Therapeutic pharmaceutical composition for bullous epidermal necrolysis and its preparation method
Through the pharmaceutical composition composed of cypress, cypress, chrysanthemum, rendanthemum and secondary pressed brassica oil, the problem of insignificant effect and poor wound healing in the treatment of bullous epidermal atrophy was solved, and significant therapeutic effects and economic costs were achieved.
Patent Information
- Application Number
- CN202510266635.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2025-03-07
- Publication Date
- 2025-06-10
- Estimated Expiration
- 2045-03-07
AI Technical Summary
The existing topical drugs for treating epidermal abscess bullae are not effective, and there are problems such as blister rupture, scab adhesion, and poor wound healing during the treatment process, which increases the pain and financial burden of the patients.
The pharmaceutical composition composed of cypress, cypress, cypress, cypress, cypress and secondary pressed brassica oil is prepared by soaking and mixing as a therapeutic drug for bullous epidermal loosening type drug rash.
This pharmaceutical composition can effectively control the formation of relaxed blisters, promote the drying and astringent of eroded wounds, accelerate the healing and repair of wounds, avoid re-damage of scab adhesions, shorten the course of the disease, improve the cure rate, and reduce the economic burden on patients.
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Figure CN119770576B_ABST
Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of pharmaceutical compositions. Specifically, it relates to a therapeutic pharmaceutical composition for bullous epidermal necrolysis 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, is prone to combined organ damage, has a critical condition, and a high fatality rate. At the beginning of the disease, it can resemble erythema multiforme, measles-like or scarlet fever-like drug eruption. Subsequently, the skin lesions rapidly develop into diffuse purplish-red or dark red and slightly iron-gray patches, and quickly spread throughout the body. In severe cases, it can involve ≥90% of the body surface area. Relaxed blisters and epidermal detachment of varying sizes (positive Nikolsky sign) appear on the erythema. With a little external force, erosion surfaces are formed, with a large amount of exudation, presenting a scald-like appearance, thus causing hypoproteinemia, hypocalcemia, iron deficiency, secondary infection or heart failure, and even systemic organ failure leading to death. Therefore, in addition to drug treatment, skin dressing change is crucial. The healing and repair of the wound surface can not only shorten the course of the disease, relieve the pain of patients, but also reduce the economic burden on patients. However, at present, there is no topically applied drug with significant clinical effect for dressing change of bullous epidermal necrolysis drug eruption. Except for draining blister fluid, mostly recombinant human epidermal growth factor Kangfuxin solution and mupirocin ointment are used for dressing change and rubbing. The cost is expensive, the treatment effect is average, and there are also problems such as avulsion and pain. Moreover, the current dressing change methods used clinically have the following problems: 1) The large amount of drug used for whole-body large-area rubbing increases the economic burden on patients. 2) The scabs and erosion surfaces formed by the rupture of blisters adhere to the bed unit and dressings. Uncovering them again is likely to cause pain to patients and will also cause secondary damage to the skin, increasing the risk of infection. 3) The efficiency of whole-body large-area rubbing and applying the drug 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 art, the present invention provides a therapeutic pharmaceutical composition for bullous epidermal necrolysis drug eruption. After being used by patients with bullous epidermal necrolysis drug eruption, it has a significant curative effect, can accelerate the healing and repair of the wound surface, is not easy to form scabs, can avoid secondary damage caused by the adhesion of scabs and erosion surfaces to the bed unit and dressings and uncovering them again, shortens the course of the disease, and improves the cure rate. In addition, the present invention has a low cost and can reduce the economic burden on patients.
[0004] To achieve the above object, the present invention is realized by the following technical solutions:
[0005] The therapeutic pharmaceutical composition for bullous epidermal necrolysis drug eruption described above includes lithospermum root, ampelopsis japonica, paris polyphylla, herba leonuri, and rapeseed oil.
[0006] Furthermore, there are 40 - 60 parts of lithospermum, 20 - 40 parts of ampelopsis japonica, 10 - 30 parts of paris vietnamensis, and 1 - 5 parts of herba leonuri; the pressed rapeseed oil is secondary pressed rapeseed oil.
