Traditional Chinese medicine composition capable of consolidating foundation and clearing provenance and application of traditional Chinese medicine composition in CR period immune reconstruction of malignant lymphoma

Abstract

The invention provides a foundation strengthening and source clearing traditional Chinese medicine composition which is prepared from the following raw materials in parts by weight: 30 g of astragalus membranaceus, 10 g of angelica sinensis, 10 g of radix rehmanniae recen, 10 g of prepared rehmannia root, 30 g of oyster, 10 g of radix scrophulariae, 20 g of leonurus, 25 g of rhodiola rosea and 3 g of pseudo-ginseng powder. The foundation-consolidating and source-clearing prescription can improve the symptoms of patients with remission lymphoma, reduce the incidence rate of infection and promote immune reconstruction after malignant lymphoma CR, and the mechanism of the foundation-consolidating and source-clearing prescription may be related to regulation and control of an NF-KB pathway, a PI3K pathway and a JAK-STR pathway.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically, it relates to a traditional Chinese medicine composition for strengthening the body's foundation and clearing the source of pathogens for immune reconstitution in the CR stage of malignant lymphoma. Background Technology

[0002] With the improvement of people's living standards and the integration of Chinese and Western dietary cultures, lymphoma is called "malignant nodules" in traditional Chinese medicine. "Lymph" belongs to the Sanjiao system of traditional Chinese medicine (written by Hua Tuo; annotated by Wu Changguo, Zhongzangjing, Nanjing: Jiangsu Science and Technology Press, 1985; Chen Qilan et al., "Exploring the Essence of Sanjiao", Journal of Beijing University of Traditional Chinese Medicine, 2013, 36(05): 311-3). Sanjiao is the pathway for the flow of qi and body fluids. Once it is affected by pathogenic factors, qi, blood and body fluids will inevitably become stagnant. If the disease persists, it will enter the collaterals, and the condition will become protracted and complex. Therefore, the treatment of lymphoma should not only focus on the lesion, but also take a holistic view, strive to promote the flow of qi and body fluids, and restore the function of Sanjiao. The prescription for Gubenqingyuan Fang (Strengthening the Root and Clearing the Source Formula) consists of: 30g of roasted Astragalus membranaceus, 15g of Codonopsis pilosula, 10g of Angelica sinensis, 10g of Rehmannia glutinosa, 30g of calcined Ostrea gigas, 20g of Scrophularia ningpoensis, 30g of Rhodiola rosea, 9g of Fritillaria thunbergii, 10g of Fritillaria thunbergii, 9g of Panax notoginseng powder, 10g of Citrus reticulata peel, and 10g of medicated leaven. Gubenqingyuan Fang uses Angelica sinensis as a key herb for nourishing and invigorating blood, replenishing deficient Yin and blood, and resolving blood stasis. Simultaneously, it heavily uses Astragalus membranaceus to tonify Qi, based on the principle that "tangible blood is generated from intangible Qi," thus promoting Qi and blood production. The combination of these two herbs embodies the concept of Danggui Buxue Tang (Angelica Blood-Nourishing Decoction) and serves as the principal herb. Rehmannia glutinosa and Scrophularia ningpoensis clear heat, nourish Yin, and generate fluids; Codonopsis pilosula and Rhodiola rosea invigorate Qi and invigorate blood, serving as the assistant herbs. Citrus reticulata peel, Fritillaria thunbergii, Fritillaria thunbergii, and Ostrea gigas regulate Qi, resolve phlegm, soften hardness, and dissipate nodules; Panax notoginseng invigorates blood and removes blood stasis. The combination of these herbs allows for the dissipation of phlegm and blood stasis, serving as the adjuvant herbs. The middle jiao is the source of qi and blood production and the pivot of qi movement. Jian Shen Qu (a traditional Chinese medicine) strengthens the spleen and promotes digestion, restoring normal digestion and assisting the generation of vital qi to gradually eliminate chronic diseases, thus having the function of adjuvant (Zhang Zihua, Quanzhou Traditional Famous Medicine - Jian Shen Qu, Strait Pharmaceutical Journal, 1997 (01): 12-3). This formula uses both tonifying and purging methods, treats both cold and hot conditions, addresses both the root cause and the symptoms, eliminates pathogens without harming the body's vital energy, and can effectively improve the efficacy and prognosis of patients with diffuse large B-cell lymphoma (DLBCL).

