Application of Sihuang heart-fire clearing preparation in preparation of medicine for treating burns and scalds
By using Sihuang Qingxin preparations to treat burns and scalds, the problems of bacterial resistance and long-term use in Western medicine treatment are solved, and rapid healing of burn and scald wounds and reduced mortality are achieved.
Patent Information
- Application Number
- CN202510960825.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-07-12
- Publication Date
- 2025-10-03
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Existing Western medicines for treating burns and scalds have the risk of bacterial resistance, secondary infection and decreased immunity caused by long-term use, and the treatment effect is not significant. Especially for patients with deep burns and scalds, the treatment cost is expensive and the healing time is long.
The Sihuang Qingxin preparation is used, which is made of artificial bezoar, phellodendron, scutellaria, rhubarb, talc, liquorice, cinnabar, gardenia, gypsum and borneol as effective ingredients. It is prepared into an external medicine for treating burns and scalds.
The Sihuang Qingxin preparation significantly reduces the area of burn wounds, shortens the healing time, promotes wound healing in mouse burn models, and reduces the mortality rate of mice.
Smart Images
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Abstract
Description
Technical Field
[0001] The invention belongs to the technical field of medical applications, and particularly relates to an application of a Sihuang Qingxin preparation in preparing medicines for treating burns and scalds. Background Art
[0002] Burns and scalds are injuries to the skin or other organs and tissues caused primarily by high temperatures, radiation, electricity, friction, or chemical contact. Burns and scalds often occur locally but can also spread throughout the body, causing serious systemic complications such as widespread secondary infection and scarring. They are a common accidental injury in modern clinical practice.
[0003] Burn wounds caused by chemicals, hot water, hot oil, and steam are sources of complications such as infection and organ damage. Effectively promoting the healing of burn wounds has long been a challenging and hot topic in burn treatment. Western medicine primarily uses antibiotics and other medications to treat burns. However, long-term use can lead to bacterial resistance and secondary infections, reduce the body's immune system, provide slow and ineffective pain relief, and prolong recovery. For patients with severe burns ranging from deep II to deep IV degrees, treatment requires not only sterile wards but also skin grafting for recovery, resulting in expensive treatment.
[0004] Traditional Chinese medicine and its preparations offer advantages over Western medicine in treating burns and scalds. These preparations have also demonstrated unique efficacy in combating infection and promoting wound healing. Sihuang Qingxin Pills, known for their ability to clear the heart, relieve fever, and awaken the mind, are used to treat high fevers in febrile diseases, as well as qi and blood stagnation. Currently, there are no reports of Sihuang Qingxin Pills' effectiveness in treating burns and scalds. Summary of the Invention
[0005] The purpose of the present invention is to provide an application of Sihuang Qingxin preparation in preparing medicines for treating burns and scalds.
[0006] Furthermore, the Sihuang Qingxin preparation is a preparation prepared with artificial bezoar, phellodendron, scutellaria, rhubarb, talc, licorice, cinnabar, gardenia, gypsum, and borneol as effective ingredients.
[0007] Furthermore, the Sihuang Qingxin preparation is an external medicine preparation.
[0008] Sihuang Qingxin Pills have the effects of clearing the heart and relieving fever, opening the mind and refreshing the spirit. The inventors have found through experimental research that Sihuang Qingxin Pills have a certain therapeutic effect on burns and scalds.
[0009] The beneficial effects of the present invention are:
[0010] The present invention provides the use of a Sihuang Qingxin preparation in the preparation of a medicament for treating burns and scalds. Experiments have demonstrated that the Sihuang Qingxin pills of the present invention can significantly reduce wound area and shorten wound healing time in a mouse burn model. In a mouse scald model, Sihuang Qingxin pills also significantly reduced wound area. Therefore, the Sihuang Qingxin preparation of the present invention promotes wound healing in burned and scalded skin. DETAILED DESCRIPTION
[0011] The present invention will be further described in detail below through specific examples. The drugs and reagents involved in the specific embodiments are all commercially available.
