CN115990204B - External pharmaceutical composition, and preparation method and application thereof - Google Patents
External pharmaceutical composition, and preparation method and application thereof Download PDFInfo
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- CN115990204B CN115990204B CN202310036688.8A CN202310036688A CN115990204B CN 115990204 B CN115990204 B CN 115990204B CN 202310036688 A CN202310036688 A CN 202310036688A CN 115990204 B CN115990204 B CN 115990204B
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Classifications
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses an external pharmaceutical composition, a preparation method and application thereof, and belongs to the field of pharmaceutical compositions. The external pharmaceutical composition comprises the following raw materials in parts by weight: 50-70 parts of honeysuckle, 50-70 parts of achyranthes bidentata, 50-70 parts of chrysanthemum, 10-20 parts of muskrat, 80-120 parts of peppermint oil, 20-40 parts of wintergreen oil, 10-20 parts of borneol, 10-20 parts of camphor, 10-20 parts of sodium dodecyl sulfate, 80-100 parts of cetyl alcohol and 40-60 parts of glycerin monostearate. The external pharmaceutical composition has obvious effects of diminishing inflammation, relieving swelling and easing pain, and the emulsifier is added in the form of the oil-in-water cream, so that the emulsion matrix has affinity to oil and water, each medicament has better release penetrability, is fresh and not greasy, has better user compliance and higher acceptance, and has wider application market.
Description
Technical Field
The invention relates to the field of pharmaceutical compositions, in particular to an external pharmaceutical composition, and a preparation method and application thereof.
Background
In recent years, with the advent of the information age, the lifestyle and working environment of people have changed greatly, and diseases such as cervical spondylosis, scapulohumeral periarthritis, lumbar muscle strain and the like have accelerated due to the busy business, work, study and the like before a user sits on a computer for a long time, and the onset trend is younger and is rising year by year. On the other hand, the aging degree of the population in China is increased, and in the middle-aged and elderly people, diseases such as neck, shoulder, waist and leg pain and the like are likely to occur, and the diseases have serious influence on the life quality of patients and bring influence and burden to the self and families to a great extent. Therefore, there is a need to administer treatment and intervention in time in order to improve the suffering of clinical diseases thereof, and thus to improve the quality of life of the patient.
At present, the treatment methods for diseases such as neck, shoulder, waist and leg pain are numerous, such as external plasters, ointments and the like. The external emplastrum is mainly prepared by the active ingredients of the Chinese and western medicines together with the common matrix, has the effects of activating blood circulation to dissipate blood stasis, promoting qi circulation to dissipate stagnation, clearing heat and detoxicating, and relieving swelling and pain, but the external emplastrum is applied for a long time to influence the beauty, and simultaneously has quick response and brings about potential safety hazards, such as stimulation to the skin and easy anaphylactic reaction because of being directly applied to focus skin; the effective components of the ointment are generally western medicines such as methyl salicylate, acetaminophen, indomethacin and the like, and the ointment can relieve inflammation and pain in a short time, but often causes local skin irritation and gastrointestinal side effects, and some hormone medicines even cause fatness and edema of human bodies, so that the ointment is high in price and can treat symptoms but not root cause. Therefore, the external analgesic paste which is convenient to use, safe in components, free of side effects and high in patient acceptance is provided, and the problem to be solved is urgent at present.
Disclosure of Invention
The invention aims to provide an external pharmaceutical composition, and a preparation method and application thereof, so as to solve the problems in the prior art. The external pharmaceutical composition has obvious effects of diminishing inflammation, relieving swelling and easing pain, is fresh and not greasy by adopting the form of oil-in-water cream, has better user compliance and higher acceptance, and has wider application market.
