Traditional Chinese medicine composition for treating myelosuppression after radiotherapy and chemotherapy and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating myelosuppression after radiotherapy and chemotherapy and a preparation method, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine is prepared from the following raw materials: prepared rehmannia root, suberect spatholobus stem, morinda officinalis, pulp of dogwood fruit, dendrobe, wine-processed desert cistanche, black prepared aconite root, schisandra chinensis, cinnamon, donkey-hide gelatin beads, rhizoma polygonati, mangnolia officinalis, endothelium corneum gigeriae galli, poria cocos, radix ophiopogonis, rhizoma acori graminei, fructus amomi, ginger, jujube and ginseng. Aiming at the core problem of myelosuppression, namely imbalance of qi, blood, yin and yang, careful medicine compatibility is carried out, and the traditional Chinese medicine aims at comprehensively nourishing qi, blood, yin and yang of patients, so that the traditional Chinese medicine is suitable for people suffering from myelosuppression, reduction of three lines of blood cells, weakness and the like caused by various reasons.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, in particular to a pharmaceutical composition related to bone marrow suppression after chemotherapy. Background Art

[0002] Bone marrow suppression is the most common toxic reaction after chemotherapy, which poses a severe challenge to the treatment and quality of life of cancer patients. It is widely reported that more than 80% of chemotherapy drugs can cause bone marrow suppression, which is mainly manifested as a decrease in neutrophils and platelets, and the incidence of chemotherapy-related anemia is as high as 70% to 90%. This phenomenon not only causes clinical symptoms such as anemia and leukopenia in patients, but also significantly increases the risk of complications such as infection and bleeding, seriously weakening the patient's body defense ability and treatment effect.

[0003] Although there are many methods in the field of Western medicine for the treatment of post-chemotherapy bone marrow suppression, they generally face problems such as unstable long-term efficacy, significant adverse reactions and high treatment costs. Therefore, exploring safer, more effective and economical treatment methods has become an important topic in current clinical tumor research. Due to its unique theoretical system and treatment concept, traditional Chinese medicine has shown potential advantages in reducing chemotherapy-related adverse reactions and enhancing chemotherapy effects, which has attracted widespread attention and research interest.

[0004] From the perspective of traditional Chinese medicine, the clinical manifestations of bone marrow suppression after chemotherapy can be classified into the categories of "deficiency", "blood deficiency" and "blood syndrome". Traditional Chinese medicine believes that chemotherapy drugs, as foreign drug toxins, first damage the spleen and stomach after invading the body, leading to dysfunction of the spleen and stomach transportation and transformation, lack of source of qi and blood production, and then causing qi and blood deficiency. At the same time, drug toxins will directly damage the bone marrow and consume kidney essence, so that the essence cannot nourish the marrow, and the marrow cannot transform into blood, eventually leading to deficiency of both essence and blood. This pathological feature mainly involves the spleen and kidney, and is closely related to the functions of the heart, liver and other internal organs, forming a pathological state of spleen and kidney deficiency, qi and blood deficiency, and deficiency of the body and accumulation of toxins.

[0005] Modern Chinese medicine scholars have conducted in-depth discussions on the pathogenesis of chemotherapy-induced bone marrow suppression and have proposed a variety of different understandings. For example, some scholars believe that chemotherapy drug toxicity first damages the spleen and stomach, causing dysfunction of their transport and transformation functions, leading to deficiency of both qi and blood; then drug toxicity accumulates and damages the kidneys, causing kidney essence loss, essence not nourishing the marrow, and marrow not being able to transform blood. Other scholars emphasize that "drug evil toxicity" invades the already weak body, and the disease is located in the bone marrow, which is closely related to dysfunction of the liver, spleen, and kidney. The pathogenesis is spleen and kidney deficiency, liver depression and qi stagnation, and internal stasis and toxicity. Based on these understandings, the Chinese medicine community has summarized a variety of treatment methods such as tonifying the kidney and generating marrow, strengthening the spleen and nourishing blood, detoxifying and activating blood circulation, invigorating qi and nourishing yin, and soothing the liver and regulating the liver, and has conducted corresponding prescription and medicine research.

[0006] However, although these traditional Chinese medicine treatment methods have achieved certain curative effects, they are still insufficient overall and the curative effects are not significant. Therefore, developing a more effective and stable traditional Chinese medicine composition to better treat bone marrow suppression after radiotherapy and chemotherapy has become an urgent problem to be solved. Summary of the invention

[0007] The present invention provides a Chinese medicine composition for treating bone marrow suppression after chemoradiotherapy and a preparation method thereof. The Chinese medicine composition has the characteristics of wide applicability, comprehensive nourishment and significant therapeutic effect, and is a safer, more effective and economical treatment option for bone marrow suppression after chemoradiotherapy.

[0008] In order to solve the above technical problems, one of the technical solutions adopted by the present invention is to provide a Chinese medicine composition for treating bone marrow suppression after radiotherapy and chemotherapy: It is made from the following raw materials: Rehmannia root, Millettia reticulata, Morinda officinalis, Cornus officinalis, Dendrobium candidum, Cistanche deserticola, Heishun tablets, Schisandra chinensis, cinnamon bark, donkey-hide gelatin beads, Polygonatum sibiricum, Magnolia bark, Chicken gizzard lining, Poria cocos, Ophiopogon japonicus, Acorus calamus, Amomum villosum, ginger, jujube, and ginseng.

