CN109758549B - Traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity, which comprises the following components in parts by weight: 10-20 parts of honeysuckle, 10-15 parts of lithospermum, 10-25 parts of glabrous greenbrier rhizome, 10-15 parts of weeping forsythia, 10-20 parts of duckweed, 10-15 parts of common selfheal fruit-spike and 10-20 parts of tree peony bark. The invention also discloses a preparation method of the traditional Chinese medicine composition and application of the traditional Chinese medicine composition in preparing a medicine for preventing and treating EGFRI skin toxicity, in particular to application of the traditional Chinese medicine composition and erlotinib in preparing a medicine for treating papulopustular rash, abnormal hair regeneration, dry and itchy skin, periungual inflammation and other diseases caused by EGFRI skin toxicity.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity, and a preparation method and application thereof.
Background
The EGFRI skin toxicity refers to the skin toxicity reaction of a tumor patient after EGFRI administration, and is represented as follows: papulopustular rash, abnormal hair regeneration, dry and itchy skin, periungual inflammation, toothache and the like appear. The skin toxicity not only can seriously affect the daily living condition of a patient and affect the mood of the patient, but also more importantly, the serious skin toxicity reaction causes the dosage of the anticancer drug EGFRI to be forcibly reduced and even stopped, thereby further causing the interruption of treatment and affecting the antitumor efficacy. The research on the prevention and treatment of the EGFRi-induced skin toxicity is still in the research stage at present, and the most common methods in western medicine are topical antibiotics, steroids or oral antibiotics, immunomodulators and the like. However, other toxic and side effects can be caused by long-term use of the drugs, the life quality of patients is not substantially improved, and in addition, the scientificity of the combination of the steroid hormone topical application and the antibiotic treatment for preventing and treating the EGFRI caused skin toxicity is still greatly controversial.
Disclosure of Invention
The purpose of the invention is as follows: aiming at the defects in the prior art, the application provides a traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity, and a preparation method and application thereof.
The technical scheme is as follows: the invention relates to a traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity, which comprises the following components in parts by weight: 10-20 parts of honeysuckle, 10-15 parts of lithospermum, 10-25 parts of glabrous greenbrier rhizome, 10-15 parts of weeping forsythia, 10-20 parts of duckweed, 10-15 parts of common selfheal fruit-spike and 10-20 parts of tree peony bark.
Further, the traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity comprises the following components in parts by weight: 12-18 parts of honeysuckle, 10-12 parts of lithospermum, 15-20 parts of glabrous greenbrier rhizome, 10-12 parts of weeping forsythia, 10-15 parts of duckweed, 10-12 parts of common selfheal fruit-spike and 10-15 parts of tree peony bark.
As the most preferable technical scheme, the traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity comprises the following components in parts by weight: 15 parts of honeysuckle, 10 parts of lithospermum, 15 parts of glabrous greenbrier rhizome, 10 parts of weeping forsythia, 10 parts of duckweed, 10 parts of selfheal and 12 parts of tree peony bark.
The preparation method of the traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity comprises the following steps: weighing each component according to the formula ratio, adding water, decocting and extracting to obtain the traditional Chinese medicine composition, specifically adding 8-12 times of water, decocting for 1-2h, continuously extracting for 2-3 times, and combining the extracting solutions to obtain the traditional Chinese medicine composition.
The traditional Chinese medicine composition can be granules, oral liquid, capsules and other one or more dosage forms in pharmaceutics.
The invention also discloses application of the traditional Chinese medicine composition in preparation of medicines for preventing and treating EGFRI skin toxicity.
Wherein, the EGFRI comprises all tyrosine kinase inhibitors, such as erlotinib and the like.
In such applications, the EGFRi skin toxicity includes papulopustular rash, abnormal hair regrowth, dry and itchy skin, periungual inflammation, and the like.
Further, in the application, the traditional Chinese medicine composition is used in combination with EGFRI.
