Lianxin shengji powder, and preparation method and application thereof

Abstract

The application discloses a lotus plumule muscle-regenerating powder as well as a preparation method and application thereof. The lotus plumule muscle-regenerating powder comprises the following components in volume fraction: 10-50 parts of lotus plumule, 5-10 parts of typhae pollen, 20-60 parts of indigo, 10-70 parts of mentha, 10-60 parts of borneol, 80-150 parts of calcined gypsum and 10-120 parts of licorice. The lotus plumule muscle-regenerating powder is prepared through the optimization steps of cleaning, crushing, screening, grinding, mixing, sterilization, sub-packaging and sealing. The lotus plumule muscle-regenerating powder is precisely aimed at the pathogenesis of oral ulcer after chemotherapy, that is, 'heat toxin accumulation, yin deficiency and mucosal damage'. Through scientific combination of monarch, minister and assistant, the lotus plumule muscle-regenerating powder plays the synergistic effect of clearing heart and purging fire, cooling blood and detoxifying, astringing and muscle-regenerating, and swelling and pain relieving. The lotus plumule muscle-regenerating powder can promote wound healing when being used for spraying and applying on ulcer wound. The preparation process is simple and controllable, the safety is high, the medicine source is extensive, and the lotus plumule muscle-regenerating powder has excellent application value in the clinical treatment of oral ulcer after chemotherapy.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compound preparation technology, and in particular to a lotus seed heart muscle-regenerating powder and its preparation method and application. Background Technology

[0002] Chemotherapy-induced oral ulcers are a common complication in cancer patients undergoing chemotherapy. They are caused by damage to the oral mucosal epithelial cells by chemotherapy drugs. Clinical manifestations include oral mucosal congestion, ulcer formation, and severe pain, which seriously affects patients' eating and leads to insufficient nutrient intake. Some patients are forced to discontinue their chemotherapy regimen due to the worsening of ulcer symptoms, which seriously reduces the therapeutic effect of chemotherapy and the quality of life of patients.

[0003] Currently, clinical treatment for oral ulcers after chemotherapy mainly focuses on local anti-inflammatory, analgesic, and oral care. Commonly used medications include Western medicine preparations such as mouthwashes and ulcer patches, but these have drawbacks such as slow onset of action, long ulcer healing cycles, and weak mucosal repair effects. Traditional Chinese medicine has unique advantages in treating sores and mucosal damage. Formulas like Shengji San are commonly used topical preparations in clinical practice, which can astringe wounds, reduce swelling and pain, and promote tissue repair. However, existing Shengji San preparations are mostly designed for common oral ulcers, and their formulations do not take into account oral ulcers caused by chemotherapy. They are not targeted enough for the specific pathogenesis of "internal heat and toxin accumulation, yin deficiency, and mucosal damage," resulting in limited therapeutic effects. Summary of the Invention

[0004] Purpose of the Invention: The first purpose of this invention is to provide a Lotus Heart Muscle-Regenerating Powder, which, through a scientific combination of principal, assistant, and adjuvant herbs, precisely targets the unique pathogenesis of oral ulcers after chemotherapy, exerting a synergistic effect of clearing heat and purging fire, cooling blood and detoxifying, promoting wound healing and tissue regeneration, and reducing swelling and relieving pain. It can quickly relieve ulcer pain and promote the healing of mucosal wounds. The second purpose of this invention is to provide a method for preparing the Lotus Heart Muscle-Regenerating Powder. The third purpose of this invention is to provide applications of the Lotus Heart Muscle-Regenerating Powder.

[0005] Technical solution: The lotus seed heart muscle-regenerating powder of the present invention comprises the following components by volume: 10-50 parts lotus seed heart, 5-10 parts cattail pollen, 20-60 parts indigo naturalis, 10-70 parts peppermint, 10-60 parts borneol, 80-150 parts calcined gypsum, and 10-120 parts licorice.

[0006] Preferably, the ingredients include the following components by volume: 10 parts lotus seed heart, 10 parts cattail pollen, 40 parts indigo naturalis, 10 parts peppermint, 60 parts borneol, 80 parts calcined gypsum, and 10 parts licorice.

[0007] The preparation method of the Lotus Heart Muscle-Regenerating Powder of the present invention includes the following steps:

[0008] (1) Cleaning process: Select, remove impurities, and wash the lotus seed heart, licorice, and mint separately, and dry them at low temperature for later use; purify the cattail pollen, indigo, borneol, and calcined gypsum directly.