[0012] Example 1 Effect of Sihuang Qingxin Pills on Mouse Skin Burn Model
[0013] 1.1 Experimental Animals
[0014] SPF KM mice, half male and half female, weighing 18-22 g, were purchased from the Animal Experimental Center of the Sichuan Academy of Traditional Chinese Medicine. Production License No.: SCXK(Chuan)2018-19. Certificate No.: 0023081. Mice were allowed to acclimate for at least 5 days after receipt.
[0015] 1.2 Experimental drugs
[0016] 1.2.1 Test drug
[0017] Sihuang Qingxin Pills (Shenyang Qinggong Pharmaceutical Group Co., Ltd., batch number: 221118, each pill weighs 5g), preparation method: take 2 Sihuang Qingxin Pills weighing 10g, add pure water and grind, and adjust the volume to 30mL.
[0018] MEBO (Shantou MEBO Pharmaceutical Co., Ltd., batch number: 2203603A, 1 g is equivalent to 0.21 g of the medicinal piece; packaged in aluminum-plastic composite tubes, 40 g per tube).
[0019] 1.2.2 Reagents
[0020] Sodium sulfide, Chengdu Kelon Chemical Reagent Factory, 500g / bottle, batch number: 2019102301.
[0021] Sodium chloride injection (0.9%), produced by Sichuan Kelun Pharmaceutical Co., Ltd., specifications: 500ml: 4.5g, batch number: L222091608.
[0022] Hematoxylin stain: Beekman Biotechnology, batch number: 20220530; Eosin stain: Beekman Biotechnology, batch number: 20220530.
[0023] 1.3 Experimental methods
[0024] 1.3.1 Animal modeling
[0025] Mice that have passed the observation during the adaptation period were selected and anesthetized with pentobarbital. The mice were placed on the operating table. A 2cm×2cm hollowed-out asbestos paper was placed on the back of the mouse. 90uL of anhydrous ethanol was aspirated with a micropipette and dropped onto a 20mg cotton ball. The ball was placed in the exposed area and ignited for 10 seconds to create a burn model.
[0026] 1.3.2 Animal grouping
[0027] After modeling, the mice were randomly divided into three groups according to their body weight, namely, model group, Sihuang Qingxin Pills group and MEBO group, with 12 mice in each group.
[0028] 1.3.3 Administration
[0029] Drug administration was started immediately after modeling, and the drugs were applied externally. Before administration, the drugs and liquefied substances remaining on the wound surface were wiped off with normal saline, and the wound surface was exposed for medication. The model group, Sihuang Qingxin group, and MEBO group were all administered according to the dosage in Table 1. Each group was administered twice a day for 14 consecutive days. The model control group was smeared with normal saline.
[0030] Table 1 Experimental dosage design
[0031] Group Route of administration Dosage volume / time Drug concentration Dosing frequency and timing Model Group For external use 0.1~0.2mL / 2 times / day for 14 days Four Yellow Pure Heart Group For external use 0.1~0.2mL 0.33g / mL 2 times / day for 14 days MEBO group For external use 0.1～0.2g 0.21g / g 2 times / day for 14 days
[0032] 1.4 Pharmacodynamic evaluation indicators
[0033] 1.4.1 Weight
[0034] Inspection time: once a week;
[0035] Test animals: All surviving experimental animals;
[0036] Inspection method: weighing with electronic balance (Ryohei Instruments).
[0037] 1.4.2 Wound area
[0038] Inspection time: twice a week;
[0039] Test animals: All surviving experimental animals;
[0040] Inspection method: Use a vernier caliper to measure the long and short diameters of the wound and calculate the wound area.
[0041] Wound area calculation formula: Wound area (mm2) = π / 4 × long diameter × short diameter
[0042] 1.4.3 Wound healing time
[0043] Inspection time: Observe once a day;
[0044] Test animals: All surviving experimental animals;
[0045] Inspection method: Observe wound healing with the naked eye.
