Traditional Chinese medicine preparation for treating plasma cell mastitis stiff blocks and preparation method of traditional Chinese medicine preparation
Through preparations composed of traditional Chinese medicine such as Bupleurum, relieving liver and promoting qi, warming yang and resolving phlegm, dispersing nodules and reducing swelling, the problem of difficulty in the treatment of plasma cell mastitis and limited efficacy in traditional Chinese medicine, and significantly improved the mass and pain symptoms improve the treatment effect.
Patent Information
- Application Number
- CN202411429796.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-14
- Publication Date
- 2025-01-07
AI Technical Summary
When existing traditional Chinese medicine treats plasmacytic mastitis stagnation, it is difficult to effectively change the pathogenesis, resulting in excessive use of cold and cool drugs to damage the yang energy and form chronic stagnation. The existing therapies have limited effect in eliminating lumps.
Preparations composed of Chinese medicines such as Bupleurum, sedge grass, Pinellia ternata, White Mustard Seed, Fairy Spleen, Spermia, Sparagus, Orange Leaf, Orange Peel, Cat's Claw Grass, White Powder Vines and Brassica Sci. Extracted by ethanol and water Prepare by steam distillation, decoction and drying, combined with ozone sterilization, it forms a dry powder, which is used to relieve liver and promote qi, warm yang and eliminate phlegm, disperse nodules and reduce swelling.
The mass size, hardness and pain symptoms were significantly improved, and the efficacy evaluation indicators were improved. Compared with the control group, the clinical symptoms and signs and laboratory indicators were significantly improved.
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Abstract
Description
Technical Field
[0001] The invention relates to the technical field of Chinese medicine prescriptions, and in particular to a Chinese medicine preparation for treating plasma cell mastitis lumps and a preparation method thereof. Background Art
[0002] At present, plasma cell mastitis is generally considered to be a sterile inflammation, which is mostly caused by physical and chemical stimulation, but it can also be complicated with bacterial infection in the later stage, so the use of antibiotics is effective. Antibiotics have strong anti-inflammatory effects and can quickly control local inflammation. Generally, the clinical course of antibiotics for plasma cell mastitis is 1 to 2 weeks, and the effect of controlling inflammation is acceptable, but it is limited in eliminating lumps, and long-term use is easy to form hard lumps.
[0003] Plasma cell mastitis is called comedonal mastitis in traditional Chinese medicine. Modern Chinese medicine believes that comedonal mastitis is mostly caused by emotional depression, liver failure to release, meridian blockage, aggregation into lumps, and liver meridian stagnation and heat leading to the acute stage. Therefore, the traditional Chinese medicine treatment of the acute mass stage of non-lactation mastitis is mainly based on the method of clearing and eliminating, and prescriptions for soothing the liver and clearing heat, and detoxifying and dispersing nodules are commonly used in clinical practice.
[0004] Traditional Chinese medicine has certain advantages in treating plasma cell mastitis, but the condition of plasma cell mastitis is changeable, and the grasp of the pathogenesis transformation is the key to treatment. If the pathogenesis changes are ignored, there will be the disadvantages of mistreatment. In the treatment of plasma cell mastitis with traditional Chinese medicine, there is a conversion of yin and yang, so the yin and yang should be identified first, and different treatments should be adopted according to different stages. The mass stage is a common stage for plasma cell mastitis. The acute mass stage belongs to Yang syndrome, and the method of clearing and eliminating is often used. After the heat and toxicity gradually subside, the conversion of yin and yang will enter, which is a half-yin and half-yang syndrome. At this time, attention should be paid to the use of warm and clear. If a large dose of cold is continued, it will become a Yin syndrome, that is, the chronic mass stage. The Yin syndrome mass is delayed and becomes a stiff mass. If the stiff mass has already formed, the treatment should be done in the opposite way. Excessive use of cold and cool will damage the Yang Qi, and the first thing to be damaged is the Yang of the spleen and stomach. Moreover, the breast of a woman is the part where the stomach meridian runs. If the stomach Yang is insufficient, the meridian Qi will not work, and the cold will condense the phlegm, thus forming a stiff mass. Summary of the invention
[0005] The purpose of the present invention is to provide a traditional Chinese medicine preparation for treating plasma cell mastitis.
[0006] In order to achieve the above object, the present invention adopts the following technical solutions:
[0007] A traditional Chinese medicine preparation for treating plasma cell mastitis lumps comprises the following components: bupleurum, sedge, pinellia, white mustard seeds, epimedium, allium macrostemon, spider plant, citrus leaf, citrus peel, cat's claw, fennel and Brassica rapa.