In the traditional Chinese medicine composition, honeysuckle, also called honeysuckle stem, has the effects of clearing away heat and toxic materials and dispelling wind and heat; the lithospermum, also called as the lithospermum erythrorhizon, has the effects of detoxifying, removing freckles, clearing heat, relieving swelling, cooling blood and promoting eruption; glabrous greenbrier rhizome, also known as Hongtulao, has the effects of detoxifying, dehumidifying and joint soothing; fructus forsythiae, also known as HUAHUANGJIAO, has effects of clearing away heat and toxic materials, resolving hard mass and relieving swelling; duckweed, also called duckweed, disperses wind-heat, promotes eruption, relieves itching, induces diuresis and reduces edema; the selfheal, also called as the cymbidium faberi, can dissipate stagnation and reduce swelling, clear away heat and toxic materials, dispel phlegm and relieve cough; moutan bark, also known as Hongtailing, has the effects of clearing heat and cooling blood, diminishing inflammation and easing pain, and activating blood and dissolving stasis.
On the basis of the theory of traditional Chinese medicine, EGFRI-induced skin toxicity is mainly caused by the fact that pathogenic toxins such as wind, dampness and heat toxin externally reach the skin due to the fact that patients suffer from intrinsic deficiency, blood heat accumulation and special drug-induced toxicity, and yin fluid is consumed for a long time. So it is used to clear heat and remove toxicity, clear heat and cool blood. The traditional Chinese medicine composition has the effects of clearing heat and removing toxicity, eliminating dampness and resolving masses, and cooling blood and promoting eruption. The honeysuckle flower and the lithospermum in the formula are monarch drugs, and have the effects of clearing away heat and toxic materials, cooling blood and promoting eruption; rhizoma smilacis glabrae, fructus forsythiae and duckweed are ministerial drugs and can strengthen dispelling wind, promoting eruption, clearing heat and eliminating dampness; the selfheal and the moutan bark are used as assistants to clear heat, activate blood and dissipate stagnation.
Has the advantages that: the traditional Chinese medicine composition for preventing and treating EGFRI-induced skin toxicity has the following advantages: the medicine has good effect and obvious curative effect, and the whole formula has the effects of clearing heat and removing toxicity, eliminating dampness and resolving masses, cooling blood and promoting eruption; the composition has definite curative effect on relieving the phenomena of abnormal thickening of stratum corneum, hair follicle blockage and inflammatory cell infiltration; the EGFRI induced skin toxicity is treated in a targeted manner, and the treatment obviously improves the papulopustular rash, abnormal hair regeneration, dry and itchy skin, periungual inflammation and the like of a patient. The Chinese medicinal composition has good medicinal properties, can adopt various dosage forms such as granules, oral liquid, capsules and the like, is convenient to take, is easy to accept by patients and has good compliance.
Drawings
FIG. 1 is an appearance observation of the pharmaceutical compositions of the present application for controlling EGFRI-induced skin toxicity;
FIGS. 2 and 3 show the results of pharmacodynamic studies of the pharmaceutical compositions of the present application on EGFRI-induced skin toxicity;
FIG. 4 is a graph showing the body weight change of mice;
FIG. 5 is a graph of the effect of a pharmaceutical composition of the present application on EGFRI-induced skin inflammation;
FIGS. 6 and 7 show that the pharmaceutical compositions of the present application reduce the erlotinib-induced up-regulated expression of STATA 3;
fig. 8 is a graph of the effect of the pharmaceutical compositions of the present application on EGFRi-induced skin damage.
Detailed Description
The present application will be described in detail with reference to specific examples.
Example 1
A traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity comprises the following components in parts by weight: 15 parts of honeysuckle, 10 parts of lithospermum, 15 parts of glabrous greenbrier rhizome, 10 parts of weeping forsythia, 10 parts of duckweed, 10 parts of selfheal and 12 parts of tree peony bark.
The preparation method of the traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity comprises the following steps: weighing the components according to the formula, adding 10 times of water to extract for two times, each time for 1.5h, combining the extracting solutions, and concentrating for later use.
Example 2
A traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity comprises the following components in parts by weight: 12 parts of honeysuckle, 10 parts of lithospermum, 15 parts of glabrous greenbrier rhizome, 10 parts of weeping forsythia, 10 parts of duckweed, 10 parts of selfheal and 10 parts of tree peony bark.
The preparation method of the traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity comprises the following steps: weighing the components according to the formula, adding 10 times of water to extract for two times, each time for 1.5h, combining the extracting solutions, and concentrating for later use.
Example 3
A traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity comprises the following components in parts by weight: 18 parts of honeysuckle, 12 parts of lithospermum, 20 parts of glabrous greenbrier rhizome, 12 parts of weeping forsythia, 15 parts of duckweed, 12 parts of selfheal and 15 parts of tree peony bark.