[0003] Modern pharmacological studies have shown that Angelica sinensis has a wide range of applications in the blood system. It can inhibit platelet aggregation, promote the recovery of hematopoietic function, and also has antioxidant, antibacterial and certain tumor-inhibiting abilities (Wang Qingyan et al., Research progress on extraction methods and pharmacological effects of active ingredients in Angelica sinensis, Chemical Reagents, 2025, 47(04): 43-51); Astragalus membranaceus has been widely studied for its immunomodulatory potential, and has also shown positive effects in the fields of antithrombosis and antitumor (Fu Huijie et al., Modern pharmacological effects and research progress of Astragalus membranaceus, Hebei Journal of Traditional Chinese Medicine, 2025, 47(04): 695-9+704); Rehmannia glutinosa can participate in the body's immune regulation through multiple pathways and has antioxidant and tumor growth-inhibiting abilities (Li Xueli et al., Research progress on pharmacological effects of Rehmannia glutinosa, Journal of Liaoning University of Traditional Chinese Medicine, 2024, 26(12): 135-9); Scrophularia components have been found to have the potential to scavenge free radicals, alleviate inflammatory responses, and weaken tumor cell activity (Chen Lixin et al., Research progress on chemical components and pharmacological effects of Scrophularia, Special Products Research, 2023, 45(01): 147-51); Codonopsis can enhance immune defense, improve digestive function, and show good performance in inflammation control and anti-tumor effects (Zhang Chongyang et al., Research progress on pharmacological effects of Codonopsis, New Drugs and Clinical Pharmacology of Traditional Chinese Medicine, 2024, 35(05): 765-70); Rhodiola rosea, as a natural adaptogen, has research value in regulating the immune system, protecting liver function, and limiting the spread of malignant cells (Du Yuxuan et al., Research progress on the main pharmacological effects and mechanisms of Rhodiola rosea, Journal of PLA Pharmacy, 2022, 35(06): 521-9); The pharmacological research on the anti-inflammatory mechanism and blocking of tumor-related signaling pathways of Fritillaria thunbergii is also constantly deepening (Xu Langxi et al., Research progress on chemical components and pharmacological effects of Fritillaria thunbergii, Chinese Journal of Medicinal Chemistry, 2022, 32(01): 61-73); Fritillaria thunbergii shows anti-tumor, antiviral and immunosuppressive pharmacological activities (Li Han et al., Research progress on chemical components, pharmacological effects and clinical applications of Fritillaria thunbergii, Chinese Journal of Traditional Chinese Medicine, 2021, 46(17): 4314-22); Panax notoginseng is widely used in traditional Chinese medicine clinical practice, and its role in inhibiting tumor cell division and promoting the recovery of the body's immune function is increasingly valued (Qin Linghong et al., Research progress on pharmacological effects and clinical applications of Panax notoginseng, Research on Zhuang and Yao Medicine, 2023, (02): 337-40).

[0004] Traditional Chinese medicine (TCM) possesses unique advantages in immune reconstitution after complete remission (CR) of malignant lymphoma due to its advanced concepts, diverse treatment methods, low economic cost, and few side effects (Lang Haiyan et al., Review of the current status and hot research of TCM treatment for malignant lymphoma, Beijing Journal of Traditional Chinese Medicine, 2024, 43(10): 1082-7; Si Tianyu et al., Research and application of data mining in the diagnosis and treatment of hematological diseases by famous TCM doctors, World Journal of Traditional Chinese Medicine, 2024, 19(06): 899-903; Wang Shuangshuang et al., TCM pathogenesis and treatment of malignant lymphoma, World Science and Technology - Modernization of Traditional Chinese Medicine, 2014, 16(11): 2425-9). This invention aims to explore the impact of the "strengthening the root and clearing the source" method on immune reconstitution after CR of malignant lymphoma, providing new ideas and methods for immune reconstitution after CR of malignant lymphoma. Summary of the Invention

