CN112107632A - External medicine composition for eliminating dampness and toxic stasis and preparation method thereof - Google Patents
External medicine composition for eliminating dampness and toxic stasis and preparation method thereof Download PDFInfo
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Abstract
The invention discloses an external medicine composition for eliminating dampness and removing stasis, which consists of the following raw material medicines: radix Sangusorbae, radix Sophorae Flavescentis, radix Et rhizoma Rhei, rhizoma Coptidis, cortex Phellodendri, and radix Angelicae Dahuricae. The composition can be made into topical unguent with herba Menthae, oleum Camelliae Japonicae, etc. Research shows that the external ointment has the effects of sterilizing, relieving itching, resisting inflammation and easing pain, can treat various skin pruritus to achieve the aim of inhibiting pruritus, and has no irritation and toxic or side effect. In addition, the invention has convenient use, simple process and definite curative effect, and opens up a new way for developing traditional national medicine.
Description
Technical Field
The invention belongs to the technical field of treatment of skin diseases, and particularly relates to an external medicine composition for clearing damp and toxic stasis and a preparation method thereof.
Background
Skin itch is a common, multiple disease of the dermatological family. When the skin itch occurs to a patient, the patient can have the symptoms of inattention, distraction and restlessness in sitting and lying, and the daily work and life of the patient are seriously influenced. Patients often have secondary skin damage due to the fact that the hands of the patients are not scratched. Scratch and blood stasis occur due to excessive scratching, and symptoms such as eczema, moss-like change, pigmentation and the like can also occur for a long time. At present, the cause of skin pruritus is not clear, and is considered to be related to certain diseases such as diabetes, hepatitis, nephropathy and the like; meanwhile, the external stimulation is also related to some external stimulation, such as dry cooling, wet heating, chemical fiber fabrics and the like. Medically, skin pruritus is mainly caused by the release of biogenic mediators (such as histamine, substance P, carnosine, protease, and the like), and can be classified into systemic pruritus and local pruritus, and the local skin pruritus is common. The local skin itch is clinically manifested as severe itching at fixed point, timing and paroxysmal, and is accompanied with feelings of burning, worm crawling to ants and the like, and also can cause the onset or aggravation of itch under the stimulation of mood fluctuation, environmental temperature and humidity change, clothes friction and the like. When pruritus is acutely suffered, patients often feel itchy and do not endure scratching, so that vicious cycles of scratching more and more are caused, and finally, the skin of serious patients is scratched, skin infection occurs and the like.
The medicines for treating skin pruritus are various in types, and western medicines comprise antihistamine medicines such as internal minoxidil and triptan and glucocorticoid ointment for external use. The medicines are contraindicated for a plurality of patients, side effects such as sleepiness, hypodynamia and the like are easily caused, dependence is easily generated after long-term use of hormone ointment, and pruritus can be aggravated after the medicine is stopped. The traditional Chinese medicine has more detailed and more practical understanding on skin pruritus, including 6 types of symptoms such as wind-cold syndrome, wind-heat syndrome, damp-heat syndrome, qi deficiency and fluid deficiency syndrome, fire-heat and blood-heat syndrome, blood deficiency and dryness syndrome and the like, and can be used for treating diseases through clinical symptoms and more specifically and accurately.
Disclosure of Invention
The technical problem to be solved by the invention is to provide an external medicine composition with the effects of resisting inflammation, relieving itching and easing pain, which is used for clearing damp and removing stasis and a preparation method thereof.
In order to solve the technical problems, the invention adopts the following technical scheme:
the externally applied medicine composition for eliminating dampness, toxin and stasis consists of the following raw material medicines: radix Sangusorbae, radix Sophorae Flavescentis, radix Et rhizoma Rhei, rhizoma Coptidis, cortex Phellodendri, and radix Angelicae Dahuricae.
