6h on 55 ℃ of thermostat water baths, ointment does not have the oil of analysing as a result, no lamination (see figure 3).
3.4 centrefuge experiment is got 0.1g self emulsifying substrate (blank substrate) and subduing swelling and relieving pain self emulsifying ointment respectively, adds water 10mL emulsifying, the centrifugal 10min of emulsion (3000r/min), (seeing Fig. 4～5).
The centrifugal back of the emulsion solution of the blank substrate of result is transparent, no layering, does not have and analyses oily phenomenon, and there is a little foam on the upper strata, and this phenomenon disappearance after the jolting twice has good stability.The centrifugal back of subduing swelling and relieving pain self emulsifying ointment emulsion solution is little yellow because of prescription Chinese medicine reason, and solution is transparent, and no layering does not have and analyses oily phenomenon, has good stability.
4 PHs are measured
(1) is clear solution after the swollen analgesic therapy self emulsifying ointment 0.1g of cancellation adds water 1mL stirring and emulsifying.White floccule appears in transparent liquid upper strata after adding 5 methyl oranges, and jolting evenly back disappears, and the solution invariant color is still transparent.Meet the PH requirement.
(2) according to the requirement of emulsion bases pH: O/W type emulsion bases pH is not more than 8.3.Measure subduing swelling and relieving pain self emulsifying ointment with precision test paper and be about 6, meet the requirements with the ph value of emulsion after the water and milkization.
The test of 5 skin irritations
Situation such as erythema and edema whether occur through animal experimental observation rabbit medicine-feeding part skin, estimate stimulus intensity according to relevant standards of grading.
5.1 experimental technique rabbit single-dose skin irritation test.Before the experiment rabbit is carried on the back with depilatory cream depilation and not injured skin of both sides, the depilation area is 2.5 * 2.5cm
2, totally 6, each 3 of every sides.Damaged skin district way: on the skin after the depilation, mark " # " shape scratch with the sterilization syringe needle before the administration, diameter 2cm to stimulate epidermis, does not hinder corium, has slight oozing of blood to be degree.6h administration after depilation and the skin damage.The amount of smearing subduing swelling and relieving pain self emulsifying ointment machin substrate is 1.5g (adding administration after the water 5mL emulsifying respectively with preceding).Write down respectively after the administration 1,12,24,48 and the 72h medicine-feeding part erythema and edema situation appear, estimate stimulus intensity by standards of grading.
5.2 the judgement of skin irritation intensity has or not situation such as erythema and edema to mark (like table 1) to smearing the position; Calculate average integrated value according to formula; Go forward side by side to assassinate and swash intensity evaluation (like table 2); Formula: every animal average integral=erythema and edema integration/number of observation, the distribution (like table 3) of rabbit skin Experimental Area.
Table 1 skin irritation standards of grading
Table 2 skin irritation intensity evaluation standard
The distribution of table 3 rabbit skin Experimental Area
5.3 experimental result
The result: behind administration 1h and 12h, can omit the show speckle, clear area and administration district do not have significant difference, and day part does not all have edema phenomenon (seeing Fig. 6～11), the situation of specifically marking (like table 4).
Grade form after the different period administrations in each zone of table 4
Every animal average integral=erythema and edema integration/number of observation=2/5=0.4
Nonirritant in the time of can knowing that by table 2 skin irritation intensity evaluation standard scale mean scores is between 0～0.49.The mean scores of this experimental rabbit is 0.4, in this scope, blank substrate and the equal nonirritant of subduing swelling and relieving pain self emulsifying ointment is described.
6 subduing swelling and relieving pain self emulsifying ointment emulsion particle diameters
The swollen analgesic therapy self emulsifying ointment 1g of cancellation places test tube, add water 10mL emulsifying fully after, put into laser particle size analyzer and measure emulsion droplet particle diameter, result's (seeing Figure 12).
Experimental result: particle size range is 1.957～3.436 μ m after the emulsifying of subduing swelling and relieving pain self emulsifying ointment, and wherein 50% emulsion droplet particle diameter is 2.332 μ m.