[0007] Furthermore, there are 50 g of lithospermum, 30 g of ampelopsis japonica, 20 g of paris vietnamensis, 3 g of herba leonuri, and 500 mL of secondary pressed rapeseed oil.
[0008] Furthermore, the lithospermum is lithospermum soaking oil soaked with pressed rapeseed oil; the herba leonuri is herba leonuri soaking oil soaked with pressed rapeseed oil; the ampelopsis japonica and paris vietnamensis are in powder form.
[0009] The preparation method of the therapeutic drug composition for bullous epidermal necrolysis includes the following steps:
[0010] (1) Cut the lithospermum into small sections and put them into a container, heat the secondary pressed rapeseed oil, and pour the heated secondary pressed rapeseed oil into the container containing the lithospermum for soaking.
[0011] (2) Filter out the lithospermum to obtain lithospermum soaking oil.
[0012] (3) Cut the herba leonuri into pieces and put them into a container, heat the secondary pressed rapeseed oil, and pour the heated secondary pressed rapeseed oil into the container containing the herba leonuri for soaking.
[0013] (4) Filter out the herba leonuri in step (3) to obtain herba leonuri soaking oil.
[0014] (5) Mix the lithospermum soaking oil in step (2) and the herba leonuri soaking oil in step (4) at a volume ratio of 1:1.
[0015] (6) Add the paris vietnamensis powder and ampelopsis japonica powder to the mixed oil in step (5) and mix well to obtain the therapeutic drug for bullous epidermal necrolysis.
[0016] Furthermore, the secondary pressed rapeseed oil in step (1) and step (3) is heated to 80 - 95 °C.
[0017] Furthermore, the soaking time in step (2) and step (4) is more than three days.
[0018] Furthermore, the solid - liquid ratio of the lithospermum to the secondary pressed rapeseed oil in step (1) is 1:3 - 7.5 g / mL, and the solid - liquid ratio of the herba leonuri to the secondary pressed rapeseed oil in step (3) is 1:40 - 300 g / mL.
[0019] The beneficial effects of the present invention:
[0020] The pharmaceutical composition of the present invention is used as an external medicine for bullous epidermal necrolysis drug eruption, which can effectively control the formation of flaccid blisters, promote the drying and convergence of erosive wounds, accelerate the healing and repair of wounds, and can avoid secondary injuries caused by the adhesion and re-uncovering of scabs and erosive surfaces with the bed unit and dressings, shorten the course of disease, and improve the cure rate.
[0021] The pharmaceutical composition of the present invention has a low cost and is convenient to use, which can greatly reduce the economic burden of patients. BRIEF DESCRIPTION OF THE DRAWINGS
[0022] Figure 1 It is a schematic diagram of the preparation method of the present invention;
[0023] Figure 2 It is a comparison of blister control time between the examples and comparative examples of the present invention;
[0024] Figure 3 It is a comparison of wound drying time between the examples and comparative examples of the present invention;
[0025] Figure 4 It is a comparison of desquamation time between the examples and comparative examples of the present invention;
[0026] Figure 5 It is a comparison of healing time between the examples and comparative examples of the present invention;
[0027] Figure 6 It shows the treatment effect of Case 1 of Example 4 of the present invention;
[0028] Figure 7 It shows the treatment effect of Case 2 of Example 4 of the present invention;
[0029] Figure 8 It shows the treatment effect of Case 3 of Example 4 of the present invention. DETAILED DESCRIPTION OF THE INVENTION
[0030] In order to make the objectives, technical solutions and beneficial effects of the present invention clearer, the technical solutions of the present invention will be described in detail below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, other embodiments obtained by those skilled in the art without making creative efforts all fall within the scope of protection of the present invention.
[0031] The therapeutic pharmaceutical composition for bullous epidermal necrolysis drug eruption of the present invention comprises 40 - 60 parts of lithospermum, 20 - 40 parts of ampelopsis japonica, 10 - 30 parts of paris polyphylla, and 1 - 5 parts of herba agastaches. Among them, the lithospermum is lithospermum soaking oil soaked in secondary-pressed rapeseed oil, and the herba agastaches is herba agastaches soaking oil soaked in secondary-pressed rapeseed oil.
