A dermatological traditional Chinese medicine composition containing a hamel extract, a traditional Chinese medicine external preparation and application thereof

Abstract

The present application relates to the field of dermatological medicine, in particular to a dermatological traditional Chinese medicine composition containing a Sanguisorba officinalis extract, a traditional Chinese medicine external preparation and application thereof. The dermatological traditional Chinese medicine composition is a Sanguisorba officinalis extract and a Rumex nepalensis Spreng extract. Through screening of the composition and exploration of the preparation method, the finally prepared dermatological traditional Chinese medicine composition achieves good hemostatic, healing-promoting and anti-inflammatory effects, and has a good application prospect.

Description

Technical Field

[0001] This invention relates to the field of dermatological drug technology, specifically to a dermatological traditional Chinese medicine composition containing Sanguisorba officinalis extract, a topical preparation of traditional Chinese medicine, and their applications. Background Technology

[0002] With the rapid development of medical technology, the scope of surgery is constantly expanding, making effective hemostasis a key issue in trauma emergency care and postoperative recovery. Currently, there are many types of hemostatic materials commonly used in clinical practice, but each has its limitations. For example, animal-derived raw materials may cause allergic reactions and worsen infections.

[0003] Sanguisorba officinalis is a traditional Chinese medicinal herb, derived from the plant Sanguisorba officinalis, belonging to the Rosaceae family. Bloodroot officinalis L. or long-leaved Sanguisorba officinalis Bloodroot officinalis The dried root of *L. var. longifolia* (Bert.) YüetLi. The latter is commonly known as "Mian Di Yu". Harvesting and processing of *L. var. longifolia*: Harvest in spring when it sprouts or in autumn after the plant has withered. Remove the fibrous roots, wash, and dry, or slice while fresh and then dry. *L. var. longifolia* is irregularly spindle-shaped or cylindrical, slightly curved, 5–25 cm long and 0.5–2 cm in diameter. The surface is grayish-brown to dark brown, rough, with longitudinal striations. It is hard, with a relatively flat cross-section, pink or pale yellow, and the xylem is arranged slightly radially. It has a faint odor and a slightly bitter taste. Mian Di Yu: This product is long cylindrical, slightly curved, growing on short, thick rhizomes; the surface is reddish-brown or brownish-purple, with fine longitudinal striations. It is tough, with a yellowish-brown or reddish-brown cross-section, and the cortex has numerous yellowish-white or yellowish-brown cottony fibers. It has a faint odor and a slightly bitter taste. Sanguisorba officinalis is slightly cold in nature and has the effects of cooling blood and stopping bleeding, detoxifying and astringing sores. Clinically, it is used to treat hematochezia, hemostasis, and burns.

[0004] Rhubarb is a traditional Chinese medicinal herb, derived from the Polygonaceae plant Rumex acetosa. Rumexpatience L. wrinkled sorrel Rumexcrispus L. and tooth-shaped soursop Rot-toothed Fresh or dried roots and rhizomes of *L.*. Harvested in late summer and early autumn, used fresh or dried. *Rheum palmatum* has heat-clearing, diuretic, blood-cooling, and insecticidal properties. It is used to treat dysentery, gonorrhea, urinary retention, hematemesis, malignant sores, and scabies. It contains eosinogenin, emodin, chrysophanol, emodin methyl ether, and anthraquinones; the known activities of these components include antioxidant, antibacterial, and anti-inflammatory effects.

[0005] Chinese invention patent application CN201410326015.7 discloses the use of American cockroach or its extract and Sanguisorba officinalis or its extract in the preparation of a combined external hemostatic and wound-healing drug; the weight ratio of each raw material in the combined drug is: 1-10 parts of American cockroach or its extract and 1-10 parts of Sanguisorba officinalis or its extract. This invention, by combining American cockroach and Sanguisorba officinalis, significantly improves the drug's wound-repairing and hemostatic effects, and its efficacy is comparable to or even better than that of the classic drug Yunnan Baiyao, providing a new option for clinical medication.