[0046] 1.4.4 Histopathological examination
[0047] Inspection time: end of the experiment;
[0048] Test animals: All surviving experimental animals;
[0049] Examination method: At the end of the experiment, the wound skin was fixed, the skin of the burn site was taken, fixed in formalin, and a cross section was made along the center of the repair site. The sample was dehydrated with gradient ethanol, transparentized with xylene, immersed in wax, embedded with the cross section downward, sliced at 4 μm, and stained with HE.
[0050] Skin tissue morphology and structure were observed under an optical microscope, and the cross-sectional area of the scar at the burn site was measured using CapStudio imaging software. The degree of inflammatory cell infiltration at the burn site was scored.
[0051] Scoring method for inflammatory cell infiltration:
[0052] 0 points: no obvious inflammatory cell infiltration was observed in the burn site;
[0053] 1 point: A small number of inflammatory cells are scattered in the burn area;
[0054] 2 points: more inflammatory cells are densely distributed in the burn area;
[0055] 3 points: There are many inflammatory cells densely distributed in multiple foci at the burn site.
[0056] 1.5 Statistical analysis
[0057] The experimental data of each group of animals in the table are expressed as mean ± standard deviation. The experimental data in the picture are expressed as mean ± standard error. Description. One-way analysis of variance (ANOVA) was used to compare continuous data between groups, with Dunnett's test or Fisher's test used for multiple comparisons between groups. Ordinal data were analyzed using the Kruskal-Wallis test (KW method), with Dunn's method used for multiple comparisons between groups. A p < 0.05 was considered statistically significant. All statistical analyses were performed using Graphpad Prism 8 software.
[0058] 1.6 Results
[0059] 1.6.1 General Observations
[0060] After the acclimation period, all animals had normal feeding, drinking, and defecation, with no significant abnormal activity or behavior. The weight of animals in each group increased normally during the experiment, and no significant differences were observed between the treatment groups and the model group (P>0.05). See Table 2.
[0061] During the drug administration process, mice died in each experimental group due to modeling reasons, with 4 deaths in the model group, 1 death each in the Sihuang Qingxin group and the MEBO group. The drug administration group showed a trend of reducing the mortality of model mice (P=0.1059).
[0062] Table 2 Effects of Sihuang Qingxin Pills on body weight of burned mice ( n=8~12)
[0063]
[0064] Note: Compared with the model group, *P<0.05, **P<0.01.
[0065] 1.6.2 Effect of Sihuang Qingxin Pills on Wound Area in Burned Mice
[0066] After burn modeling in mice, the burned skin showed obvious burn marks and edema developed around the burned area. The edema disappeared and scabs formed in the burned area 2-3 days after modeling. Sihuang Qingxin Pills significantly reduced the wound area in mice 12, 15, and 19 days after administration, with significant differences compared to the model group (P < 0.05 or P < 0.01). Both Sihuang Qingxin Pills and MEBO also shortened the time to wound healing (P < 0.05). The results are shown in Table 3.
[0067] Table 3 Effect of Sihuang Qingxin Pills on the wound area of burned mice ( n=8~12)
[0068]
[0069] Note: Compared with the model group, *P<0.05, **P<0.01.
[0070] 1.6.3 Pathological results
[0071] See Table 4.
[0072] Table 4 Effects of Sihuang Qingxin Pills on the pathological morphology of burned skin in mice
[0073] Group Number of animals Inflammatory cell infiltration score (points) <![CDATA[Scar cross-sectional area (mm 2 )]]> Burn model 8 1.63±0.52 4.95±2.42 Four Yellow Pure Heart Group 11 1.35±0.82 4.23±2.35 Moist burn ointment 11 1.26±1.03 4.12±3.18
[0074] Example 2 Effect of Sihuang Qingxin Pills on Mouse Skin Scald Model
[0075] 2.1 Experimental animals
[0076] SPF KM mice, half male and half female, weighing 18-22 g, were purchased from the Animal Experimental Center of the Sichuan Academy of Traditional Chinese Medicine. Production License No.: SCXK(Chuan)2018-19. Certificate No.: 0023076. Mice were allowed to acclimate for at least 5 days after receipt.
