Pharmaceutical composition for treating bullous epidermis release type drug eruption and preparation method thereof

Abstract

The invention relates to a pharmaceutical composition for treating bullous epidermis release type drug eruption and a preparation method thereof, and belongs to the technical field of pharmaceutical compositions.The pharmaceutical composition is prepared from lithospermum erythrorhizon extract oil, sudangrass extract oil, radix ampelopsis powder and paris polyphylla powder; through external use, the traditional Chinese medicine composition has a remarkable curative effect on bullous epidermis release type drug eruption, can accelerate healing and repairing of wound surfaces, is not easy to scabs, can avoid secondary injury caused by re-uncovering after adhesion of scab skin and an erosive surface with a bed unit and a dressing, shortens the course of disease, improves the cure rate, is simple in preparation method and low in cost, and can relieve the economic burden of a patient.

Description

Technical Field

[0001] The invention belongs to the technical field of pharmaceutical compositions, and in particular relates to a pharmaceutical composition for treating epidermolysis bullosa drug eruption and a preparation method thereof. Background Art

[0002] Bullous epidermal necrolysis drug eruption, also known as toxic epidermal necrolysis (TEN), is the most severe type of drug eruption. It has an acute onset and is easily complicated by damage to various organs. The condition is severe and has a high mortality rate. At the beginning of the disease, it may resemble erythema multiforme, measles or scarlet fever drug eruption. Later, the skin lesions rapidly develop into diffuse purple-red or dark red and slightly iron-gray patches, and quickly spread throughout the body. In severe cases, it may involve ≥90% of the body surface area; loose blisters and epidermal necrolysis of varying sizes (Nikolsky sign) appear at the erythema, and erosions will form when slightly subjected to external force, with a large amount of exudation, like a scald-like appearance, resulting in hypoproteinemia, hypocalcemia, iron deficiency, secondary infection or heart failure, and even systemic organ damage. Failure leads to death. Therefore, in addition to drug treatment, skin dressing is crucial. The healing and repair of the wound surface can not only shorten the course of the disease and relieve the patient's pain, but also reduce the patient's economic burden. However, there is currently no clinically effective topical drug for dressing changes for bullous epidermolysis drug eruption. In addition to draining the blister fluid, most of them use recombinant human epidermal growth factor Kangfuxin solution and mupirocin ointment for dressing changes. The cost is expensive, the treatment effect is general, and there is also tearing and pain. In addition, the current clinical dressing method has the following problems: 1) The amount of medication used for large-scale application on the whole body is large, which increases the patient's economic burden. 2) The scabs and eroded surfaces formed by the rupture of the blisters adhere to the bed unit and dressings. Uncovering them again can easily cause pain to the patient, and will also cause secondary damage to the skin, increasing the risk of infection. 3) The efficiency of applying medication on a large area of ​​the body is low, there is a problem of uneven application, and the effect is not significant. Summary of the invention

[0003] In order to overcome the problems existing in the background technology, the present invention provides a therapeutic drug composition for bullous epidermolysis drug eruption. After being used by patients with bullous epidermal necrolysis drug eruption, the therapeutic effect is significant, the healing and repair of the wound surface can be accelerated, and it is not easy to form scabs. It can also avoid the secondary damage caused by the adhesion of the scab and eroded surface to the bed unit and the dressing and then being uncovered again, shortening the course of the disease and improving the cure rate. In addition, the present invention has low cost and can reduce the economic burden on patients.

[0004] To achieve the above object, the present invention is implemented through the following technical solutions: The therapeutic drug composition for bullous epidermolysis drug eruption comprises lithospermum officinale, atractylodes lancea, parsley, rhizoma rutaecarpa and pressed brassica rapa seed oil.

[0005] Furthermore, 40-60 parts of Lithospermum officinale, 20-40 parts of Atractylodes macrocephala, 10-30 parts of Paris polyphylla, and 1-5 parts of Herba Lysimachiae; the pressed Brassicae seed oil is secondary pressed Brassicae seed oil.

[0006] Furthermore, 50 g of Lithospermum officinale, 30 g of Atractylodes macrocephala, 20 g of Paris polyphylla, 3 g of Herba Rhizoma Cynoglossi, and 500 mL of secondary pressed Brassica rapa seed oil.