[0005] According to a first aspect of the present invention, a traditional Chinese medicine composition for strengthening the body's foundation and clearing away pathogenic factors is provided, wherein the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Astragalus membranaceus 30g, Angelica sinensis 10g, Rehmannia glutinosa 10g, Rehmannia glutinosa (processed) 10g, Ostrea gigas 30g, Scrophularia ningpoensis 10g, Leonurus japonicus 20g, Rhodiola rosea 25g, and Panax notoginseng powder 3g.

[0006] The traditional Chinese medicine composition has the effects of strengthening the body's resistance, replenishing qi and nourishing yin, softening and dispersing masses, promoting blood circulation and removing blood stasis, regulating qi and improving appetite. It is used to treat patients with malignant lymphoma who have insufficient vital energy and uncleared pathogenic factors after chemotherapy, radiotherapy or immunotherapy.

[0007] Preferably, the traditional Chinese medicine composition is formulated into a paste, pill, tablet, granule, capsule, powder, drop pill, film, or oral liquid. More preferably, the final traditional Chinese medicine composition is prepared into a paste. More preferably, the step of preparing the paste includes:

[0008] 1) Preparation of materials: Prepare Chinese herbal medicine granules and excipients according to the prescription; dissolve the Chinese herbal medicine granules in water; preferably, the excipients are maltose or xylitol (xylitol is preferred for diabetic patients); preferably, pour the Chinese herbal medicine granules into a stainless steel container, add an appropriate amount of warm water to moisten them and stir until completely dissolved;

[0009] 2) Heating and Concentration: Heat the dissolved medicine to a boil, then reduce to a simmer and stir constantly to prevent sticking. Concentrate until the mixture becomes a thick paste, depending on the volume and concentration of the medicine. Preferably, the specific time varies depending on the situation, ranging from approximately 30 minutes to 2 hours.

[0010] 3) Add excipients: After the medicine solution has been concentrated to the appropriate degree, add the excipients and continue to stir evenly;

[0011] 4) Thickening the paste: Keep the heat low and stir continuously until the paste has a suitable viscosity and a relative density of about 1.2-1.5; preferably, continue stirring until the paste reaches the "hanging flag" state;

[0012] 5) Bottle storage. Preferably, the paste is poured into a clean, dry wide-mouthed bottle, cooled, and then sealed; more preferably, it is refrigerated (0-5℃) and should be consumed within one month.

[0013] According to another aspect of the present invention, a pharmaceutical composition for immune reconstitution in the CR stage or after CR of malignant lymphoma is also provided, comprising the aforementioned traditional Chinese medicine composition and pidotimod. Preferably, the pharmaceutical composition consists of the aforementioned traditional Chinese medicine composition and pidotimod. More preferably, the traditional Chinese medicine composition is an ointment; preferably, the ointment is prepared by the aforementioned method; more preferably, the mass ratio of the traditional Chinese medicine ointment to pidotimod is 0.8:10.

[0014] According to another aspect of the present invention, the use of the traditional Chinese medicine composition for strengthening the body's foundation and clearing the source, or the use of the pharmaceutical composition for preparing a drug for immune reconstitution in the CR phase or after CR of malignant lymphoma, is also provided. Preferably, the malignant lymphoma is diffuse large B-cell lymphoma, mantle cell lymphoma, follicular cell lymphoma, high-grade B-cell lymphoma, small B-cell lymphoma, peripheral T-cell lymphoma, or NK / T-cell lymphoma. More preferably, the malignant lymphoma is diffuse large B-cell lymphoma. More preferably, the treatment includes adding the formula for strengthening the body's foundation and clearing the source to the administration of pidotimod dispersible tablets; more preferably, one month is considered as one course of treatment, and the efficacy is evaluated after two courses of treatment, for a total of six courses of treatment; more preferably, the traditional Chinese medicine composition is prepared into a paste dosage form; more preferably, the above 15 doses are processed into a paste, with 10g each time, taken twice a day after meals, for two consecutive months.