The externally applied medicine composition for eliminating dampness, toxin and stasis consists of the following raw material medicines in parts by weight: 50-100 parts of street snake, 20-80 parts of bitter plum root, 10-50 parts of rhubarb, 10-50 parts of coptis root, 10-50 parts of golden cypress, 20-80 parts of angelica dahurica and 20-80 parts of garden burnet root.
The externally applied medicine composition for eliminating dampness, toxin and stasis consists of the following raw material medicines in parts by weight: 80 parts of Chinese lizardtail, 60 parts of bitter plum root, 30 parts of rhubarb, 30 parts of coptis root, 30 parts of phellodendron, 40 parts of angelica dahurica and 40 parts of garden burnet root.
The application of the externally applied medicine composition for eliminating dampness, toxin and stasis in preparing externally applied paste.
The preparation method of the external ointment comprises the following steps:
A. soaking the raw medicinal materials of the zaocys dhumnades, the bitter plum root, the rhubarb, the coptis chinensis, the golden cypress, the angelica dahurica and the garden burnet in an ethanol solution with the weight and volume concentration of 10 times of that of the medicinal materials of 70 percent overnight, filtering, decompressing the filtrate, recovering the ethanol until no alcohol smell exists, adding 100 parts of propylene glycol and 30 parts of triethanolamine, uniformly stirring to obtain a solution A, and keeping the temperature at 80 ℃ for later use;
B. heating 300 parts of camellia oil 100 and 100 parts of stearic acid, 100 parts of paraffin, 50 parts of vaseline and 40 parts of glyceryl monostearate at 80 ℃ to melt the camellia oil, and uniformly stirring to obtain liquid B for later use;
C. slowly injecting the solution A into the solution B, continuously stirring, taking out after completely mixing uniformly, cooling to 40 ℃, adding 10-30 parts of methyl salicylate, 15-60 parts of menthol, 10-30 parts of borneol, 5 parts of azone and 2 parts of ethylparaben, stirring uniformly, cooling to room temperature, and subpackaging to obtain the traditional Chinese medicine composition.
The raw medicinal materials comprise 80 parts by weight of zaocys damascena, 60 parts by weight of bitter plum root, 30 parts by weight of rhubarb, 30 parts by weight of coptis, 30 parts by weight of phellodendron, 40 parts by weight of angelica dahurica and 40 parts by weight of sanguisorba officinalis; 200 parts of camellia oil in the solution B; 20 parts of methyl salicylate, 40 parts of menthol and 20 parts of borneol.
Aiming at the problems of the existing skin itch treatment medicines, the inventor develops an external medicine composition for clearing damp and removing toxic stasis by combining national medicine theories, and the external medicine composition is composed of the following raw material medicines: radix Sangusorbae, radix Sophorae Flavescentis, radix Et rhizoma Rhei, rhizoma Coptidis, cortex Phellodendri, and radix Angelicae Dahuricae. The composition can be made into topical unguent with herba Menthae, oleum Camelliae Japonicae, etc. Research shows that the external ointment has the effects of sterilizing, relieving itching, resisting inflammation and easing pain, can treat various skin pruritus to achieve the aim of inhibiting pruritus, and has no irritation and toxic or side effect. In addition, the invention has convenient use, simple process and definite curative effect, and opens up a new way for developing traditional national medicine.
In the formula, the road-blocking snake is derived from Begonia fimbristipula Hance (Begonia fimbristipula Hance) of Begoniaceae, has the effects of clearing heat and cooling blood, and activating blood and detoxifying, and belongs to the field of pesticide application. It is good at treating summer heat high fever, cough due to lung heat, hemoptysis, traumatic injury and sprain, blood stasis and pain, scabies and tinea, scald due to hot water and fire, and herpes zoster, eczema, skin pruritus and the like which are commonly used by Yao nationality; the bitter plum root is derived from wild plant folium Rhamni utilis, has effects of clearing away heat and toxic materials, removing toxic substances, and relieving itching, and can be used for treating skin inflammation, scabies, intractable tinea and impetigo; rhubarb, coptis root and phellodendron bark all can clear heat, remove toxicity and dry dampness; the angelica dahurica is used for expelling pus and clearing damp, and belongs to the concurrent medicines of wind attack; sanguisorba officinalis has effects of cooling blood, removing toxic substance and removing blood stasis, and can be used for treating burn, scald and skin pruritus. The mint can dispel wind, relieve itching and promote eruption; the camellia oil has antibacterial, antiviral, tinea capitis, alopecia, dandruff preventing, and antipruritic effects.