[0008] Preferably, the mass ratio of each component in the traditional Chinese medicine preparation is as follows: Bupleurum: Cyperus: Pinellia: Sinapis alba: Epimedium: Allium macrostemon: Chlorophytum corylifolia: Citrus aurantium leaf: Citrus aurantium peel: Cat's Claw: Psoralea corylifolia: Brassica juncea is 1:1:1:1:1:1:1:0.9:0.9:1.5:1:1, respectively.
[0009] Preferably, the preparation method is as follows:
[0010] S1: preparing white mustard seed powder and Brassica rapa seed powder, extracting with ethanol and filtering to obtain a first extract;
[0011] S2: Slice the Pinellia ternata and Cissus leucoderma, extract the volatile oil by steam distillation, and collect the second extract;
[0012] S3: Mix bupleurum, sedge, epimedium, Allium macrostemon, spider plant, tangerine peel, tangerine leaf, and cat's claw, add sufficient amount of distilled water, and after decocting, sieve to obtain the third extract;
[0013] S4: adding the first extract in S1 and the second extract in S2 to the third extract in S3, and then drying to prepare a dry powder;
[0014] S5: the dry powder obtained in S4 is further pulverized;
[0015] S6: Ozone sterilization to obtain Chinese medicine preparations.
[0016] Preferably, the ethanol extraction step in S1 is: adding 65% to 90% ethanol to extract twice, each time for 2 to 3 hours, and filtering.
[0017] Preferably, the decoction time in S3 is 30-60 minutes, and after the decoction is completed, the mixture is sieved through an 80-mesh sieve.
[0018] Preferably, in S4, a cabinet-type reduced pressure desiccant is used to perform reduced pressure drying.
[0019] Preferably, the ozone sterilization conditions are: ozone concentration 50g / m 3 , air flow velocity 40m / s, air source oxygen purity>85%, sterilization temperature less than 40℃.
[0020] In the above-mentioned Chinese medicine preparation for treating plasma cell mastitis stiff masses, Bupleurum and Cyperus can soothe the liver and promote qi, Xianlingpi warms the kidney and replenishes yang, Pinellia and white mustard seeds warm and transform cold phlegm, Tangerine peel leaves and Pinellia can promote qi and eliminate dampness and resolve phlegm, Xiebai can promote qi and relieve fullness, Stone Chlorophytum, Cat's Claw, and White Powdery Fern can resolve phlegm and disperse nodules, and Brassica rapa can promote qi and resolve blood stasis and resolve nodules. The whole prescription can soothe the liver and promote qi, warm yang and resolve phlegm, and resolve nodules and reduce swelling. In addition, the application proves through specific verification experiments that the use of the preparation of the application after treatment has significant improvements in clinical symptoms and signs such as lump size, lump hardness, pain and score, and the efficacy evaluation index is significantly different from the control group. DETAILED DESCRIPTION
[0021] The present invention is further described in detail below in conjunction with specific embodiments.
[0022] A Chinese medicine preparation for treating plasma cell mastitis lumps, the Chinese medicine preparation comprising the following Chinese medicines:
[0023] 10g of Bupleurum, 10g of Cyperus, 10g of Pinellia, 10g of White Sinapis, 10g of Epimedium, 10g of Allium macrostemon, 10g of Chlorophytum corylifolia, 9g each of Citrus aurantium peel, 15g of Cat's Claw, 10g of Psoralea corylifolia and 10g of Brassica juncea.
[0024] Among the above-mentioned Chinese medicines:
[0025] Bupleurum: bitter and slightly cold in nature, it is a drug for the meridian of the foot jueyin meridian, and has the effect of soothing the liver and relieving depression. Modern pharmacological studies have shown that its active ingredient, bupleurum saponin, has a certain anti-inflammatory effect;
[0026] Cyperus: It is bitter and flat in nature and taste, and has the effects of soothing the liver and relieving depression, regulating qi and relieving fullness. Modern pharmacological studies have shown that its active ingredient cyperone has a certain effect on improving breast structure, and cyperone has a certain analgesic effect;
[0027] French Pinellia: pungent and warm in nature, effective in drying dampness and resolving phlegm, dispersing nodules and reducing swelling;
[0028] White mustard seeds: pungent and warm in nature, effective in resolving phlegm and dispersing nodules, dredge meridians and relieve pain. Modern pharmacology studies have shown that its water extract has a certain antibacterial effect.
[0029] Xianlingpi: It is pungent, sweet and warm in nature. It warms the kidney, replenishes yang and removes dampness. Modern pharmacological studies have shown that its active ingredients have anti-inflammatory, immune-regulating and hormone-regulating effects.