[0015] The advantages of this invention are:

[0016] 1. In the group treated with the Gubenqingyuan formula, the mean white blood cell count and neutrophil count were both >1.5*10. ^9 The recovery time for the group with a blood alcohol content was significantly longer than that of the control group;

[0017] 2. The average levels of serum complement C3, immunoglobulin A, and immunoglobulin G in the treatment group of Gubenqingyuanfang were significantly higher than those in the control group, while there was no significant difference in the average levels of serum complement C4 and immunoglobulin M.

[0018] 3. Lymphocyte subset analysis showed that the percentage of NK / T cells in the Gubenqingyuan formula treatment group was higher than that in the control group, while there was no significant difference in the percentage of total T cells and total B lymphocytes.

[0019] 4. The syndrome types of lymphoma patients in remission are mostly spleen and stomach qi deficiency, qi and blood deficiency, and qi and yin deficiency. Gubenqingyuan Decoction can improve the TCM syndrome scores of lymphoma patients in remission. Compared with the control group, the infection rate of patients treated with Gubenqingyuan Decoction is significantly lower.

[0020] 5. Network pharmacology analysis revealed that Gubenqingyuan Formula may exert anti-tumor immunomodulatory effects by regulating the NF-KB, PI3K, and JAK-STR pathways.

[0021] 6. The formula for strengthening the body and clearing the source can improve the symptoms of lymphoma patients in remission, reduce the incidence of infection, and promote immune reconstitution after CR of malignant lymphoma. Its mechanism may be related to the regulation of the NF-KB pathway, PI3K pathway and JAK-STR pathway. Attached Figure Description

[0022] Figure 1: PPI network analysis of the Gubenqingyuan formula. Among them, Figure 1(A) is the core target information table; Figure 1(B) is the GO enrichment analysis; Figure 1(C) is the KEGG enrichment analysis.

[0023] Figure 2 Network pharmacology analysis showed that the intervention effect of Gubenqingyuan Formula on DLBCL includes multiple targets and pathways such as tumor apoptosis, tumor drug resistance, immune regulation, and inflammatory factors.

[0024] Figure 3 Network pharmacology analysis revealed that the Gubenqingyuan formula may exert its anti-tumor immunomodulatory effects by regulating the PI3K-AKT and JAK1-STAT3 pathways. Detailed Implementation

[0025] The present invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and not intended to limit the invention.

[0026] Example 1:

[0027] Preparation of Gubenqingyuan ointment:

[0028] The ingredients of the Gubenqingyuan paste are: Astragalus membranaceus 30g, Angelica sinensis 10g, Rehmannia glutinosa (raw) 10g, Rehmannia glutinosa (processed) 10g, Oyster shell 30g, Scrophularia ningpoensis 10g, Leonurus japonicus 20g, Rhodiola rosea 25g, and Panax notoginseng powder 3g. Its preparation method includes the following steps:

[0029] 1. Preparation: Prepare the Chinese herbal medicine granules and excipients (maltose or xylitol (for diabetic patients)) according to the prescription. Pour the granules into a stainless steel container, add an appropriate amount of warm water to moisten them, and stir until completely dissolved.

[0030] 2. Heating and Concentration: Heat the dissolved medicine to a boil, then reduce to a simmer and stir constantly to prevent sticking. Depending on the volume and concentration of the medicine, concentrate until it becomes a thick paste (approximately 30 minutes to 2 hours, depending on the specific circumstances).

[0031] 3. Add excipients: After the medicine solution is concentrated to the appropriate degree, add excipients and continue to stir evenly.