Detailed Description
EXAMPLE 1 emulsion-type ointment
1. Accurately weighing 80 parts of Chinese brake snake, 60 parts of bitter plum root, 30 parts of rhubarb, 30 parts of coptis root, 30 parts of phellodendron, 40 parts of angelica dahurica, 40 parts of garden burnet, 20 parts of methyl salicylate, 40 parts of menthol, 20 parts of borneol and 200 parts of camellia oil according to the prescription amount for later use;
2. soaking the Chinese medicinal materials such as the zaocys, the bitter plum root, the rhubarb, the coptis root, the golden cypress, the angelica dahurica and the garden burnet overnight in 70 percent ethanol with the weight of 10 times of the medicinal materials, filtering, recovering ethanol from filtrate under reduced pressure until no alcohol smell exists, adding 100 parts of propylene glycol and 30 parts of triethanolamine, uniformly stirring, and keeping the temperature at 80 ℃ to obtain solution A for later use;
3. heating tea oil, stearic acid 100 parts, paraffin 100 parts, vaseline 50 parts, and glyceryl monostearate 40 parts at 80 deg.C to melt, and stirring to obtain solution B.
4. Slowly injecting the solution A into the solution B, stirring, cooling to 40 deg.C, adding methyl salicylate, Mentholum, Borneolum Syntheticum, 5 parts azone, and 2 parts ethylparaben, stirring, cooling to room temperature, and packaging.
EXAMPLE 2 oleaginous ointment
1. Accurately weighing 80 parts of Chinese brake snake, 60 parts of bitter plum root, 30 parts of rhubarb, 30 parts of coptis root, 30 parts of phellodendron, 40 parts of angelica dahurica, 40 parts of garden burnet, 20 parts of methyl salicylate, 40 parts of menthol, 20 parts of borneol and 200 parts of camellia oil according to the prescription amount for later use;
2. soaking radix Sangusorbae, radix Sophorae Flavescentis, radix et rhizoma Rhei, Coptidis rhizoma, cortex Phellodendri, radix Angelicae Dahuricae, and radix Sangusorbae in 70% ethanol overnight, filtering, recovering ethanol from the filtrate under reduced pressure until no alcohol smell exists, maintaining at 80 deg.C, adding oleum Camelliae Japonicae, vaseline 100 parts, and paraffin 100 parts, stirring, cooling to 40 deg.C, adding methyl salicylate, Mentholum, and Borneolum, stirring, cooling to room temperature, and packaging.
EXAMPLE 3 Water-soluble ointment
1. Accurately weighing 80 parts of Chinese brake snake, 60 parts of bitter plum root, 30 parts of rhubarb, 30 parts of coptis root, 30 parts of phellodendron, 40 parts of angelica dahurica, 40 parts of garden burnet, 20 parts of methyl salicylate, 40 parts of menthol and 20 parts of borneol according to the prescription amount for later use;
2. soaking Agkistrodon acutus, radix Pruni Salicinae, radix et rhizoma Rhei, Coptidis rhizoma, cortex Phellodendri, radix Angelicae Dahuricae, and radix Sangusorbae with 70% ethanol overnight, filtering, and recovering ethanol from the filtrate under reduced pressure to obtain solution A;
3. taking 50 parts of sodium carboxymethylcellulose, adding 100 parts of glycerol and 5 parts of sodium benzoate, grinding uniformly, adding the solution A after the sodium carboxymethylcellulose is fully expanded, stirring uniformly, supplementing to 1000 parts of purified water, and subpackaging to obtain the traditional Chinese medicine composition.