[0009] In the above technical scheme, a more specific technical scheme is: the weight parts of each raw material are as follows: 10-12 portions of Rehmannia glutinosa, 28-30 portions of Millettia reticulata, 7-9 portions of Morinda officinalis, 7-9 portions of Cornus officinalis, 7-9 portions of Dendrobium candidum, 8-9 portions of Cistanche deserticola, 4-6 portions of Heishun Pian, 4-6 portions of Schisandra chinensis, 1-3 portions of Cinnamon bark, 8-10 portions of Ejiao beads, 10-12 portions of Polygonatum sibiricum, 4-6 portions of Magnolia officinalis, 13-15 portions of Chicken gizzard lining, 13-15 portions of Poria cocos, 7-9 portions of Ophiopogon japonicus, 4-6 portions of Acorus calamus, 4-6 portions of Amomum villosum, 4-6 portions of Ginger, 13-15 portions of Jujube, and 4-6 portions of Ginseng.

[0010] Further, the weight parts of each raw material are as follows: 12 parts of Radix Rehmanniae Preparata, 30 parts of Caulis Spatholobi, 9 parts of Morinda Officinalis, 9 parts of Fructus Corni, 9 parts of Herba Dendrobii, 9 parts of Herba Cistanches Wine, 6 parts of Pian Hei Shun Pian, 6 parts of Fructus Schisandrae Chinensis, 3 parts of Cortex Cinnamomi, 10 parts of Ejiao Beads, 12 parts of Spermum Polygonatum, 6 parts of Magnolia Bark, 15 parts of Endothelium Corneum Giddens Galli, 15 parts of Poria, 9 parts of Radix Ophiopogonis, 6 parts of Rhizoma Acorus Calamus, 6 parts of Fructus Amomi, 6 parts of Rhizoma Zingiberis, 15 parts of Jujube, and 6 parts of Radix Ginseng.

[0011] Furthermore, the Chinese medicine composition for treating bone marrow suppression after radiotherapy and chemotherapy is prepared into an ointment for oral administration.

[0012] Furthermore, among the above raw materials, the Heishun tablets are first decocted; The donkey-hide gelatin beads need to be melted; The Amomum villosum is a drug to be taken later.

[0013] The second technical solution adopted by the present invention is to provide a preparation method of the above-mentioned Chinese medicine composition for treating bone marrow suppression after radiotherapy and chemotherapy, and the preparation method comprises the following preparation steps: ①Except for the donkey-hide gelatin beads, all other raw materials are soaked in advance; ②Decoction the soaked raw materials; among them, Heishunpian is the first drug to be decocted, and Amomum villosum is the drug to be added later, so Heishunpian needs to be decocted separately first, and then other soaked raw materials are added to continue decocting, and finally Amomum villosum is added to continue decocting; ③ Filter the decoction to obtain a filtrate; ④ Heat and concentrate the obtained filtrate, and add the previously melted donkey-hide gelatin beads during the concentration process until it is concentrated into a paste.

[0014] In the above technical scheme, a more specific technical scheme is: in the above step ①, when soaking the raw materials, add 8 to 10 times the amount of cold water, and the soaking time is not less than 6 hours.

[0015] Furthermore, in the above step ②, the soaked raw materials are decocted twice, and the medicinal liquids obtained from the two decoctions are combined and allowed to stand.

[0016] Furthermore, in the above step ④, the filtrate is heated to boiling, and then evaporated and concentrated over a low heat, and the filtrate is continuously stirred to prevent the filtrate from burning on the bottom and sticking to the pan.

[0017] Furthermore, in the above step ④, during the heating and concentration process of the filtrate, auxiliary materials such as refined sugar or honey may be added.

[0018] The prepared rehmannia root described in the present invention is a processed product of raw rehmannia root of the Scrophulariaceae family, and the medicinal part is the rhizome, which is slightly warm in nature, sweet in taste, and enters the liver meridian and kidney meridian. It is also known as prepared rehmannia root, rehmannia root, and radix rehmanniae.

[0019] The Millettia reticulata is the dried vine stem of the leguminous plant Bean with a warm nature, bitter and slightly sweet taste, and enters the liver, heart, and kidney meridians. Its aliases include blood wind vine, red deer vine, red vine, blood-activating vine, blood dragon vine, guoganglong, purple stem vine, pig blood vine, nine-layer wind, five-layer blood, blood wind, blood vine, big blood vine, three-leaf Millettia reticulata, and blood tendon vine.

[0020] The Morinda officinalis is the dried root of the Rubiaceae plant Morinda officinalis How. It is slightly warm in nature, sweet and spicy in taste, and enters the kidney and liver meridians. It has aliases such as Morinda officinalis, chicken intestine wind, black vine drill, rabbit intestine, triangle vine, bran vine, three vine grass, and everlasting grass.