[0032] 4. Reduce the paste: Keep the heat low and stir continuously until the paste reaches the "hanging flag" state. At this time, the paste has a moderate viscosity and a relative density of about 1.2-1.5.

[0033] 5. Bottle storage: Pour the paste into a clean, dry wide-mouthed bottle, seal it after cooling, and store it in the refrigerator (0-5℃). It is recommended to consume it within one month.

[0034] Example 2:

[0035] A total of 186 patients with malignant lymphoma who achieved complete remission (CR) and received outpatient and inpatient treatment at the Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine between January 1, 2022 and December 31, 2023 were selected. The study was reviewed and approved by the Ethics Committee of the Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine (Approval No.: 2022-kl-006).

[0036] Diagnostic criteria and inclusion / exclusion criteria

[0037] Western medicine diagnostic criteria

[0038] Those who achieved complete remission (CR) on PET-CT follow-up examination, according to the diagnostic criteria in "Diagnostic and Efficacy Standards for Hematological Diseases" (3rd edition) edited by Zhang Zhinan and Shen Ti.

[0039] Inclusion criteria

[0040] Those who meet all of the following criteria will be included: Meets the above-mentioned Western medicine diagnostic criteria; No active infection that cannot be controlled by antibiotic or antiviral treatment; I hereby agree to participate in this experimental research. Inclusion was approved by the medical ethics committee.

[0041] Exclusion criteria

[0042] Those who do not meet the above inclusion diagnostic criteria; Special populations, such as pregnant and breastfeeding women, and patients with mental illness; Those who are allergic to other hematologic or non-hematologic system tumors, or have serious organic lesions of vital organs such as the heart, liver, and kidneys; ④ those with poor compliance or who are likely to terminate the study for various reasons and are unable to complete the study process; ⑤ those with gastrointestinal bleeding, intestinal perforation, gastritis, or active gastric ulcers that affect drug administration; ⑥ those with serious primary diseases of the heart, brain, liver, and hematopoietic system; ⑦ those whose condition is critical and makes it difficult to make an accurate evaluation of the effectiveness of this experiment; ⑧ those who are allergic to the drug used in this study, or those who are participating in other clinical trials.

[0043] Shedding Standard

[0044] ① Poor subject compliance (medication compliance <80% or >120%), or combined use of Chinese or Western medicines prohibited by the implementation plan; ② Natural dropout during observation; ③ Serious adverse events and complications that make it unsuitable to continue the clinical trial.

[0045] Example 3:

[0046] Sample size estimation

[0047] This invention is a randomized controlled trial. Sample size estimation (Xu Yongyong, ed., Medical Statistics, 3rd ed., Beijing: Higher Education Press, 2014): Using G*Power 3.1 software, with a significance level of α=0.05 and a power of 1-β=0.95, two-tailed, the minimum sample size was estimated to be 54. Assuming a dropout rate of 10%, the minimum sample size was 60. The sample size was expanded to include 186 cases.

[0048] Treatment plan and course of treatment

[0049] Control group regimen: Pidotimod dispersible tablets 0.8g bid po.

[0050] Treatment group regimen: The treatment group received the same treatment as the control group, plus 10g of Gubenqingyuan paste twice daily orally. The above formula was prepared in 15 doses, with all ingredients processed from granules into a paste. Each dose was 10g, taken twice daily after meals, for two consecutive months.

[0051] One month constitutes one course of treatment. After two courses of treatment, the efficacy is evaluated. A total of six courses of treatment are administered.

[0052] Example 4:

[0053] Clinical efficacy evaluation grading standards: The efficacy judgment standards are based on the standardized standards in the "Standards for Diagnosis and Efficacy of Hematological Diseases" edited by Zhang Zhinan and Shen Ti in 2007 (third edition).

[0054] Hematological improvement criteria: statistically significant changes in T lymphocyte subsets, B cells, NK cells, and humoral immunity levels before and after intervention (P < 0.05).