[0009] (2) Crushing and sieving: Crush the above raw materials separately and sieve them through a medicine sieve to obtain fine powder;

[0010] (3) Grind separately: Place the borneol in a mortar and grind it separately into a fine powder for later use;

[0011] (4) Mixing preparation: Mix the remaining powders evenly, and then mix them thoroughly with borneol powder using the equal incremental method to ensure uniform color;

[0012] (5) Sterilization treatment: The mixed powder is sterilized to meet the aseptic requirements;

[0013] (6) Dispensing and sealing: Dispense the sterilized powder into sterile containers, seal them, and store them in a cool, dry place away from light.

[0014] Preferably, the low-temperature drying in step (1) is 40-50°C, and the raw material is dried to a moisture content of 5%-8%.

[0015] Preferably, in step (2), a universal pulverizer is used for pulverization, and the un-sieved part is pulverized again until all of it is sieved.

[0016] Preferably, in step (2), the drug sieve is a 100-120 mesh sieve.

[0017] Preferably, in step (5), the number of colonies after sterilization is <10 cfu / g.

[0018] Preferably, in step (5), the sterilization is performed by 60Co-γ irradiation.

[0019] The application of the Lotus Heart Muscle-Generating Powder described in this invention in the preparation of a medicine for treating oral ulcers.

[0020] Preferably, the oral ulcer is a post-chemotherapy oral ulcer. Post-chemotherapy oral ulcers are characterized by congestion, pain, ulceration, and non-healing of the oral mucosa.

[0021] Preferably, the Lianxin Shengji Powder is used externally. After cleaning the oral cavity, take 0.1-0.3 g of Lianxin Shengji Powder and spray it evenly onto the ulcer surface, 3-4 times a day, 30 minutes after meals and before bedtime, for 5-7 days as one course of treatment.

[0022] Mechanism of Invention: This invention, Lianxin Shengji Powder, targets the unique pathogenesis of oral ulcers following chemotherapy, characterized by internal heat and toxin accumulation, yin deficiency, and mucosal damage. Based on the principles of traditional Chinese medicine's monarch-minister-assistant-guide formula, the various herbs work synergistically to clear heat and fire, cool the blood and detoxify, promote wound healing and tissue regeneration, and reduce swelling and pain. The specific mechanism of formulation is as follows: Calcined gypsum is the principal ingredient. It is sweet, pungent, and slightly cold in nature, and enters the lung and stomach meridians. It excels at astringing and is effective in absorbing dampness, healing sores, promoting tissue regeneration, and stopping pain. Blood can directly repair damaged oral mucosa, laying the foundation for ulcer healing. Indigo naturalis and Typha pollen are used as auxiliary ingredients. Indigo naturalis is salty and cold, entering the liver and lung meridians, clearing heat and detoxifying, cooling blood and reducing swelling, effectively clearing stagnant heat and blood-related heat toxins, precisely targeting symptoms of internal heat toxins. Typha pollen is sweet and neutral, entering the liver and pericardium meridians, cooling blood and promoting blood circulation, removing blood stasis and reducing swelling, helping to dissipate local congestion of qi and blood in the oral cavity, conforming to the principle of "new flesh grows when blood stasis is removed." The two ingredients complement each other. This formula is used to clear heat and stagnation in the blood to expel pathogens, and to disperse local stagnation to unblock the meridians, creating a favorable local environment for the principal drug to promote wound healing and tissue regeneration. Lotus seed heart and licorice are used as adjuvants. Lotus seed heart is bitter and cold, enters the heart meridian, clears heart fire, cools blood and relieves pain, clears heart fire and detoxifies, clears heart fire and preserves yin fluid, and also addresses the yin fluid deficiency of patients after chemotherapy. Licorice is sweet and neutral, enters the heart, lung, spleen and stomach meridians, clears heat and detoxifies, relieves spasms and pain, and harmonizes the various drugs. It helps to clear local heat toxins in the oral cavity, relieves severe pain from ulcers, and harmonizes the cold and hot properties of the entire formula, so that the drugs work together without harming the body's vital energy. Peppermint and borneol are used as guiding agents. Peppermint is pungent and cool, enters the lung and liver meridians, disperses wind-heat, benefits the throat and reduces swelling, and is a light and penetrating agent. Borneol is bitter, pungent and slightly cold, enters the heart, spleen and lung meridians, clears heat and relieves pain, opens the orifices and disperses stagnation. The two are light and ascending, which can guide the medicinal power of the drugs directly to the oral and pharyngeal ulcers, significantly enhancing the local efficacy.