[0006] Another Chinese invention patent application, CN201410406886.X, discloses a Sanguisorba officinalis sponge for external hemostasis and its preparation method. It is prepared from the following main raw materials in the indicated weight ratios: 1-2 parts of Sanguisorba officinalis water extract, 10-20 parts of starch, and 50-150 parts of water for injection. The raw materials used in this invention for external hemostasis are inexpensive, safe, and effective. The preparation process is simple, requires little investment, and yields high returns; it provides rapid and significant hemostasis, is convenient to use, and also has heat-clearing and detoxifying effects; it has no toxic side effects.

[0007] Existing technologies have a certain research foundation for hemostasis, anti-inflammatory and anti-inflammatory treatment in dermatology and have achieved considerable results. However, their effects on wound treatment and healing, hemostasis and anti-inflammatory effects still need to be improved. While fully exploring and utilizing the application of traditional medicine in dermatological treatment, how to achieve better efficacy with fewer raw material components is an important topic that those skilled in the art are still researching. Summary of the Invention

[0008] In view of the shortcomings of the existing technology, the technical problem to be solved by the present invention is to provide a dermatological traditional Chinese medicine composition containing Sanguisorba officinalis extract, a topical preparation of traditional Chinese medicine, and its application.

[0009] To solve the above-mentioned technical problems, the present invention provides the following technical solution: On one hand, the present invention provides a dermatological traditional Chinese medicine composition containing Sanguisorba officinalis extract, wherein the raw materials of the dermatological traditional Chinese medicine composition are Sanguisorba officinalis extract and Rheum palmatum extract.

[0010] In some specific embodiments of the present invention, the raw materials of the dermatological traditional Chinese medicine composition are 15-25 parts of Sanguisorba officinalis extract and 2-5 parts of Rheum palmatum extract, by weight.

[0011] In some specific embodiments of the present invention, the Sanguisorba officinalis extract is obtained by extracting Sanguisorba officinalis with water.

[0012] In some specific embodiments of the present invention, the preparation of the rhubarb extract includes the following steps: (1) Extract rhubarb with ethanol to obtain the extract; (2) Concentrate the extract under reduced pressure, dry it, and pulverize it to obtain the final product.

[0013] In some specific embodiments of the present invention, the ethanol mentioned in step (1) is a 65%-85% aqueous ethanol solution, and the mass of the ethanol is 8-15 times the mass of rhubarb.

[0014] In some specific embodiments of the present invention, the extraction in step (1) is a heating reflux extraction, the number of extractions is 1-2 times, and the extraction time for each extraction is 0.5-1h.

[0015] Secondly, the present invention provides a topical Chinese medicine preparation containing Sanguisorba officinalis extract, the topical Chinese medicine preparation comprising: the aforementioned dermatological Chinese medicine composition, and pharmaceutically acceptable excipients.

[0016] In some specific embodiments of the present invention, the topical preparation of traditional Chinese medicine comprises, by weight, 5-15 parts of the dermatological traditional Chinese medicine composition, 35-45 parts of gelatin, and 5-15 parts of anhydrous ethanol.

[0017] In some specific embodiments of the present invention, the gelatin, by weight percentage, can pass through a 60-mesh sieve by 100%, but not more than 20% can pass through a 100-mesh sieve.

[0018] Thirdly, the present invention provides a method for preparing the aforementioned topical Chinese medicine preparation, comprising the following steps: (1) Take the aforementioned dermatological traditional Chinese medicine composition, add anhydrous ethanol, and grind it until uniform; (2) Add gelatin, mix evenly, dry, pulverize, pass through an 80-120 mesh sieve, and package to obtain the product.

[0019] In another aspect, the present invention provides the application of the above-mentioned dermatological traditional Chinese medicine composition or the above-mentioned topical traditional Chinese medicine preparation in the preparation of wound hemostatic agents and / or anti-inflammatory and healing-promoting agents.