In order to achieve the above object, the present invention provides the following solutions:
the invention provides an external pharmaceutical composition, which comprises the following raw materials in parts by weight: 50-70 parts of honeysuckle, 50-70 parts of achyranthes bidentata, 50-70 parts of chrysanthemum, 10-20 parts of muskrat, 80-120 parts of peppermint oil, 20-40 parts of wintergreen oil, 10-20 parts of borneol, 10-20 parts of camphor, 10-20 parts of sodium dodecyl sulfate, 80-100 parts of cetyl alcohol and 40-60 parts of glycerin monostearate.
Further, the material comprises the following raw materials in parts by weight: 70 parts of honeysuckle, 70 parts of achyranthes bidentata, 70 parts of chrysanthemum, 20 parts of musk, 120 parts of peppermint oil, 40 parts of wintergreen oil, 20 parts of borneol, 20 parts of camphor, 10 parts of sodium dodecyl sulfate, 80 parts of cetyl alcohol and 40 parts of glycerin monostearate.
The invention also provides a preparation method of the external pharmaceutical composition, which comprises the following steps:
(1) Pretreatment: cleaning flos Lonicerae, achyranthis radix and flos Chrysanthemi, removing silt impurities, pulverizing, sieving, and mixing to obtain coarse powder;
(2) Extracting: adding distilled water into the coarse powder, heating, and collecting volatile oil and aromatic water;
(3) Preparation: mixing the volatile oil and aromatic water extracted in the step (2) with sodium dodecyl sulfate, adding distilled water as water phase, respectively heating and melting cetyl alcohol and glyceryl monostearate as oil phase, mixing well, stirring well to obtain matrix, adding Borneolum Syntheticum, camphora, thyme, oleum Menthae Dementholatum and wintergreen oil into the matrix, stirring well, making into ointment, and packaging.
Further, in the step (2), the mass-volume ratio of the crude drug powder to the distilled water is 1 g/15 mL.
Further, in the step (2), the heating temperature is 95-105 ℃, and the heating time is 4-6 hours.
The invention also provides application of the external pharmaceutical composition in preparing external analgesic paste.
The invention also provides application of the external pharmaceutical composition in preparing external detumescence paste.
The invention also provides application of the external pharmaceutical composition in preparing external anti-inflammatory paste.
The invention discloses the following technical effects:
1. the external pharmaceutical composition adopts the form of oil-in-water cream, and the raw materials contain the emulsifying agent which has the function of the surfactant, so that the emulsion matrix has affinity to oil and water, and the medicine in the cream can have better release penetrability. In addition, the oil-in-water type matrix can be mixed with a large amount of water, is fresh and not greasy, has fresh and cool coating feeling, has better compliance of users, has higher acceptance and has wider application market.
The external pharmaceutical composition adopts three of four Chinese medicines, and the volatile oil in the three medicines is extracted from honeysuckle, achyranthes root and chrysanthemum. Honeysuckle contains rich organic acid, flavone, volatile oil and other components, and the volatile oil has the effects of anti-inflammatory, antibacterial, antioxidation and the like; the saponin components in the achyranthes root can resist inflammation and oxidization, and can effectively improve rat arthritis caused by an adjuvant; the chrysanthemum can promote the five vessels and regulate the limbs, wherein the volatile oil has the effects of resisting inflammation, resisting bacteria, relieving fever and the like, has obvious curative effect on various acute and chronic inflammations, and has better anti-inflammatory and analgesic effects. The peppermint oil, the wintergreen oil, the borneol and the camphor can promote blood circulation, and play roles in detumescence and analgesia. The components are synergistic, wherein muskrat has the effects of diminishing inflammation, relieving pain, promoting blood circulation and removing blood stasis, has the effects of aromatic resuscitation, can enhance the penetrability of other medicaments and increase the effect of transdermal absorption, enhances the overall effect of the medicinal composition, has better treatment effect, and is safe and free from toxic and side effects.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
Fig. 1 shows experimental results of ear swelling of mice caused by xylene in different treatment modes, wherein P < 0.05 is significantly different from that of the model group, and P < 0.01 is significantly different from that of the model group;
fig. 2 is the results of carrageenan-induced swelling experiments on the feet of mice with different treatments, representing significant differences in P < 0.05 compared to the model group;
fig. 3 shows the results of the torsion number experiments after injection of acetic acid solution in different treatment modes, wherein P < 0.05 is significantly different from the model group, and P < 0.01 is significantly different from the model group;
fig. 4 shows the results of the mice on hot plate analgesia test under different treatment modes, wherein P < 0.05 is significantly different from the model group, and P < 0.01 is significantly different from the model group;
fig. 5 shows experimental results of the levels of inflammatory factors TNF- α, IL-1 and IL-6 in mice under different treatment modes, representing significant differences in P < 0.05 compared to the model group, and representing significant differences in P < 0.01 compared to the model group.
