Preparation method of novel tissue regeneration promoting jade red paste dressing and dressing thereof

Abstract

The invention relates to the field of medical apparatus and instruments, in particular to a preparation method of a novel tissue-engendering jade red paste dressing, which comprises a step of preparing a novel tissue-engendering jade red paste and a step of uniformly smearing the prepared novel tissue-engendering jade red paste on polyimide fiber gauze with the size of 10cm * 10cm and the weight of 50g / m < 2 >, the novel tissue-engendering jade red paste does not contain calomel, and the dosage of the novel tissue-engendering jade red paste is 2-10g. The dressing prepared by the method disclosed by the invention has an excellent effect of promoting wound healing.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and in particular relates to a preparation method of a traditional Chinese medicine dressing and the dressing. Background Art

[0002] Wound healing refers to the recovery process after the body is subjected to external forces and the skin and other tissues are severed or damaged. It includes a complex combination of regeneration of various tissues, proliferation of granulation tissue, and formation of scar tissue, showing the synergistic effect of various processes. Wound healing includes the following four basic processes: acute inflammatory phase → cell proliferation phase → scar formation phase → regeneration of the epidermis and other tissues.

[0003] Shengji Yuhong ointment is a classic topical Chinese medicine preparation commonly used in Traditional Chinese Medicine surgery to dissolve dead tissue and promote tissue regeneration. It is used to treat conditions such as carbuncles and skin ulcers, shortening skin healing time and alleviating pain. Traditional Shengji Yuhong ointment is composed of licorice, angelica root, angelica sinensis, lithospermum officinale, white wax, dragon's blood, and calomel. Calomel is composed of mercurous chloride (HgCl2), but calomel is pungent, bitter, and toxic. It readily decomposes under light or heat to form mercuric chloride and metallic mercury, which are highly toxic and can accumulate and cause toxicity with long-term use. It can cause adverse reactions such as local redness, swelling, and itching. Furthermore, calomel is a Class II toxic Chinese medicine. According to relevant national regulations, its prescription and use are the responsibility of medical institutions and authorized pharmacies. Purchases must be made with a formal prescription signed by a physician, and the prescribed dosage must not exceed the two-day maximum. Calomel purchases are strictly regulated, and the drug's preparation process is subject to certain restrictions.

[0004] Polyimide (PI), a polymer containing an imide ring (-CO-NR-CO-) in its main chain, is one of the best-performing organic polymer materials. It possesses excellent thermal stability and heat resistance, as well as superior mechanical and chemical properties. Summary of the Invention

[0005] The purpose of the present invention is to provide a preparation method of a novel Shengji Yuhong ointment dressing and the dressing.

[0006] The first aspect of the present invention is to provide a method for preparing a novel Shengji Yuhong ointment dressing, comprising the steps of preparing the novel Shengji Yuhong ointment and applying the prepared novel Shengji Yuhong ointment evenly on a 10 cm × 10 cm thick dressing having a weight of 50 g / m 2 The step of applying the ointment on the polyimide fiber gauze, wherein the new Shengji Yuhong ointment does not contain light powder and its dosage is 2 to 10 g.

[0007] In a preferred example, the steps of preparing the new Shengji Yuhong ointment include adding 15g of angelica, 3.75g of angelica dahurica, 1.5g of lithospermum officinale, and 9g of licorice to 125g of sesame oil, soaking at room temperature for 3 days, decocting for 10 to 20 minutes, filtering, adding 15g of white wax, and melting the white wax over a low fire; when the temperature drops to 80°C, adding 3g of Sanguisorba officinalis while stirring, and obtaining the new Shengji Yuhong ointment after the Sanguisorba officinalis is dissolved.

[0008] In another preferred embodiment, the dosage of the novel Shengji Yuhong ointment is 5g.

[0009] The second aspect of the present invention is to provide a novel Shengji Yuhong Gao dressing, which is prepared by the above-mentioned preparation method.