[0007] Furthermore, the lithospermum officinale is lithospermum officinale oil soaked in pressed Brassica oleracea seed oil; the rhizoma rehmanniae is rhizoma rehmanniae oil soaked in pressed Brassica oleracea seed oil; and the atractylodes macrocephala and parsley are in powder form.

[0008] The preparation method of the pharmaceutical composition for treating bullous epidermolysis drug eruption comprises the following steps: (1) Cut the lithospermum into small pieces and put them into a container, heat the secondary pressed brassica seed oil, and pour the heated secondary pressed brassica seed oil into the container containing the lithospermum for soaking; (2) filtering out the lithospermum officinale to obtain lithospermum officinale soaked oil; (3) Cut the Rendan grass into pieces and put them into a container, heat the secondary pressed Brassica oil, and pour the heated secondary pressed Brassica oil into the container containing the Rendan grass to soak; (4) filtering out the herbaceous ginseng obtained in step (3) to obtain herbaceous ginseng soaked oil; (5) mixing the lithospermum officinale oil obtained in step (2) and the rhizoma rutaecarpa oil obtained in step (4) in a volume ratio of 1:1; (6) Add Paris polyphylla powder and Bletilla striata powder to the mixed oil of step (5) and mix thoroughly to obtain a drug for treating epidermolysis bullosa drug eruption.

[0009] Furthermore, the secondary pressed canola oil in step (1) and step (3) is heated to 80-95°C.

[0010] Furthermore, the soaking time in step (2) and step (4) is greater than three days.

[0011] Furthermore, in step (2), the solid-liquid ratio of lithospermum officinale to the secondary pressed Brassica rapa seed oil is 1:3-7.5 g / mL, and the solid-liquid ratio of rhizoma rutinae to the secondary pressed Brassica rapa seed oil is 1:40-300 g / mL.

[0012] Beneficial effects of the present invention: The pharmaceutical composition of the present invention is used as an external medicine for bullous epidermolysis drug eruption, can effectively control the formation of flaccid blisters, promote the drying and astringency of erosive wounds, accelerate the healing and repair of wounds, and can avoid secondary damage caused by the adhesion of scabs and erosive surfaces to bed units and dressings and the subsequent removal, thereby shortening the course of the disease and improving the cure rate.

[0013] The pharmaceutical composition of the present invention has low cost and is easy to use, and can greatly reduce the economic burden on patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 It is a schematic diagram of the preparation method of the present invention; Figure 2 Comparison of bubble control time between the embodiment of the present invention and the comparative example; Figure 3 Comparison of wound drying time between the embodiment of the present invention and the comparative example; Figure 4 The desquamation time comparison between the embodiment of the present invention and the comparative example; Figure 5 Comparison of healing time between the embodiments of the present invention and the comparative examples; Figure 6 This is a demonstration of the therapeutic effect of Case 1 of Example 4 of the present invention; Figure 7 This is a demonstration of the therapeutic effect of Case 2 of Example 4 of the present invention; Figure 8 This is a demonstration of the therapeutic effect of Case 3 of Example 4 of the present invention. DETAILED DESCRIPTION

[0015] In order to make the purpose, technical solution and beneficial effects of the present invention clearer, the technical solution of the present invention will be described in detail below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, other embodiments obtained by those skilled in the art without creative work are all within the scope of protection of the present invention.

[0016] The pharmaceutical composition for treating bullous epidermolysis drug eruption of the present invention comprises 40-60 parts of lithospermum officinale, 20-40 parts of atractylodes lancea, 10-30 parts of parsley and 1-5 parts of rhizoma rutaecarpa. The lithospermum officinale is lithospermum officinale oil soaked in secondary pressed brassica oil, and the rhizoma rutaecarpa is rhizoma rutaecarpa oil soaked in secondary pressed brassica oil.

[0017] Brassica seeds are the seeds of Brassica campestris L., a cruciferous plant. They have the effects of promoting blood circulation, breaking qi, reducing swelling and dispersing nodules. The seeds contain 40-50% fat, 23% protein, palmitoleic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, arachidic acid, erucic acid, and brassi-casterol and 22-dehydrocampesterol. Some active ingredients in brassica seeds have anti-inflammatory and antibacterial effects, which can help the body resist the invasion of pathogens and reduce the risk of infection. The brassica seed oil after secondary pressing is relatively dark in color and has a strong aroma. While removing impurities, it can better retain some nutrients such as phospholipids, carotene and vitamin E.