[0077] 2.2 Experimental drugs
[0078] 2.2.1 Test drug
[0079] Sihuang Qingxin Pills (Shenyang Qinggong Pharmaceutical Group Co., Ltd., batch number: 221118, each pill weighs 5g), preparation method: take 2 Sihuang Qingxin Pills weighing 10g, add pure water and grind, and adjust the volume to 30mL.
[0080] MEBO (Shantou MEBO Pharmaceutical Co., Ltd., batch number: 2203603A, 1 g is equivalent to 0.21 g of the medicinal piece; packaged in aluminum-plastic composite tubes, 40 g per tube).
[0081] 2.2.2 Reagents
[0082] Sodium sulfide, Chengdu Kelon Chemical Reagent Factory, 500g / bottle, batch number: 2019102301.
[0083] Sodium chloride injection (0.9%), produced by Sichuan Kelun Pharmaceutical Co., Ltd., specifications: 500ml: 4.5g, batch number: L222091608.
[0084] Hematoxylin stain: Beekman Biotechnology, batch number: 20220530; Eosin stain: Beekman Biotechnology, batch number: 20220530.
[0085] 2.3 Experimental methods
[0086] 2.3.1 Animal modeling
[0087] The mice were fixed and their backs were shaved. After shaving, the hair was removed with 8% sodium sulfide solution. 24 hours after depilation, a round weight that had been preheated in a super constant temperature water bath (82°C ± 0.05°C) was placed vertically on the depilated area on the mouse's back for 7 seconds to create a mouse skin burn model.
[0088] 2.3.2 Animal grouping
[0089] After modeling, the mice were randomly divided into three groups according to their body weight, namely, model group, Sihuang Qingxin group and MEBO group, with 10 mice in each group.
[0090] 2.3.3 Drug administration
[0091] Drug administration was started immediately after modeling, and the drugs were applied externally. Before administration, the drugs and liquefied substances remaining on the wound surface were wiped off with normal saline, and the wound surface was exposed for medication. The model group, Sihuang Qingxin group, and MEBO group were all administered according to the dosage in Table 5. Each group was administered twice a day for 14 consecutive days. The model control group was smeared with normal saline.
[0092] Table 5 Experimental dosage design
[0093] Group Route of administration Dosage volume / time Drug concentration Dosing frequency and timing Model Group For external use 0.1~0.2mL / 2 times / day for 14 days Four Yellow Pure Heart Group For external use 0.1~0.2mL 0.33g / mL 2 times / day for 14 days MEBO group For external use 0.1～0.2g 0.21g / g 2 times / day for 14 days
[0094] 2.4 Pharmacodynamic evaluation indicators
[0095] 2.4.1 Weight
[0096] Inspection time: once a week;
[0097] Test animals: All surviving experimental animals;
[0098] Inspection method: weighing with electronic balance (Ryohei Instruments).
[0099] 2.4.2 Wound area
[0100] Inspection time: twice a week;
[0101] Test animals: All surviving experimental animals;
[0102] Inspection method: Use a vernier caliper to measure the long and short diameters of the wound and calculate the wound area.
[0103] Wound area calculation formula: Wound area (mm2) = π / 4 × long diameter × short diameter
[0104] 2.4.3 Wound healing time
[0105] Inspection time: Observe once a day;
[0106] Test animals: All surviving experimental animals;
[0107] Inspection method: Observe wound healing with the naked eye.