Detailed Description
Various exemplary embodiments of the invention will now be described in detail, which should not be considered as limiting the invention, but rather as more detailed descriptions of certain aspects, features and embodiments of the invention.
It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. In addition, for numerical ranges in this disclosure, it is understood that each intermediate value between the upper and lower limits of the ranges is also specifically disclosed. Every smaller range between any stated value or stated range, and any other stated value or intermediate value within the stated range, is also encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference for the purpose of disclosing and describing the methods and/or materials associated with the documents. In case of conflict with any incorporated document, the present specification will control.
It will be apparent to those skilled in the art that various modifications and variations can be made in the specific embodiments of the invention described herein without departing from the scope or spirit of the invention. Other embodiments will be apparent to those skilled in the art from consideration of the specification of the present invention. The specification and examples are exemplary only.
As used herein, the terms "comprising," "including," "having," "containing," and the like are intended to be inclusive and mean an inclusion, but not limited to.
The raw materials of the invention are as follows:
honeysuckle flower: is dried flower bud or flower with primary opening of Lonicera japonica Thunb. Honeysuckle is rich in organic acid, flavone, volatile oil, iridoid glycoside and other components, and the volatile oil has the effects of resisting inflammation, bacteria, oxidization and the like, and can achieve the anti-inflammatory effect by inhibiting the production of pro-inflammatory factors TNF-alpha, IL-1 beta and IL-6.
Achyranthes bidentata: is dry root of achyranthes bidentata Achyranthes bidentata Bl. belonging to Amaranthaceae, and has bitter, sweet and sour taste and mild nature. Has effects of removing blood stasis, dredging channels, nourishing liver and kidney, strengthening tendons and bones, inducing diuresis, treating stranguria, and promoting blood circulation, and can be used for treating amenorrhea, dysmenorrhea, soreness of waist and knees, tendons and bones weakness, etc. The achyranthes root contains polysaccharides, saponins, sterone, flavonoids, polypeptides, organic acids, volatile oil and the like, and the saponins are main active ingredients, have anti-inflammatory and antioxidant effects, can effectively improve rat arthritis caused by an adjuvant, lighten joint swelling degree to a certain extent, inhibit synovial hyperplasia and have certain anti-inflammatory and analgesic effects on joint diseases.
Huai chrysanthemum: is a dry head flower of chrysanthemum Chrysanthemum morifolium Ramat of Compositae, and has sweet and bitter taste and slightly cold nature. According to the description of the outline of materia medica, chrysanthemum can promote five vessels, regulate limbs, and modern component researches show that the medicine contains flavonoid, volatile oil, phenylpropanoids, terpenes, amino acids and the like, and the volatile oil mainly contains oxygen-containing derivatives and sesquiterpenes (terpene, terpene alcohol, terpene ketone), has the effects of resisting inflammation, resisting bacteria, relieving fever and the like, has obvious curative effects on various acute and chronic inflammations, and has better anti-inflammatory and analgesic effects.