The preparation method of the traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity comprises the following steps: weighing the components according to the formula, adding 10 times of water to extract for three times, each time for 1.5h, combining the extracting solutions, and concentrating for later use.
Example 4
A traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity comprises the following components in parts by weight: 20 parts of honeysuckle, 15 parts of lithospermum, 25 parts of glabrous greenbrier rhizome, 15 parts of weeping forsythia, 20 parts of duckweed, 15 parts of selfheal and 20 parts of tree peony bark.
The preparation method of the traditional Chinese medicine composition for preventing and treating EGFRI skin toxicity comprises the following steps: weighing the components according to the formula, adding 10 times of water to extract for two times, each time for 2h, combining the extracting solutions, and concentrating for later use.
In vivo pharmacodynamic study of the aqueous extract of the Chinese medicinal composition (abbreviated as "XZF", "Xiaozheng" or "Xiaozheng" in example 1) on mouse skin toxicity caused by erlotinib
A mouse model of EGFRI-induced skin toxicity was established using BALB/c mice with 150mg/kg erlotinib hydrochloride (purchased from Shanghai Arlatin Biotechnology Co., Ltd., CAS number: 183319-69-9), and the model was used to investigate the skin protective effect of the composition.
The experimental process comprises the following steps: female BALB/c mice were depilated on the back, and erlotinib hydrochloride was administered by gavage at 150mg/kg daily while being illuminated by an incandescent lamp for 10 h/day for 49 consecutive days until rash appeared. Referring to the method of converting the body surface area into the administration dose in the pharmacological experimental methodology, the clinical amount of the Chinese traditional patent medicine for treating the herpes is 140 g/day and 0.72 g/mL, and the amount of the Chinese traditional patent medicine for treating the herpes is 0.25mL/10g per day (the weight of the human body is calculated according to 70kg, and the conversion coefficient is 9). The low-dose group is given with 0.25mL/10g of water extract of the rash removing formulation of 1.8g crude drug/mL each day; the high dose group was administered 4.50g crude drug/mL aqueous extract of Xiaorash-removing formulation 0.25mL/10g per day. Erlotinib hydrochloride is administered at 150mg/kg per day by gavage, i.e. 15mg/mL of erlotinib hydrochloride suspension is administered at 0.1mL/10 g.
As a result: the appearance observation results after 49 days of administration are shown in fig. 1, and the specific statistical results are shown in tables 1-3.
TABLE 1 mouse Limb redness and swelling severity statistics
TABLE 2 mouse herpes severity statistics
TABLE 3 mouse rash severity statistics
The results were observed according to figure 1: the blank mice have the advantages that after shaving, the hair grows faster, the hair grows basically completely after three weeks, the activity condition is good, and the symptoms such as rash, herpes, beard falling, eye hair loss and the like do not appear. The control mice had slow hair growth, severe alopecia in neck, shoulder and eye, moustache, herpes, rash, etc. around the mouth and limbs, and poor activity. The low-dose group had slow hair regrowth, with symptoms of beard, periocular alopecia, red swelling of the mouth and limbs, herpes, and no rash. The high-dose group had slow hair regrowth, light hair loss in beard and eye, light red and swollen degree around mouth and periphery, and no herpes, rash, etc.
As can be seen from table 1, the four limbs of the mice in the administration group all suffered from different degrees of redness and swelling, and compared with the control group, the redness and swelling degree of the low-dose and high-dose groups were lighter, the moderate degree of redness and swelling of the four limbs in the control group was 80%, the severe degree of redness was 20%, the mild degree of redness and swelling of the four limbs in the low-dose and high-dose groups was 60%, and the moderate degree of swelling was 40%. As can be seen from table 2, the incidence of herpes in the control group was 80%, with 40% both mild and moderate; the incidence rate of herpes in the low-dose group is 20%, and the incidence degree is mild; the high dose group did not develop herpes. As can be seen from Table 3, the incidence of rash in the control group was 80% and the degree of rash was mild; the incidence rate of the skin rash in the low-dose group is 20 percent, and the incidence degree is mild; no rash occurred in the high dose group. Therefore, 150mg/kg of erlotinib hydrochloride can cause skin toxicity such as limb redness, hair regeneration disorder and herpes of mice, and the occurrence of the skin toxicity can be alleviated to a certain extent by 18g/kg and 45g/kg of rash removing formulation.