[0020] Compared with the prior art, the beneficial effects of the present invention are as follows: (1) This invention screened the compound components and obtained a refined formula consisting of Sanguisorba officinalis and Rheum palmatum. Sanguisorba officinalis contains active ingredients such as tannins and saponins, which achieve hemostasis by constricting blood vessels and promoting platelet aggregation. Rheum palmatum contains anthraquinone components such as emodin, chrysophanol, emodin methyl ether, and eosinogen glycoside, which can exert anti-inflammatory, antioxidant, and hemostatic effects. The combination of the two forms a dual hemostatic effect of "astringency-procoagulation", which is suitable for bleeding caused by various reasons. Pharmacological experiments have shown that the two have a strong synergistic effect and can achieve significant hemostatic, healing-promoting, and anti-inflammatory effects.

[0021] (2) This invention employs a specific process to extract rhubarb from the soil, using ethanol extraction with 65%-85% ethanol to maximize the extraction of active ingredients such as emodin, emodin methyl ether, chrysophanol, and eosin glycosides. Its hemostatic, healing-promoting, and anti-inflammatory effects are further enhanced, showing promising application prospects. Detailed Implementation

[0022] The present invention will be described in detail below with reference to specific embodiments, but the scope of the present invention is not limited thereto.

[0023] In the following specific embodiments, unless otherwise specified, the reagents and instruments used are commonly used in the art and can be obtained commercially; the methods used are conventional methods in the art, and those skilled in the art can understand how to specifically implement the methods and achieve the corresponding results based on the embodiments. All ethanol concentrations below are volume concentrations. The gelatin, by weight percentage, can pass through a 60-mesh sieve with 100% passability, but no more than 20% can pass through a 100-mesh sieve.

[0024] Example 1 This embodiment provides a dermatological traditional Chinese medicine composition containing Sanguisorba officinalis extract. By weight, the raw material composition of the dermatological traditional Chinese medicine composition consists of 25 parts of Sanguisorba officinalis extract and 5 parts of Rheum palmatum extract.

[0025] The preparation method of the Sanguisorba officinalis extract is as follows: Sanguisorba officinalis is decocted twice with 10 times the amount of water, each time for 30 minutes. The decoction is filtered, the filtrates are combined, concentrated, and dried to obtain a dry extract powder.

[0026] The preparation method of Rheum palmatum extract is as follows: Rheum palmatum is heated and refluxed twice with 12 times the amount of 75% ethanol for 40 minutes each time. The extract is filtered, the filtrates are combined, concentrated under reduced pressure, dried, and pulverized to obtain the extract.

[0027] This embodiment provides a topical dermatological preparation, a healing powder, containing a water extract of Sanguisorba officinalis. The prescription is as follows: Example 1: 10g of a dermatological herbal composition; Gelatin (pharmaceutical grade) 39.5g; 10 mL of anhydrous ethanol.

[0028] The preparation method of the dermatological topical Chinese medicine healing powder is as follows: (1) Take the prescribed amount of the dermatological Chinese medicine composition, add anhydrous ethanol, and grind it until uniform; (2) Add pharmaceutical grade gelatin powder (by weight percentage, 100% can pass through a 60-mesh sieve, but no more than 20% can pass through a 100-mesh sieve), mix evenly, dry, grind appropriately, pass through a 100-mesh sieve, and package to obtain the product.

[0029] Clinical applications: It has astringent and hemostatic properties, antibacterial and anti-inflammatory effects, and can be used externally as a wound hemostatic agent, a filling hemostatic agent for broken wounds, and an anti-inflammatory and healing-promoting agent during the wound recovery stage.

[0030] Example 2 This embodiment provides a dermatological traditional Chinese medicine composition containing Sanguisorba officinalis extract. By weight, the raw material composition of the dermatological traditional Chinese medicine composition consists of 15 parts of Sanguisorba officinalis extract and 2 parts of Rheum palmatum extract.