[0018] In order to more clearly illustrate the present invention, it is described in detail through the following examples.

[0019] Example 1

[0020] A medicinal composition for treating bullous epidermolysis drug eruption is composed of the following raw materials: 40g of lithospermum officinale, 2g of rhubarb, 10g of parsley powder, 20g of ampelopsis pilosula powder, and 500mL of secondary pressed brassica seed oil.

[0021] Preparation method of therapeutic drug composition for epidermolysis bullosa drug eruption (1) Cut 40 g of lithospermum into small pieces and put them into a container. Heat 250 mL of secondary pressed Brassica oleifera seed oil to 90°C. Pour the heated secondary pressed Brassica oleifera seed oil into the container containing lithospermum and soak the oil. The soaking environment temperature is greater than 18°C.

[0022] (2) After soaking for 5 days, filter out the lithospermum and obtain lithospermum soaked oil.

[0023] (3) Cut 2 g of the herb into pieces and put it into a container. Heat 250 mL of secondary pressed Brassica rapa seed oil to 90°C. Pour the heated secondary pressed Brassica rapa seed oil into the container containing the herb and soak it in the soaking environment temperature greater than 18°C.

[0024] (4) After soaking for 5 days, filter out the rehmannia root and obtain the rehmannia root soaked oil.

[0025] (5) mixing the lithospermum officinale oil obtained in step (2) and the rhizoma rutaecarpa oil obtained in step (4) in a volume ratio of 1:1; (6) Add 10 g of Paris polyphylla powder and 20 g of Bletilla striata powder to the mixed oil of step (5) and mix thoroughly to obtain a drug for treating epidermolysis bullosa drug eruption.

[0026] Example 2

[0027] A medicinal composition for treating bullous epidermolysis drug eruption is composed of the following raw materials: 50g of lithospermum officinale, 3g of rhubarb, 20g of parsley powder, 30g of white peony root powder, and 500mL of secondary pressed brassica seed oil.

[0028] Preparation method of therapeutic drug composition for epidermolysis bullosa drug eruption (1) Cut 50 g of lithospermum into small pieces and put them into a container. Heat 250 mL of secondary pressed Brassica oleifera seed oil to 90°C. Pour the heated secondary pressed Brassica oleifera seed oil into the container containing lithospermum and soak the oil. The soaking environment temperature is greater than 18°C.

[0029] (2) After soaking for 5 days, filter out the lithospermum and obtain lithospermum soaked oil.

[0030] (3) Cut 3 g of the herb into pieces and put it into a container. Heat 250 mL of secondary pressed Brassica rapa seed oil to 90°C. Pour the heated secondary pressed Brassica rapa seed oil into the container containing the herb and soak it in an environment temperature greater than 18°C.

[0031] (4) After soaking for 5 days, filter out the rehmannia root and obtain the rehmannia root soaked oil.

[0032] (5) mixing the lithospermum officinale oil obtained in step (2) and the rhizoma rutaecarpa oil obtained in step (4) in a volume ratio of 1:1; (6) Add 20 g of Paris polyphylla powder and 30 g of Bletilla striata powder to the mixed oil of step (5) and mix thoroughly to obtain a drug for treating bullous epidermolysis drug eruption.

[0033] Example 3

[0034] A medicinal composition for treating bullous epidermolysis drug eruption is composed of the following raw materials: 60g of lithospermum officinale, 4g of rhubarb, 30g of parsley powder, 40g of white ampel powder, and 500mL of secondary pressed Brassica rapa seed oil.

[0035] Preparation method of therapeutic drug composition for epidermolysis bullosa drug eruption (1) Cut 60 g of lithospermum into small pieces and put them into a container. Heat 250 mL of secondary pressed Brassica oleifera seed oil to 90°C. Pour the heated secondary pressed Brassica oleifera seed oil into the container containing lithospermum and soak the oil. The soaking environment temperature is greater than 18°C.