We take skin tissues to respectively perform HE staining and oil red O staining, and the results are shown in fig. 2 and fig. 3, and according to the graph, whether longitudinal cutting or transverse cutting shows that 150mg/kg of erlotinib hydrochloride can cause the phenomena of abnormal thickening of horny layer, hair follicle blockage and inflammatory cell infiltration of the skin of mice, and different dosages of rash removing methods can reduce the phenomena, which are specifically shown in the following steps: the oil red staining results show: compared with the blank group, the oil red-stained sebaceous glands of the single erlotinib intragastric group can obviously increase expanded follicles. Compared with the single erlotinib intragastric group, the numbers of the expanded follicles of the intragastric erlotinib and the rash removing formula intragastric group are obviously reduced, which shows that erlotinib can induce the thickening of the skin epidermis of the mouse and the aggregation of inflammatory cells, and the rash removing formula aqueous extract can prevent erlotinib from inducing the thickening of the skin epidermis of the mouse and the aggregation of inflammatory cells. We also counted the number of hair follicle expansions in the skin tissue of the mice, the number of hair follicle expansions in the model group mice was significantly increased compared with the normal group, and the rash-eliminating group could reduce this abnormal hair follicle expansion.
In addition, the weight change of the mice is also concerned, the mice are weighed every week during the administration period, the experimental result is shown in figure 4, the weight of the mice in the blank group is in a stable rising trend, and the weight of the mice in the single erlotinib group is obviously reduced in the administration process (P <0.01), which indicates that the toxic and side effect of the erlotinib is obvious; the weight of mice in the group with low dose and high dose of the water extract of the rash removing prescription and the erlotinib jointly gavage is reduced firstly and then slowly increased, the total body is kept stable and is increased to a certain extent, the high dose is obviously increased compared with the low dose, and the weight of the mice in the group with low dose and high dose of the water extract of the rash removing prescription and the erlotinib jointly gavage is remarkably different from that in the group with the simple erlotinib (P < 0.05); the weight of the mice in the common gavage group is reduced firstly, which shows that the erlotinib has toxic and side effects, and then slowly rises, which shows that the water extract of the rash removing formulation can condition the bodies of the mice after being taken for a long time, the toxic and side effects of the erlotinib are reduced, and the water extract of the rash removing formulation can improve the life quality of the mice to a certain extent.
Influence of rash-eliminating prescription on organ coefficient of mouse
After 49 days, the mice were sacrificed, liver and spleen tissues were separated, weighed, and organ coefficients were calculated. Calculating the formula: the organ coefficient (g/g) is the organ weight g/mouse weight g × l 00%.
The test data and results are shown in table 4, and the test results show that: compared with the blank group, the liver index and spleen index of the control group mouse are obviously increased (P <0.01), which indicates that the immune system of the mouse is seriously damaged, and the low-dosage and high-dosage group of the test drug Xiaorash removing prescription can restore the organ coefficient to a certain extent to be close to the level of the normal group mouse, which indicates that the Xiaorash removing prescription can have certain reversion and protection effects on the immune injury caused by erlotinib hydrochloride.
TABLE 4 viscera index comparison statistics of Erythrocin hydrochloride induced rash mice by Xiaoshafang
Note: comparison with blank group##Significant correlation at the 0.01 level; comparison with pure group**Significant correlation at the 0.01 level;*at 0.05
The water extract (abbreviated as "XZF", "Xiaozheng" or "Xiaozheng" in example 1) prevents the mechanism of skin toxicity caused by erlotinib
(1) Mechanism of action for reducing in vivo skin inflammation caused by EGFR inhibitors
Serum of each group of mice in previous animal experiments is collected and tested for cytokines (IL-10, IL-12A, IL-2, TNF-alpha, IL-6 and IFN-gamma), statistical results are shown in figure 5, according to the results, the expressions of IL-10, IL-12A, IL-2, TNF-alpha, IL-6 and IFN-gamma of the erlotinib group are obviously increased compared with the blank group, and the expression of the cytokines related to the inflammation is obviously reduced after the rash removing formula aqueous extract is administered, and the cytokines tend to the normal group. In addition, the influence of erlotinib modeling and the rash-eliminating prescription water extract on the expression of STAT3 on the skin of mice after administration is examined by an immunohistochemical method, and the results are shown in FIGS. 6 and 7, which show that compared with a blank group, erlotinib alone significantly up-regulates the expression of STAT 3; the administration of the aqueous extract of the rash-eliminating formulation can reduce the erlotinib-induced STAT3 up-regulation, and the quantitative graph further shows that erlotinib can up-regulate the expression of STAT3, and the rash-eliminating formulation can reduce the erlotinib-induced up-regulated expression of STATA 3.