[0055] Traditional Chinese Medicine (TCM) syndrome differentiation and efficacy evaluation criteria: Information from the four diagnostic methods of TCM was collected from the patient, and the improvement of TCM syndromes before and after treatment was observed. Referring to the "Guiding Principles for Clinical Research of New Chinese Medicines" and "Clinical Pharmacology of Chinese Medicines," the results were categorized as clinically cured, significantly effective, effective, and ineffective.

[0056] Clinical cure: The score is reduced by ≥95% and the TCM clinical symptoms and signs disappear or basically disappear.

[0057] Significant effect: The score is reduced by ≥70% and the clinical symptoms and signs in traditional Chinese medicine are significantly improved.

[0058] Effective: The score is reduced by ≥30% and the clinical symptoms and signs in traditional Chinese medicine are improved.

[0059] Ineffective: The score decreases by less than 30% and there is no significant improvement in TCM clinical symptoms and signs, or even aggravation.

[0060] Note: Calculation formula (nimodipine method): [(pre-treatment score - post-treatment score) ÷ pre-treatment score] × 100%.

[0061] The measured measurement data should first undergo a normality test. For measurement data that conform to a normal distribution, the mean ± standard deviation should be used. The data are described using mean ± standard deviation (±s). If the data are normally distributed and have homogeneous variances after testing, independent t-tests are used for comparisons between groups, and paired t-tests are used for comparisons within groups; if the data do not conform to a normal distribution, the rank-sum test is used. P < 0.05 is considered statistically significant. All data were processed using SPSS 22.0 software.

[0062] Example 5:

[0063] Baseline characteristics of the research subjects

[0064] A total of 186 patients with malignant lymphoma who achieved complete remission (CR) and visited the outpatient and inpatient departments of the Department of Hematology at the Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine between January 1, 2022 and December 31, 2023 were selected. Their ages ranged from 18 to 60 years. Among them, 101 were male and 85 were female, with a mean age of (43.27±5.08) years and a mean disease duration of (7.13±3.85) months. The patients were classified as follows: 107 with diffuse large B-cell lymphoma, 15 with mantle cell lymphoma, 22 with follicular cell lymphoma, 8 with high-grade B-cell lymphoma, 12 with small B-cell lymphoma, 17 with peripheral T-cell lymphoma, and 5 with NK / T-cell lymphoma.

[0065] Effects of Gubenqingyuan Formula on Blood Counts of Subjects

[0066] The experimental group of patients treated with the Gubenqingyuan formula had an average white blood cell count and neutrophil count, with neutrophils >1.5*102. ^9 The recovery time for the control group was significantly longer than that for the control group (P < 0.05). The results are shown in Table 1.

[0067] Table 1. Effects of the Gubenqingyuan formula on the blood counts of the subjects ( ±s)

[0068]

[0069] Note: * in the P value indicates a significant difference (P<0.05).

[0070] Effects of the "Strengthening the Root and Clearing the Source" Formula on the Humoral Immune Function of Subjects

[0071] The average levels of serum complement C3, immunoglobulin A, and immunoglobulin G in the treatment group were significantly higher than those in the control group (P < 0.05), while there was no significant difference in the average levels of serum complement C4 and immunoglobulin M. The results are shown in Table 2.

[0072] Table 2. Effects of the Gubenqingyuan formula on humoral immune function in the subjects ( ±s)

[0073]

[0074] Note: * in the P value indicates a significant difference (P<0.05).

[0075] Effects of Gubenqingyuan Formula on Lymphocyte Subsets in Subjects

[0076] Lymphocyte subset analysis showed that the percentage of suppressor / cytotoxic T cells in the Gubenqingyuan formula treatment group was higher than that in the control group (P < 0.05). The results are shown in Table 3.

[0077] Table 3. Effects of the Gubenqingyuan formula on lymphocyte subsets in the subjects ( ±s)

[0078]

[0079] Note: * in the P value indicates a significant difference (P<0.05).

[0080] Distribution and improvement of TCM syndrome types and infection rate in lymphoma patients in remission (based on clear etiological, imaging evidence or use of intravenous anti-infective drugs during treatment).