[0021] The cornus officinalis is the dried mature pulp of Cornus officinalis Sieb. et Zucc., a plant of the Cornaceae family. It is slightly warm in nature, sour and astringent in taste, and enters the liver and kidney meridians. It is also known as taro meat, mountain meat, Hangzhou taro meat, Hangzhou cornus officinalis, cornus, cornus officinalis meat, Shuzao, Shusuanzao, chicken foot, real jujube, meat jujube, medicinal jujube, Kousi, Siyi, cornus officinalis, pure cornus officinalis, jujube peel, taro meat, etc.

[0022] The Dendrobium is a plant of the genus Dendrobium of the Orchidaceae family. It is slightly cold in nature, sweet in taste, and enters the stomach meridian and kidney meridian. It has aliases such as Linlan, Jinsheng, Dulan, Jinchaihua, Qiannianrun, Huangcao, and Chlorophytum.

[0023] The wine Cistanche is made from the fleshy stems of the Orobanchaceae plant Cistanche deserticola YCMa processed into wine. It is sweet, slightly warm, non-toxic, and enters the kidney and large intestine meridians. Cistanche deserticola is also known as Rousong Rong, Black Commander, Zong Rong, Goblin, Horse Foot, Ma Zhi, Dayun, Cun Yun, Light Dayun, Golden Bamboo Shoot, Goblin, Black Siming, etc.

[0024] The Heishun tablets are made from the processed rootlets of the Ranunculaceae plant Aconitum, are very hot in nature, pungent and sweet in taste, and enter the heart, kidney, and spleen meridians. They are also known as Heifu Pian, Heifuzi, and Heishun.

[0025] The Schisandra chinensis is the dried mature fruit of the Magnoliaceae plant Schisandra chinensis. It is warm, sour and sweet in nature, and enters the lung, heart and kidney meridians. It has aliases such as Xuanji, Huiji, Wumeizi, Shanhuajiao, Zhuangwei and Schisandra chinensis.

[0026] The cinnamon is the dried bark of the cinnamon plant of the Lauraceae family. It is hot in nature, pungent and sweet in taste, and enters the kidney, spleen, and bladder meridians. It is also known as Chinese cassia, purple cinnamon, big cinnamon, jade cinnamon, official cinnamon, cinnamon heart, oil cinnamon, purple oil cinnamon, yellow cinnamon, Guangdong cinnamon, Annan cinnamon, Qibian cinnamon, and red cinnamon.

[0027] The donkey-hide gelatin beads are solid gelatin blocks or beads made by decocting and concentrating the dried or fresh skin of the donkey, an equine animal. They are mild in nature, slightly sweet in taste, and enter the lung, liver, and kidney meridians. They are also known as donkey-hide gelatin, Fuzhi gelatin, Penfu gelatin, donkey skin gelatin, gelatin beads, and fried donkey-hide gelatin.

[0028] The polygonatum sibiricum is the dried rhizome of the lily family plants polygonatum yunnanensis, polygonatum sibiricum or polygonatum sibiricum. It is mild in nature, sweet in taste, and enters the lung meridian, spleen meridian, and kidney meridian. Its aliases include dragon's mouth, white ji, rabbit bamboo, hanging beads, chicken grid, rice bran, dodder bamboo, deer bamboo, Paris polyphylla, Jiuqiong, Weirui, Gou Ge, and horse arrow.

[0029] The Magnolia officinalis is the dried bark, root bark and branch bark of the Magnolia officinalis or Magnolia officinalis of the Magnoliaceae family. It is warm in nature, bitter and pungent in taste, and enters the spleen meridian, stomach meridian, lung meridian and large intestine meridian. It is also known as Sichuan Magnolia officinalis, Purple Magnolia officinalis, Purple Oil Magnolia officinalis, Wen Pu, Thick Bark, Heavy Bark, Red Magnolia officinalis, Oil Magnolia officinalis, Lie Pu and Purple Oil Magnolia officinalis.

[0030] The chicken gizzard lining is the dried inner wall of the gizzard of the domestic chicken (Gallus gallus domesticus Brisson), a pheasant family animal, that is, the inner stomach membrane of the chicken. It is mild in nature, sweet in taste, and enters the spleen meridian, stomach meridian, small intestine meridian, and bladder meridian. It has aliases such as chicken skin, raw gizzard lining, fried gizzard lining, chicken gizzard skin, chicken yellow skin, chicken zygote, chicken gold, fossilized gallbladder, and bone-dissolving gallbladder.

[0031] The Poria cocos is the dried sclerotium of the Polyporaceae fungus Poria cocos. It is flat in nature, sweet and light in taste, and enters the heart meridian, lung meridian, spleen meridian, and kidney meridian. It has aliases such as Futu, Yunling, Songling, Songshu, Fuling, Poria cocos, and Yun Fuling.

[0032] The Ophiopogon japonicus is a tuberous root of a perennial herb of the genus Ophiopogonis of the Asparagaceae family. It is sweet, slightly bitter, slightly cold, and enters the heart, lung, and stomach meridians. It has aliases such as Ophiopogon japonicus, Ophiopogon japonicus, Hangzhou Ophiopogon japonicus, Sichuan Ophiopogon japonicus, Cundong, Wheat Ophiopogon japonicus, and Leek Leaf Ophiopogon japonicus.