Muskrat incense: is milk white secretion in sachet of Ondatrazine of animals of muskrat of hamster, has good taste and warm nature, and has effects of relieving inflammation and pain, promoting blood circulation, dispelling blood stasis, and inducing resuscitation, and can be used for treating carbuncle, sore, coma, and traumatic injury.
Peppermint oil: the aromatic oil obtained by cutting branches and leaves of plant white tree (commonly called holly) of Ericaceae and steam distilling has effects of promoting blood circulation, relieving inflammation and pain, increasing refreshing feeling of analgesic paste, and relieving pain.
Wintergreen oil: the aromatic oil obtained by distilling leaves of ilex pedunculata Ilex chinensis Sims of ilex has effects of detumescence, relieving pain, dilating blood vessel, promoting local blood circulation, relieving swelling, inflammation and pain, and relieving itching.
Borneol: is prepared from branches and leaves of camphorwood Cinnamomum camphora of Lauraceae by steam distillation and recrystallization, has effects of inducing resuscitation, refreshing, clearing heat and relieving pain, and has effects of detumescence, relieving pain, anti-inflammatory, promoting wound healing, etc., and has good sore healing and granulation promoting effects on treating burn and scald.
Camphor: is obtained by cutting trunk of Cinnamomum camphora Cinnamomum camphora (L.) presl of Lauraceae, distilling with steam, and coagulating, and has effects of dredging orifices, activating stagnated qi, relieving swelling and pain, and can be used for relieving pain, inhibiting bacteria, expelling parasites, and relieving fever, etc., and can also be used for relieving pain caused by rheumatism, and has cooling effect, and relieving pain.
The parts of the raw materials in the examples of the present invention are all parts by weight unless otherwise specified.
Example 1
A pharmaceutical composition for external use comprises the following raw materials in parts by weight: 50 parts of honeysuckle, 50 parts of achyranthes bidentata, 50 parts of chrysanthemum, 10 parts of musk, 80 parts of peppermint oil, 20 parts of wintergreen oil, 10 parts of borneol, 10 parts of camphor, 20 parts of sodium dodecyl sulfate, 100 parts of cetyl alcohol and 60 parts of glycerin monostearate.
The preparation method comprises the following steps:
(1) Pretreatment: cleaning flos Lonicerae, achyranthis radix, and flos Chrysanthemi, and removing silt and impurities; taking 50 parts of honeysuckle, 50 parts of achyranthes root and 50 parts of chrysanthemum, crushing, sieving and mixing to obtain crude powder of medicinal materials.
(2) Extracting: distilled water is added into the crude powder of the medicinal materials according to the ratio of 1g to 10mL, heating is carried out for 4 hours at 95 ℃, and volatile oil and aromatic water are collected.
(3) Preparation: mixing the volatile oil and aromatic water extracted in the step (2) with 20 parts of sodium dodecyl sulfate, and adding 540 parts of distilled water to obtain a water phase; taking 100 parts of cetyl alcohol and 60 parts of glyceryl monostearate as an oil phase, respectively heating and melting, uniformly mixing, and uniformly stirring to prepare a matrix. Mixing Borneolum Syntheticum 10 parts, camphora 10 parts, moschus 10 parts, oleum Menthae Dementholatum 80 parts, and wintergreen oil 20 parts, stirring, making into ointment, and packaging.
Example 2
A pharmaceutical composition for external use comprises the following raw materials in parts by weight: 60 parts of honeysuckle, 60 parts of achyranthes root, 60 parts of chrysanthemum, 15 parts of musk, 100 parts of peppermint oil, 30 parts of wintergreen oil, 15 parts of borneol, 15 parts of camphor, 15 parts of sodium dodecyl sulfate, 90 parts of cetyl alcohol and 50 parts of glycerin monostearate.
The preparation method comprises the following steps:
(1) Pretreatment: cleaning flos Lonicerae, achyranthis radix, and flos Chrysanthemi, and removing silt and impurities; 60 parts of honeysuckle, 60 parts of achyranthes root and 60 parts of chrysanthemum, crushing, sieving and mixing to obtain crude powder of medicinal materials.