(2) Reducing the effects of EGFR inhibitor induced skin damage
The MTT method is adopted for detection, the MTT result is shown in fig. 8, the result shows that the inhibition of erlotinib on HaCaT cells is increased along with the increase of the concentration of erlotinib, the erlotinib concentration is shown to have certain concentration dependence on the damage of HaCaT cells between 0.39 and 25.00 mu M, and the erlotinib concentration at the position of about 40 percent of the survival rate of HaCaT cells is selected to investigate the effect of HaCaT cell toxicity caused by erlotinib reversal of the water extract of the rash removing prescription (fig. 8A). The anti-rash agent has an inhibitory effect on HaCaT cells at a concentration of 2.0-16.0mg/mL, and an inhibitory effect is enhanced with the increase of anti-rash agent concentration, and the proliferation effect on the growth of HaCaT cells at a concentration of 0.125-1.0mg/mL (P <0.05, P < 0.01). Therefore, the administration concentrations of the rash removing formulation of 0.125, 0.25, 0.50 and 1.0mg/mL are selected to examine the HaCaT cytotoxicity effect caused by the reversal of erlotinib of the aqueous extract of the rash removing formulation. HaCaT cell survival rate of erlotinib and the rash-removing drug combination group rose within the concentration range of 0.125-1.0mg/mL, and only the water extract of the rash-removing drug was significantly different from that of the single erlotinib drug group at the concentration of 1.0mg/mL (P <0.05) (FIG. 8B). Therefore, the water extract of the rash removing formulation with the concentration of 1.0mg/mL is selected to inhibit the erlotinib from inducing the apoptosis of HaCaT cells. As shown in FIGS. 8C-D, HaCaT cells were treated for 24h in each of the administration groups, and HaCaT cell apoptosis and necrosis rates were significantly increased in the erlotinib-only group compared to the blank group, but apoptosis rates were not significantly changed in the eruption-eliminating and erlotinib-co-administration groups compared to the erlotinib-only group. By adopting an immunofluorescence staining experiment, a DNA damage marker 53BP1 is examined, and the result is shown in FIG. 8E, the expression of 53BP1 is increased in a model group, and the expression of the rash removing agent can be reduced, which shows that the EGFRI-caused skin damage is reduced to a certain extent.
Claims (7)
1. The traditional Chinese medicine composition for preventing and treating erlotinib skin toxicity is characterized by being prepared from the following components in parts by weight: 10-20 parts of honeysuckle, 10-15 parts of lithospermum, 10-25 parts of glabrous greenbrier rhizome, 10-15 parts of weeping forsythia, 10-20 parts of duckweed, 10-15 parts of common selfheal fruit-spike and 10-20 parts of tree peony bark.
2. The traditional Chinese medicine composition for preventing and treating erlotinib skin toxicity according to claim 1, which is characterized by being prepared from the following components in parts by weight: 15 parts of honeysuckle, 10 parts of lithospermum, 15 parts of glabrous greenbrier rhizome, 10 parts of weeping forsythia, 10 parts of duckweed, 10 parts of selfheal and 12 parts of tree peony bark.
3. The method for preparing a traditional Chinese medicine composition for preventing and treating erlotinib skin toxicity according to claim 1 or 2, characterized in that the preparation method comprises the steps of weighing each component according to the formula amount, adding 8-12 times of water, decocting for 1-2h, continuously extracting for 2-3 times, and combining the extracting solutions to obtain the erlotinib skin toxicity preventing and treating composition.
4. The traditional Chinese medicine composition for preventing and treating erlotinib skin toxicity according to claim 1 or 2, wherein the traditional Chinese medicine composition is granules, oral liquid or capsules.
5. The use of the traditional Chinese medicine composition for preventing and treating erlotinib skin toxicity according to claim 1 or 2 in the preparation of a medicament for preventing and treating EGFRi skin toxicity.
6. The use of claim 5, wherein said erlotinib dermal toxicity comprises papulopustular rash, abnormal hair regrowth, dry and itchy skin, periungual inflammation.
7. The use of claim 5, wherein the combination is administered in combination with erlotinib.
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| CN103656513A (en) * | 2013-12-13 | 2014-03-26 | 徐士魁 | Medicine for treating pityriasis rosea and preparation method thereof |
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