7 subduing swelling and relieving pain self emulsifying ointment observation of curative effect
7.1 data and method
7.1.1 inclusion criteria
The rheumatoid arthritis inpatient that clarified a diagnosis only selects wrist, the sick joint of swelling and pain in knee to go into anthology research.Be divided into two groups at random, 50 every group treatment joints.Two groups of patient age, sex, arthralgia situation are not found statistical significant difference.All patients do not have obvious visceral injury, do not take hormone, non-steroidal anti-inflammatory drug in the recent period.
7.1.2 joint swelling and pain index
Joint swelling index: 0. no swelling; 1. arthroncus, but do not surpass juxtra-articular apophysis part; 2. the obvious swelling in joint, swelling place are equal with apophysis portion; 3. near the apophysis portion joint height swelling, swelling place are higher than.
Articular pain index: 0. no tenderness; 1. tenderness; 2. the tenderness companion shrinks; 3. the tenderness companion shrinks and hides.
7.2 Therapeutic Method
Subduing swelling and relieving pain cream extract is processed by Semen Strychni, Radix Aconiti, Radix Aconiti Kusnezoffii, Radix Angelicae Sinensis, the Radix Angelicae Dahuricae, Olibanum, Myrrha, the preparation of ointment subduing swelling and relieving pain cream effluent south wind damp disease hospital, and subduing swelling and relieving pain self emulsifying ointment is provided by College of Pharmacy, Henan College of Traditional Chinese Medicine.
(1) the swollen analgesic therapy emulsifiable paste of cancellation is an amount of, directly at swollen joint sore spot coating.
(2) the swollen analgesic therapy self emulsifying ointment of cancellation is an amount of, adds water and in palm, grinds well self emulsifying gently and become Emulsion, at swollen joint sore spot coating.
The coating area is a bit larger tham the place that swells and ache, and gently rubbed 1～2 minute the part behind the coating, every day 2 times, logotype 5 days.
7.3. result
7.3.1 the two groups of swelling indexes in treatment front and back, tenderness index (like table 5).
Two groups of swelling indexes in table 5 treatment front and back and tenderness index
Compare P＜0.05 before and after the treatment of △ emulsifiable paste group; Compare P＜0.01 before and after the treatment of ▲ self emulsifying group; * treat back emulsifiable paste group and compare P＜0.05 with treatment back self emulsifying group.
Joint swelling index, tenderness index no difference of science of statistics before two groups of treatments.The emulsifiable paste group is treated the front and back joint swelling index, there were significant differences for the tenderness index.Joint swelling index, tenderness index have highly significant difference before and after the treatment of self emulsifying group.The emulsifiable paste group compares joint swelling index after treating back self emulsifying group and treating, there were significant differences for the tenderness index.
7.3.2 dosage self emulsifying group reduces 1/2 than emulsifiable paste group dosage.
7.4 untoward reaction
Do not see obvious adverse reaction.
7.5 discuss
It is the synovitis in joint that the basic pathology of rheumatoid arthritis changes, and diseased region is darker.This research adopts the external treatment of distinguished veteran doctors of TCM Lou multimodal treatment rheumatism arthralgia through the proved recipe black plaster---and the improvement dosage form subduing swelling and relieving pain ointment of " arthromyodynia cream " is contrast; Carry out Comparison of therapeutic with the self emulsifying ointment of processing; The result shows; Adopting the self emulsifying ointment can strengthen its effective ingredient penetrates; Synovitis to the darker rheumatoid arthritis of diseased region has obviously reducing swelling and alleviating pain effect, and effect is superior to ointment, and does not have usual cream agent massage to occur the slivering obscission when rubbing.The clinical subduing swelling and relieving pain self emulsifying ointment good effect that shows is not seen obvious adverse reaction, is a kind of promising self emulsifying ointment dosage form.
8 sum up
Subduing swelling and relieving pain self emulsifying ointment prescription is reasonable, and stability is strong, nonirritant.Ointment is with can form the little translucent emulsion of emulsion droplet particle diameter fast after the water and milkization, subduing swelling and relieving pain self emulsifying ointment can increase the dissolubility of medicine such as insoluble drug such as Olibanum, Myrrha in the prescription, and this ointment method for using is unique; Get an amount of dosing ointment during use and add water and gently grind on a small quantity and be emulsified into transparency emulsion, evenly smear on the skin and get final product, can infiltrate skin fast and be absorbed and used; The no greasy feeling of soft and smooth exquisiteness, no ointment obscission, more former pharmaceutical dosage form is easy to use; Therefore, subduing swelling and relieving pain self emulsifying ointment prescription is reasonable, and processing technology is simple; Evident in efficacy, easy to use.