[0023] The entire formula is based on nourishing yin and astringing sores, and uses clearing heat and purging fire as its function, combining clearing and tonifying, and treating both the root cause and the symptoms. Among them, calcined gypsum and licorice are sweet and cold to nourish yin, and lotus seed heart is bitter and cold to clear heat. The three work together to nourish yin and reduce fire, while also addressing the root cause of yin deficiency. Indigo and cattail pollen cool the blood, detoxify, remove blood stasis and reduce swelling, while peppermint and borneol penetrate heat to the outside and guide the medicine upward. The combined use of these medicines allows the pathogenic heat to be expelled externally, ultimately achieving the therapeutic effects of clearing heat toxins, dispersing blood stasis, replenishing yin fluids and repairing mucous membranes, which precisely matches the pathological characteristics of oral ulcers after chemotherapy.

[0024] Beneficial effects: Compared with the prior art, the present invention has the following significant advantages:

[0025] (1) Precise formulation and effective efficacy: The Lianxin Shengji Powder of this invention is designed for the unique pathogenesis of oral ulcers after chemotherapy, namely "internal heat and toxin, deficiency of yin fluid and damage to mucosa". The combination of principal, assistant and adjuvant herbs is scientific. The synergistic effect of each herb can quickly relieve ulcer pain and shorten the wound healing time. It is highly targeted and effective in treating oral mucositis after chemotherapy.

[0026] (2) Standardized preparation process and controllable quality: This invention provides a standardized preparation method for Lianxin Shengji Powder, which quantifies and defines the parameters of each process step. The process is simple and easy to operate, avoiding the problems of vague process parameters and non-standard operation in traditional processes. It is suitable for large-scale industrial production. Furthermore, the sterilization standard is strictly controlled during the preparation process to ensure that the quality of the finished product is stable and controllable.

[0027] (3) High safety and no obvious adverse reactions: This invention is a pure Chinese medicine external preparation. It is applied by local spraying. The medicine acts directly on the ulcer wound, avoiding the toxic side effects of systemic medication. There are no obvious adverse reactions in clinical application. It is safe to use and suitable for long-term use by cancer chemotherapy patients.

[0028] (4) Wide range of medicinal sources and moderate cost: The raw materials used in this invention are all commonly used Chinese medicines. The medicinal sources are widely distributed and easy to obtain. The preparation process does not require special equipment. The production cost is moderate and it is convenient for clinical promotion and application.

[0029] (5) Improve patients’ quality of life and ensure smooth chemotherapy: This invention can effectively improve the symptoms of oral pain and mucosal ulceration in patients with oral ulcers after chemotherapy, ensure patients can eat and drink, ensure the body’s nutritional intake, avoid patients being forced to interrupt the chemotherapy regimen due to ulcer symptoms, significantly improve the quality of life of cancer chemotherapy patients, and ensure the smooth progress of chemotherapy treatment. Attached Figure Description

[0030] Figure 1 A graph showing the percentage change in rat body weight;

[0031] Figure 2 A graph showing the ulcer area in rats;

[0032] Figure 3 This is a comparison image of oral ulcers before and after chemotherapy in patients undergoing clinical chemotherapy. Detailed Implementation

[0033] The technical solution of the present invention will be further described below with reference to the embodiments.

[0034] Example 1

[0035] The Lotus Seed Heart Muscle-Regenerating Powder of the present invention comprises, by volume, 10 parts lotus seed heart, 5 parts cattail pollen, 20 parts indigo naturalis, 10 parts peppermint, 10 parts borneol, 80 parts calcined gypsum, and 10 parts licorice.

[0036] The preparation method includes the following steps:

[0037] (1) Cleaning process: Select, remove impurities and wash lotus seed hearts, licorice and mint respectively, and dry them at low temperature until the moisture content is 5% to 8% for later use; select and remove impurities directly from cattail pollen, indigo, borneol and calcined gypsum for later use.

[0038] (2) Crushing and sieving: The above raw materials are crushed separately using a high-speed universal crusher and all are passed through a 100-mesh sieve. The un-sieved parts are crushed again.