[0031] The preparation method of the Sanguisorba officinalis extract is as follows: Sanguisorba officinalis is decocted twice with 10 times the amount of water, each time for 30 minutes. The decoction is filtered, the filtrates are combined, concentrated, and dried to obtain a dry extract powder.

[0032] The preparation method of Rheum palmatum extract is as follows: Rheum palmatum is heated and refluxed with 15 times the amount of 85% ethanol for 1 hour, filtered, the filtrate is concentrated under reduced pressure, dried, and pulverized to obtain the extract.

[0033] This embodiment provides a topical dermatological preparation, a healing powder, containing Sanguisorba officinalis water extract. The prescription is as follows: Example 2: 10g of a dermatological herbal composition; Gelatin (pharmaceutical grade) 39.5g; 10 mL of anhydrous ethanol.

[0034] Preparation method of topical Chinese herbal medicine healing powder for dermatology: (1) Take the prescribed amount of the dermatological Chinese medicine composition, add anhydrous ethanol, and grind it until uniform; (2) Add pharmaceutical grade gelatin powder (by weight percentage, 100% can pass through a 60-mesh sieve, but no more than 20% can pass through a 100-mesh sieve), mix evenly, dry, grind appropriately, pass through a 100-mesh sieve, and package to obtain the product.

[0035] Clinical applications: It has astringent and hemostatic properties, antibacterial and anti-inflammatory effects, and can be used externally as a wound hemostatic agent, a filling hemostatic agent for broken wounds, and an anti-inflammatory and healing-promoting agent during the wound recovery stage.

[0036] Example 3 This embodiment provides a dermatological traditional Chinese medicine composition containing Sanguisorba officinalis extract. By weight, the raw materials of the dermatological traditional Chinese medicine composition are 20 parts of Sanguisorba officinalis extract and 3 parts of Rheum palmatum extract.

[0037] The preparation method of the Sanguisorba officinalis extract is as follows: Sanguisorba officinalis is decocted twice with 10 times the amount of water, each time for 30 minutes. The decoction is filtered, the filtrates are combined, concentrated, and dried to obtain a dry extract powder.

[0038] The preparation method of Rheum palmatum extract is as follows: Rheum palmatum is heated and refluxed twice with 10 times the amount of 65% ethanol for 50 minutes each time. The extract is filtered, the filtrates are combined, concentrated under reduced pressure, dried, and pulverized to obtain the extract.

[0039] This embodiment provides a topical dermatological preparation, a healing powder, containing Sanguisorba officinalis water extract. The prescription is as follows: Example 3: 10g of a dermatological herbal composition; Gelatin (pharmaceutical grade) 39.5g; 10 mL of anhydrous ethanol.

[0040] Preparation method of topical Chinese herbal medicine healing powder for dermatology: (1) Take the prescribed amount of the dermatological Chinese medicine composition, add anhydrous ethanol, and grind it until uniform; (2) Add pharmaceutical grade gelatin powder (by weight percentage, 100% can pass through a 60-mesh sieve, but no more than 20% can pass through a 100-mesh sieve), mix evenly, dry, grind appropriately, pass through a 100-mesh sieve, and package to obtain the product.

[0041] Clinical applications: It has astringent and hemostatic properties, antibacterial and anti-inflammatory effects, and can be used externally as a wound hemostatic agent, a filling hemostatic agent for broken wounds, and an anti-inflammatory and healing-promoting agent during the wound recovery stage.

[0042] Comparative Example 1 The only difference between this comparative example and Example 1 is the raw material components of the dermatological traditional Chinese medicine composition, specifically 30 parts of Sanguisorba officinalis extract.

[0043] The preparation method of its Sanguisorba officinalis extract is consistent with that in Example 1.

[0044] Comparative Example 2 The difference between this comparative example and Example 1 lies in the different raw material components of the dermatological traditional Chinese medicine composition, specifically 30 parts of rhubarb extract.

