Traditional Chinese medicine powder for treating oral ulcer and preparation method thereof

Abstract

The invention provides traditional Chinese medicine powder for treating oral ulcer and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine powder is prepared from the following raw medicinal materials in parts by weight: 8-15 parts of pseudo-ginseng, 10-20 parts of indigo naturalis, 15-25 parts of calcined cuttlebone, 5-12 parts of catechu, 1-3 parts of menthol, 1-4 parts of borneol, 10-18 parts of astragalus membranaceus, 6-12 parts of liquorice and pharmaceutically acceptable powder auxiliary materials, has the effects of clearing away heat and toxic materials, relieving swelling and pain, removing slough and promoting tissue regeneration, and tonifying qi and healing sore, can quickly relieve pain, and is free of toxic and side effects. The ulcer healing time is obviously shortened, the local immunity can be regulated, and the recurrence frequency is reduced.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a traditional Chinese medicine powder for treating oral ulcers and its preparation method. Background Technology

[0002] Oral ulcers are one of the most common diseases of the oral mucosa, clinically manifested as periodic, recurrent, self-limiting localized ulceration of the oral mucosa, accompanied by significant pain, affecting patients' eating, speech, and quality of life. Modern medicine believes that its pathogenesis is related to multiple factors such as immunity, genetics, infection, mental stress, and trace element deficiency. Western medicine treatment often uses topical glucocorticoids, antibacterial and anti-inflammatory drugs, analgesics, or immunosuppressants, which can relieve symptoms in the short term, but have problems such as significant side effects and easy recurrence.

[0003] Traditional Chinese medicine (TCM) has a long history of treating oral ulcers, often addressing underlying causes and mechanisms such as heat accumulation in the heart and spleen, yin deficiency with excessive fire, and spleen and stomach weakness. It offers advantages such as holistic regulation and fewer side effects. Currently, various TCM powders are available for the treatment of oral ulcers.

[0004] However, analysis of existing technologies reveals that existing Chinese medicine powders still have room for improvement in the following aspects: (1) Some powders are cold or irritating, and long-term use may damage the spleen, stomach or mucosa; (2) For recurrent aphthous ulcers, the effect of simply clearing heat or astringing sores is limited, and the effect of preventing recurrence is insufficient; (3) The adhesion, moisturizing and sustained-release effects of powders on the ulcer surface are not good, which affects the duration of efficacy and patient compliance; (4) Some traditional powders have poor taste, with a strong odor or spiciness, and patients have poor tolerance.

[0005] Therefore, developing a novel traditional Chinese medicine powder that can quickly relieve pain, promote healing, regulate the local immune microenvironment, reduce the recurrence rate, and is comfortable to use and has good adhesion is of great clinical significance and market value. Summary of the Invention

[0006] The primary objective of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine powder for treating oral ulcers. This powder has the effects of clearing heat and detoxifying, reducing swelling and relieving pain, removing necrotic tissue and promoting tissue regeneration, and invigorating qi and astringing sores. It can quickly relieve pain, significantly shorten the ulcer healing time, regulate local immunity, and reduce the frequency of recurrence.

[0007] Another objective of this invention is to provide a method for preparing the above-mentioned Chinese herbal powder, which has a stable process, can retain and synergize the effective components of each herb to the greatest extent, and improves the physical properties of the powder, thereby enhancing its mucosal adhesion and comfort.

[0008] A traditional Chinese medicine powder for treating oral ulcers, made from the following raw materials in parts by weight: 8-15 parts of Panax notoginseng, 10-20 parts of Indigo naturalis, 15-25 parts of calcined cuttlebone, 5-12 parts of catechu, 1-3 parts of menthol, 1-4 parts of borneol, 10-18 parts of Astragalus membranaceus, 6-12 parts of licorice, and pharmaceutically acceptable powder excipients.

[0009] Preferably, the powder is made from the following raw materials in parts by weight: 10 parts Panax notoginseng, 15 parts Indigo naturalis, 20 parts Calcined Cuttlebone, 8 parts Catechu, 2 parts Menthol, 2 parts Borneol, 15 parts Astragalus membranaceus, and 9 parts Licorice.