Pharmacological efficacy test
In order to further verify the efficacy of the ethnic pharmaceutical composition of the present invention, the ointments prepared in the examples were used for corresponding pharmacological and pharmacodynamic tests, and now the pharmacological and pharmacodynamic results of example 1 are summarized as follows, and the test results of example 2 and example 3 are equivalent to those of example 1, and are not repeated herein.
Examination of antipruritic action
40 mice, male and female halves, were randomly divided into 4 groups (10 per group): negative control group (physiological saline), positive control group (0.2g dermatitis), high dose group (0.5g ointment), low dose group (0.2g ointment), and 24h before administration, the back is shaved, and the area is about 6cm2. The shaving parts of the mice are coated with the medicine for 1 time per day on the next day, and the medicine is continuously coated for 7 days. 10min after the last drug application, 0.01 percent of 4-aminopyridine solution is injected into the mice subcutaneously by 0.2 mL/mouse, the times of the body licking reaction of the mice within 10min are immediately observed, the latency time(s) of the body licking reaction of the mice is observed, and the reaction inhibition rate is calculated at the same time. Latency(s): 4-aminopyridine was injected subcutaneously until the first time licking reactions occurred.
Compared with a negative control group, the high-dose group, the low-dose group and the positive control group of the pharmaceutical composition can prolong the latent time (P <0.05) of skin itch of mice caused by 4-aminopyridine and can reduce the times (P <0.05) of licking bodies of the mice caused by itch. The inhibition rates of the licking body reaction of the mice causing itching of the high-dose group, the low-dose group and the positive control group of the product are respectively 30.22%, 36.47% and 15.09%, which indicates that the product has better itching relieving effect, and the results are shown in table 1.
TABLE 1 Effect on cutaneous pruritus response in mice with 4-aminopyridine: (
n＝10)
Note: compared with the negative control group, the test results show that,*P<0.05; compared with the positive control group, the test results show that,#P<0.05.
second, examination of anti-inflammatory action
1. Influence on acetic acid-induced increase in mouse capillary permeability
40 mice, half male and half female, were randomly divided into 5 groups (8 per group). In smallDepilating mouse back with depilator having area of 2 × 2cm2. The negative control group is administered with physiological saline (0.1 ml/ointment), and the positive control group is administered with compound dexamethasone acetate cream (0.1 g/ointment), high, medium and low dose groups (0.5g, 0.35g and 0.2 g/ointment), and applied for 7 days for 1 time per day. After the last administration for 1h, the tail vein of each group of mice is injected with 1% Evans blue physiological saline with the dosage of 0.2ml per mouse, and is simultaneously injected with 0.2ml of 0.6% acetic acid solution in the abdominal cavity, the mice are killed after 0.5h, the abdominal cavity is cut open, and 5ml of physiological saline is used for repeatedly flushing, so that flushing fluid is obtained. Centrifuging at 1000r/min for 5min, and measuring absorbance at 590nm of the supernatant.
Compared with a negative control group, the high, medium and low dose groups of the compound can remarkably reduce the capillary permeability of mice and reduce the exudation of Evans blue (P is less than 0.01), which indicates that the compound has the functions of better reducing the capillary permeability of mice and inhibiting the exudation of edema liquid, and shows certain dose dependence, and the results are shown in Table 2.
TABLE 2 Effect on acetic acid-induced increase in mouse capillary Permeability (II)
n＝8)
Note: p <0.05, P <0.01, compared to the negative control group.