[0045] The preparation method of its rhubarb extract is consistent with that in Example 1.

[0046] Comparative Example 3 The difference between this comparative example and Example 1 is that the preparation method of the rhubarb extract is different, specifically: Add 12 times the amount of water to the rhubarb medicinal material, heat and reflux to extract twice, 40 minutes each time, filter, combine the filtrates, concentrate under reduced pressure, dry, and pulverize to obtain the final product.

[0047] Comparative Example 4 The difference between this comparative example and Example 1 is that the proportions of the raw material composition are different. Specifically, by weight, the raw materials of the dermatological herbal composition are 12 parts of Sanguisorba officinalis extract and 18 parts of Rheum palmatum extract. The rest of the process remains the same as in Example 1.

[0048] Experiment 1: Study on the hemostatic efficacy of the dermatological traditional Chinese medicine composition of the present invention Eighty healthy adult male Kunming mice (SPF grade, weighing 28±2g) were used. After one week of normal feeding and water intake and acclimatization, the mice were randomly divided into eight groups: the model group, Example 1-Example 3 groups, and Comparative Example 1-Comparative Example 4 groups. Mice were anesthetized by intraperitoneal injection (ig) of 4% sodium pentobarbital (50mg / kg). The experiment began approximately 120 minutes after administration when the mice were fully anesthetized. Equivalent amounts of healing powder prepared for Examples 1-Example 3 or Comparative Example 1-Comparative Example 4 were weighed and placed in separate display bottles. Physiological saline was placed in another display bottle. The tail of each mouse was cut approximately 10mm from the tip using sterile surgical scissors. The severed tail was immediately inserted into the display bottle to absorb the healing powder, ensuring complete coverage of the wound. In the model group, the residual tail was briefly dipped in physiological saline before removal. Timing was started, and the time to cessation of bleeding was recorded. The results are shown in Table 1.

[0049] Table 1

[0050] Note: Compared to the model group, * P<0.05, ** P<0.01; compared with Example 1, # P<0.05.

[0051] Compared to the model group, the hemostasis time in each drug administration group of this invention was significantly shortened, and the hemostasis time in the example groups was significantly better. The hemostasis time in Comparative Examples 1-4 was longer than that in each example group, with Comparative Example 3 having a relatively shorter hemostasis time.

[0052] Experiment 2: Study on the anti-inflammatory and wound-healing efficacy of the dermatological traditional Chinese medicine composition of this invention. Grouping and Modeling: Sixty-four SD rats, half male and half female, weighing 200±20g, were used. The rats were randomly divided into the model group, Example 1-Example 3 groups, and Comparative Example 1-Comparative Example 4 groups, with 8 rats in each group. The hair on the back of all rats was removed. After anesthesia, the hairless area on the back of the rats was disinfected with 70% alcohol, and a circular full-thickness skin with a diameter of 1.5cm was cut off with scissors, reaching the fascia.

[0053] Drug administration: Except for the model group, the other groups of rats were given the healing powder prepared in the corresponding examples 1-3 or comparative examples 1-4, which was sprinkled on the wound to completely cover the wound. The dosage was equivalent to 1g (crude drug) / kg. The model group was given physiological saline to lightly apply to the wound and covered with sterile gauze and fixed to prevent the rats from licking the wound and causing infection. The drug was applied once a day for 7 consecutive days.

[0054] The next day, 4.5 × 10⁴ kJ of the drug was injected subcutaneously into the aforementioned wound. 8 0.1 ml of CFU / mL Staphylococcus aureus solution was applied, and the medication was continued. 24 hours after the last application, the redness, swelling, and discharge of the affected skin were visually observed. The efficacy evaluation criteria are shown in Table 2 below, and the scores for each reaction symptom (rounded to two decimal places) are shown in Table 3. The time for epithelialization to appear on the wound surface in each group of rats was also recorded (rounded to one decimal place) in Table 4.