[0032] Rape seeds are the seeds of Brassica campestris L., a cruciferous plant, and have the effects of promoting blood circulation, breaking qi, reducing swelling, and dissipating nodules. The seeds contain 40-50% fat and 23% protein, including palmitoleic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, arachidic acid, erucic acid, and also contain brassicasterol and 22-dehydrocampesterol, etc. Some active ingredients contained in rape seeds have anti-inflammatory and antibacterial effects, which can help the body resist the invasion of pathogens and reduce the risk of infection. The rape seed oil obtained by secondary pressing has a relatively dark color and a strong fragrance. While removing impurities, it can better retain some nutritional components such as phospholipids, carotenoids, and vitamin E.
[0033] To illustrate the present invention more clearly, the following examples are provided for detailed description.
[0034] Example 1
[0035] A therapeutic drug composition for bullous epidermal necrolysis is composed of the following raw materials: 40 g of lithospermum, 2 g of rendan grass, 10 g of paris polyphylla powder, 20 g of ampelopsis japonica powder, and 500 mL of secondary-pressed rape seed oil.
[0036] Preparation method of the therapeutic drug composition for bullous epidermal necrolysis
[0037] (1) Cut 40 g of lithospermum into small sections and put them into a container. Heat 250 mL of secondary-pressed rape seed oil to 90 °C, and pour the heated secondary-pressed rape seed oil into the container containing lithospermum for soaking, with the soaking environment temperature being greater than 18 °C.
[0038] (2) After soaking for 5 days, filter out the lithospermum to obtain lithospermum soaking oil.
[0039] (3) Cut 2 g of rendan grass into pieces and put them into a container. Heat 250 mL of secondary-pressed rape seed oil to 90 °C, and pour the heated secondary-pressed rape seed oil into the container containing rendan grass for soaking, with the soaking environment temperature being greater than 18 °C.
[0040] (4) After soaking for 5 days, filter out the rendan grass to obtain rendan grass soaking oil.
[0041] (5) Mix the lithospermum soaking oil in step (2) and the rendan grass soaking oil in step (4) at a volume ratio of 1:1;
[0042] (6) Add 10 g of Paris polyphylla powder and 20 g of Ampelopsis japonica powder to the mixed oil in step (5) and mix well to obtain the therapeutic drug for bullous epidermal necrolysis drug eruption.
[0043] Example 2
[0044] A therapeutic drug composition for bullous epidermal necrolysis drug eruption, which is composed of the following raw materials: 50 g of Lithospermum erythrorhizon, 3 g of Herba Ecliptae, 20 g of Paris polyphylla powder, 30 g of Ampelopsis japonica powder, and 500 mL of second-pressed rapeseed oil.
[0045] Preparation method of therapeutic drug composition for bullous epidermal necrolysis drug eruption
[0046] (1) Cut 50 g of Lithospermum erythrorhizon into small sections and put them into a container. Heat 250 mL of second-pressed rapeseed oil to 90 °C, and pour the heated second-pressed rapeseed oil into the container containing Lithospermum erythrorhizon for soaking, and the soaking environment temperature is greater than 18 °C.
[0047] (2) After soaking for 5 days, filter out Lithospermum erythrorhizon to obtain Lithospermum erythrorhizon soaking oil.
[0048] (3) Cut 3 g of Herba Ecliptae into pieces and put them into a container. Heat 250 mL of second-pressed rapeseed oil to 90 °C, and pour the heated second-pressed rapeseed oil into the container containing Herba Ecliptae for soaking, and the soaking environment temperature is greater than 18 °C.
[0049] (4) After soaking for 5 days, filter out Herba Ecliptae to obtain Herba Ecliptae soaking oil.
[0050] (5) Mix the Lithospermum erythrorhizon soaking oil in step (2) and the Herba Ecliptae soaking oil in step (4) in a volume ratio of 1:1;
[0051] (6) Add 20 g of Paris polyphylla powder and 30 g of Ampelopsis japonica powder to the mixed oil in step (5) and mix well to obtain the therapeutic drug for bullous epidermal necrolysis drug eruption.