[0081] In lymphoma patients in remission, the most common TCM syndrome types were spleen and stomach qi deficiency, qi and blood deficiency, and qi and yin deficiency. Patients taking the Gubenqingyuan formula showed significantly better symptom improvement than the control group during 6 courses of treatment (P < 0.05). The incidence of infection was also significantly lower in patients taking the Gubenqingyuan formula compared to the control group (P < 0.05). Results are shown in Table 4.

[0082] Table 4. Distribution of TCM syndrome types and their improvement in lymphoma patients in remission, and the incidence of infection (n=186)

[0083]

[0084] Network pharmacology analysis studies the possible anti-tumor immunomodulatory effects of Gubenqingyuan formula.

[0085] Based on network pharmacology analysis, it was found that Gubenqingyuan Formula exerts regulatory effects on multiple targets and pathways in DLBCL, including tumor apoptosis, tumor drug resistance, immune regulation, and inflammatory factors. Gubenqingyuan Formula may exert its anti-tumor immunomodulatory effects by regulating the PI3K / AKT and JAK / STR pathways. Results are shown below. Figure 1(A)-Figure 1(C) , Figures 2-3 .

[0086] Unless otherwise specified, the raw materials and equipment used in this invention are all commonly used in the field; unless otherwise specified, the methods used in this invention are all conventional methods in the field.

[0087] The above description is a further detailed explanation of the present invention in conjunction with specific preferred embodiments. It should not be considered that the specific embodiments of the present invention are limited to this. For those skilled in the art, several simple deductions or substitutions can be made without departing from the concept of the present invention, and all such deductions or substitutions should be considered to fall within the scope of protection of the present invention as defined by the submitted claims.

Claims

1. A traditional Chinese medicine composition for strengthening the body's foundation and clearing away pathogens, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Astragalus membranaceus 30g, Angelica sinensis 10g, Rehmannia glutinosa (raw) 10g, Rehmannia glutinosa (processed) 10g, Ostrea gigas 30g, Scrophularia ningpoensis 10g, Leonurus japonicus 20g, Rhodiola rosea 25g, and Panax notoginseng powder 3g.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition can be made into ointments, pills, tablets, granules, capsules, powders, drop pills, films, or oral liquids.

3. The traditional Chinese medicine composition as described in claim 2, characterized in that: The traditional Chinese medicine composition is prepared into an ointment.

4. The traditional Chinese medicine composition according to claim 3, characterized in that: The steps for preparing the ointment include: 1) Preparation: Prepare the Chinese herbal medicine granules and excipients according to the prescription; dissolve the Chinese herbal medicine granules in water; 2) Heating and Concentration: Heat the dissolved medicine to a boil, then reduce to a simmer and stir constantly to prevent sticking; concentrate until the paste becomes viscous, depending on the volume and concentration of the medicine. 3) Add excipients: After the medicine solution has been concentrated to the appropriate degree, add the excipients and continue to stir evenly; 4) Reduce the paste: Keep the heat low and stir continuously until the paste has a suitable viscosity and a relative density of about 1.2-1.5; 5) Bottle and store.

5. A pharmaceutical composition for immune reconstitution in the CR stage or after CR of malignant lymphoma, comprising the traditional Chinese medicine composition according to any one of claims 1-4 and pidotimod.

6. The use of the traditional Chinese medicine composition according to any one of claims 1-4 or the pharmaceutical composition according to claim 5 in the preparation of a drug for immune reconstitution in the CR stage or after CR of malignant lymphoma.

7. The application as described in claim 6, characterized in that: The malignant lymphomas mentioned are diffuse large B-cell lymphoma, mantle cell lymphoma, follicular cell lymphoma, high-grade B-cell lymphoma, small B-cell lymphoma, peripheral T-cell lymphoma, or NK / T-cell lymphoma.

8. The application as described in claim 7, characterized in that: The malignant lymphoma is diffuse large B-cell lymphoma.

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