[0055] Table 2

[0056] Table 3

[0057] Note: Compared to the model group * P<0.05, ** P<0.01; compared with Example 1, # P<0.05, ## P<0.01.

[0058] In Table 3, the differences between the experimental groups and the model group are statistically significant (P < 0.01). The comparisons between the comparative example groups and Example 1 group are also statistically significant. # P<0.05, ## P < 0.01 indicates a statistically significant difference. x ± s,n= 8). The results showed that the combined use of the Sanguisorba officinalis extract and Rheum palmatum extract prepared by the specific method of this invention significantly reduced the scores of skin redness and swelling and the degree of secretion in rat sores in the example group.

[0059] Table 4

[0060] Note: Compared to the model group * P<0.05, ** P<0.01; compared with Example 1, # P<0.05.

[0061] Table 4 shows that, compared to the model group, the time for epithelial development was significantly shorter in each of the embodiment groups. **P<0.01. Comparative Examples 1-4 showed a longer time to epithelial development compared to Examples 1-3.

[0062] In summary, the healing powder prepared by this invention shortens the wound hemostasis time and exhibits good wound healing effect.

[0063] The above detailed description is a specific description of one of the feasible embodiments of the present invention. This embodiment is not intended to limit the patent scope of the present invention. All equivalent implementations or modifications that do not depart from the present invention should be included within the scope of the technical solution of the present invention.

Claims

1. A dermatological traditional Chinese medicine composition containing Sanguisorba officinalis extract, characterized in that, The raw materials of the dermatological traditional Chinese medicine composition are Sanguisorba officinalis extract and Rheum palmatum extract.

2. The traditional Chinese medicine composition for dermatology according to claim 1, characterized in that, The raw materials of the dermatological traditional Chinese medicine composition, by weight, are 15-25 parts of Sanguisorba officinalis extract and 2-5 parts of Rheum palmatum extract.

3. The traditional Chinese medicine composition for dermatology according to claim 1, characterized in that, The Sanguisorba officinalis extract is obtained by extracting Sanguisorba officinalis with water.

4. The traditional Chinese medicine composition for dermatology according to claim 1, characterized in that, The preparation of the rhubarb extract includes the following steps: (1) Extract rhubarb with ethanol to obtain the extract; (2) Concentrate the extract under reduced pressure, dry it, and pulverize it to obtain the final product.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The ethanol mentioned in step (1) is a 65%-85% aqueous ethanol solution, and the mass of the ethanol is 8-15 times the mass of rhubarb.

6. The traditional Chinese medicine composition according to claim 4, characterized in that, The extraction in step (1) is a heating reflux extraction, and the extraction is performed 1-2 times, with each extraction lasting 0.5-1h.

7. A topical preparation of traditional Chinese medicine containing Sanguisorba officinalis extract, characterized in that, The topical preparations of traditional Chinese medicine include: the dermatological traditional Chinese medicine composition according to any one of claims 1-6, and pharmaceutically acceptable excipients.

8. The topical preparation of traditional Chinese medicine according to claim 7, characterized in that, By weight, the topical Chinese medicine preparation comprises: 5-15 parts of the dermatological Chinese medicine composition, 35-45 parts of gelatin, and 5-15 parts of anhydrous ethanol; the gelatin, by weight percentage, shall be 100% passable through a 60-mesh sieve, but not more than 20% passable through a 100-mesh sieve.

9. A method for preparing a traditional Chinese medicine external application preparation according to any one of claims 7-8, characterized in that, Includes the following steps: (1) Take the dermatological Chinese medicine composition, add anhydrous ethanol, and grind it until uniform; (2) Add gelatin, mix evenly, dry, pulverize, pass through an 80-120 mesh sieve, and package to obtain the product.

10. The use of the dermatological traditional Chinese medicine composition according to any one of claims 1-6 or the traditional Chinese medicine external preparation according to any one of claims 7-8 in the preparation of wound hemostatic agents and / or anti-inflammatory and healing-promoting agents.

Images