[0030] Xiebai: It is bitter, pungent and warm in nature and has the effects of warming the middle and promoting yang, regulating qi and relieving chest tightness.
[0031] Stone spider plant: bitter and warm in nature, effective in resolving phlegm, softening and dispersing lumps;
[0032] Tangerine leaves and peels: bitter, pungent and warm in nature, regulating qi and drying dampness, resolving phlegm and dispersing stagnation;
[0033] Cat's Claw: It is sweet, spicy and warm in nature, and has the effects of resolving phlegm, dispersing lumps and reducing swelling. Modern pharmacological studies have shown that its active ingredients have anti-inflammatory and immune-regulating effects.
[0034] Psoralea corylifolia: mild in nature and flavor, effective in resolving phlegm, dispersing nodules and relieving swelling;
[0035] Brassica rapa seeds: sweet, spicy and warm in nature, and have the effects of promoting qi and removing blood stasis, reducing swelling and dispersing nodules.
[0036] In addition, the present application also provides a method for preparing the above-mentioned Chinese medicine preparation, and the specific steps are as follows:
[0037] (1) crushing the prescribed amount of white mustard seeds and brassica seeds to prepare white mustard seed powder and brassica seed powder, adding 65% to 90% ethanol to extract twice, each time for 2 to 3 hours, filtering, and collecting the first extract;
[0038] (2) slicing the formulated amount of Pinellia ternata and Cissus leucoderma, extracting the volatile oils by steam distillation, and collecting the volatile oils as the second extract;
[0039] (3) Mix the formulated amounts of bupleurum, sedge, epimedium, Allium macrostemon, spider plant, tangerine peel, tangerine leaf, and cat's claw, add sufficient amount of distilled water, boil for 30 to 60 minutes, and pass through an 80-mesh sieve to obtain a third extract;
[0040] (4) adding the first extract obtained in step (1) and the second extract obtained in step (2) to the third extract obtained in step (3), and drying under reduced pressure in a cabinet-type reduced pressure dryer to obtain dry powder;
[0041] (5) using a traditional Chinese medicine ultrafine grinder to further grind the powder obtained in step (4) into fine powder of more than 100 mesh;
[0042] (6) At an ozone concentration of 50 g / m 3 The fine powder obtained in step (5) is sterilized by ozone under the following conditions: an air flow rate of 40 m / s, an oxygen purity of the air source > 85%, and a sterilization temperature of less than 40° C., so as to preserve the drug components under the maximum conditions and prepare a traditional Chinese medicine preparation.
[0043] The above-mentioned Chinese medicine preparations are verified by combining specific verification experiments as follows:
[0044] General information: The retrospective study included a total of 48 outpatient and inpatient plasma cell mastitis with mass formation in Nantong Traditional Chinese Medicine Hospital from 2023 to 2024, including 24 patients in the treatment group and 24 patients in the control group. There was no statistical difference in the general information (age, onset time, number of lesions) between the two groups, and the two groups were comparable.
[0045] Table 1 Comparison of general data between the two groups
[0046]
[0047] In the above table, t is the value of the T test, χ2 is the value of the chi-square test, and P is the result of the test. If P>0.05, there is no difference.
[0048] Treatment:
[0049] The treatment group was given the Chinese medicine preparation prepared by the present invention (10g of bupleurum, 10g of vinegar cyperus, 10g of pinellia, 10g of white mustard seeds, 10g of epimedium, 10g of scutellaria, 10g of stone spider plant, 9g each of citrus leaf peel, 15g of cat's claw, 10g of citrus lily, 10g of brassica rapa), mixed with warm water to 200ml, and taken orally, once in the morning and evening.
[0050] The control group was treated with the classic prescription Yanghe Decoction (30g of Rehmannia glutinosa, 3g of cinnamon powder, 2g of ephedra, 9g of antler glue, 6g of white mustard, 2g of ginger charcoal, and 3g of raw licorice) taken orally, diluted to 200ml with warm water, one dose per day, taken in the morning and evening, for a total of 8 weeks.