[0010] The details of various aspects of the present invention will be described in detail in the following sections. The features, objectives and advantages of the present invention will become more apparent through the description below and the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 .Comparison of different polyimide gauze weights

[0012] A is a typical picture, and B is the quantification result of the wound area

[0013] DZ, control group; SJYH, traditional Shengji Yuhong ointment group; XXSJYH1, new Shengji Yuhong ointment dressing group 1; XXSJYH2, new Shengji Yuhong ointment dressing group 2; XXSJYH13, new Shengji Yuhong ointment dressing group 3; XXSJYH4, new Shengji Yuhong ointment dressing group 4. Compared with the control group (DZ), *P < 0.05; **P < 0.01; ***P < 0.001; compared with the new Shengji Yuhong ointment dressing group 2 (XXSJYH2), ## P < 0.01; ### P < 0.001; #### P < 0.0001;

[0014] Figure 2 .Comparison of the quality of different Shengji Yuhong ointments

[0015] A is a typical picture, B is a good result of wound area

[0016] DZ, control group; SJYH, traditional Shengji Yuhong ointment group; XXSJYH2, new Shengji Yuhong ointment dressing group 2; XXSJYH6, new Shengji Yuhong ointment dressing group 6; XXSJYH7, new Shengji Yuhong ointment dressing group 7. Compared with the control group (DZ), **P < 0.01; ***P < 0.001; ****P < 0.0001; compared with the Shengji Yuhong ointment group (XXSJYH2), ## P < 0.01; #### P < 0.001;

[0017] Figure 3 Typical pictures of wound healing

[0018] DZ, control group; JXYA, polyimide group; SJYH, traditional Shengji Yuhong ointment group; XXSJYH, new Shengji Yuhong ointment dressing group; DBFL1, comparison dressing group 1; DBFL2, comparison dressing group 2; DBFL3, comparison dressing group 3;

[0019] Figure 4 Quantification results of wound area at different time points in each group

[0020] Compared with the control group (DZ), *P<0.05; **P<0.01; ***P<0.001; ****P<0.0001

[0021] Compared with the new Shengji Yuhong ointment dressing group (XXSJYH), # P < 0.05; ## P < 0.01; ### P < 0.001; #### P<0.0001. DETAILED DESCRIPTION

[0022] The novel Shengji Yuhong ointment of the present invention follows the traditional Shengji Yuhong ointment formula, and only removes the light powder component therein. The specific composition is as follows: 15g of angelica sinensis, 3.75g of angelica dahurica, 1.5g of lithospermum officinale, 3g of dragon's blood, 9g of liquorice, and 125g of sesame oil.

[0023] The preparation method of the novel Shengji Yuhong ointment of the present invention is similar to that of conventional Shengji Yuhong ointment: 15g of angelica sinensis, 3.75g of angelica dahurica, 1.5g of lithospermum officinale, and 9g of liquorice are added to 125g of sesame oil, soaked at room temperature for 3 days, decocted for 10-20 minutes, filtered, and then 15g of white wax is added and melted over a low flame. When the temperature drops to 80°C, 3g of dragon's blood is added while stirring. Once the dragon's blood is dissolved, the novel Shengji Yuhong ointment is obtained.

[0024] Then, keep the temperature at 80℃, take 2-10g of the new Shengji Yuhong ointment and apply it evenly on a 10cm×10cm square with a weight of 50g / m2. 2 The polyimide fiber gauze is naturally cooled to room temperature to obtain the new Shengji Yuhong ointment dressing.

[0025] Preferably, the dosage of the novel Shengji Yuhong ointment is 5 g. The polyimide fiber gauze was purchased from Changchun Gaoqi Polyimide Materials Co., Ltd.

[0026] The novel Shengji Yuhong ointment dressing of the present invention has an excellent effect of promoting wound healing.

[0027] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended to illustrate the present invention only and are not intended to limit the scope of the invention. The experimental methods in the following examples, for which specific conditions are not specified, are generally based on conventional conditions or the conditions recommended by the manufacturer. Unless otherwise stated, all percentages, ratios, proportions, or parts are by weight.

[0028] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those familiar to those skilled in the art. Furthermore, any methods and materials similar or equivalent to those described herein can be applied to the methods of the present invention. The preferred embodiments and materials described herein are for illustrative purposes only.

