CN116688017A - Rabdosia glabra compound ointment with psoriasis treatment effect and preparation method thereof - Google Patents
Rabdosia glabra compound ointment with psoriasis treatment effect and preparation method thereof Download PDFInfo
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/756—Phellodendron, e.g. corktree
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- 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
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Abstract
The invention discloses a compound ointment of rabdosia glabra with psoriasis treatment effect and a preparation method thereof, wherein the compound ointment is prepared by taking traditional Chinese medicine powder obtained by ethanol-water ultrasonic extraction, concentration and drying of three medicinal materials of rabdosia glabra, radix scutellariae and cortex phellodendri as a medicinal effect substance basis; the medicine is in the form of paste, and the administration form is external application and application, and clinical experiments show that the rabdosia amethystoides compound ointment can inhibit proliferation of psoriasis dander and relieve thickening, falling and itching symptoms of the psoriasis dander when being applied to the affected part of a psoriasis patient, and has good practical application value in the treatment of the psoriasis.
Description
Technical Field
The invention belongs to the technical field of biological medicines, and particularly relates to a rabdosia amethystoides compound ointment and a preparation method thereof.
Background
The Rabdosia glabra Rabdosia amethystoides (benth.) Hara is a Labiatae plant and has the effects of removing toxic substances, relieving swelling, promoting blood circulation, removing blood stasis, clearing heat and promoting diuresis. Wherein the whole herb of the rabdosia amethystoides is used as a medicine for treating amenorrhea, traumatic injury and acute mastitis; the root is used as a main medicine for treating snake bite, and is used for treating diseases such as strain, aching muscles and bones, sore toxin, long-noded pit viper bite and the like. Research shows that the Isodon glaucocalyx contains a large amount of diterpene, triterpene, sterol, flavone, lignan, polyphenol and other compounds, in particular diterpene and triterpene compounds with various structure types.
The Scutellariae radix Scutellaria baicalensis Georgi is dry root of Scutellariae radix of Labiatae, has bitter taste, and cold property, and has effects of clearing heat, eliminating dampness, purging pathogenic fire, removing toxic substances, cooling blood, stopping bleeding, removing heat, and preventing miscarriage. Modern researches have shown that the radix Scutellariae mainly contains flavone and flavonoid glycoside, polysaccharides, terpenes, lignans, volatile oil and trace elements, and has anti-inflammatory, anti-tumor, antiviral, blood pressure lowering, tranquilizing, antipyretic, antibacterial, antioxidant and free radical scavenging effects.
Cortex Phellodendri Phellodendri chinensis Cortex is bark of Clausena lansium (Rutaceae) with bitter taste and cold nature, and has effects of purging pathogenic fire, eliminating dampness, clearing heat and detoxicating, and can be used for treating damp-heat dysentery, jaundice, dark urine, itching of lower extremities, night sweat, spermatorrhea, pyocutaneous disease, swelling and sore, eczema, etc. The chemical components of the composition mainly comprise alkaloids, limonoids, phenolic acids, phenylpropanoids, volatile oils and the like, and have pharmacological effects of anti-inflammatory, antibacterial, antioxidant, anti-tumor, blood glucose reducing, nerve protecting, antidiarrheal and the like.
Psoriasis may manifest as different clinical symptoms, like classical plaque psoriasis, pustular psoriasis, and then as breakthrough punctate psoriasis. Although the majority of psoriatic patients develop a disease in the age of thirty years, it also occurs in childhood, a papular squamous disease, accounting for 10% of the common dermatological conditions in pediatric dermatology clinics. The treatment of pediatric psoriasis should take appropriate conservative treatment depending on the type and severity, as the effectiveness of the treatment and long-term safety are of paramount importance to the child.
Traditional Chinese medicine is reported to be one of alternative therapies with potential anti-psoriasis efficacy. Among them, rabdosia glabra has proven useful for systemic treatment of psoriasis. However, long-term systemic administration often causes adverse reactions to the gastrointestinal tract. In order to optimize the use of the rabdosia amethystoides as an anti-psoriasis drug, local treatment without obvious adverse reaction is the first choice. The use of topical rather than oral administration can avoid first pass effects and chemical degradation of the drug in the gastrointestinal tract and minimize the risk of toxic side effects, including gastric irritation and liver damage. Because psoriasis is a persistent and recurrent disease, patients often need continuous treatment, preferably with drugs having low cumulative toxicity potential. The local application can not only have direct and better curative effect, but also avoid long-term adverse reaction. Based on the problems and defects of curative effect, toxic and side effects and the like of the existing psoriasis treatment medicines, the invention provides a rabdosia amethystoides compound ointment, a preparation method thereof and application thereof in preparing medicines for treating children psoriasis for the first time.