[0051] Observation indicators
[0052] Clinical symptom and sign score:
[0053] ① Tumor size: The longest diameter of the tumor under ultrasound was measured by the same ultrasound doctor. If there were multiple tumors, the sum of the long diameters was calculated. The long diameter ≤ 3 cm was scored as 1 point, 3 cm < long diameter ≤ 6 cm was scored as 2 points, and 6 cm < long diameter ≤
[0054] 9cm is 3 points, long diameter>9cm is 4 points;
[0055] ② Lump hardness: 0 points, no lump; 1 point, soft like a normal gland; 2 points, tough like the tip of the nose; 3 points, hard like a normal gland;
[0056] Hard as forehead;
[0057] ③ Pain: No pain is 1 point, occasional pain and mild pain is 2 points, occasional pain but severe pain or mild pain that persists is 3 points, and persistent severe pain is 4 points. Data were collected at enrollment and 8 weeks after treatment.
[0058] There was no difference in the size, hardness, pain and total score between the treatment group and the control group before treatment. After treatment, the scores of both groups were significantly improved, with the improvement in the treatment group being more significant (see Table 2).
[0059] Table 2 Clinical symptom and sign scores [M (P25-P75)]
[0060]
[0061] Efficacy evaluation criteria: The efficacy was evaluated using the nimodipine method, and the efficacy index (n) = (pre-treatment score - post-treatment score) / pre-treatment score × 100%.
[0062] ① Cured: n≥90%, the lump has basically disappeared, and the pain symptoms have basically disappeared;
[0063] ② Significantly effective: 70%≤n<90%, the mass is reduced by more than half, the texture is normal, and the pain is significantly relieved;
[0064] ③ Effective: 30%≤n<70%, the mass is slightly reduced, the texture is tough like the tip of the nose, and the pain is slightly relieved;
[0065] ④ Ineffective: n<30%, the lump does not disappear or gradually increases in size, the lump is as hard as the forehead, and the pain is not significantly relieved.
[0066] Comparison of efficacy evaluation indicators
[0067] The total effective rate of the treatment group (100.00%) was higher than that of the control group (75.00%), and the difference was significant, as shown in Table 3.
[0068] Table 3 Comparison of efficacy evaluation indicators between the two groups [n(%)]
[0069]
[0070] Laboratory indicators:
[0071] White blood cells (WBC), prolactin (PRL), interleukin-6 (IL-6), immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) were tested once at enrollment and 8 weeks after treatment.
[0072] There was no difference in WBC, PRL, IL-6, IgA, IgG, and IgM between the treatment group and the control group before treatment. After treatment, all indicators in the two groups were significantly improved, among which the improvement in the treatment group was more significant, as shown in Table 4.
[0073] Table 4 Comparison of laboratory parameters between the two groups / M(P25-P75)]
[0074]
[0075] Statistical methods
[0076] SPSS 25.0 statistical software was used for statistical analysis. The chi-square test was used for categorical count data. The measurement data that met the normal distribution were analyzed. The data were described as follows. If the variance was homogeneous, the inter-group comparison was performed with the group t test, and the intra-group comparison was performed with the paired t test. The measurement data that did not conform to the normal distribution or conformed to the normal distribution but the variance was not homogeneous were logarithmically transformed and tested for normality again. If they were normally distributed, the comparison method was the same as before. The measurement data that did not conform to the normal distribution were described as M[P25,P75], and the intra-group comparison was performed with the signed rank test; the inter-group comparison was performed with the Wilcoxon rank test, and P<0.05 was considered statistically significant.
[0077] The following are typical pathologies using the Chinese medicine preparation of the present application to demonstrate the efficacy of the above preparation of the present application:
[0078] Li, female, 42 years old. First visit on February 6, 2023.
[0079] Chief complaint: right breast lump for 4 months. The patient touched the right breast lump by herself 4 months ago, accompanied by redness, swelling and pain. She was diagnosed with plasma cell mastitis by puncture biopsy at a local hospital. She was treated with antibiotics (cephalosporins, details unknown) for 2 weeks, and the local redness, swelling and pain improved. After taking cefixime capsules for more than 1 month, the local skin temperature and complexion returned to normal. The lump did not shrink in the past 2 months, and she came to our outpatient department for treatment after being introduced. Current diagnosis: fear of cold, cold hands and feet, frequent urination, rotten stool, and good sleep at night. A lump of about 8*6cm in size can be felt behind the right areola. It is hard in texture, can be moved by pushing, has unclear boundaries, is not painful when pressed, has normal skin color and temperature, and does not fluctuate. The tongue is light red with thin white fur, and the pulse is deep and stringy. Breast ultrasound results: Behind and below the right nipple, there is an uneven echo of 8*6cm, considering the possibility of mastitis. Western medicine diagnosis: plasma cell mastitis; Chinese medicine diagnosis: acne mastitis (Yang deficiency and cold stagnation syndrome). Treat with soothing the liver and relieving depression, promoting qi and resolving phlegm, warming yang and dispelling cold. Take the preparation of the present invention (10g of bupleurum, 10g of vinegar cyperus, 10g of pinellia, 10g of white mustard seeds, 10g of epimedium, 10g of Allium macrostemon, 10g of stone spider plant, 9g each of orange leaf peel, 15g of cat's claw, 10g of citrus aurantium, 10g of white citrus seed, 10g of Brassica rapa) orally, dilute with warm water to 200ml, and take it in the morning and evening.