[0033] The Acorus calamus is the rhizome of the grass-like perennial herb Acorus calamus of the Araceae family and the genus Acorus. It tastes pungent and bitter, is warm in nature, and enters the heart and stomach meridians. It has aliases such as nine-section calamus, mountain calamus, medicinal calamus, golden money calamus, calamus leaf, water sword grass, sword-leaf calamus, sword grass, bitter calamus, pink calamus, and fragrant calamus.

[0034] The Amomum villosum is the dried mature fruit or seed of the Zingiberaceae plants Amomum villosum, Amomum villosum green shell or Amomum villosum hainanensis. It is warm in nature, pungent in taste, and enters the stomach meridian, spleen meridian, and kidney meridian. It has aliases such as Amomum villosum, Amomum villosum honey, Amomum villosum, and Spring Amomum villosum.

[0035] The ginger is the fresh rhizome of the ginger plant of the ginger family. It is slightly warm in nature, spicy in taste, and enters the lung meridian, spleen meridian, and stomach meridian. It has aliases such as ginger root, Bai Layun, Hooked Finger, Indisin, Yanliang Boy, and fresh ginger.

[0036] The jujube is a plant of the genus Ziziphus of the family Rhamnaceae of the order Rosales. It is sweet and warm in nature, and enters the spleen and stomach meridians. It has aliases such as red dates, dried dates, dates, big red dates, beautiful dates, good dates, thorny dates, and red dates.

[0037] The ginseng is the dried root of the ginseng plant of the Araliaceae family. It is slightly warm in nature, sweet and slightly bitter in taste, and enters the lung and spleen meridians. It has aliases such as jade essence, blood ginseng, earth essence, earth essence, mountain ginseng, garden ginseng, ghost cover, and yellow ginseng.

[0038] By adopting the above technical solution, the beneficial effects obtained by the present invention are: 1. Aiming at the core problem of bone marrow suppression - imbalance of qi, blood, yin and yang, the present invention has made careful drug compatibility, aiming to comprehensively nourish the patient's qi, blood, yin and yang, so that it is suitable for people with bone marrow suppression, three-line reduction of blood cells and physical weakness caused by various reasons.

[0039] 2. Common clinical bone marrow suppression is more common in patients with tumor radiotherapy and chemotherapy. Chemotherapy damages the yang of the spleen and stomach of patients. In addition, tumor patients often have deficiency of vital energy, which will damage the kidneys over time. Yang deficiency will damage yin over time, thus causing yin and yang deficiency. Radiotherapy is easy to damage the body's yin and fluid. Long-term damage to the yin of the lungs and stomach will also affect the yin of the kidneys. Yin deficiency will damage its yang over time, thus also causing yin and yang deficiency. Therefore, the present invention is composed of Rehmannia glutinosa, Millettia reticulata, Morinda officinalis, Cornus officinalis, Dendrobium officinale, Cistanche deserticola, Heishun tablets (decoction for a long time) It is composed of Schisandra chinensis, cinnamon bark, donkey-hide gelatin beads (melted), Polygonatum sibiricum, Magnolia officinalis, Chicken gizzard lining, Poria cocos, Ophiopogon japonicus, Acorus gramineus, Amomum villosum (added later), ginger, jujube, and ginseng. In the formula, the sweet and warm Rehmannia glutinosa is matched with the sour and warm Fructus Corni to nourish the kidney and replenish essence; Cistanche deserticola and Morinda officinalis warm and strengthen kidney yang; the pungent and hot properties of Heishun tablets and cinnamon bark help warm and nourish the lower abdomen and guide fire back to the origin; Dendrobium officinale, Ophiopogon japonicus, Schisandra chinensis nourish yin and retain fluid, strengthen water to relieve fire; Acorus gramineus Cattail and Poria cocos are used together to open up the mind, resolve phlegm, and connect the heart and kidney; ginger, jujube and Chinese medicine are used as the middle regulating medicine, and jujube, Millettia reticulata, and donkey-hide gelatin beads are added to nourish yin, replenish blood, and stop bleeding. Ginseng is added to greatly replenish vital energy, replenish the spleen and stomach, and Polygonatum sibiricum replenishes essence and blood. Amomum villosum, chicken gizzard lining, and Magnolia officinalis are added to warm the spleen and stimulate the appetite, stop vomiting and diarrhea, resolve dampness and promote qi circulation, and make the tonics move without staying, so as not to replenish and cause stagnation. Based on the above, the present invention can achieve the purpose of treating bone marrow suppression after radiotherapy and chemotherapy. DETAILED DESCRIPTION

[0040] The present invention is further described in detail below in conjunction with specific embodiments: Example 1 - A Chinese medicine composition for treating bone marrow suppression after chemoradiotherapy and preparation method The weight parts of each raw material used in the preparation of the Chinese medicine composition are as follows: 12 parts of Radix Rehmanniae Preparata, 30 parts of Caulis Spatholobi, 9 parts of Morinda Officinalis, 9 parts of Fructus Corni, 9 parts of Herba Dendrobii, 9 parts of Herba Cistanches Wine, 6 parts of Pian Hei Shun Pian, 6 parts of Fructus Schisandrae Chinensis, 3 parts of Cortex Cinnamomi, 10 parts of Ejiao Beads, 12 parts of Spermum Polygonatum, 6 parts of Magnolia Bark, 15 parts of Endothelium Corneum Giddens Galli, 15 parts of Poria, 9 parts of Radix Ophiopogonis, 6 parts of Rhizoma Acorus Calamus, 6 parts of Fructus Amomi, 6 parts of Rhizoma Zingiberis, 15 parts of Jujube, and 6 parts of Radix Ginseng.