[0039] (3) Grind separately: Place the borneol in a mortar and grind it separately into a fine powder for later use;

[0040] (4) Mixing preparation: Mix lotus seed heart, cattail pollen, indigo naturalis, peppermint, calcined gypsum and licorice powder evenly, and mix with borneol powder by equal increment until the color is uniform;

[0041] (5) Sterilization treatment: The mixed powder was sterilized by 60Co-γ irradiation. The colony count after sterilization was <10cfu / g;

[0042] (6) Dispensing and sealing: The powder is dispensed into sterile spray bottles under aseptic conditions, sealed, and stored in a cool, dry place away from light.

[0043] Example 2

[0044] The Lotus Seed Heart Muscle-Regenerating Powder of the present invention comprises, by volume, 10 parts lotus seed heart, 10 parts cattail pollen, 40 parts indigo naturalis, 10 parts peppermint, 60 parts borneol, 80 parts calcined gypsum, and 10 parts licorice.

[0045] The preparation method is the same as in Example 1.

[0046] Example 3

[0047] The Lotus Seed Heart Muscle-Regenerating Powder of the present invention comprises, by volume, 50 parts lotus seed heart, 10 parts cattail pollen, 60 parts indigo naturalis, 70 parts peppermint, 60 parts borneol, 150 parts calcined gypsum, and 120 parts licorice.

[0048] The preparation method is the same as in Example 1.

[0049] Example 4: Efficacy verification of Lianxin Shengji Powder in treating oral ulcers after chemotherapy

[0050] 1. Mouse experiment

[0051] (1) Thirty male SD rats aged 6-8 weeks were raised under specific pathogen-free conditions and injected intraperitoneally with 5-FU (30 mg / kg) to simulate chemotherapy. A rat oral ulcer model was constructed using filter paper (5 mm in diameter) soaked in 50% acetic acid. The rats were randomly divided into six groups: control group: PBS treatment; model group: physiological saline treatment (positive control); experimental group 1: Yipushu oral gel; experimental group 2: lotus seed heart; experimental group 3: lotus seed heart removal and muscle-regenerating powder (the formula of Example 2 was used without lotus seed heart); experimental group 4: lotus seed heart muscle-regenerating powder (Example 2).

[0052] (2) Each group was administered the medicine by spraying 3 times a day. After cleaning the oral cavity, 0.2 g of the medicinal powder was taken and sprayed on the ulcer surface to observe the clinical efficacy.

[0053] The experimental results are as Figure 1 and 2 shown.

[0054] It can be seen from Figure 1 that the curve position of the whole formula group of Lianxin Shengji Powder is significantly higher than that of the single herb of lotus plumule group and the group without lotus plumule of Lianxin Shengji Powder (deficient - flavor compound group). Its weight loss amplitude is the smallest, the recovery slope is the largest, and it is the closest to the normal control group. The weight change trend of the group without lotus plumule of Lianxin Shengji Powder is almost exactly the same as that of the single herb of lotus plumule group, and both are higher than the model group. The above results show that the whole formula of Lianxin Shengji Powder can significantly improve the weight loss of rats with chemotherapy - induced oral ulcer model, promote weight recovery, and its effect is better than that of the single herb of lotus plumule and the deficient - flavor compound without lotus plumule. This confirms that there is a synergistic effect among the drug components in the whole formula of Lianxin Shengji Powder, and the compound compatibility has obvious superiority. In addition, no obvious adverse reactions occurred in each group during the treatment, indicating good drug safety.

[0055] It can be seen from Figure 2 that the ulcer area decline rate of the whole formula group of Lianxin Shengji Powder is significantly faster than that of the single herb of lotus plumule group and the group without lotus plumule of Lianxin Shengji Powder (deficient - flavor compound group), and its decline amplitude is the largest. The ulcer area change trend of the group without lotus plumule of Lianxin Shengji Powder is almost exactly the same as that of the single herb of lotus plumule group, and both are smaller than the model group. The above results show that both the single herb of lotus plumule and the group without lotus plumule of Lianxin Shengji Powder can improve the ulcer area of rats with chemotherapy - induced oral ulcer model, but their effects are lower than that of the whole formula group of Lianxin Shengji Powder. This confirms that there is a synergistic effect among the drug components in the whole formula of Lianxin Shengji Powder, and lotus plumule and other drugs synergize with each other to jointly exert a better effect on promoting ulcer healing.

[0056] 2. Clinical trial

[0057] Patients with moderate - severe oral ulcers (WHO oral mucositis grade ≥ 2) after chemotherapy were selected as the research objects, and the initial ulcer area of the patients was recorded. Each patient was administered the medicine by blowing once half an hour after meals and once before going to bed every day, 3 times a day. During the operation, the powder of Lianxin Shengji Powder (Example 2) was evenly blown on the oral ulcer surface to directly cover the ulcer surface with the medicine. Fast food and drink were prohibited within 15 minutes after blowing the medicine to facilitate the attachment of the medicine. Lianxin Shengji Powder was continuously used for several days until the ulcer was completely healed.