[0036] (2) After soaking for 5 days, filter out the lithospermum and obtain lithospermum soaked oil.

[0037] (3) Cut 4 g of the herb into pieces and put it into a container. Heat 250 mL of secondary pressed Brassica rapa seed oil to 90°C. Pour the heated secondary pressed Brassica rapa seed oil into the container containing the herb and soak it in the soaking environment temperature greater than 18°C.

[0038] (4) After soaking for 5 days, filter out the rehmannia root and obtain the rehmannia root soaked oil.

[0039] (5) mixing the lithospermum officinale oil obtained in step (2) and the rhizoma rutaecarpa oil obtained in step (4) in a volume ratio of 1:1; (6) Add 30 g of Paris polyphylla powder and 40 g of Bletilla striata powder to the mixed oil of step (5) and mix thoroughly to obtain a drug for treating epidermolysis bullosa drug eruption.

[0040] The preparation method of the present invention uses secondary pressed brassica seed oil to soak lithospermum officinale or radix rutinae for the main purpose of leaching out the effective components in lithospermum officinale or radix rutinae. The secondary pressed brassica seed oil can be heated or kept at room temperature. When soaking at room temperature, the soaking time can be extended.

[0041] Comparative Example 1 A therapeutic drug for treating bullous epidermolysis drug eruption is composed of the following raw materials: 50 g of lithospermum officinale and 250 mL of secondary pressed brassica seed oil.

[0042] (1) Cut 50 g of lithospermum into small pieces and put them into a container. Heat 250 mL of secondary pressed Brassica oleifera seed oil to 90°C. Pour the heated secondary pressed Brassica oleifera seed oil into the container containing lithospermum and soak the oil. The soaking environment temperature is greater than 18°C.

[0043] (2) After soaking for 5 days, filter out the lithospermum and obtain the lithospermum soaked oil, which is the therapeutic medicine.

[0044] Comparative Example 2 A therapeutic drug for treating bullous epidermolysis drug eruption, comprising the following raw materials: 50 g of lithospermum officinale, 500 mL of secondary pressed brassica seed oil, and 3 g of rhubarb.

[0045] (1) Cut 50 g of lithospermum into small pieces and put them into a container. Heat 250 mL of secondary pressed Brassica oleifera seed oil to 90°C. Pour the heated secondary pressed Brassica oleifera seed oil into the container containing lithospermum and soak the oil. The soaking environment temperature is greater than 18°C.

[0046] (2) After soaking for 5 days, filter out the lithospermum and obtain lithospermum soaked oil.

[0047] (3) Cut 3 g of the herb into pieces and put it into a container. Heat 250 mL of secondary pressed Brassica rapa seed oil to 90°C. Pour the heated secondary pressed Brassica rapa seed oil into the container containing the herb and soak it in an environment temperature greater than 18°C.

[0048] (4) After soaking for 5 days, filter out the rehmannia root and obtain the rehmannia root soaked oil.

[0049] (5) The lithospermum infused oil of step (2) and the rhizoma rutaecarpa infused oil of step (4) are mixed in a volume ratio of 1:1 to obtain a therapeutic drug.

[0050] Comparative Example 3 A therapeutic drug for treating bullous epidermolysis drug eruption is composed of the following raw materials: 50 g of lithospermum officinale, 250 mL of secondary pressed brassica seed oil, and 20 g of Paris polyphylla powder.

[0051] (1) Cut 50 g of lithospermum into small pieces and put them into a container. Heat 250 mL of secondary pressed Brassica oleifera seed oil to 90°C. Pour the heated secondary pressed Brassica oleifera seed oil into the container containing lithospermum and soak the oil. The soaking environment temperature is greater than 18°C.

[0052] (2) After soaking for 5 days, filter out the lithospermum and obtain lithospermum soaked oil.

[0053] (3) Add 20 g of Paris polyphylla powder to the mixed oil of step (2) and mix thoroughly to obtain a therapeutic drug.

[0054] Comparative Example 4 A therapeutic drug for treating bullous epidermolysis drug eruption, comprising the following raw materials: 50 g of lithospermum officinale, 250 mL of secondary pressed brassica seed oil, and 30 g of ampelopsis pilosula powder.