[0108] 2.4.4 Histopathological examination
[0109] Inspection time: end of the experiment;
[0110] Test animals: All surviving experimental animals;
[0111] Examination method: At the end of the experiment, the wound skin was fixed, the skin of the scalded area was taken, fixed with formalin, and a cross section was made along the center of the repair area. The samples were dehydrated with gradient ethanol, transparentized with xylene, immersed in wax, embedded with the cross section downward, sliced at 4 μm, and stained with HE.
[0112] The skin tissue morphology and structure were observed under an optical microscope, and the cross-sectional area of the scar at the burn site was measured using CapStudio imaging software. The degree of inflammatory cell infiltration at the burn site was scored.
[0113] Scoring method for inflammatory cell infiltration:
[0114] 0 points: no obvious inflammatory cell infiltration was observed at the burn site;
[0115] 1 point: A small number of inflammatory cells are scattered in the burn area;
[0116] 2 points: There are many inflammatory cells with dense distribution in the burn area;
[0117] 3 points: There are many inflammatory cells densely distributed in multiple foci at the burn site.
[0118] 2.5 Statistical analysis
[0119] The experimental data of each group of animals in the table are expressed as mean ± standard deviation. The experimental data in the picture are expressed as mean ± standard error. Description. One-way analysis of variance (ANOVA) was used to compare continuous data between groups, with Dunnett's test or Fisher's test used for multiple comparisons between groups. Ordinal data were analyzed using the Kruskal-Wallis test (KW method), with Dunn's method used for multiple comparisons between groups. A p < 0.05 was considered statistically significant. All statistical analyses were performed using Graphpad Prism 8 software.
[0120] 2.6 Results
[0121] 2.6.1 General Observations
[0122] After the acclimation period, all animals maintained normal feeding, drinking, and defecation, with no significant abnormal activity or behavior. During the experimental period, the animals in each group gained weight normally, with no significant differences observed between the treatment groups and the model group (P>0.05). During the treatment period, one mouse in each experimental group died due to modeling issues (see Table 6).
[0123] Table 6 Effects of Sihuang Qingxin Pills on the body weight of scalded mice ( n=9~10)
[0124]
[0125] Note: *P<0.05, **P<0.01, compared with the model group
[0126] 2.6.2 Effect of Sihuang Qingxin Pills on the wound area of scalded mice
[0127] After the mice were scalded, obvious burn marks were observed on the skin of the burned area, and edema appeared in the burned area and surrounding skin. The edema disappeared 2-3 days after administration, and scabs formed in the burned area. Eleven and fifteen days after administration, both the Sihuang Qingxin and MEBO groups reduced the wound area in the mice, showing significant differences compared with the model group (P < 0.05 or P < 0.01). The results are shown in Table 7.
[0128] Table 7 Effect of Sihuang Qingxin Pills on the wound area of scalded mice ( n=9~10)
[0129]
[0130] Note: *P<0.05, **P<0.01, compared with the model group
[0131] 2.6.3 Pathological results
[0132] See Table 8.
[0133] Table 8 Effects of Sihuang Qingxin Pills on the pathological morphology of scalded skin in mice
[0134] Group Number of animals Inflammatory cell infiltration score (points) Burn model 9 2.36±0.72 Four Yellow Pure Heart Group 9 1.25±0.64 Moist burn ointment 9 1.16±10.38
[0135] In summary, the Sihuang Qingxin Pills of the present invention can significantly reduce the wound area and shorten the wound healing time in the mouse burn and scald model. Therefore, the Sihuang Qingxin preparation of the present invention has the effect of promoting wound healing on burned and scalded skin.
Claims
1. Application of Sihuang Qingxin preparation in the preparation of medicines for treating burns and scalds.
2. The Sihuang Qingxin preparation is a preparation prepared with artificial bezoar, phellodendron, scutellaria, rhubarb, talc, licorice, cinnabar, gardenia, gypsum and borneol as effective ingredients.
3. The use according to claim 1, wherein the Sihuang Qingxin preparation is an external medicine preparation.