2. Effect on Cotton balls causing granuloma in mice
40 mice, half male and half female, were randomly divided into 5 groups (8 per group). Under the anesthesia of 10% chloral hydrate, the median line of the back of each mouse was unhaired, an incision about 1cm long was opened with surgical scissors, 1 (5. + -. 0.1) mg of sterilized cotton balls (0.2 ml each of penicillin G sodium salt solution was added after autoclaving, and dried at 60 ℃ C.) were implanted, followed by suturing the incision. Penicillin G sodium salt 0.2ml is injected into muscle on the day of operation to prevent infection. The next day after operation, the administration was started in the operation area, the physiological saline (0.1 ml/tube) was given to the negative control group, the compound dexamethasone acetate cream (0.1 g/tube), the high, medium and low dose groups (0.5g, 0.35g and 0.2 g/tube) was given to the positive control group, and the application was performed 1 time per day for 7 days. After 1h of the last administration, the mice were sacrificed, the suture was opened, the cotton ball and the adhered other tissues were removed, the adipose tissues were separated and removed, the cotton ball was baked at 60 ℃ until the weight did not change, and the weight of granuloma was obtained by removing the original weight.
Compared with a negative control group, the high, medium and low dose groups of the composition can obviously reduce the weight of the mouse granuloma (P <0.05 or P <0.01), and the results are shown in table 3.
TABLE 3 Effect on Cotton boll-induced granuloma in mice: (
n＝8)
Note: p <0.05, P <0.01, compared to the negative control group.
Examination of analgesic Effect
1. Twisting body method
40 mice, half female males, were randomly divided into 5 groups (8 per group). Depilating the back of the mouse with a depilator having an area of 2 × 2cm2The negative control group was given physiological saline (0.1 ml/stick), the positive control group was given nataline cream (0.1 g/stick), the high, medium and low dose groups (0.5g, 0.35g and 0.2 g/stick) and applied 1 time daily for 7 days. After the last administration for 0.5h, each group of mice was injected with 0.2ml of 0.6% acetic acid solution intraperitoneally. And observing and recording the times of writhing reaction of the mice within 0.5h after the injection of the acetic acid solution (reaction indexes: inward sunken abdomen, elongation of body and hind limb and high and upwarping of hip).
Compared with the negative control group, the high, medium and low dose groups of the product can obviously reduce the mouse writhing frequency (P is less than 0.05 or P is less than 0.01), and the results of the product with better analgesic effect are shown in table 4.
Table 4 effect on acetic acid induced writhing response in mice: (
n＝8)
Note: p <0.05, P <0.01, compared to the negative control group.
2. Hot plate method
Firstly, measuring the pain threshold value of a mouse in a constant temperature hot plate instrument (the temperature is 55 +/-0.5 ℃) for 2 times (the time interval from the moment that the mouse is placed on the hot plate instrument to the moment that the time interval until the foot licks is the pain threshold value of the mouse is obtained), wherein the time interval of two times is 0.5h, and calculating the average value of the results of the data measured by two times. 40 mice with an average value of 5-30 s were selected and randomly divided into 5 groups (8 mice per group). Depilating the back of the mouse with a depilator having an area of 2 × 2cm2The negative control group was given physiological saline (0.1 ml/stick), the positive control group was given nataline cream (0.1 g/stick), the high, medium and low dose groups (0.5g, 0.35g and 0.2 g/stick) and applied 1 time daily for 7 days. The pain threshold was measured once at 60min, 120min after the last administration and recorded (60 s was used as pain threshold if 60s was exceeded at the time of measurement).
Compared with a negative control group, each dosage group of the composition can obviously prolong the pain threshold of mice (P is less than 0.01), and the pain threshold is improved closely to the administration duration, and the results are shown in table 5.
TABLE 5 Effect on mouse Hot plate method (
n＝8)
Note: p <0.05, P <0.01, P <0.001, compared to the negative control group.