(2) Extracting: distilled water is added into crude powder of the medicinal materials according to the feed liquid ratio of 1g to 12mL, heating is carried out for 5 hours at 100 ℃, and volatile oil and aromatic water are collected.
(3) Preparation: mixing the volatile oil and aromatic water extracted in the step (2) with 15 parts of sodium dodecyl sulfate, and adding 490 parts of distilled water to serve as a water phase; taking 90 parts of hexadecanol and 50 parts of glyceryl monostearate as oil phases, respectively heating and melting, uniformly mixing, and uniformly stirring to prepare a matrix. Mixing Borneolum 15 parts, camphora 15 parts, moschus 15 parts, oleum Menthae Dementholatum 100 parts, and wintergreen oil 30 parts, stirring, making into ointment, and packaging.
Example 3
A pharmaceutical composition for external use comprises the following raw materials in parts by weight: 70 parts of honeysuckle, 70 parts of achyranthes root, 70 parts of chrysanthemum, 20 parts of musk, 120 parts of peppermint oil, 40 parts of wintergreen oil, 20 parts of borneol, 20 parts of camphor, 10 parts of sodium dodecyl sulfate, 80 parts of cetyl alcohol and 40 parts of glycerin monostearate.
The preparation method comprises the following steps:
(1) Pretreatment: cleaning flos Lonicerae, achyranthis radix, and flos Chrysanthemi, and removing silt and impurities; taking 70 parts of honeysuckle, 70 parts of achyranthes root and 70 parts of chrysanthemum, crushing, sieving and mixing to obtain crude powder of medicinal materials.
(2) Extracting: distilled water is added into the crude powder according to the feed liquid ratio of 1g to 15mL, heating is carried out for 6 hours at 105 ℃, and volatile oil and aromatic water are collected.
(3) Preparation: mixing the volatile oil and aromatic water extracted in the step (2) with 10 parts of sodium dodecyl sulfate, and adding 510 parts of distilled water to obtain a water phase; taking 80 parts of cetyl alcohol and 40 parts of glyceryl monostearate as an oil phase, respectively heating and melting, uniformly mixing, and uniformly stirring to prepare a matrix. Mixing Borneolum Syntheticum 20 parts, camphora 20 parts, moschus 20 parts, oleum Menthae Dementholatum 120 parts, and wintergreen oil 40 parts, stirring, making into ointment, and packaging.
Comparative example 1
The difference is that the raw material does not contain musk mouse fragrance as in example 3.
Comparative example 2
The difference from example 3 is that the muskrat fragrance is replaced by the same weight part of red peony root in the raw material.
Comparative example 3
The difference with example 3 is that the raw materials comprise the following components in parts by weight: 45 parts of honeysuckle, 60 parts of achyranthes root, 75 parts of chrysanthemum, 40 parts of muskrat, 120 parts of peppermint oil, 40 parts of wintergreen oil, 20 parts of borneol and 20 parts of camphor.
Comparative example 4
The difference with example 3 is that the raw materials comprise the following components in parts by weight: 80 parts of honeysuckle, 70 parts of achyranthes root, 70 parts of chrysanthemum, 20 parts of musk, 20 parts of pseudo-ginseng, 120 parts of peppermint oil, 40 parts of wintergreen oil, 20 parts of borneol and 20 parts of camphor.
Test examples
Pharmacodynamic experiments
Experimental animals: SPF-class Kunming mice (purchased from Jinan Pengyue laboratory animal breeding Co., ltd.) are used both as male and female, and have a body weight of 18-22g, and are free to feed, drink water and light before the experiment begins.
Data analysis: the SPSS Statistics 26.0 software is adopted to analyze the significance of the following experimental data, and the measurement result is usedThe comparison between groups is statistically significant by using a one-way analysis of variance and P < 0.05 as the difference.