[0052] Example 3
[0053] A therapeutic drug composition for bullous epidermal necrolysis drug eruption, which is composed of the following raw materials: 60 g of Lithospermum erythrorhizon, 4 g of Herba Ecliptae, 30 g of Paris polyphylla powder, 40 g of Ampelopsis japonica powder, and 500 mL of second-pressed rapeseed oil.
[0054] Preparation method of therapeutic drug composition for bullous epidermal necrolysis drug eruption
[0055] (1) Cut 60 g of Lithospermum erythrorhizon into small sections and put them into a container. Heat 250 mL of second-pressed rapeseed oil to 90 °C, and pour the heated second-pressed rapeseed oil into the container containing Lithospermum erythrorhizon for soaking, and the soaking environment temperature is greater than 18 °C.
[0056] (2) After soaking for 5 days, filter out Lithospermum erythrorhizon to obtain Lithospermum erythrorhizon soaking oil.
[0057] (3) Cut 4 g of Jindancao into pieces and put them into a container. Heat 250 mL of second-stage pressed rapeseed oil to 90 °C, pour the heated second-stage pressed rapeseed oil into the container containing Jindancao for soaking, and the soaking environment temperature is greater than 18 °C.
[0058] (4) After soaking for 5 days, filter out Jindancao to obtain Jindancao soaking oil.
[0059] (5) Mix the lithospermum erythrorhizon soaking oil in step (2) and the Jindancao soaking oil in step (4) in a volume ratio of 1:1;
[0060] (6) Add 30 g of Paris polyphylla powder and 40 g of Ampelopsis japonica powder to the mixed oil in step (5) and mix well to obtain a therapeutic drug for bullous epidermal necrolysis.
[0061] The preparation method of the present invention, the main purpose of soaking lithospermum erythrorhizon or Jindancao with second-stage pressed rapeseed oil is to leach out the active ingredients in lithospermum erythrorhizon or Jindancao. The second-stage pressed rapeseed oil can be heated or at room temperature. When soaking at room temperature, just extend the soaking time.
[0062] Comparative Example 1
[0063] A therapeutic drug for bullous epidermal necrolysis is composed of the following raw materials: 50 g of lithospermum erythrorhizon and 250 mL of second-stage pressed rapeseed oil.
[0064] (1) Cut 50 g of lithospermum erythrorhizon into small sections and put them into a container. Heat 250 mL of second-stage pressed rapeseed oil to 90 °C, pour the heated second-stage pressed rapeseed oil into the container containing lithospermum erythrorhizon for soaking, and the soaking environment temperature is greater than 18 °C.
[0065] (2) After soaking for 5 days, filter out lithospermum erythrorhizon to obtain lithospermum erythrorhizon soaking oil, which is the therapeutic drug.
[0066] Comparative Example 2
[0067] A therapeutic drug for bullous epidermal necrolysis is composed of the following raw materials: 50 g of lithospermum erythrorhizon, 500 mL of second-stage pressed rapeseed oil, and 3 g of Jindancao.
[0068] (1) Cut 50 g of lithospermum erythrorhizon into small sections and put them into a container. Heat 250 mL of second-stage pressed rapeseed oil to 90 °C, pour the heated second-stage pressed rapeseed oil into the container containing lithospermum erythrorhizon for soaking, and the soaking environment temperature is greater than 18 °C.
[0069] (2) After soaking for 5 days, filter out lithospermum erythrorhizon to obtain lithospermum erythrorhizon soaking oil.
[0070] (3) Cut 3 g of Jindancao into pieces and put them into a container. Heat 250 mL of second-pressed rapeseed oil to 90 °C, pour the heated second-pressed rapeseed oil into the container containing Jindancao for soaking, and the soaking environment temperature is greater than 18 °C.
[0071] (4) After soaking for 5 days, filter out Jindancao to obtain Jindancao soaking oil.
[0072] (5) Mix the lithospermum root soaking oil in step (2) and the Jindancao soaking oil in step (4) in a volume ratio of 1:1 to obtain a therapeutic drug.
[0073] Comparative Example 3
[0074] A therapeutic drug for treating bullous epidermal necrolysis-type drug eruption, which is composed of the following raw materials: 50 g of lithospermum root, 250 mL of second-pressed rapeseed oil, and 20 g of Paris polyphylla powder.