[0029] The above-mentioned features of the present invention or the features described in the embodiments may be combined in any combination. All features disclosed in this patent specification may be used in any combination, and each feature disclosed in the specification may be replaced by any alternative feature that can provide the same, equal, or similar purpose. Therefore, unless otherwise specified, the features disclosed are only general examples of equal or similar features.

[0030] [Example 1] Preparation of a new type of Shengji Yuhong ointment dressing

[0031] First, add 15g of Chinese Angelica, 3.75g of Angelica dahurica, 1.5g of Lithospermum officinale, and 9g of Licorice root into 125g of sesame oil, soak at room temperature for 3 days, and simmer for 15 minutes. After filtering with gauze, add 15g of white wax and melt it over a low fire. When the temperature drops to 80℃, add 3g of Dragon's Blood, stirring while adding. After the Dragon's Blood dissolves, the new Shengji Yuhong ointment is obtained. Maintain the temperature at 80℃, take 5g of the new Shengji Yuhong ointment and apply it to a 10cm×10cm area with a weight of 30g / m2. 2 The polyimide fiber gauze is naturally cooled to room temperature to obtain the new Shengji Yuhong ointment dressing.

[0032] [Example 2] Preparation of a new Shengji Yuhong ointment dressing

[0033] First, add 15g of Chinese Angelica, 3.75g of Angelica dahurica, 1.5g of Lithospermum officinale, and 9g of Licorice root into 125g of sesame oil, soak at room temperature for 3 days, and simmer for 15 minutes. After filtering with gauze, add 15g of white wax and melt it over a low fire. When the temperature drops to 80℃, add 3g of Dragon's Blood, stirring while adding. After the Dragon's Blood dissolves, the new Shengji Yuhong ointment is obtained. Maintain the temperature at 80℃, take 5g of the new Shengji Yuhong ointment and apply it to a 10cm×10cm area with a weight of 50g / m2. 2 The polyimide fiber gauze is naturally cooled to room temperature to obtain the new Shengji Yuhong ointment dressing.

[0034] [Example 3] Preparation of a new Shengji Yuhong ointment dressing

[0035] First, add 15g of Chinese Angelica, 3.75g of Angelica dahurica, 1.5g of Lithospermum officinale, and 9g of Licorice root into 125g of sesame oil, soak at room temperature for 3 days, and simmer for 10 minutes. After filtering with gauze, add 15g of white wax and melt it over a low fire. When the temperature drops to 80℃, add 3g of Sanguisorba officinalis while stirring. After the Sanguisorba officinalis dissolves, the new Shengji Yuhong ointment is obtained. Maintain the temperature at 80℃ and apply 5g of the new Shengji Yuhong ointment to a 10cm×10cm area with a weight of 80g / m2. 2 The polyimide fiber gauze is naturally cooled to room temperature to obtain the new Shengji Yuhong ointment dressing.

[0036] [Example 4] Preparation of a new Shengji Yuhong ointment dressing

[0037] First, add 15g of Chinese Angelica, 3.75g of Angelica dahurica, 1.5g of Lithospermum officinale, and 9g of Licorice root into 125g of sesame oil, soak at room temperature for 3 days, and simmer for 10 minutes. After filtering with gauze, add 15g of white wax and melt it over a low fire. When the temperature drops to 80℃, add 3g of Dragon's Blood, stirring while adding. After the Dragon's Blood dissolves, the new Shengji Yuhong ointment is obtained. Maintain the temperature at 80℃, take 5g of the new Shengji Yuhong ointment and apply it to a 10cm×10cm area with a gram weight of 100g / m 2 The polyimide fiber gauze is naturally cooled to room temperature to obtain the new Shengji Yuhong ointment dressing.

[0038] [Example 5] Experimental study on the promotion of wound healing by the new Shengji Yuhong ointment dressing (preferred weight of polyimide fiber gauze)

[0039] Experimental animals: 20±2g male SPF grade C57BL / 6J mice

[0040] Experimental drugs: The dressings used were prepared according to Examples 1, 2, 3, and 4, respectively.