[0058] The experimental results are as Figure 3 and Table 1 shown.

[0059] It can be seen from Figure 3It was found that before medication, patients with oral ulcers after chemotherapy had multiple obvious ulcers on the side of their tongue; after using Lianxin Shengji Powder, the ulcers on the side of the tongue healed without significant ulceration. This indicates that Lianxin Shengji Powder has a significant therapeutic effect on oral ulcers caused by chemotherapy in cancer patients.

[0060] Table 1 Pain Assessment Form

[0061] Assessment Time Point VAS score (0-10 points) Pain level Remark Before treatment (D0) 6 Moderate pain Pain affects eating Day 3 of treatment (D3) 3 Mild pain The pain has lessened and is tolerable. Day 7 of treatment (D7) 0 painless Ulcer healing

[0062] As shown in Table 1, before medication, patients with oral ulcers after chemotherapy had a VAS score of 6, indicating moderate pain that affected their daily eating. On the third day after using Lianxin Shengji Powder, the VAS score dropped to 3, and the pain was reduced. On the seventh day after using Lianxin Shengji Powder, the ulcers healed and there was no pain.

[0063] In summary, the Lianxin Shengji Powder of this invention is effective in treating oral ulcers after chemotherapy, can quickly relieve pain and promote wound healing, and has high safety, which is superior to conventional Western medicine treatment and has good clinical application value.

Claims

1. A lotus seed-based muscle-regenerating powder, characterized in that, By volume, it includes the following components: 10-50 parts lotus seed heart, 5-10 parts cattail pollen, 20-60 parts indigo naturalis, 10-70 parts peppermint, 10-60 parts borneol, 80-150 parts calcined gypsum, and 10-120 parts licorice.

2. The Lotus Heart Muscle-Regenerating Powder according to claim 1, characterized in that, The ingredients, by volume, are as follows: 10 parts lotus seed heart, 10 parts cattail pollen, 40 parts indigo naturalis, 10 parts peppermint, 60 parts borneol, 80 parts calcined gypsum, and 10 parts licorice.

3. A method for preparing the lotus seed muscle-regenerating powder according to claim 1 or 2, characterized in that, Includes the following steps: (1) Cleaning process: Select, remove impurities, and wash the lotus seed heart, licorice, and mint separately, and dry them at low temperature for later use; purify the cattail pollen, indigo, borneol, and calcined gypsum directly. (2) Grinding and sieving: Grind the above raw materials separately and sieve them to obtain fine powder; (3) Grind separately: Place the borneol in a mortar and grind it separately into a fine powder for later use; (4) Mixing preparation: Mix the remaining powders evenly, and then mix them thoroughly with borneol powder using the equal incremental method to ensure uniform color; (5) Sterilization treatment: The mixed powder is sterilized to meet the aseptic requirements; (6) Dispensing and sealing: Dispense the sterilized powder into sterile containers, seal them, and store them in a cool, dry place away from light.

4. The preparation method of the lotus seed muscle-regenerating powder according to claim 3, characterized in that, The low-temperature drying in step (1) is 40-50°C, drying until the moisture content of the raw material is 5%-8%.

5. The method for preparing the lotus seed muscle-regenerating powder according to claim 3, characterized in that, In step (2), the drug sieve is a 100-120 mesh sieve.

6. The method for preparing the lotus seed muscle-regenerating powder according to claim 3, characterized in that, In step (5), the number of colonies after sterilization is <10 cfu / g.

7. The method for preparing the lotus seed muscle-regenerating powder according to claim 3, characterized in that, In step (5), the sterilization is performed by 60Co-γ irradiation.

8. The use of the Lianxin Shengji Powder according to claim 1 or 2 in the preparation of a medicament for treating oral ulcers.

9. The application according to claim 8, characterized in that, The oral ulcers mentioned are oral ulcers caused by chemotherapy.

10. According to claim 8, the Lianxin Shengji Powder is used externally. After cleaning the oral cavity, take 0.1-0.3 g of Lianxin Shengji Powder and spray it evenly onto the ulcer surface, 3-4 times a day, 15-30 minutes after meals and before bedtime, for 5-7 days as one course of treatment.

Images