[0010] Preferably, the powder is made from the following raw materials in parts by weight: 8 parts Panax notoginseng, 10 parts Indigo naturalis, 15 parts calcined cuttlebone, 5 parts catechu, 1 part menthol, 1 part borneol, 10 parts Astragalus membranaceus, 6 parts licorice, and 3 parts microcrystalline cellulose.

[0011] Preferably, the powder is made from the following raw materials in parts by weight: 12 parts Panax notoginseng, 18 parts Indigo naturalis, 22 parts calcined cuttlebone, 10 parts catechu, 2.5 parts menthol, 3 parts borneol, 17 parts Astragalus membranaceus, 11 parts licorice, 4 parts mannitol and 3 parts hydroxypropyl cellulose.

[0012] Preferably, the method for preparing the calcined cuttlebone is as follows: place the cleaned cuttlebone in a smokeless furnace or a suitable container, and calcine it over a high flame until the surface is charred black, the interior is dark brown, and the texture is brittle. Remove it, let it cool, and grind it into a fine powder. This specific processing technique enhances its astringent, hemostatic, acid-neutralizing, and wound-healing effects, and also makes the texture more porous and easier to disperse.

[0013] Furthermore, the pharmaceutically acceptable excipients for the powder include, but are not limited to, one or more of hydroxypropyl cellulose, microcrystalline cellulose, and mannitol, with a total addition amount of 5%-15% of the total weight of the raw materials of the traditional Chinese medicine. Hydroxypropyl cellulose is preferred, as it can significantly improve the adhesion and retention time of the powder on moist mucous membrane surfaces.

[0014] The method for preparing the traditional Chinese medicine powder for treating oral ulcers according to the present invention includes the following steps: 1. Weigh each raw material according to the stated weight proportions; 2. Boil Astragalus and Licorice twice with water. For the first decoction, add 8-10 times the amount of water and boil for 1-1.5 hours. For the second decoction, add 6-8 times the amount of water and boil for 0.5-1 hour. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.15-1.20 at 60℃. Set aside for later use. 3. Grind Panax notoginseng, calcined cuttlebone, and catechu into powder, and pass them through a No. 7 sieve (120 mesh) to obtain fine powder A; 4. Mix the indigo powder with the fine powder A obtained in step 3 in equal increments until homogeneous, to obtain mixed powder B; 5. Grind borneol and menthol together until liquefied, then grind and melt them together with an appropriate amount (e.g., equal amount) of the mixed powder B obtained in step 4). After mixing evenly, mix it with the remaining mixed powder B to obtain mixed powder C. 6. Mix the thick paste obtained in step 2 with the mixed powder C obtained in step 5 and the excipients, dry, granulate, pulverize, pass through a No. 7 sieve (120 mesh), and package to obtain the final product. Beneficial effects of the present invention

[0015] Compared with the prior art, the present invention has the following significant advantages and beneficial effects:

[0016] (1) The formula is novel and the efficacy is comprehensive: This invention uses Panax notoginseng as the chief ingredient to remove blood stasis, stop bleeding, reduce swelling and relieve pain, targeting the core pathogenesis of local blood stasis and pain in ulcers; Indigo naturalis, borneol and menthol are the assistant ingredients to clear heat and detoxify, cool blood and reduce swelling, and relieve pain; Calcined cuttlebone and catechu are the adjuvant ingredients to enhance the effects of wound healing, tissue regeneration, hemostasis and dampness removal; Astragalus membranaceus and licorice are the guiding ingredients to invigorate qi and detoxify, relieve pain, harmonize the effects of the other ingredients, and protect the spleen and stomach to prevent cold and dampness from damaging the body's vital energy. The whole formula uses both cold and warm ingredients, and combines attack and tonification, treating both the root cause and the symptoms. It targets the "heat, toxin, blood stasis and putrefaction" of the ulcer, and also takes into account the overall "deficiency". In particular, the introduction of Astragalus membranaceus reflects the traditional Chinese medicine concepts of "strengthening the body's resistance to eliminate pathogens" and "regenerating tissue and flesh", which has a positive significance for preventing recurrence.