1. Mouse ear swelling experiment caused by dimethylbenzene
80 mice were randomly grouped according to 10 mice/group, the number is 1-8, the 1 st group is a model group, the 2 nd-8 th group is a dosing group, corresponding drugs (physiological saline is smeared on the model group) are uniformly smeared on the two sides of the right ear of the mice every day according to the table 1, and the mice are continuously dosed for 3 days, and after the dosing, the mice are properly massaged to promote absorption.
Table 1 administration of mice in groups
After 30min of last dose, 50 μl of xylene was uniformly applied to both sides of the right ear of the mice/inflammatory only, and the left ear was not applied as a control. After 1h, the mice were sacrificed by cervical dislocation, the left and right auricles were cut off, discs were punched on the same positions of the left and right auricles of the mice by a 6mm diameter punch, and the discs were weighed in sequence on an analytical balance. The ear swelling degree and the inhibition rate of the mice were calculated with the difference in the mass of the two ears as the ear swelling degree, and the inhibition rate of swelling = [ (mass of model group ear-mass of administration group ear)/mass of model group ear ] ×100%. The experimental results are shown in table 2 and fig. 1.
TABLE 2 Effect of different treatments on ear swelling in mice
As can be seen from Table 2, the pharmaceutical compositions of examples 1-3 and comparative examples 1-4 have a certain inhibitory effect on ear swelling of mice caused by xylene, and the compositions of examples 1-3 have a better effect; as can be seen from fig. 1, examples 1-3 have a significant difference from the model group, and comparative examples 1,2,4 have a significant difference from the model group.
2. Carrageenan-induced murine foot swelling experiment
80 mice were randomly grouped according to 10 mice/group, the number of the mice is 1-8, the 1 st group is a model group, the 2 nd-8 th group is a dosing group, corresponding drugs are smeared on the outer side of the right rear lower limb of the mice (physiological saline is smeared on the model group) according to the table 1, and the mice are continuously dosed for 7 days, and after the dosing, the mice are properly massaged to promote absorption.
The thickness of the right hind toe of the mice in the normal state was measured with a vernier caliper before the last administration, after 30min of the last administration, physiological saline solution containing carrageenan of 1% concentration was injected under the skin of the right hind paw of the mice at a dose of 0.05 mL/mouse, the thickness of the same portion of the right hind toe was measured with a vernier caliper at 30min and 60min after the injection, and the paw swelling degree and swelling inhibition rate were calculated. The calculation formula is as follows: foot swelling degree = post-inflammatory foot plantar thickness-pre-inflammatory foot plantar thickness, foot swelling inhibition (%) = [ (model group foot swelling degree-dosing group foot swelling degree)/model group foot swelling degree ] ×100%. The experimental results are shown in table 3 and fig. 2.
TABLE 3 effects of different treatments on the swelling of the feet of mice
As can be seen from Table 3, the pharmaceutical compositions of examples 1-3 and comparative examples 1-4 have a certain inhibitory effect on swelling of the mouse feet caused by carrageenan; as can be seen from fig. 2, examples 1 to 3 and comparative examples 1 to 2 have significant differences from the model group and comparative examples 3 to 4 have insignificant differences from the model group after 30 minutes of administration; examples 2-3 had significant differences from the model group and no significant differences from the model group for the other compositions after 60min of dosing.
3. Acetic acid torsion method analgesic experiment
80 mice were randomly grouped according to 10 mice/group, the number of the mice is 1-8, the group 1 is a model group, the group 2-8 is a dosing group, all the mice have their abdomen dehaired, the corresponding medicines (physiological saline is smeared in the model group) are smeared at the abdomen dehaired position of the mice every day according to the treatment of table 1, the continuous dosing is carried out for 7 days, and the proper massage is carried out after the dosing to promote the absorption.