Claims (5)
1. a subduing swelling and relieving pain self emulsifying ointment is characterized in that, described subduing swelling and relieving pain self emulsifying ointment is done medicine with subduing swelling and relieving pain cream extract; Process as the pharmaceutical carrier mix homogeneously with self emulsifying substrate, subduing swelling and relieving pain cream extractive content is 100～400mg in every 1g subduing swelling and relieving pain self emulsifying ointment, and described self emulsifying substrate is by the weight meter: oil phase 12～20%, emulsifying agent 40～60% and co-emulsifier 20～40% are processed; Described oil phase is oil refining, glyceryl monostearate and octadecanol; Its weight ratio is 8:2:1, and described emulsifying agent is polyoxyethylene sorbitan monoleate and polyoxyethylene hydrogenated Oleum Ricini, and its weight ratio is 2:8; Perhaps be polyoxyethylene sorbitan monoleate and polyoxyethylene castor oil; Its weight ratio is 6:4, and described co-emulsifier is a glycerin, and described subduing swelling and relieving pain cream extract is processed by Semen Strychni 1000g, Radix Aconiti 150g, Radix Aconiti Kusnezoffii 150g, Radix Angelicae Sinensis 150g, Radix Angelicae Dahuricae 150g, Olibanum 150g, Myrrha 150g; Semen Strychni, Radix Aconiti, Radix Aconiti Kusnezoffii, Radix Angelicae Sinensis, the Radix Angelicae Dahuricae are ground into coarse powder; 8 times of amount volumetric concentrations using Semen Strychni, Radix Aconiti, Radix Aconiti Kusnezoffii, Radix Angelicae Sinensis, Radix Angelicae Dahuricae weight are 70% soak with ethanol 1h, and heating and refluxing extraction 1 hour is filtered; 6 times of amount volumetric concentrations that medicinal residues add Semen Strychni, Radix Aconiti, Radix Aconiti Kusnezoffii, Radix Angelicae Sinensis, Radix Angelicae Dahuricae weight again are 70% soak with ethanol 1h, and heating and refluxing extraction 1 hour is filtered; Merging filtrate, kind of the extracting solution of winning, subsequent use; Again Olibanum, Myrrha are ground into fine powder, 8 times of amount volumetric concentrations using Olibanum, Myrrha weight are 70% soak with ethanol 1h, heating for dissolving half an hour in 80 ℃ of water-baths, filter, second kind of extracting solution, subsequent use; Two kinds of extracting solution are merged, decompression recycling ethanol, be concentrated into the thick paste shape that every 1g is equivalent to crude drug 5g, cryopreservation, subsequent use; Wherein, earlier oil phase is placed 80 ℃ of water bath with thermostatic control heating and meltings, and then add emulsifying agent, co-emulsifier and subduing swelling and relieving pain cream extract successively, after dissolving stirs, leave standstill, be cooled to curing;
Under the room temperature, the swollen analgesic therapy self emulsifying ointment 1.5～2.0g of cancellation puts in the palm or in the container, adds water 1～2mL, grinds gently, can form the Emulsion that uniform and smooth, particle diameter reach micron level fast.
2. subduing swelling and relieving pain self emulsifying ointment according to claim 1 is characterized in that, described subduing swelling and relieving pain self emulsifying ointment is done medicine with subduing swelling and relieving pain cream extract; Process as the pharmaceutical carrier mix homogeneously with self emulsifying substrate, subduing swelling and relieving pain cream extractive content is 100～400mg in every 1g subduing swelling and relieving pain self emulsifying ointment, and described self emulsifying substrate is by the weight meter: oil phase 12%, emulsifying agent 48% and co-emulsifier 40% are processed; Described oil phase is oil refining, glyceryl monostearate and octadecanol, and its weight ratio is 8:2:1, and described emulsifying agent is polyoxyethylene sorbitan monoleate and polyoxyethylene hydrogenated Oleum Ricini; Its weight ratio is 2:8, perhaps is polyoxyethylene sorbitan monoleate and polyoxyethylene castor oil, and its weight ratio is 6:4; Described co-emulsifier is a glycerin, wherein, earlier oil phase is placed 80 ℃ of water bath with thermostatic control heating and meltings; And then add emulsifying agent, co-emulsifier and subduing swelling and relieving pain cream extract successively; After dissolving stirs, leave standstill, be cooled to curing;
Under the room temperature, the swollen analgesic therapy self emulsifying ointment 1.5～2.0g of cancellation puts in the palm or in the container, adds water 1～2mL, grinds gently, can form the Emulsion that uniform and smooth, particle diameter reach micron level fast.