[0017] (2) Unique processing and preparation techniques enhance efficacy and user experience: Cuttlebone is calcined at a specific temperature to enhance its astringent and acid-neutralizing effects, and its texture is easier to pulverize and disperse. During the preparation process, the water-soluble active ingredients of Astragalus membranaceus and Glycyrrhiza uralensis are first extracted to form a thick paste, which is then blended with other medicinal powders and excipients. This process retains the activity of volatile components (borneol and menthol) while fully extracting the qi-boosting components. The addition of excipients such as hydroxypropyl cellulose significantly improves the shortcomings of traditional powders, such as being easily washed away by saliva and having a short duration of action, and prolongs the duration of local effective drug concentration.

[0018] (3) Significant clinical efficacy and low recurrence rate: Preliminary clinical trials (Example 4) show that the powder of the present invention is significantly better than the control group (commercially available ice boron powder) in terms of ulcer pain relief time and ulcer healing time, and the recurrence rate is significantly reduced 3 months after the end of treatment, showing good short-term and long-term efficacy.

[0019] (4) Safe to use and good compliance: All medicinal materials used in the formulation are included in the pharmacopoeia and have high safety. The powder has a fine texture and is less irritating when sprayed or applied to the ulcer surface. The cooling sensation brought by menthol can relieve pain immediately, improving the patient's medication experience and compliance. Detailed Implementation

[0020] The present invention will be further described in detail below with reference to embodiments, but these are not intended to limit the scope of the invention. Example 1

[0021] Weigh the raw materials as follows: 100g Panax notoginseng, 150g Indigo naturalis, 200g calcined cuttlebone, 80g catechu, 20g menthol, 20g borneol, 150g Astragalus membranaceus, 90g Glycyrrhiza uralensis, and 50g hydroxypropyl cellulose.

[0022] (2) Add water to Astragalus membranaceus and Glycyrrhiza uralensis and decoct twice. Add 10 times the amount of water and boil for 1.5 hours the first time. Add 8 times the amount of water and boil for 1 hour the second time. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure at 60°C to a thick paste with a relative density of 1.18.

[0023] (3) Grind Panax notoginseng, calcined cuttlebone and catechu into fine powder A by grinding them separately and passing them through a 120-mesh sieve.

[0024] (4) Mix indigo and fine powder A in a mixer in equal increments to obtain mixed powder B.

[0025] (5) Place borneol and menthol in a mortar and grind them together until completely liquefied. Add mixed powder B and grind to make the eutectic adsorbed evenly onto the powder. Then mix this premix with the remaining mixed powder B in a mixer for 30 minutes to obtain mixed powder C.

[0026] (6) The thick paste obtained in step (1) and the mixed powder C and hydroxypropyl cellulose are put into a high-efficiency mixing granulator, stirred and mixed evenly, and dried at a temperature below 50°C with a low temperature vacuum drying technology until the moisture content is ≤5%. Then, it is pulverized by a pulverizer, passed through a 120-mesh sieve, and packaged into sterile spray bottles (3g per bottle) to obtain the Chinese medicine powder of the present invention. Example 2

[0027] Weigh the raw materials as follows: 80g Panax notoginseng, 100g Indigo naturalis, 150g calcined cuttlebone, 50g catechu, 10g menthol, 10g borneol, 100g Astragalus membranaceus, 60g licorice, and 30g microcrystalline cellulose.

[0028] The powder dosage form was prepared according to the method in Implementation Case 1. Example 3

[0029] Weigh the raw materials as follows: 120g of Panax notoginseng, 180g of Indigo naturalis, 220g of calcined cuttlebone, 100g of catechu, 25g of menthol, 30g of borneol, 170g of Astragalus membranaceus, 110g of licorice, 40g of mannitol, and 30g of hydroxypropyl cellulose.

[0030] The powder dosage form was prepared according to the method in Implementation Case 1. Example 4: Clinical efficacy observation trial

[0031] (1) General information: 120 patients with recurrent aphthous ulcers who met the diagnostic criteria were randomly divided into a treatment group and a control group, with 60 patients in each group. There were no statistically significant differences between the two groups in terms of gender, age, course of disease, number and size of ulcers (P>0.05).