[0075] (1) Cut 50 g of lithospermum root into small sections and put them into a container. Heat 250 mL of second-pressed rapeseed oil to 90 °C, pour the heated second-pressed rapeseed oil into the container containing lithospermum root for soaking, and the soaking environment temperature is greater than 18 °C.
[0076] (2) After soaking for 5 days, filter out lithospermum root to obtain lithospermum root soaking oil.
[0077] (3) Add 20 g of Paris polyphylla powder to the mixed oil in step (2) and mix well to obtain a therapeutic drug.
[0078] Comparative Example 4
[0079] A therapeutic drug for treating bullous epidermal necrolysis-type drug eruption, which is composed of the following raw materials: 50 g of lithospermum root, 250 mL of second-pressed rapeseed oil, and 30 g of Ampelopsis japonica powder.
[0080] (1) Cut 60 g of lithospermum root into small sections and put them into a container. Heat 250 mL of second-pressed rapeseed oil to 90 °C, pour the heated second-pressed rapeseed oil into the container containing lithospermum root for soaking, and the soaking environment temperature is greater than 18 °C.
[0081] (2) After soaking for 5 days, filter out lithospermum root to obtain lithospermum root soaking oil.
[0082] (3) Add 30 g of Ampelopsis japonica powder to the mixed oil in step (2) and mix well to obtain a therapeutic drug.
[0083] Effect comparison of the therapeutic drugs obtained in the above examples and comparative examples
[0084] Conduct the following clinical experiments on the therapeutic drugs obtained in Examples 1-3 and Comparative Examples 1-4:
[0085] (I) Test method
[0086] (1) Inclusion criteria:
[0087] 1) Patients aged 20 to 52 years old;
[0088] 2) Referring to "Chinese Clinical Dermatology" edited by Zhao Bian, meeting the diagnosis criteria of TEN: having a clear medication history before the onset, after a certain incubation period, presenting with systemic erythema, blisters, large blisters, accompanied by epidermal exfoliation, positive Nikolsky sign, with or without mucosal damage.
[0089] 3) Agree to participate in this study and sign the informed consent form, and can follow the doctor's advice on medication and return for follow-up visits on time.
[0090] (2) Exclusion criteria:
[0091] 1) Patients with scarring diathesis; 2) Allergic to the components of Zicao oil; 3) In pregnancy or lactation; 4) Having mental illness.
[0092] (3) Treatment methods
[0093] From January 2021 to October 2024, 160 TEN patients admitted to the Department of Rheumatology and Immunology of the First People's Hospital of Yunnan Province were randomly selected, including 76 males and 84 females, aged 20 - 52 years old. They were divided into Example 1 - 3 groups, Comparative Example 1 - 4 groups, and Positive Control Group by the random number table method, with 20 cases in each group (the differences in general data among the groups were not statistically significant).
[0094] For Example 1 - 3 groups and Comparative Example 1 - 4 groups: First, rinse the wound secretions with normal saline, then soak the medical absorbent gauze with the pharmaceutical composition and apply it to the affected area for 30 minutes each time, twice a day.
[0095] Positive Control Group: First, rinse the secretions at the wound breakage with normal saline, then spray the Kangfuxin solution on the skin surface. After 20 minutes, cover the breakage with mupirocin ointment, and after 30 minutes, apply recombinant human epidermal growth factor again for rubbing, twice a day.
[0096] (2) Observation indexes and judgment methods
[0097] Table 1 Observation indexes and judgment methods
[0098]
[0099] (3) Observation results
[0100] (1) Comparison of blister control time
[0101] After medication, observe the blister control situation, and the comparison results of different groups are shown in Table 2 and Figure 2Statistical analysis was performed using SPSS 26.0 software. The time points of blister control in the samples were recorded, and an analysis of variance was conducted on the time points of blister control for each group. A P < 0.05 was considered statistically significant.
[0102] Table 2 Comparison of blister control time among different groups
[0103]
[0104] There was a statistically significant difference in the blister control time among different groups (p < 0.05). Further pairwise comparison results (Table 3) showed that the blister control time in the Example 1 group and the Example 3 group was lower than that in the Comparative Example 1 group, the Comparative Example 2 group, and the Comparative Example 3 group (p < 0.05); the blister control time in the Example 2 group was lower than that in the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group, the Comparative Example 4 group, and the Positive Control group (p < 0.05).