[0041] The preparation method comprises the following preparation steps: ①Except for the donkey-hide gelatin beads, all other raw materials are soaked in advance; when soaking the raw materials, add 8 to 10 times the amount of cold water (or soak the water 10 to 15 cm above the medicine surface), and the soaking time is not less than 6 hours (generally overnight soaking is preferred); ② decoct the soaked raw materials; among them, Heishun Pian is the first decoction drug, and Amomum villosum is the last decoction drug, so Heishun Pian needs to be decocted separately first, and then other soaked raw materials are added to continue decocting, and finally Amomum villosum is added to continue decocting, and the liquid medicine is poured out; water is added again for secondary decoction to obtain secondary decoction liquid medicine; ③ Combine the medicinal solutions obtained from the two decoctions, let stand, and filter to obtain a filtrate; ④ Heat the filtrate to boiling, then use low heat to evaporate and concentrate. During this period, the filtrate needs to be stirred constantly to prevent it from burning and sticking to the pot. When it is concentrated to the specified degree, a clear paste is obtained (the traditional judgment standard for clear paste is to drop it on mulberry paper to check for water seepage, but now a hydrometer is used to measure the specific gravity as the judgment standard); put the concentrated clear paste in a container, continue to heat and concentrate to evaporate the water, and add the previously melted donkey-hide gelatin beads (at the same time, you can also add refined sugar or honey and other auxiliary materials as needed). During this period, it is also necessary to stir constantly to prevent it from sticking to the bottom, burning, and boiling, until it is concentrated into a paste.

[0042] Example 2 - A Chinese medicine composition for treating bone marrow suppression after chemoradiotherapy and preparation method The weight parts of each raw material used in the preparation of the Chinese medicine composition are as follows: 10 parts of Radix Rehmanniae Preparata, 28 parts of Caulis Spatholobi, 7 parts of Morinda Officinalis, 7 parts of Fructus Corni, 7 parts of Dendrobium, 8 parts of Herba Cistanches Wine, 4 parts of Heishun Pian, 4 parts of Fructus Schisandrae Chinensis, 1 part of Cortex Cinnamomi, 8 parts of Ejiao Beads, 10 parts of Scutellariae Sinensis, 4 parts of Magnolia Bark, 13 parts of Endothelium Corneum Galli, 13 parts of Poria, 7 parts of Radix Ophiopogonis, 4 parts of Rhizoma Acorus Calamus, 4 parts of Fructus Amomi, 4 parts of Rhizoma Zingiberis, 13 parts of Jujube, and 4 parts of Radix Ginseng.

[0043] This example adopts the same preparation method as that of Example 1, except for the weight ratio of each raw material.

[0044] Example 3 - A Chinese medicine composition for treating bone marrow suppression after chemoradiotherapy and preparation method The weight parts of each raw material used in the preparation of the Chinese medicine composition are as follows: 11 parts of Radix Rehmanniae Preparata, 29 parts of Caulis Spatholobi, 8 parts of Morinda Officinalis, 8 parts of Fructus Corni, 8 parts of Herba Dendrobii, 9 parts of Herba Cistanches Wine, 5 parts of Pian Hei Shun Pian, 5 parts of Fructus Schisandrae Chinensis, 2 parts of Cortex Cinnamomi, 9 parts of Ejiao Beads, 11 parts of Spermum Cynomorium, 5 parts of Magnolia Bark, 14 parts of Endothelium Corneum Giddens Galli, 14 parts of Poria, 8 parts of Radix Ophiopogonis, 5 parts of Rhizoma Acorus Calamus, 5 parts of Fructus Amomi, 5 parts of Rhizoma Zingiberis, 14 parts of Jujube, and 5 parts of Radix Ginseng.

[0045] Similarly, this embodiment also adopts the same preparation method as that of embodiment 1, except that the weight proportions of the raw materials are different.

[0046] Effect test part: The prescription of the present invention has been used for many years by the applicant, Liuzhou Hospital of Traditional Chinese Medicine (Liuzhou Zhuangyi Hospital). In order to better verify the therapeutic effect of the present invention on bone marrow suppression after radiotherapy and chemotherapy, the applicant randomly selected 120 patients with radiotherapy and chemotherapy who were hospitalized in the Department of Oncology of Liuzhou Hospital of Traditional Chinese Medicine from June 2024 to December 2024. Among them, 65 males and 55 females, aged 23-85 years old, with an average age of (53.7±6.3 years old), were randomly divided into a control group (60 cases) and an observation group (60 cases). The control group was given radiotherapy, chemotherapy, or radiotherapy + chemotherapy according to the patient's condition, and the observation group was given the prescription of the present invention on the basis of the control group. The occurrence of bone marrow suppression in the two groups of patients is shown in Table 1.