[0032] (2) Treatment methods: The treatment group used the powder prepared in Example 1 of this invention, which was sprayed onto the ulcer surface after cleaning the oral cavity, 4 times a day, after meals and before bedtime. The control group used commercially available ice-boron powder, with the same dosage and administration as the treatment group. The course of treatment for both groups was 5 days. During the treatment period, spicy and irritating foods were prohibited, and other related medications were discontinued.

[0033] (3) Observation indicators and efficacy criteria:

[0034] Pain relief time: the time from the first dose to a decrease of ≥50% in the visual analog scale (VAS) score for pain.

[0035] Ulcer healing time: The time from the start of treatment until the ulcer surface is completely epithelialized and the pain disappears.

[0036] Overall effective rate: Refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines". Cured: Ulcers healed and pain disappeared; Significantly effective: Ulcer area reduced by ≥70%, pain significantly reduced; Effective: Ulcer area reduced by ≥30%, pain somewhat reduced; Ineffective: Did not meet the effective criteria. Overall effective rate = (Cure + Significantly effective + Effective) / Total number of cases × 100%.

[0037] Recurrence rate: Follow up for 3 months after the end of treatment to record the proportion of patients with ulcer recurrence.

[0038] (4) Experimental results: Table 1. Comparison of clinical efficacy between the two groups of patients (n=60) Group Cured (case) Significant effect (example) Valid (example) Invalid (example) Overall efficiency Treatment group 28 22 8 2 96.7% control group 20 18 12 10 83.3% Note: Compared with the control group, P<0.05.

[0039] Table 2 Comparison of pain relief time, ulcer healing time and recurrence rate between the two groups of patients (n=60) Group Pain relief time (h, x±s) Ulcer healing time (d, x±s) 3-month recurrence rate Treatment group 8.5±2.1 3.2±0.8 13.3% control group 12.3±3.4 4.5±1.2 31.7% Note: Compared with the control group, P<0.01.

[0040] Conclusion: The traditional Chinese medicine powder of this invention is significantly superior to commercially available Bingpeng powder in terms of overall effective rate, pain relief speed, and ulcer healing speed, and can effectively reduce the recurrence rate in the short term, showing excellent comprehensive therapeutic effect. Example 5: Safety Evaluation

[0041] Skin irritation and allergy tests were performed on the powder prepared in Example 1 (according to relevant guidelines), and the results were negative. During clinical use, only 2 out of 60 patients in the treatment group experienced mild and transient local burning sensation, and no other significant adverse reactions were observed, indicating that the powder of the present invention has good safety.

Claims

1. A traditional Chinese medicine powder for treating oral ulcer and a preparation method thereof, characterized in that, This powder is made from the following raw materials in parts by weight: 8-15 parts Panax notoginseng, 10-20 parts Indigo naturalis, 15-25 parts Calcined Cuttlebone, 5-12 parts Catechu, 1-3 parts Menthol, 1-4 parts Borneol, 10-18 parts Astragalus membranaceus, 6-12 parts Licorice, and pharmaceutically acceptable powder excipients.

2. A method for preparing a traditional Chinese medicine powder for treating oral ulcers as described in claim 1, characterized in that... This includes the following steps: (1) Weigh each raw material according to the stated weight proportions; (2) Add water to Astragalus membranaceus and Glycyrrhiza uralensis and decoct twice. Add 8-10 times the amount of water for the first decoction and boil for 1-1.5 hours. Add 6-8 times the amount of water for the second decoction and boil for 0.5-1 hours. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.15-1.20 at 60°C for later use. (3) Grind Panax notoginseng, calcined cuttlebone and catechu into powder, pass through a No. 7 sieve (120 mesh) to obtain fine powder A; (4) Mix indigo with fine powder A obtained in step 3 in equal increments to obtain mixed powder B; (5) Grind borneol and menthol together until liquefied, then grind and melt them together with an appropriate amount (e.g., equal amount) of the mixed powder B obtained in step 4). After the mixture is evenly mixed, mix it with the remaining mixed powder B to obtain mixed powder C. (6) The thick paste obtained in step 2 is mixed with the mixed powder C obtained in step 5 and the excipients, and then dried, granulated, pulverized, and passed through a No. 7 sieve (120 mesh) and packaged.