[0041] Experimental Methods: Male SPF-grade C57BL / 6J mice weighing 20±2 g were selected as model animals and randomly divided into a control group, a conventional Shengji Yuhong ointment group, a novel Shengji Yuhong ointment dressing group 1 (Example 1), a novel Shengji Yuhong ointment dressing group 2 (Example 2), a novel Shengji Yuhong ointment dressing group 3 (Example 3), and a novel Shengji Yuhong ointment dressing group 4 (Example 4), with 5 mice in each group. After depilation, a 1 cm × 1 cm wound was created on the dorsal skin of the mice.

[0042] The control group was bandaged with sterile medical gauze only; the traditional Shengji Yuhong ointment group was bandaged with sterile medical gauze after applying the traditional Shengji Yuhong ointment to the wound; the new Shengji Yuhong ointment dressing groups 1, 2, 3, and 4 were bandaged with the new Shengji Yuhong ointment dressing prepared in Examples 1, 2, 3, and 4, respectively. The dressing was changed every other day (to fully cover the wound), and the intervention lasted for 10 days. The wound area of the mice (mm) was analyzed using Image J analysis software.2 ).

[0043] Statistical methods: SPSS 25.0 was used for statistical analysis. Data were analyzed using the repeated measures analysis of variance (ANOVA) method. Inter-group comparisons were performed using the LSD test. P < 0.05 indicated statistically significant differences.

[0044] Experimental results: Figure 1 As shown in A and B, compared with the control group (DZ), the traditional Shengji Yuhong ointment group and the new Shengji Yuhong ointment dressing groups 1, 2, and 3 significantly promoted wound healing (P < 0.05), and the effect of the new Shengji Yuhong ointment dressing group 2 (XXSJYH2) was the most significant (P < 0.0001), and was significantly better than the new Shengji Yuhong ointment dressings 1, 3, and 4 (XXSJYH1, XXSJYH2, XXSJYH3) (P < 0.05). The effect of XXSJYH2 was significantly better than that of the traditional Shengji Yuhong ointment group (SJYH) (P < 0.01). Therefore, preferably, the polyimide fiber gauze used in the new Shengji Yuhong ointment dressing has a gram weight of 50 g / m 2 .

[0045] [Example 6] Preparation of a new type of Shengji Yuhong ointment dressing

[0046] First, add 15g of Chinese Angelica, 3.75g of Angelica dahurica, 1.5g of Lithospermum officinale, and 9g of Licorice root into 125g of sesame oil, soak at room temperature for 3 days, and simmer for 10 minutes. After filtering with gauze, add 15g of white wax and melt it over a low fire. When the temperature drops to 80℃, add 3g of Sanguisorba officinalis while stirring. After the Sanguisorba officinalis dissolves, the new Shengji Yuhong ointment is obtained. Maintain the temperature at 80℃ and apply 2g of the new Shengji Yuhong ointment to a 10cm×10cm area with a weight of 50g / m2. 2 The polyimide fiber gauze is naturally cooled to room temperature to obtain the new Shengji Yuhong ointment dressing.

[0047] [Example 7] Preparation of a new Shengji Yuhong ointment dressing

[0048] First, add 15g of Chinese Angelica, 3.75g of Angelica dahurica, 1.5g of Lithospermum officinale, and 9g of Licorice root into 125g of sesame oil, soak at room temperature for 3 days, and simmer for 20 minutes. After filtering with gauze, add 15g of white wax and melt it over a low fire. When the temperature drops to 80℃, add 3g of Sanguisorba officinalis while stirring. After the Sanguisorba officinalis dissolves, the new Shengji Yuhong ointment is obtained. Maintain the temperature at 80℃ and apply 10g of the new Shengji Yuhong ointment to a 10cm×10cm area with a weight of 50g / m2. 2 The polyimide fiber gauze is naturally cooled to room temperature to obtain the new Shengji Yuhong ointment dressing.