Disclosure of Invention
The invention aims to provide a rabdosia glabra compound ointment with a psoriasis treatment effect and a preparation method thereof.
The technical scheme of the invention is as follows:
a compound ointment of herba Rabdosiae Glaucocalycis is prepared from three medicinal materials including herba Rabdosiae Glaucocalycis, scutellariae radix and cortex Phellodendri by ultrasonic extraction with ethanol-water, concentrating and drying to obtain traditional Chinese medicine powder as medicinal material base;
wherein, the mass parts of the rabdosia amethystoides, the baical skullcap root and the amur corktree bark are respectively 10-20 parts, 20-40 parts and 20-40 parts, and preferably 15 parts, 30 parts and 30 parts of the rabdosia amethystoides, the baical skullcap root and the amur corktree bark;
specifically, the rabdosia amethystoides is dried whole herb of rabdosia amethystoides belonging to the genus rabdosia of the family Labiatae;
the Scutellariae radix is dry root of Scutellariae radix of Labiatae;
cortex Phellodendri is dry bark of cortex Phellodendri belonging to Rutaceae.
The compatibility principle of the compound ointment of the invention is as follows: the rabdosia amethystoides, the baical skullcap root and the amur corktree bark have the effects of clearing heat and detoxicating, cooling blood and relieving itching, inhibiting the excessive proliferation of keratinocytes and the like, and are commonly used for treating skin diseases in traditional Chinese medicine. The rabdosia glabra reduces skin inflammation and redness and swelling, the baical skullcap root regulates the immune system function, the amur corktree bark inhibits the excessive proliferation of keratinocytes, and the three can play a synergistic and complementary role by combined application, so that unexpected psoriasis treatment effect can be achieved.
A preparation method of a rabdosia amethystoides compound ointment comprises the following steps:
(1) Crushing: cleaning herba Rabdosiae Glaucocalycis, scutellariae radix and cortex Phellodendri with water, oven drying, pulverizing with a traditional Chinese medicine pulverizing machine, and sieving with 50-80 mesh sieve to obtain mixed powder;
(2) Extracting: adding an extraction solvent into the mixed powder obtained in the step (1), performing ultrasonic extraction at 40-100 ℃ for 30-60min, centrifuging (3000-5000 rpm), and taking supernatant to obtain an alcohol-soluble crude extract;
in the step (2), the extraction solvent is a mixed solvent of ethanol and water, and the volume fraction of the ethanol is 50-75%; the volume mass ratio of the extraction solvent to the mixed powder is 4-10:1, mL/g;
the ultrasonic extraction frequency is 50-80kHz, and the ultrasonic power is 200-300W;
(3) Concentrating: concentrating the alcohol-soluble crude extract obtained in the step (2) in a rotary evaporator at 60-100 ℃ until the density is 0.8-1.0 to obtain a concentrated extract;
(4) And (3) drying: freeze-drying the concentrated extract obtained in the step (3) in a freeze dryer to obtain traditional Chinese medicine powder;
(5) Preparing: heating and dissolving the auxiliary agent at 70-80 ℃, adding the traditional Chinese medicine powder obtained in the step (4), and uniformly mixing to prepare a compound medicine;
in the step (5), the composition of the auxiliary agent is as follows: 10-25 parts by mass of vaseline, 30-40 parts by mass of yellow wax and 20-45 parts by mass of olive oil;
in the obtained compound medicine, the mass fraction of the traditional Chinese medicine powder is 20-30%, and the mass fraction of the auxiliary agent is 70-80%; the compound medicine is in the form of ointment.
The compound rabdosia glabra ointment can be used for treating children psoriasis, is preferably applied for external use, and can inhibit proliferation and thickening of psoriasis surface skin dander, reduce the falling of psoriasis dander and relieve itching of psoriasis when applied to the skin affected part of a psoriasis patient.