[0047] Treatment of the observation group: one set a day, divided into two doses, once in the morning and once in the evening, for 14 consecutive days. The composition of each set of prescriptions (weight parts are as follows): 10-12 parts of Radix Rehmanniae, 28-30 parts of Millettia Spatholobi, 7-9 parts of Morinda Officinalis, 7-9 parts of Fructus Corni, 7-9 parts of Dendrobium, 8-9 parts of Cistanche deserticola, 4-6 parts of Heishun Pian, 4-6 parts of Schisandrae Chinensis, 1-3 parts of Cinnamon, 8-10 parts of Ejiao beads, 10-12 parts of Polygonatum, 4-6 parts of Magnolia officinalis, 13-15 parts of Gallus gallus domesticus, 13-15 parts of Poria, 7-9 parts of Ophiopogon japonicus, 4-6 parts of Acorus calamus, 4-6 parts of Amomum villosum, 4-6 parts of Ginger, 13-15 parts of Jujube, and 4-6 parts of Ginseng. According to the characteristics of different cases, the dosage of each drug varies within the above range. The preparation method is shown in Example 1.

[0048] Table 1 .

[0049] Remark: 1. The total incidence of bone marrow suppression = (grade I + grade II + grade III + grade IV) / total number of cases × 100%.

[0050] 2. Efficacy criteria: Bone marrow suppression: The patient's blood routine was tested using the Sysmex xn9000 fully automatic blood cell analyzer, and the World Health Organization's acute and subacute toxicity standards for anticancer drugs were used to evaluate the patient's bone marrow suppression: Grade I: Hb 95 ~ 109 g / L, WBC (3.0 ~ 3.9) × 10 9 / L, neutrophil count (NEUT) (1.5 ~ 1.9)×10 9 / L, PLT(75~99)×10 9 / L; Grade II: Hb 80-94 g / L, WBC (2.0-2.9) × 10 9 / L, NEUT (1.0 ~ 1.4) ×10 9 / L, PLT(50~74)×10 9 / L; Grade III: Hb 65 to 79 g / L, WBC (1.0 to 1.9) × 10 9 / L, NEUT(0.5~0.9)×10 9 / L, PLT(25~49)×10 9 / L; IV degree: Hb <65 g / L, WBC <1.0 ×10 9 / L, NEUT <0.5× 10 9 / L,PLT<25×10 9 / L.

[0051] It can be seen from the above studies that after using the prescription of the present invention, the total incidence of bone marrow suppression in patients undergoing radiotherapy and chemotherapy is significantly reduced, and the treatment effect is significant.

[0052] Among them, the present invention specifically introduces several cases among the above numerous cases as follows: (1) Patient Huang, female, 55 years old.

[0053] Chief complaint: Breast cancer treatment for more than 5 years.

[0054] Current medical history: The patient reported that he had a right breast tumor puncture biopsy in April 2019, and the pathological report showed: right breast invasive ductal carcinoma, immunohistochemistry ER (about 20%+, weak-moderate), PR (15%+, moderate), Her-2 (2+), Ki-67 (about 80%+), clinical stage T3N1M0III stage Luminal B, 6 cycles of neoadjuvant chemotherapy from 2019-4-16 to 2019-8-2, the regimen was TAC, and then endocrine therapy. The patient's disease progressed 3 months ago and he underwent doxorubicin chemotherapy. Admission symptoms: fatigue, shortness of breath and laziness, dizziness, no exudation and bleeding, fatigue, dizziness, no fever and chills, no cough and sputum, no abdominal pain and diarrhea, no nausea and vomiting, poor appetite and sleep, and normal bowel movements. Physical examination showed pale red tongue, thin white fur, and weak pulse.

[0055] Western medicine diagnosis: 1. Right breast invasive ductal carcinoma cT4N1M1 stage IV, metastasis to the right chest and abdominal wall 2. Bone marrow suppression after chemotherapy TCM diagnosis: Breast cancer - Qi and blood deficiency syndrome Treatment principle: replenishing qi and nourishing blood Treatment method: one dose per day, divided into two doses, once in the morning and once in the evening, for 14 consecutive days. Each dose of prescription composition: 12g of Radix Rehmanniae, 30g of Millettia Spatholobi, 9g of Morinda Officinalis, 9g of Fructus Corni, 9g of Dendrobium, 9g of Cistanche deserticola, 6g of Heishun Pian (pre-decocted), 6g of Schisandrae Chinensis, 3g of Cinnamon Bark, 10g of Ejiao Beads (melted), 12g of Polygonatum, 6g of Magnolia Bark, 15g of Gallus Gallus Ternifolia, 15g of Poria, 9g of Ophiopogon Japonicus, 6g of Acorus Calamus, 6g of Amomum Villosum (added later), 6g of Ginger, 15g of Jujube, and 6g of Ginseng. The preparation method thereof is shown in Example 1.

[0056] Efficacy: After 14 days, the patient's fatigue improved, dizziness disappeared, and diet and sleep were improved. After chemotherapy, the total white blood cell count (WBC) was 2.49 × 10^9 / L, platelets (PLT): 51×10^9 / L, hemoglobin (HGB) 85g / L. After treatment according to the above treatment method, blood analysis was repeated: the total white blood cell count (WBC) was 3.91×10^9 / L, which was higher than before, platelets (PLT): 156×10^9 / L, which was higher than before, and hemoglobin (HGB) was 84g / L, with no significant decrease.