[0055] (1) Cut 60 g of lithospermum into small pieces and put them into a container. Heat 250 mL of secondary pressed Brassica oleifera seed oil to 90°C. Pour the heated secondary pressed Brassica oleifera seed oil into the container containing lithospermum and soak the oil. The soaking environment temperature is greater than 18°C.

[0056] (2) After soaking for 5 days, filter out the lithospermum and obtain lithospermum soaked oil.

[0057] (3) Add 30 g of Bletilla striata powder to the mixed oil of step (2) and mix thoroughly to obtain a therapeutic drug.

[0058] Comparison of the effects of the therapeutic drugs obtained in the above examples and comparative examples The therapeutic drugs obtained in Examples 1-3 and Comparative Examples 1-4 were subjected to the following clinical experiments: 1. Test methods (1) Inclusion criteria: 1) Patients aged 20 to 52 years; 2) According to the "Chinese Clinical Dermatology" edited by Zhao Bian, the TEN diagnostic criteria are met: there is a clear history of medication before the onset of the disease, and after a certain incubation period, systemic erythema, blisters, and bullae appear, accompanied by epidermal exfoliation, positive Nikolsky sign, with or without mucosal damage.

[0059] 3) Agree to participate in this study and sign the informed consent form, and be able to take medication as prescribed by the doctor and attend follow-up visits on time.

[0060] (2) Exclusion criteria: 1) Patients with scar constitution; 2) Allergic to comfrey oil; 3) Pregnant or lactating women; 4) Mental illness.

[0061] (3) Treatment methods From January 2021 to October 2024, 160 TEN patients admitted to the Department of Rheumatology and Immunology of Yunnan Provincial First People's Hospital were randomly divided into Example groups 1-3, comparative example groups 1-4, and a positive control group using a random number table method, with 20 cases in each group (there was no statistically significant difference in general data among the groups).

[0062] For Example 1-3 and Comparative Example 1-4, the wound secretions were first rinsed with physiological saline, and then the drug composition was soaked with medical absorbent gauze and applied to the affected area, each time for 30 minutes, twice a day.

[0063] Positive control group: First, the wound secretions were washed with normal saline, and then Kangfuxin solution was sprayed on the skin surface. After 20 minutes, mupirocin ointment was covered on the ulcerated area. After 30 minutes, recombinant human epidermal growth factor was applied again, twice a day.

[0064] (II) Evaluation indicators and determination methods Table 1 Inspection indicators and determination methods

[0065] (III) Investigation results (1) Comparison of blister control time After the medication, the blister control was observed, and the comparison results of different groups were obtained as shown in Table 2 and Figure 2 SPSS26.0 software was used for statistical analysis, and the time points of blister control in the samples were recorded. ANOVA was performed on the time points of blister control in each sample. P < 0.05 was considered statistically significant.

[0066] Table 2 Comparison of blister control time in different groups

[0067] There were significant differences in blister control time among different groups (p<0.05). Further pairwise comparison results (Table 3) showed that the blister control time of Example 1 and Example 3 was lower than that of Comparative Example 1, Comparative Example 2, and Comparative Example 3 (p<0.05); the blister control time of Example 2 was lower than that of Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4, and the positive control group (p<0.05).

[0068] From the above results, it can be seen that the blister control time of patients in Example 1-3 groups, Comparative Example 1-4 groups, and the positive control group is compared: the blister control time of the Example group is shorter than that of the Comparative Example and the positive control group, and the difference is statistically significant (p<0.05). The above results show that the pharmaceutical composition for treating bullous epidermolysis drug eruption prepared in this application can effectively control the formation of blisters and effectively promote the absorption of blisters.

[0069] Table 3 Post hoc multiple comparison results of blister control time in different groups

[0070] (2) Comparison of wound drying time After the medication was applied, the dryness of the wound surface was observed (the time it took for the erosive wound surface to go from moist to dry). The results are shown in Table 4 and Figure 3 SPSS 26.0 software was used for statistical analysis. The time points of wound drying of the samples were recorded, and variance analysis was performed on the time points of wound drying of each sample. P < 0.05 was considered statistically significant.