3. subduing swelling and relieving pain self emulsifying ointment according to claim 1 is characterized in that, described subduing swelling and relieving pain self emulsifying ointment is done medicine with subduing swelling and relieving pain cream extract; Process as the pharmaceutical carrier mix homogeneously with self emulsifying substrate, subduing swelling and relieving pain cream extractive content is 100～400mg in every 1g subduing swelling and relieving pain self emulsifying ointment, and described self emulsifying substrate is by the weight meter: oil phase 15%, emulsifying agent 50% and co-emulsifier 35% are processed; Described oil phase is oil refining, glyceryl monostearate and octadecanol, and its weight ratio is 8:2:1, and described emulsifying agent is polyoxyethylene sorbitan monoleate and polyoxyethylene hydrogenated Oleum Ricini; Its weight ratio is 2:8, perhaps is polyoxyethylene sorbitan monoleate and polyoxyethylene castor oil, and its weight ratio is 6:4; Described co-emulsifier is a glycerin, wherein, earlier oil phase is placed 80 ℃ of water bath with thermostatic control heating and meltings; And then add emulsifying agent, co-emulsifier and subduing swelling and relieving pain cream extract successively; After dissolving stirs, leave standstill, be cooled to curing;
Under the room temperature, the swollen analgesic therapy self emulsifying ointment 1.5～2.0g of cancellation puts in the palm or in the container, adds water 1～2mL, grinds gently, can form the Emulsion that uniform and smooth, particle diameter reach micron level fast.
4. subduing swelling and relieving pain self emulsifying ointment according to claim 1 is characterized in that, described subduing swelling and relieving pain self emulsifying ointment is done medicine with subduing swelling and relieving pain cream extract; Process as the pharmaceutical carrier mix homogeneously with self emulsifying substrate, subduing swelling and relieving pain cream extractive content is 100～400mg in every 1g subduing swelling and relieving pain self emulsifying ointment, and described self emulsifying substrate is by the weight meter: oil phase 18%, emulsifying agent 52% and co-emulsifier 30% are processed; Described oil phase is oil refining, glyceryl monostearate and octadecanol, and its weight ratio is 8:2:1, and described emulsifying agent is polyoxyethylene sorbitan monoleate and polyoxyethylene hydrogenated Oleum Ricini; Its weight ratio is 2:8, perhaps is polyoxyethylene sorbitan monoleate and polyoxyethylene castor oil, and its weight ratio is 6:4; Described co-emulsifier is a glycerin, wherein, earlier oil phase is placed 80 ℃ of water bath with thermostatic control heating and meltings; And then add emulsifying agent, co-emulsifier and subduing swelling and relieving pain cream extract successively; After dissolving stirs, leave standstill, be cooled to curing;
Under the room temperature, the swollen analgesic therapy self emulsifying ointment 1.5～2.0g of cancellation puts in the palm or in the container, adds water 1～2mL, grinds gently, can form the Emulsion that uniform and smooth, particle diameter reach micron level fast.