[0057] (II) Patient Xu, female, 56 years old Chief complaint: Abdominal distension and pain for 2 days nearly 3 years after surgery for ovarian endometrioid adenocarcinoma.

[0058] Current medical history: The patient reported that she found a left adnexal mass in March 2022 and went to Tanzhong People's Hospital in Liuzhou for treatment. Pelvic magnetic resonance imaging showed a mass visible on the left side of the pelvis, about 4.2*3.8*5cm in size. On March 9, 2023, she underwent laparoscopic pelvic adhesion separation + intestinal adhesion separation + left oophorectomy under general anesthesia. Postoperative pathology showed left adnexal ovarian endometrioid carcinoma (moderate differentiation). On March 18, she underwent abdominal ovarian cancer comprehensive staging surgery (total hysterectomy + right oophorectomy + omentectomy + appendectomy + pelvic lymph node resection). Postoperative pathology showed endometrioid adenocarcinoma, and cancer metastasis was found in the left pelvic lymph nodes (2 / 7). A total of 6 chemotherapy sessions (paclitaxel + carboplatin) were performed from April 2022 to January 2023 after surgery. In November 2023, the disease progressed and paclitaxel liposome + carboplatin chemotherapy was performed. Symptoms on admission: abdominal distension and pain, bitter and dry mouth, occasional nausea without vomiting, no chest tightness or pain, no dizziness or headache, no diarrhea or other discomfort, poor appetite and sleep, slightly normal bowel movements. Physical examination showed red tongue, yellow fur, and stringy pulse.

[0059] Western medicine diagnosis: 1. Recurrent ovarian endometrioid adenocarcinoma, stage IV 2. Bone marrow suppression after chemotherapy TCM diagnosis: Ovarian cancer-Shaoyang disease Treatment principle: tonify the middle and replenish Qi.

[0060] Treatment method: one dose per day, divided into two doses, once in the morning and once in the evening, for 14 consecutive days. Each dose of prescription composition: 12g of Radix Rehmanniae, 30g of Millettia Spatholobi, 9g of Morinda Officinalis, 9g of Fructus Corni, 9g of Dendrobium, 9g of Cistanche deserticola, 6g of Heishun Pian (pre-decocted), 6g of Schisandrae Chinensis, 3g of Cinnamon Bark, 10g of Ejiao Beads (melted), 12g of Polygonatum, 6g of Magnolia Bark, 15g of Gallus Gallus Ternifolia, 15g of Poria, 9g of Ophiopogon Japonicus, 6g of Acorus Calamus, 6g of Amomum Villosum (added later), 6g of Ginger, 15g of Jujube, and 6g of Ginseng. The preparation method thereof is shown in Example 1.

[0061] Efficacy: After 14 days, the patient had no abdominal pain, bloating, dry mouth or bitter taste. Namei Ke. Total white blood cell count (WBC) after chemotherapy: 2.87×10^9 / L. After treatment according to the above treatment method, the total white blood cell count (WBC) of the blood analysis was 4.81×10^9 / L.

[0062] (III) Patient Tan, female, 47 years old Chief complaint: Comprehensive treatment for cervical cancer for more than 4 years, fatigue for 1 week.

[0063] Current medical history: The patient reported that she went to Liuzhou People's Hospital for irregular vaginal bleeding on September 30, 2018. The biopsy of the cervical tumor showed squamous cell carcinoma of cervical invasive keratosis and squamous cell carcinoma of the left vaginal wall. After that, she underwent 2 courses of chemotherapy (docetaxel 100mg d1 + nedaplatin 120mg d1), and pelvic radiotherapy at the same time, with a dose of 46GY / 23F. Later, radiotherapy and chemotherapy were suspended due to IV degree bone marrow suppression. After that, she took Chinese medicine for recuperation in our hospital. Admission symptoms: general fatigue, dry mouth and bitter mouth, spontaneous sweating and night sweats, abdominal distension, no fever and chills, no sore throat, no cough and sputum, no dizziness and headache, poor appetite and sleep, and normal bowel movements. Physical examination: red tongue, yellow fur, slippery and rapid pulse.

[0064] Western medicine diagnosis: 1. After radiotherapy and chemotherapy for cervical cancer 2. Bone marrow suppression (thrombocytopenia) after chemotherapy TCM diagnosis: Cervical cancer - damp-heat and stasis syndrome Treatment principle: tonify Qi and nourish Yin, clear away heat and detoxify.

[0065] Treatment method: one dose per day, divided into two doses, once in the morning and once in the evening, for 14 consecutive days. Each dose of prescription composition: 12g of Radix Rehmanniae, 30g of Millettia Spatholobi, 9g of Morinda Officinalis, 9g of Fructus Corni, 9g of Dendrobium, 9g of Cistanche deserticola, 6g of Heishun Pian (pre-decocted), 6g of Schisandrae Chinensis, 3g of Cinnamon Bark, 10g of Ejiao Beads (melted), 12g of Polygonatum, 6g of Magnolia Bark, 15g of Gallus Gallus Ternifolia, 15g of Poria, 9g of Ophiopogon Japonicus, 6g of Acorus Calamus, 6g of Amomum Villosum (added later), 6g of Ginger, 15g of Jujube, and 6g of Ginseng. The preparation method thereof is shown in Example 1.