[0049] [Example 8] Experimental Study on the Effect of the New Shengji Yuhong Ointment Dressing on Promoting Wound Healing (Optimal Dosage of the New Shengji Yuhong Ointment)

[0050] Experimental animals: 20±2g male SPF grade C57BL / 6J mice

[0051] Experimental drugs: The dressings used were prepared according to Examples 2, 6, and 7, respectively.

[0052] Experimental Methods: Male SPF-grade C57BL / 6J mice weighing 20±2 g were selected as model animals and randomly divided into a control group, a conventional Shengji Yuhong ointment group, two groups treated with the new Shengji Yuhong ointment dressing (Example 2), six groups treated with the new Shengji Yuhong ointment dressing (Example 6), and seven groups treated with the new Shengji Yuhong ointment dressing (Example 7), with five mice in each group. After depilation, a 1 cm × 1 cm wound was created on the dorsal skin of the mice.

[0053] The control group was bandaged with only sterile medical gauze; the traditional Shengji Yuhong ointment group was bandaged with sterile medical gauze after applying traditional Shengji Yuhong ointment on the wound; the new Shengji Yuhong ointment dressing groups 2, 6, and 7 were bandaged with the new Shengji Yuhong ointment dressing prepared in Examples 2, 6, and 7, respectively.

[0054] The dressing was changed every other day (to fully cover the wound), and the intervention lasted for 10 days. The wound area of mice was analyzed using Image J analysis software (mm 2 ).

[0055] Statistical methods: SPSS 25.0 was used for statistical analysis. Data were analyzed using the repeated measures analysis of variance (ANOVA) method. Inter-group comparisons were performed using the LSD test. P < 0.05 indicated statistically significant differences.

[0056] Experimental results: Figure 2 As shown in A and B, compared with the control group (DZ), all groups significantly promoted wound healing (P < 0.05); compared with the traditional Shengji Yuhong ointment group (SJYH), the effects of the new Shengji Yuhong ointment dressing groups 2, 6, and 7 (XXSJYH2) all significantly promoted wound healing, which was superior to that of SJYH (P < 0.05), and the effect of the new Shengji Yuhong ointment dressing group 2 (XXSJYH2) was even better. Therefore, the preferred dosage of the new Shengji Yuhong ointment is 5g.

[0057] [Example 9] Comparative study on the effect of the new Shengji Yuhong ointment dressing on wound healing

[0058] Experimental animals: 20±2g male SPF grade C57BL / 6J mice

[0059] Experimental drug: The new Shengji Yuhong ointment dressing was prepared according to Example 2.

[0060] The preparation of contrast dressing 1, contrast dressing 2, and contrast dressing 3 is similar to the preparation method of the novel Shengji Yuhong ointment dressing of Example 2, except that the polyimide fiber gauze is replaced with medical sterile gauze, Baikerui gauze (a commonly used wound dressing), and nanosilver dressing (a commonly used wound dressing). First, 15g of angelica sinensis, 3.75g of angelica dahurica, 1.5g of lithospermum officinale, and 9g of liquorice are added to 125g of sesame oil, soaked at room temperature for 3 days, decocted for 15 minutes, filtered through gauze, and then 15g of white wax is added. The white wax is melted on a low fire. When the temperature drops to 80°C, 3g of Sanguisorba officinalis is added and stirred. After the Sanguisorba officinalis is dissolved, a novel Shengji Yuhong ointment is obtained. Maintaining the temperature at 80°C, 5 g of the new Shengji Yuhong ointment was evenly applied to medical sterile gauze, Biocore gauze, and nano-silver gauze (all 10 cm × 10 cm in size), and then naturally cooled to room temperature to obtain dressing 1, dressing 2, and dressing 3, respectively.

[0061] Experimental Methods: Male SPF-grade C57BL / 6J mice weighing 20 ± 2 g were selected as model animals and randomly divided into a control group, a polyimide group, a traditional Shengji Yuhong ointment group, a new Shengji Yuhong ointment dressing group, a comparison dressing group 1, a comparison dressing group 2, and a comparison dressing group 3, with 5 mice in each group. After depilation, 1 cm × 1 cm wounds were created on the dorsal skin of the mice.