[0071] Table 4 Comparison of wound drying time in different groups

[0072] There was a statistically significant difference in wound drying time between the different groups (p < 0.05). Further pairwise comparisons showed that (Table 5 and Figure 3 ): The wound drying time of Example 1 and Example 2 groups was lower than that of Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group and the positive control group (p<0.05); The wound drying time of Example 3 group was lower than that of Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group and Comparative Example 4 group (p<0.05).

[0073] From the above results, it can be seen that the wound drying time of patients in Example 1-3 groups, Comparative Example 1-4 groups and the positive control group is compared: the wound drying time of the Example group is shorter than that of the Comparative Example and the positive control group, and the difference is statistically significant (P<0.05).

[0074] The above results show that the pharmaceutical composition for treating bullous epidermolysis drug eruption prepared by the present invention can shorten the time it takes for the eroded wound surface to shrink from wet to dry.

[0075] Table 5 Post hoc multiple comparison results of wound drying time in different groups

[0076] (3) Comparison of desquamation time After medication, skin desquamation was observed (Table 6 and Figure 4SPSS 26.0 software was used for statistical analysis, and the time points of sample desquamation were recorded. Variance analysis was performed on the time points of desquamation. P < 0.05 was considered statistically significant.

[0077] Table 6 Comparison of desquamation time in different groups

[0078] There were significant differences in desquamation time among different groups (p<0.05). Further pairwise comparison results (Table 7) showed that the desquamation time of Example 1, Example 2 and Example 3 were lower than that of Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4 and the positive control group (p<0.05).

[0079] From the above results, it can be seen that the desquamation time of the wound surface of patients in Example 1-3 groups, Comparative Example 1-4 groups and the positive control group is compared: the desquamation time of the Example group is shorter than that of the Comparative Example and the positive control group, and the difference is statistically significant (P<0.05).

[0080] The above results show that the pharmaceutical composition for treating bullous epidermolysis drug eruption prepared in the present application can accelerate the desquamation time of the rash and promote wound healing.

[0081] Table 7 Post hoc multiple comparison results of desquamation time in different groups

[0082] (4) Comparison of skin healing time After medication, the skin healing condition was observed and the time point of skin healing of the samples was recorded (Table 8 and Figure 5 SPSS 26.0 software was used for statistical analysis, and variance analysis was performed on the time points of each healing. P < 0.05 was considered statistically significant.

[0083] Table 8 Comparison of healing time in different groups

[0084] There were significant differences in healing time among different groups (p<0.05). Further pairwise comparison results (Table 9) showed that the healing time of Example 1 and Example 2 were shorter than those of Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4 and the positive control group (p<0.05); the healing time of Example 3 was shorter than that of Comparative Example 1, Comparative Example 2, Comparative Example 3 and Comparative Example 4 (p<0.05).

[0085] From the above results, it can be seen that the skin healing time of patients in Example 1-3 groups, Comparative Example 1-4 groups, and the positive control group is compared: the skin healing time of the Example group is shorter than that of the Comparative Example and the positive control group, and the difference is statistically significant (P<0.05).

[0086] The above results show that the pharmaceutical composition for treating epidermolysis bullosa drug eruption prepared in the present application can shorten the healing time.

[0087] Table 9 Post hoc multiple comparison results of healing time in different groups

[0088] The results show that the effect of the pharmaceutical composition of the present invention in the treatment of bullous epidermolysis necrotizing drug eruption is significantly higher in the embodiment group than in the comparison group and the positive control group, indicating that wound dressing change through the present invention can effectively promote the repair of bullous epidermolysis necrotizing drug eruption, as well as wound contraction and epithelial regeneration to achieve healing, which can shorten the patient's wound recovery time to a certain extent and promote the patient's wound to recover at a faster rate.

[0089] Note: The numerical units in Tables 2 to 9 are all "days".

[0090] Example 4 The following cases used the medicinal composition of Example 2. Medical absorbent gauze was soaked in the medicinal composition and then covered on the skin, twice a day, each application lasting 30 minutes.

[0091] Case 1: The patient is a male, Mr. Li, 44 years old. He had itching on the back and waist with scattered red rashes 10 days ago. He did not treat it. Later, the rash gradually spread to the trunk, face, and limbs. The rash was distributed in flakes, red, and could not be relieved by pressure. The itching was obvious. Later, loose blisters and epidermolysis appeared. After the dressing treatment of the present invention, twice a day, each time for 30 minutes, the rash disappeared after half a month (see the attached data for the use Figure 6 ).