[0066] Efficacy: After 14 days, the patient's fatigue improved, and there was no dry mouth, bitter taste, spontaneous sweating, or night sweats, and no abdominal pain or bloating. Namei Ke. Platelet count (PLT) after chemotherapy: 28×10^9 / L. After treatment according to the above treatment method, blood analysis of platelet count (PLT) was rechecked: 62×10^9 / L.

[0067] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicine composition for treating bone marrow suppression after chemoradiotherapy, characterized in that Made from the following raw materials: Rehmannia root, Millettia reticulata, Morinda officinalis, Cornus officinalis, Dendrobium candidum, Cistanche deserticola, Heishun tablets, Schisandra chinensis, cinnamon bark, donkey-hide gelatin beads, Polygonatum sibiricum, Magnolia bark, Chicken gizzard lining, Poria cocos, Ophiopogon japonicus, Acorus calamus, Amomum villosum, ginger, jujube, and ginseng.

2. The Chinese medicine composition for treating bone marrow suppression after chemoradiotherapy according to claim 1, characterized in that The weight parts of each raw material are as follows: 10-12 portions of Rehmannia glutinosa, 28-30 portions of Millettia reticulata, 7-9 portions of Morinda officinalis, 7-9 portions of Cornus officinalis, 7-9 portions of Dendrobium candidum, 8-9 portions of Cistanche deserticola, 4-6 portions of Heishun Pian, 4-6 portions of Schisandra chinensis, 1-3 portions of Cinnamon bark, 8-10 portions of Ejiao beads, 10-12 portions of Polygonatum sibiricum, 4-6 portions of Magnolia officinalis, 13-15 portions of Chicken gizzard lining, 13-15 portions of Poria cocos, 7-9 portions of Ophiopogon japonicus, 4-6 portions of Acorus calamus, 4-6 portions of Amomum villosum, 4-6 portions of Ginger, 13-15 portions of Jujube, and 4-6 portions of Ginseng.

3. The Chinese medicine composition for treating bone marrow suppression after chemoradiotherapy according to claim 2, characterized in that The weight parts of each raw material are as follows: 12 parts of Radix Rehmanniae Preparata, 30 parts of Caulis Spatholobi, 9 parts of Morinda Officinalis, 9 parts of Fructus Corni, 9 parts of Herba Dendrobii, 9 parts of Herba Cistanches Wine, 6 parts of Pian Hei Shun Pian, 6 parts of Fructus Schisandrae Chinensis, 3 parts of Cortex Cinnamomi, 10 parts of Ejiao Beads, 12 parts of Spermum Polygonatum, 6 parts of Magnolia Bark, 15 parts of Endothelium Corneum Giddens Galli, 15 parts of Poria, 9 parts of Radix Ophiopogonis, 6 parts of Rhizoma Acorus Calamus, 6 parts of Fructus Amomi, 6 parts of Rhizoma Zingiberis, 15 parts of Jujube, and 6 parts of Radix Ginseng.

4. The Chinese medicine composition for treating bone marrow suppression after chemoradiotherapy according to claim 1, 2 or 3, characterized in that: The Chinese medicine composition for treating bone marrow suppression after radiotherapy and chemotherapy is prepared into an ointment for oral administration.

5. The Chinese medicine composition for treating bone marrow suppression after chemoradiotherapy according to claim 4, characterized in that: Among the above raw materials, the Heishun tablets are first decocted; The donkey-hide gelatin beads need to be melted; The Amomum villosum is a drug to be taken later.

6. A method for preparing a Chinese medicine composition for treating bone marrow suppression after chemoradiotherapy as claimed in claims 1 to 5, characterized in that The method comprises the following preparation steps: ①Except for the donkey-hide gelatin beads, all other raw materials are soaked in advance; ②Decoction the soaked raw materials; among them, Heishunpian is the first drug to be decocted, and Amomum villosum is the drug to be added later, so Heishunpian needs to be decocted separately first, and then other soaked raw materials are added to continue decocting, and finally Amomum villosum is added to continue decocting; ③ Filter the decoction to obtain a filtrate; ④ Heat and concentrate the obtained filtrate, and add the previously melted donkey-hide gelatin beads during the concentration process until it is concentrated into a paste.

7. The method for preparing the Chinese medicine composition for treating myelosuppression after chemoradiotherapy according to claim 6, characterized in that: In the above step ①, when soaking the raw materials, add 8 to 10 times the amount of cold water, and the soaking time is not less than 6 hours.

8. The method for preparing the Chinese medicine composition for treating bone marrow suppression after chemoradiotherapy according to claim 6 or 7, characterized in that: In the above step ②, the soaked raw materials are decocted twice, and the medicinal liquids obtained from the two decoctions are combined and allowed to stand.

9. The method for preparing the Chinese medicine composition for treating bone marrow suppression after chemoradiotherapy according to claim 8, characterized in that: In step ④ above, heat the filtrate to boiling, then use low heat to evaporate and concentrate, and stir the filtrate constantly to prevent it from burning on the bottom and sticking to the pan.

10. The method for preparing the Chinese medicine composition for treating myelosuppression after chemoradiotherapy according to claim 9, characterized in that: In the above step ④, auxiliary materials such as refined sugar or honey may be added during the heating and concentration process of the filtrate.