Acetic acid solution with concentration of 1% is injected into abdominal cavity 30min after the last administration, the injection dosage is 0.1 mL/mouse, the torsion latency period and the number of times of torsion reaction of each group of mice in 15min are recorded, and the time from the end of injection to the first torsion occurrence is taken as the torsion latency period. And the analgesic rate of each administration group was calculated, analgesic rate (%) = [ (mean number of times of twisting in model group-mean number of times of twisting in administration group)/mean number of times of twisting in model group ] ×100%. The experimental results are shown in table 4 and fig. 3.
TABLE 4 influence of different treatments on mice torsion
As can be seen from the analgesic experimental results of the acetic acid torsion method Table 4, the pharmaceutical compositions of examples 1-3 and comparative examples 1-4 can reduce the number of times of torsion of mice caused by acetic acid, and the analgesic rate of examples 1-3 is significantly higher than that of comparative examples 1-4; as can be seen from fig. 3, examples 1 to 3 have a significant difference from the model group, comparative example 2 has a significant difference from the model group, and the other compositions have no significant difference in the number of twisting times from the model group. .
4. Pain relieving experiment by hot plate method
The temperature is controlled at (55+/-0.5) DEG C by adopting an intelligent hot plate instrument, the time required by the female mice from the automatic feeding of the hot plate to the licking of the feet is used as a pain threshold, and 80 female mice with the pain threshold of 5-30 s are selected. The mice were randomly grouped into 10 groups, numbered 1-8 groups, group 1 was model group, and groups 2-8 were dosing groups, and according to table 1, the corresponding drugs were applied to 4 toes of the mice (physiological saline was applied to model group) daily for 3 days, and after the dosing, appropriate massage was performed to promote absorption. The pain threshold of mice was measured 10min,25min,40min after the last dose. The experimental results are shown in table 5 and fig. 4.
TABLE 5 Hot plate pain threshold of mice under different treatment modes
As can be seen from the results of the hot plate analgesia experiments in Table 5, the pain threshold values of 10min,25min and 40min after administration are prolonged compared with those before administration; as can be seen from fig. 4, 10min after dosing and 40min after dosing, examples 1-3 have a significant difference in pain threshold results compared to the model group, and comparative examples 1-4 have a significant difference compared to the model group; at 25min post-dose, examples 1-3 were significantly different from comparative examples 1-4 compared to the model group, and it can be seen that examples 1-3 were significantly different from comparative examples 1-4 compared to the model group.
5. Effects on inflammatory factors in serum
Collecting eyeball of a mouse subjected to inflammation 1h in a carrageenan-induced mouse foot swelling experiment of part 2, standing for 2h, centrifuging at 3500r/min in a refrigerated centrifuge at 4 ℃ for 10min, collecting upper serum, and measuring the contents of TNF-alpha, IL-1 and IL-6 in the serum. The experimental results are shown in table 6 and fig. 5.
TABLE 6 TNF-alpha, IL-1, IL-6 content in mouse serum under different treatments
From the results in Table 6, the inflammatory levels were reduced in both the examples and the comparative examples compared to the model group; as can be seen from fig. 5, TNF- α inflammatory factor levels example 3 has a more significant difference from the model group, example 2 has a significant difference from the model group, and the other groups have no significant difference from the model group; IL-1 inflammation levels examples 1-3 have significant differences compared to the model group, and comparative examples 1-4 have no significant differences compared to the model group; the compositions of the IL-1 groups were not significantly different from the model groups.
The pharmacological experiments of anti-inflammatory and analgesic are carried out on mice by preparing the pharmaceutical compositions with different formulas, and the results show that all the pharmaceutical compositions have a certain degree of anti-inflammatory and analgesic effects, the pharmacological experiments show that the anti-inflammatory and analgesic effects of the compositions are enhanced after musk is added, and the inflammatory level can be effectively reduced after the musk is added by measuring 3 inflammatory factors in serum.