[0105] From the above results, it can be seen that when comparing the blister control time of the patients in the Example 1 - 3 groups, the Comparative Example 1 - 4 groups, and the Positive Control group: the blister control time in the Example groups was shorter than that in the Comparative Example groups and the Positive Control group, with a statistically significant difference (p < 0.05). The above results indicate that the therapeutic drug composition for bullous epidermal necrolysis prepared in this application can effectively control the formation of blisters and can effectively promote the absorption of blisters.
[0106] Table 3 Results of post - hoc multiple comparisons of blister control time among different groups
[0107]
[0108] (2) Investigation and comparison of wound drying time
[0109] After administration, the wound drying condition (the time from a moist erosive wound to dry and convergent) was observed. The results are shown in Table 4 and Figure 3 , and statistical analysis was performed using SPSS 26.0 software. The time points of wound drying in the samples were recorded, and an analysis of variance was conducted on the time points of wound drying for each group. A P < 0.05 was considered statistically significant. A P < 0.05 was considered statistically significant.
[0110] Table 4 Comparison of wound drying time among different groups
[0111]
[0112] There was a statistically significant difference in the wound drying time among different groups (p < 0.05). Further pairwise comparison results showed (Table 5 and Figure 3): The wound surface drying time of the Example 1 group and the Example 2 group was lower than that of the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group, the Comparative Example 4 group, and the Positive Control Group (p < 0.05); the wound surface drying time of the Example 3 group was lower than that of the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group, and the Comparative Example 4 group (p < 0.05).
[0113] From the above results, it can be seen that for the comparison of the wound surface drying time of the patients in the Example 1-3 groups, the Comparative Example 1-4 groups, and the Positive Control Group: the wound surface drying time of the Example groups was shorter than that of the Comparative Example and Positive Control Groups, and the difference was statistically significant (P < 0.05).
[0114] The above results indicate that the therapeutic drug composition for bullous epidermal necrolysis prepared by the present invention can shorten the time for the erosive wound surface to converge from wet to dry.
[0115] Table 5 Post hoc multiple comparison results of wound surface drying time in different groups
[0116]
[0117] (3)Investigation and comparison of desquamation time
[0118] After administration, observe the skin desquamation condition (Table 6 and Figure 4 ). Use SPSS 26.0 software for statistical analysis, record the time points of sample desquamation, and perform analysis of variance on the time points of respective desquamation. P < 0.05 indicates that the difference is statistically significant.
[0119] Table 6 Comparison of desquamation time in different groups
[0120]
[0121] There was a statistically significant difference in desquamation time among different groups (p < 0.05). The further pairwise comparison results (Table 7) showed that the desquamation time of the Example 1 group, the Example 2 group, and the Example 3 group was lower than that of the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group, the Comparative Example 4 group, and the Positive Control Group (p < 0.05).
[0122] From the above results, it can be seen that for the comparison of the wound surface desquamation time of the patients in the Example 1-3 groups, the Comparative Example 1-4 groups, and the Positive Control Group: the desquamation time of the Example groups was shorter than that of the Comparative Example and Positive Control Groups, and the difference was statistically significant (P < 0.05).
[0123] The above results indicate that the therapeutic drug composition for bullous epidermal necrolysis prepared by the present application can accelerate the desquamation time of the rash and promote the healing of the wound surface.
[0124] Table 7 Post hoc multiple comparison results of desquamation time in different groups
[0125]
[0126] (4)Investigation and comparison of skin healing time
[0127] After administration, observe the skin healing condition and record the time points of skin healing of the samples (Table 8 and Figure 5 ). Use SPSS 26.0 software for statistical analysis, perform analysis of variance on the time points of reaching healing respectively, and P < 0.05 indicates that the difference is statistically significant.
[0128] Table 8 Comparison of healing time in different groups
[0129]
[0130] There was a statistically significant difference in the healing time among different groups (p < 0.05). The further pairwise comparison results (Table 9) showed that the healing times of the Example 1 group and the Example 2 group were lower than those of the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group, the Comparative Example 4 group, and the Positive Control Group (p < 0.05); the healing time of the Example 3 group was lower than that of the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group, and the Comparative Example 4 group (p < 0.05).