[0080] Second visit on March 6, 2023: The patient's limbs became warm, bowel movements were normal, the local mass became softer than before, the range was significantly smaller than before, there was no obvious sense of fluctuation, the tongue was red with thin white fur, and the pulse was stringy. The scope of the lesion on the reexamination of both breasts was smaller than before. The medication method is the same as above.
[0081] Third visit on April 3, 2023: The patient's local mass disappeared, his skin color and temperature were normal, his tongue was red with a thin white coating, and his pulse was stringy. He was cured and had no recurrence.
[0082] The present application provides a Chinese medicine preparation for treating plasma cell mastitis stiff masses and a preparation method thereof, wherein the prescription contains Bupleurum and Cyperus to soothe the liver and promote qi circulation, Herba Epimedii warms the kidney and replenishes yang, Rhizoma Pinelliae and Semen Sinapis warms and transforms cold phlegm, Citrus tangerine peel leaves and Rhizoma Pinelliae promote qi circulation, dry dampness and resolve phlegm, Rhizoma Allii macrostemon promotes qi circulation and relieves fullness, Herba Chlorophytum, Herba Catsfoot and Herba Psoraleae resolve phlegm and disperse nodules, and Rhizoma Brassicae promotes qi circulation, resolves blood stasis and disperses nodules, and the whole prescription soothes the liver and promotes qi circulation, warms yang and resolves phlegm, and disperses nodules and reduces swelling. In addition, the present application has proved through verification experiments that the use of the present application preparation after treatment has significantly improved clinical symptoms and signs such as lump size, lump hardness, pain and score, and the efficacy evaluation index is significantly different from that of the control group.
Claims
1. A Chinese medicine preparation for treating plasma cell mastitis, characterized in that: It contains the following ingredients: bupleurum, sedge, pinellia, white mustard seeds, epimedium, allium macrostemon, spider plant, tangerine leaf, tangerine peel, cat's claw, white powder vine and Brassica juncea.
2. A Chinese medicine preparation for treating plasma cell mastitis according to claim 1, characterized in that: The mass ratios of the components in the traditional Chinese medicine preparation are as follows: bupleurum: cyperus: pinellia: white mustard: epimedium: allium macrostemon: spider plant: citrus leaf: citrus peel: cat's claw: fennel: brassica juncea are 1:1:1:1:1:1:1:0.9:0.9:1.5:1:1, respectively.
3. A Chinese medicine preparation for treating plasma cell mastitis according to claim 2, characterized in that: The preparation method thereof is as follows: S1: preparing white mustard seed powder and Brassica rapa seed powder, extracting with ethanol and filtering to obtain a first extract; S2: Slice the Pinellia ternata and Cissus leucoderma, extract the volatile oil by steam distillation, and collect the second extract; S3: Mix bupleurum, sedge, epimedium, Allium macrostemon, spider plant, tangerine peel, tangerine leaf, and cat's claw, add sufficient amount of distilled water, and after decocting, sieve to obtain the third extract; S4: adding the first extract in S1 and the second extract in S2 to the third extract in S3, and then drying to prepare a dry powder; S5: the dry powder obtained in S4 is further pulverized; S6: Ozone sterilization to obtain Chinese medicine preparations.
4. A Chinese medicine preparation for treating plasma cell mastitis according to claim 3, characterized in that: The ethanol extraction step in S1 is: adding 65% to 90% ethanol to extract twice, each time for 2 to 3 hours, and filtering.
5. A Chinese medicine preparation for treating plasma cell mastitis according to claim 3, characterized in that: The decoction time in S3 is 30-60 minutes. After the decoction is completed, the mixture is passed through an 80-mesh sieve.
6. A Chinese medicine preparation for treating plasma cell mastitis according to claim 3, characterized in that: In the step S4, a cabinet-type decompression desiccant is used to perform decompression drying.
7. A Chinese medicine preparation for treating plasma cell mastitis according to claim 3, characterized in that: The conditions for ozone sterilization are: ozone concentration 50g / m 3 , air flow velocity 40m / s, air source oxygen purity>85%, sterilization temperature less than 40℃.