5. subduing swelling and relieving pain self emulsifying ointment according to claim 1 is characterized in that, described subduing swelling and relieving pain self emulsifying ointment is done medicine with subduing swelling and relieving pain cream extract; Process as the pharmaceutical carrier mix homogeneously with self emulsifying substrate, subduing swelling and relieving pain cream extractive content is 100～400mg in every 1g subduing swelling and relieving pain self emulsifying ointment, and described self emulsifying substrate is by the weight meter: oil phase 20%, emulsifying agent 60% and co-emulsifier 20% are processed; Described oil phase is oil refining, glyceryl monostearate and octadecanol, and its weight ratio is 8:2:1, and described emulsifying agent is polyoxyethylene sorbitan monoleate and polyoxyethylene hydrogenated Oleum Ricini; Its weight ratio is 2:8, perhaps is polyoxyethylene sorbitan monoleate and polyoxyethylene castor oil, and its weight ratio is 6:4; Described co-emulsifier is a glycerin, wherein, earlier oil phase is placed 80 ℃ of water bath with thermostatic control heating and meltings; And then add emulsifying agent, co-emulsifier and subduing swelling and relieving pain cream extract successively; After dissolving stirs, leave standstill, be cooled to curing;
Under the room temperature, the swollen analgesic therapy self emulsifying ointment 1.5～2.0g of cancellation puts in the palm or in the container, adds water 1～2mL, grinds gently, can form the Emulsion that uniform and smooth, particle diameter reach micron level fast.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105878613A (en) * | 2014-10-28 | 2016-08-24 | 左英学 | Bitongling external application tincture and preparation method thereof |
| CN106728099A (en) * | 2016-12-30 | 2017-05-31 | 张秀兰 | It is a kind of to treat medicine of rheumatic arthritis and preparation method thereof |
| CN108245564A (en) * | 2018-02-07 | 2018-07-06 | 周吉鹏 | A kind of black plaster and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1943567A (en) * | 2006-10-12 | 2007-04-11 | 华东理工大学 | Self micro emulsifying composition of tretinoin medicines and its preparing method |
| CN101190182A (en) * | 2006-12-01 | 2008-06-04 | 北京大学 | Self-emulsifying composition |
| CN101579310A (en) * | 2009-05-27 | 2009-11-18 | 沈阳药科大学 | Decataxel self-microemulsifying composition and preparation method thereof |
| CN102188508A (en) * | 2011-04-22 | 2011-09-21 | 上海中医药大学附属岳阳中西医结合医院 | Chinese medicine composition for treating knee osteoarthritis and preparation method thereof |
| GB2480459A (en) * | 2010-05-19 | 2011-11-23 | Gary William Wheatley | Subcritical water extraction methods and apparatus |
-
2012
- 2012-04-26 CN CN 201210125991 patent/CN102614265B/en not_active Expired - Fee Related
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1943567A (en) * | 2006-10-12 | 2007-04-11 | 华东理工大学 | Self micro emulsifying composition of tretinoin medicines and its preparing method |
| CN101190182A (en) * | 2006-12-01 | 2008-06-04 | 北京大学 | Self-emulsifying composition |
| CN101579310A (en) * | 2009-05-27 | 2009-11-18 | 沈阳药科大学 | Decataxel self-microemulsifying composition and preparation method thereof |
| GB2480459A (en) * | 2010-05-19 | 2011-11-23 | Gary William Wheatley | Subcritical water extraction methods and apparatus |
| CN102188508A (en) * | 2011-04-22 | 2011-09-21 | 上海中医药大学附属岳阳中西医结合医院 | Chinese medicine composition for treating knee osteoarthritis and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| JING-LING TANG,ET AL: "Self-Emulsifying Drug Delivery Systems: Strategy for Improving Oral Delivery of Poorly Soluble Drugs", 《CURRENT DRUG THERAPY》 * |
| 周韶华，等: "新型给药系统及其在中药制剂中的研究进展", 《中国中药杂志》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105878613A (en) * | 2014-10-28 | 2016-08-24 | 左英学 | Bitongling external application tincture and preparation method thereof |
| CN106728099A (en) * | 2016-12-30 | 2017-05-31 | 张秀兰 | It is a kind of to treat medicine of rheumatic arthritis and preparation method thereof |
| CN108245564A (en) * | 2018-02-07 | 2018-07-06 | 周吉鹏 | A kind of black plaster and preparation method thereof |
| CN108245564B (en) * | 2018-02-07 | 2021-03-16 | 周吉鹏 | Black plaster and preparation method thereof |
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Inventor after: Liu Yamin Inventor after: Lou Yuhan Inventor after: Wei Yu Inventor after: Zhang Dachuan Inventor after: Zhang Xin Inventor before: Liu Yamin Inventor before: Lou Yuling Inventor before: Wei Yu Inventor before: Zhang Dachuan Inventor before: Zhang Xin |
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Free format text: CORRECT: INVENTOR; FROM: LIU YAMIN LOU YULING WEI YU ZHANG DACHUAN ZHANG XIN TO: LIU YAMIN LOU YUQIAN WEI YU ZHANG DACHUAN ZHANG XIN |
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