The invention has the beneficial effects that:
the invention uses three medicinal materials such as rabdosia glabra and the like to be extracted by ultrasound, then the three medicinal materials are purified and concentrated, the medicinal form is preferably paste, and the administration form is preferably external application. Clinical experiments show that the compound ointment of the rabdosia glabra is smeared on the affected part of a psoriasis patient, can inhibit proliferation of psoriasis dander, relieve the symptoms of psoriasis dander thickening, falling and pruritus, and has good practical application value in the treatment of psoriasis.
Drawings
Fig. 1 is a diagram of an embodiment of the present invention prior to treatment of a patient: (a) left leg, (b) right leg.
Figure 2 is a graph of the present invention for 2 months after patient treatment: (a) left leg, (b) right leg.
Detailed Description
The present invention is further described below by way of specific examples, but the scope of the present invention is not limited thereto.
Example 1:
in a typical specific embodiment of the invention, a preparation method of a rabdosia amethystoides compound ointment is provided, and the preparation method comprises the steps of crushing, extracting, concentrating, drying and preparing three traditional Chinese medicinal materials of rabdosia amethystoides, radix scutellariae and cortex phellodendri;
the specific method for the crushing step comprises the following steps: taking 15g of rabdosia amethystoides, 30g of baikal skullcap root and 30g of phellodendron bark, adding water for cleaning, drying, crushing by a traditional Chinese medicine powder grinding machine, and sieving the crushed mixed medicinal material powder with a 50-mesh sieve;
in the extraction step, an extracting agent adopts a 50% ethanol water mixture as a solvent, 65g of the sieved traditional Chinese medicine mixed powder is added with 260mL of solvent for ultrasonic extraction;
in the extraction step, the temperature is 40 ℃, ultrasonic extraction is carried out for 30 minutes, centrifugation is carried out under the condition of 3000 revolutions, and the supernatant fluid is taken to obtain a crude extract;
in the concentrating step, evaporating the crude extract in a rotary evaporator, and concentrating at 60 ℃ until the density is 0.8 to obtain a concentrated extract;
in the drying step, the obtained concentrated extract is put into a freeze dryer for freeze drying, so as to obtain traditional Chinese medicine powder;
in the preparation step, the auxiliary agent is heated and dissolved at 70 ℃, the auxiliary agent comprises 4g of vaseline, 4.8g of yellow wax and 7.2g of olive oil, and 4g of traditional Chinese medicine powder and 16g of auxiliary agent are uniformly mixed to obtain the compound ointment.
Example 2:
the preparation method of the rabdosia amethystoides compound ointment comprises the steps of crushing, extracting, concentrating, drying and preparing three traditional Chinese medicinal materials of rabdosia amethystoides, radix scutellariae and cortex phellodendri;
the specific method for the crushing step comprises the following steps: taking 15g of rabdosia amethystoides, 30g of baikal skullcap root and 30g of phellodendron bark, adding water for cleaning, drying, crushing by a traditional Chinese medicine powder grinding machine, and sieving the crushed mixed medicinal material powder with a 80-mesh sieve;
in the extraction step, an extracting agent adopts a 50% ethanol water mixture as a solvent, 65g of the sieved traditional Chinese medicine mixed powder is added with 520mL of solvent for ultrasonic extraction;
in the extraction step, the temperature is 70 ℃, ultrasonic extraction is carried out for 45 minutes, centrifugation is carried out under 4000 revolutions, and the supernatant fluid is taken to obtain a crude extract;
in the concentrating step, evaporating the crude extract in a rotary evaporator, and concentrating at 80deg.C to a density of 0.9 to obtain concentrated extract;
in the drying step, the obtained concentrated extract is put into a freeze dryer for freeze drying, so as to obtain traditional Chinese medicine powder;
in the preparation step, the auxiliary agent is heated and dissolved at 75 ℃, the auxiliary agent comprises 3.75g of vaseline, 4.5g of yellow wax and 6.75g of olive oil, and the traditional Chinese medicine powder and the auxiliary agent are mixed according to the proportion of 5g of traditional Chinese medicine powder and 15g of auxiliary agent to obtain the compound ointment.