(II) investigation of safety, adhesion and Water-washable Effect
The pharmaceutical compositions prepared in examples 1-3 and comparative examples 1-4 were tried by the same 20 volunteers and counted for the number of people who had good sensory safety, good adhesion and easy washing with water, respectively. The safety mainly refers to whether the sample is smeared on the skin for a certain time, and whether the phenomena such as allergy, erythra and the like or other adverse reactions occur or not; the adhesiveness mainly refers to that a sample is coated on skin to examine whether the sample flows or falls off; the easy washing with water is mainly to smear the sample on the hand of volunteers, and then wash with purified water to examine whether easy washing or greasy feeling is easy. The results are shown in Table 7.
TABLE 7 evaluation of the perception of different pharmaceutical compositions
The inspection result shows that the external analgesic paste is safe, has no stimulation, good adhesiveness, is easy to clean with water, is fresh and not greasy, and can effectively improve the compliance of the user for medication.
The above embodiments are only illustrative of the preferred embodiments of the present invention and are not intended to limit the scope of the present invention, and various modifications and improvements made by those skilled in the art to the technical solutions of the present invention should fall within the protection scope defined by the claims of the present invention without departing from the design spirit of the present invention.
Claims (7)
1. The external pharmaceutical composition is characterized by being prepared from the following raw materials in parts by weight: 70 parts of honeysuckle, 70 parts of achyranthes bidentata, 70 parts of chrysanthemum, 20 parts of musk, 120 parts of peppermint oil, 40 parts of wintergreen oil, 20 parts of borneol, 20 parts of camphor, 10 parts of sodium dodecyl sulfate, 80 parts of cetyl alcohol and 40 parts of glycerin monostearate.
2. A method of preparing the topical pharmaceutical composition of claim 1, comprising the steps of:
(1) Pretreatment: cleaning flos Lonicerae, achyranthis radix and flos Chrysanthemi, removing silt impurities, pulverizing, sieving, and mixing to obtain coarse powder;
(2) Extracting: adding distilled water into the coarse powder, heating, and collecting volatile oil and aromatic water;
(3) Preparation: mixing the volatile oil and aromatic water extracted in the step (2) with sodium dodecyl sulfate, adding distilled water as water phase, respectively heating and melting cetyl alcohol and glyceryl monostearate as oil phase, mixing well, stirring well to obtain matrix, adding Borneolum Syntheticum, camphora, thyme, oleum Menthae Dementholatum and wintergreen oil into the matrix, stirring well, making into ointment, and packaging.
3. The method of claim 2, wherein in step (2), the mass to volume ratio of the crude drug powder to the distilled water is 1g:15ml.
4. The method according to claim 2, wherein in the step (2), the heating temperature is 95 ℃ to 105 ℃ and the heating time is 4 to 6 hours.
5. Use of the topical pharmaceutical composition of claim 1 in the preparation of topical analgesic ointments.
6. The use of the topical pharmaceutical composition of claim 1 in the preparation of a topical detumescence paste.
7. The use of the topical pharmaceutical composition of claim 1 in the preparation of a topical anti-inflammatory paste.
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| 健步消肿止痛油化学成分的GC-MS分析;陈土荣;赵毛香;王秀丽;吴雪茹;;中国中医药现代远程教育;第9卷(第16期);第143页左栏第1段、右栏第1段 * |
| 寒痹软膏中樟脑、冰片和薄荷脑含量的测定;春;黄警;;海峡药学;20131115;-(11);90-95 * |
| 气相色谱法测定麝香祛痛凝胶的4种有效成分的含量;杨淑艳;李兆东;;现代生物医学进展;20061128;-(11);89-90 * |
| 麝鼠香与麝香抗炎及镇痛作用的比较研究;陈心智, 邱智东, 张永和, 张辉;吉林大学学报(医学版);第31卷(第03期);第414页摘要部分 * |
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