[0131] From the above display results, it can be seen that for the comparison of the skin healing time of the patients in the Example 1 - 3 groups, the Comparative Example 1 - 4 groups, and the Positive Control Group: the skin healing time of the Example groups was shorter than that of the Comparative Example groups and the Positive Control Group, and the difference was statistically significant (P < 0.05).
[0132] The above results indicate that the therapeutic drug composition for bullous epidermal necrolysis prepared in this application can shorten the healing time.
[0133] Table 9 Results of post - hoc multiple comparisons of healing time in different groups
[0134]
[0135] The results showed that: in the treatment effect of bullous epidermal necrolysis, the effect of the Example groups of the drug composition of the present invention was significantly higher than that of the Comparative Example groups and the Positive Control Group, indicating that changing the dressing of the wound through this invention can effectively promote the repair of bullous epidermal necrolysis, as well as wound contraction and epithelial regeneration, and then achieve healing, which can shorten the wound recovery time of patients to a certain extent and prompt the patients' wounds to recover at a faster speed.
[0136] Note: The numerical unit in Tables 2 to 9 is "days".
[0137] Example 4
[0138] For the following cases, use the medicinal composition of Example 2. Soak the medical absorbent gauze with the medicinal composition and cover it on the skin twice a day, and apply the medicine for 30 minutes each time.
[0139] Case 1:
[0140] The patient is a 44-year-old male named Li. Ten days ago, he had itching on the lower back accompanied by scattered red rashes. Without any treatment, the rashes gradually spread to the trunk, face, and limbs. The rashes were distributed in patches, red in color, non-bleaching when pressed, and accompanied by obvious itching. Subsequently, flaccid blisters and epidermal detachment occurred. After treatment with the dressing of the present invention, twice a day for 30 minutes each time, the rashes subsided after half a month (see the attachment for usage details). Figure 6 )
[0141] Case 2:
[0142] The patient is a 33-year-old female named Zhang. Due to no obvious cause, she had a rash all over the body accompanied by itching. Subsequently, the skin lesions rapidly developed into diffuse purplish-red or dark red and slightly iron-gray patches, which quickly spread throughout the body. Flaccid blisters and epidermal detachment of various sizes occurred. With a little external force, erosions were formed, accompanied by a large amount of exudation, presenting a scald-like appearance. After treatment with the dressing of the present invention, twice a day for 30 minutes each time, the rashes subsided after one month ( Figure 7 )
[0143] Case 3: The patient is a 31-year-old female named Liu. She was admitted to the hospital due to fever accompanied by a rash for 13 days. The highest body temperature reached 39.3°C. When having a fever, she had a rash all over the body. Two days ago, the red rashes all over the body progressed to large-scale ulceration, blisters, and exfoliation. Glove-like and sock-like exfoliation occurred on the limbs. After treatment with the dressing of the present invention, twice a day for 30 minutes each time, the ulcerated areas gradually healed after half a month ( Figure 8 )
[0144] Finally, it should be noted that the above preferred embodiments are only used to illustrate the technical solutions of the present invention and are not restrictive. 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 terms of 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: The pharmaceutical composition consists of 40-60 g of lithospermum officinale, 1-5 g of rhizoma rutaecarpa, 20-40 g of ampelopsis pilosula, 10-30 g of parsley and 500 mL of secondary pressed brassica seed oil.
2. The method for preparing the pharmaceutical composition according to claim 1, 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.
3. The preparation method according to claim 2, characterized in that: The secondary pressed canola oil in step (1) and step (3) is heated to 80-95°C.
4. The preparation method according to claim 2, characterized in that: The soaking time in step (2) and step (4) is greater than three days.
5. The preparation method according to claim 2, characterized in that: The solid-liquid ratio of the lithospermum officinale to the secondary pressed brassica seed oil in step (1) is 1:3-7.5 g / mL, and the solid-liquid ratio of the rhizoma rutinae to the secondary pressed brassica seed oil in step (3) is 1:40-300 g / mL.