Example 3:
the preparation method of the rabdosia amethystoides compound ointment comprises the steps of crushing, extracting, concentrating, drying and preparing three traditional Chinese medicinal materials of rabdosia amethystoides, radix scutellariae and cortex phellodendri;
the specific method for the crushing step comprises the following steps: taking 15g of rabdosia amethystoides, 30g of baikal skullcap root and 30g of phellodendron bark, adding water for cleaning, drying, crushing by a traditional Chinese medicine powder grinding machine, and sieving the crushed mixed medicinal material powder with a 80-mesh sieve;
in the extraction step, a 75% ethanol water mixture is used as a solvent for extracting the 65g of the sieved traditional Chinese medicine mixed powder by adding 650mL of solvent for ultrasonic extraction;
in the extraction step, the temperature is 100 ℃, ultrasonic extraction is carried out for 60 minutes, centrifugation is carried out under the condition of 5000 revolutions, and the supernatant fluid is taken to obtain a crude extract;
in the concentrating step, evaporating the crude extract in a rotary evaporator, and concentrating at 100deg.C to density of 1.0 to obtain concentrated extract;
in the drying step, the obtained concentrated extract is put into a freeze dryer for freeze drying, so as to obtain traditional Chinese medicine powder;
in the preparation step, the auxiliary agent is heated and dissolved at 80 ℃, the auxiliary agent comprises 3.5g of vaseline, 4.2g of yellow wax and 6.3g of olive oil, and the traditional Chinese medicine powder and the auxiliary agent are mixed according to the proportion of 6g of traditional Chinese medicine powder and 14g of auxiliary agent to obtain the compound ointment;
the application range is as follows: can be used for treating psoriasis.
The usage and the dosage are as follows: the ointment is applied to the affected part 2 times daily.
Example 4:
1. general data
The clinical treatment and observation of 20 cases of psoriasis patients are randomly divided into 10 cases of a compound glaucocalyx and rabdosia rubescens ointment group and a Qinbai ointment group respectively.
2. Diagnostic criteria
(1) Western diagnosis standard refers to China psoriasis diagnosis and treatment guide (2018, abbreviated edition): the skin damage is mainly red light pimple, maculopapule and patch with different sizes, silvery white scales are covered on the skin, a light red bright film is visible after scraping, and punctiform bleeding is visible under the film; rashes can occur on the surface of the body in the form of coins, drops, maps or mixtures, and are marked in boundaries with different degrees of itching, and are diagnosed after identification of seborrheic dermatitis, tinea capitis, chronic eczema and lichen planus.
(2) The diagnosis standard of the traditional Chinese medicine refers to the guidelines of clinical research of new traditional Chinese medicines: the skin injury has bright red color, swelling or infiltration, or erythema erosion with itching, can be seen as a screen bleeding point, and can be scraped off by silvery white scales to be seen as punctiform bleeding; the disease progress is rapid at the initial stage or the recurrence initial stage; thirst, vexation, chest and gastric fullness, heavy head and body, loose stool or constipation; a red tongue with yellow and greasy coating and a soft and rapid pulse.
3. Therapeutic method
Group A: the compound ointment of the rabdosia glabra of the example 2 is used for the skin injury part of psoriasis and is smeared for 2 months.
Group B: radix Scutellariae Bai Ruangao (common ointment) prepared from radix Scutellariae and cortex Phellodendri is applied to skin injury part of psoriasis for 2 months.
4. Observation index
4.1 therapeutic efficacy criterion
The curative effect judgment standard of the porrigo is formulated by referring to the Chinese medicine new medicine clinical research guidelines.
And (3) healing: the clinical symptoms and the physical signs of the skin loss disappear or basically disappear;
the effect is shown: the skin damage of clinical symptoms and signs is obviously changed;
the method is effective: the clinical symptoms and the physical signs of the skin loss are all improved;
invalidation: the clinical symptoms and the physical signs of the skin loss are not obviously improved;
total effective rate = clinical recovery rate + significant efficiency + effective rate.
4.2 skin lesion efficacy scoring
The skin lesions of pre-and post-treatment pediatric psoriasis patients were evaluated using a psoriasis skin lesion area and severity index (PASI) score, respectively.
(1) Skin area score: 4 parts of the head, the upper limb, the trunk and the lower limb are respectively counted as 0, 1, 2, 3, 4, 5 and 6 according to the total weight of no part, less than 10 percent, less than or equal to 30 percent, 30 percent and less than or equal to 50 percent, less than or equal to 70 percent, 70 percent and less than or equal to 90 percent;
(2) severity index: the skin damage observation indexes are red spots, scales and infiltration, and the scales are respectively counted to be 0, 1, 2, 3 and 4 according to the non-moderate, severe and extremely severe;
(3) PASI total = PASI head x 0.1+ PASI upper limb x 0.2+ PASI torso x 0.3+ PASI lower limb x 0.4. The PASI score for each site was (erythema + infiltration + scaling) x lesion area score. A higher score indicates a more severe condition.