[0092] Case 2: The patient was a 33-year-old female patient named Zhang. She developed a rash all over her body without obvious causes, accompanied by itching. Later, the skin lesions rapidly developed into diffuse purple-red or dark red and slightly iron-gray patches, and quickly spread to the whole body. Flaccid blisters of varying sizes and epidermolysis appeared. The erosion surface formed with a large amount of exudation, like a scald-like appearance. After the dressing treatment of the present invention, twice a day, each time for 30 minutes, the rash subsided after one month ( Figure 7 ).

[0093] Case 3: The patient is a female, Liu, 31 years old. She was admitted to the hospital for fever and rash for 13 days. The highest temperature reached 39.3℃. She had rash all over her body when she had fever. Two days ago, the red rash on her body progressed to large-scale ulceration, blisters and peeling. Glove-like and sock-like peeling appeared on her limbs. After the dressing treatment of the present invention, twice a day, 30 minutes each time, the ulcer gradually healed after half a month ( Figure 8 ).

[0094] Finally, it should be noted that the above preferred embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Although the present invention has been described in detail through the above preferred embodiments, those skilled in the art should understand that various changes can be made in form and details without departing from the scope defined by the claims of the present invention.

Claims

1. A pharmaceutical composition for treating epidermolysis bullosa drug eruption, characterized in that: Including Lithospermum officinale, Atractylodes macrocephala, Paris polyphylla, Herba Lycopodii and pressed Brassica juncea seed oil.

2. The pharmaceutical composition for treating epidermolysis bullosa drug eruption according to claim 1, characterized in that: 40-60 parts of Lithospermum officinale, 20-40 parts of Atractylodes macrocephala, 10-30 parts of Paris polyphylla and 1-5 parts of Herba Lysimachiae; the pressed Brassicae seed oil is secondary pressed Brassicae seed oil.

3. The pharmaceutical composition for treating epidermolysis bullosa drug eruption according to claim 1, characterized in that: 50g of Lithospermum officinale, 30g of Atractylodes macrocephala, 20g of Paris polyphylla, and 3g of Herba Rhizoma Cynoglossi.

4. The pharmaceutical composition for treating epidermolysis bullosa drug eruption according to any one of claims 1 to 3, characterized in that: The lithospermum officinale is lithospermum officinale oil soaked in pressed Brassica oleracea seed oil; the rhizoma rehmanniae is rhizoma rehmanniae oil soaked in pressed Brassica oleracea seed oil; and the atractylodes lancea and parsley are in powder form.

5. The method for preparing the pharmaceutical composition according to any one of claims 1 to 4, characterized in that: The following steps are involved: (1) Cut the lithospermum into small pieces and put them into a container, heat the secondary pressed brassica seed oil, and pour the heated secondary pressed brassica seed oil into the container containing the lithospermum for soaking; (2) filtering out the lithospermum officinale to obtain lithospermum officinale soaked oil; (3) Cut the Rendan grass into pieces and put them into a container, heat the secondary pressed Brassica oil, and pour the heated secondary pressed Brassica oil into the container containing the Rendan grass to soak; (4) filtering out the herbaceous ginseng obtained in step (3) to obtain herbaceous ginseng soaked oil; (5) mixing the lithospermum officinale oil obtained in step (2) and the rhizoma rutaecarpa oil obtained in step (4) in a volume ratio of 1:1; (6) Add Paris polyphylla powder and Bletilla striata powder to the mixed oil of step (5) and mix thoroughly to obtain a pharmaceutical composition for treating epidermolysis bullosa drug eruption.

6. The preparation method according to claim 5, characterized in that: The secondary pressed canola oil in step (1) and step (3) is heated to 80-95°C.

7. The preparation method according to claim 5, characterized in that: The soaking time in step (2) and step (4) is greater than three days.

8. The preparation method according to claim 5, characterized in that: The solid-liquid ratio of lithospermum officinale to the secondary pressed brassica seed oil in step (2) is 1:3-7.5 g / mL, and the solid-liquid ratio of rhizoma rutinae to the secondary pressed brassica seed oil is 1:40-300 g / mL.

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