[0062] The control group used only sterile medical gauze for bandaging; the polyimide group used polyimide fiber gauze for bandaging; the traditional Shengji Yuhong ointment group used traditional Shengji Yuhong ointment to apply the wound and bandaged it with sterile medical gauze; the new Shengji Yuhong ointment dressing group used the new Shengji Yuhong ointment dressing prepared in Example 2 for bandaging; the comparison dressing group 1 used comparison dressing 1 for bandaging; the comparison dressing group 2 used comparison dressing 2 for bandaging; and the comparison dressing group 3 used comparison dressing 3 for bandaging.

[0063] The dressing was changed every other day (to fully cover the wound surface), and the wound surface area of the mice was analyzed using Image J analysis software (mm 2 ).

[0064] Statistical methods: SPSS 25.0 was used for statistical analysis. Data were analyzed using the repeated measures analysis of variance (ANOVA) method. Inter-group comparisons were performed using the LSD test. P < 0.05 indicated statistically significant differences.

[0065] Experimental results: Figure 3As shown in Figure 4, on the third day, compared with the control group (DZ), the Shengji Yuhong ointment group (SJYH) and the new Shengji Yuhong ointment dressing group (XXSJYH) significantly promoted wound healing, with statistical differences (P < 0.05); and the new Shengji Yuhong ointment dressing group has shown its advantage in promoting wound healing (P < 0.01), which is significantly better than the Shengji Yuhong ointment group (SJYH) (P < 0.05).

[0066] On day 7, compared with the control group (DZ), all groups showed a trend toward improved wound healing, with the Shengji Yuhong Ointment group (SJYH) showing a statistically significant difference (P < 0.05). However, the new Shengji Yuhong Ointment dressing group (XXSJYH) demonstrated an absolute advantage (P < 0.001), outperforming not only the Shengji Yuhong Ointment group (SJYH) but also the other improved dressings (P < 0.01).

[0067] On the 10th day, although all intervention groups had a significant effect on promoting wound healing compared with the control group (P < 0.05), the wound of the new Shengji Yuhong ointment dressing group (XXSJYH) was basically healed, with significant statistical differences (P < 0.0001). It was not only better than the Shengji Yuhong ointment dressing group (SJYH), but also better than other improved dressings (P < 0.001), and even better than the polyimide group (JXYA) (P < 0.0001).

[0068] At the same time, we also found that the effects of other improved dressings (DBFL1, DBFL2, DBFL3) were not significantly different from those of the traditional Shengji Yuhong ointment group (SJYH) (P>0.05).

[0069] The various aspects of the present invention have been described above. However, it should be understood that, without departing from the spirit of the present invention, those skilled in the art may make equivalent changes and modifications thereto, which also fall within the scope of the appended claims.

Claims

1. A method for preparing a new type of Shengji Yuhong ointment dressing, comprising the steps of preparing the new type of Shengji Yuhong ointment and applying the prepared new type of Shengji Yuhong ointment evenly on a 10 cm × 10 cm area with a weight of 50 g / m 2 The step of applying the ointment on the polyimide fiber gauze, wherein the new Shengji Yuhong ointment does not contain light powder and its dosage is 2 to 10 g.

2. The preparation method of the novel Shengji Yuhong Gao dressing according to claim 1, wherein The steps of preparing the novel Shengji Yuhong ointment include adding 15g of angelica sinensis, 3.75g of angelica dahurica, 1.5g of lithospermum officinale, and 9g of liquorice to 125g of sesame oil, soaking the mixture at room temperature for 3 days, decocting the mixture for 10 to 20 minutes, filtering the mixture, adding 15g of white wax, and melting the wax over a low fire; when the temperature drops to 80°C, adding 3g of Sanguisorba officinalis while stirring, and obtaining the novel Shengji Yuhong ointment after the Sanguisorba officinalis is dissolved.

3. The preparation method of the novel Shengji Yuhong Gao dressing according to claim 1 or 2, characterized in that: The dosage of the novel Shengji Yuhong ointment is 5g.

4. A new type of Shengji Yuhong ointment dressing, characterized in that: The dressing is prepared by the preparation method of claim 1.

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