5. Results
5.1 results of treatment efficacy determination
The total effective rate after treatment of group a was 90.0% significantly higher than that of group B, with statistically significant (P < 0.05) results shown in table 1.
Table 1 comparison of clinical efficacy in two groups of patients
| Group of | Number of examples | Healing of the wound | Has obvious effect | Effective and effective | Invalidation of | Total effective rate |
| Group A | 10 | 2 | 3 | 4 | 1 | 90.0％* |
| Group B | 10 | 1 | 2 | 4 | 3 | 70.0％ |
Note that: in comparison with the group B, * P＜0.05。
5.2, PASI scoring results
Prior to treatment, the two groups of patients were compared for PASI scores, with no statistical significance of the differences (P > 0.05). The PASI scores of both groups of patients decreased after 2 months of treatment compared to pre-treatment, and group a was lower than group B (P < 0.05), and the results are shown in table 2.
Table 2 comparison of PASI scores before and after treatment for two groups of patients
Note that: in comparison with the group B, △ P＞0.05， * p is less than 0.05; in comparison with the prior treatment of the same group, # P＜0.05。
in conclusion, the rabdosia glabra compound ointment provided by the invention can effectively relieve the skin damage symptoms of children psoriasis patients such as erythema, scales, infiltration and the like, reduce the PASI score of the psoriasis patients, and has obvious clinical curative effect.
Claims (7)
1. The compound ointment is characterized by being prepared by taking Chinese medicinal powder obtained by ethanol-water ultrasonic extraction, concentration and drying of three medicinal materials of rabdosia amethystoides, radix scutellariae and cortex phellodendri as a medicinal effect substance basis;
wherein the mass parts of the rabdosia amethystoides, the baical skullcap root and the amur corktree bark are respectively 10-20 parts, 20-40 parts and 20-40 parts;
the Rabdosia glabra is dried whole herb of Rabdosia glabra of Rabdosia of Labiatae;
the Scutellariae radix is dry root of Scutellariae radix of Labiatae;
cortex Phellodendri is dry bark of cortex Phellodendri belonging to Rutaceae.
2. The rabdosia amethystoides compound ointment according to claim 1, wherein the rabdosia amethystoides, the radix scutellariae and the cortex phellodendri are 15 parts by weight, 30 parts by weight and 30 parts by weight respectively.
3. The method for preparing the rabdosia glabra compound ointment according to claim 1, which is characterized by comprising the following steps:
(1) Crushing: cleaning herba Rabdosiae Glaucocalycis, scutellariae radix and cortex Phellodendri with water, oven drying, pulverizing with a traditional Chinese medicine pulverizing machine, and sieving with 50-80 mesh sieve to obtain mixed powder;
(2) Extracting: adding an extraction solvent into the mixed powder obtained in the step (1), performing ultrasonic extraction at 40-100 ℃ for 30-60min, centrifuging, and taking supernatant to obtain an alcohol-soluble crude extract;
in the step (2), the extraction solvent is a mixed solvent of ethanol and water;
(3) Concentrating: concentrating the alcohol-soluble crude extract obtained in the step (2) in a rotary evaporator at 60-100 ℃ until the density is 0.8-1.0 to obtain a concentrated extract;
(4) And (3) drying: freeze-drying the concentrated extract obtained in the step (3) in a freeze dryer to obtain traditional Chinese medicine powder;
(5) Preparing: heating and dissolving the auxiliary agent at 70-80 ℃, adding the traditional Chinese medicine powder obtained in the step (4), and uniformly mixing to prepare the compound medicine.
4. The process according to claim 3, wherein the ethanol volume fraction in the extraction solvent of step (2) is 50-75%.
5. The method of claim 3, wherein in the step (2), the volume/mass ratio of the extraction solvent to the mixed powder is 4 to 10:1, mL/g.
6. A method according to claim 3, wherein in step (5), the composition of the auxiliary agent is: 10-25 parts by mass of vaseline, 30-40 parts by mass of yellow wax and 20-45 parts by mass of olive oil.
7. The preparation method of claim 3, wherein in the compound medicine obtained in the step (5), the mass fraction of the traditional Chinese medicine powder is 20-30%, and the mass fraction of the auxiliary agent is 70-80%.
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