Fourth, the influence of long-term administration on the body
40 rats, female and male halfAnd randomly divided into 4 groups (10 per group). The back is shaved 24h before the experiment, and the area is about 60cm2In the experiment, the test substance was uniformly applied to the shaved area. Negative control group (physiological saline solution 2ml), high, medium and low dosage groups (2, 1, 0.5 g/mouse) of the product are administered 1 time per day for 30 days. The appearance signs, behavior activities, stool and urine traits, eye and nose secretion, skin irritation and animal death were observed daily. As a result: during the administration period, the rats have no external signs, behavioral activity, abnormal stool and urine, no abnormal secretion in eyes and nose, no skin irritation such as skin pimple, red swelling, ulceration and the like at the administration part, and no death condition. The invention is proved to have higher safety.
In conclusion, the external ointment has obvious effects of relieving itching, resisting inflammation and easing pain, and is safe and nontoxic. Compared with greasy and water-soluble ointment, the emulsion ointment of example 1 has the advantages of comfortable use, easy absorption and long attachment time, so that the emulsion ointment is expected to be developed into a novel medicine for treating skin pruritus.
Claims (6)
1. A topical pharmaceutical composition for eliminating dampness and removing toxic stasis is characterized by comprising the following raw material medicines: radix Sangusorbae, radix Sophorae Flavescentis, radix Et rhizoma Rhei, rhizoma Coptidis, cortex Phellodendri, and radix Angelicae Dahuricae.
2. The externally applied medicine composition for eliminating dampness and removing blood stasis as claimed in claim 1, is characterized by comprising the following raw material medicines in parts by weight: 50-100 parts of street snake, 20-80 parts of bitter plum root, 10-50 parts of rhubarb, 10-50 parts of coptis root, 10-50 parts of golden cypress, 20-80 parts of angelica dahurica and 20-80 parts of garden burnet root.
3. The externally applied medicine composition for eliminating dampness and removing blood stasis as claimed in claim 1, is characterized by comprising the following raw material medicines in parts by weight: 80 parts of Chinese lizardtail, 60 parts of bitter plum root, 30 parts of rhubarb, 30 parts of coptis root, 30 parts of phellodendron, 40 parts of angelica dahurica and 40 parts of garden burnet root.
4. The use of the topical pharmaceutical composition of claim 1 for eliminating dampness and blood stasis, in the preparation of a topical paste.
5. The process for producing an external ointment according to claim 4, which comprises the steps of:
A. soaking the raw medicinal materials of the zaocys dhumnades, the bitter plum root, the rhubarb, the coptis chinensis, the golden cypress, the angelica dahurica and the garden burnet in an ethanol solution with the weight and volume concentration of 10 times of that of the medicinal materials of 70 percent overnight, filtering, decompressing the filtrate, recovering the ethanol until no alcohol smell exists, adding 100 parts of propylene glycol and 30 parts of triethanolamine, uniformly stirring to obtain a solution A, and keeping the temperature at 80 ℃ for later use;
B. heating 300 parts of camellia oil 100 and 100 parts of stearic acid, 100 parts of paraffin, 50 parts of vaseline and 40 parts of glyceryl monostearate at 80 ℃ to melt the camellia oil, and uniformly stirring to obtain liquid B for later use;
C. slowly injecting the solution A into the solution B, continuously stirring, taking out after completely mixing uniformly, cooling to 40 ℃, adding 10-30 parts of methyl salicylate, 15-60 parts of menthol, 10-30 parts of borneol, 5 parts of azone and 2 parts of ethylparaben, stirring uniformly, cooling to room temperature, and subpackaging to obtain the traditional Chinese medicine composition.
6. The method for producing an external paste according to claim 5, wherein: the raw medicinal materials comprise 80 parts by weight of zaocys damascena, 60 parts by weight of bitter plum root, 30 parts by weight of rhubarb, 30 parts by weight of coptis root, 30 parts by weight of phellodendron, 40 parts by weight of angelica dahurica and 40 parts by weight of sanguisorba officinalis; 200 parts of camellia oil in the solution B; 20 parts of methyl salicylate, 40 parts of menthol and 20 parts of borneol.
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Application publication date: 20201222 |