Traditional Chinese medicine composition for treating consumptive disease caused by radiotherapy and chemotherapy and preparation process thereof

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition prepared from radix pseudostellariae, raw radix astragali, rhizoma atractylodis macrocephalae, poria cocos, radix paeoniae alba, angelica sinensis, fructus lycii, glossy privet fruit, hairyvein agrimony, pericarpium citri reticulatae, plum blossom, medicated leaven, hawthorn, malt, fingered citron, thunberg dendrobium stem and rice-grain sprout. The traditional Chinese medicine composition is used for radiotherapy, chemotherapy and consumptive disease caused by postoperative body deficiency. The traditional Chinese medicine composition is mild in medicine property and capable of comprehensively adjusting human body functions, enhancing immunity, promoting qi and blood circulation and shortening the postoperative recovery period, and meanwhile the preparation method is easy to operate, reasonable in process, small in medicine component loss, stable and controllable in quality and suitable for industrial production.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating consumptive disease caused by radiotherapy, chemotherapy and postoperative physical weakness, and a preparation method thereof. Background Art

[0002] Tumor is one of the common diseases endangering human health. Surgery, radiotherapy or chemotherapy are common modern medical treatment methods for malignant tumors at present, but they also have certain reactions on the human body. After radiotherapy and chemotherapy, the physiological functions of normal tissues and organs are damaged to a certain extent, and the immunity and resistance are also affected to varying degrees. The main manifestation is deficiency of healthy qi, especially obvious deficiency of qi, blood, yin and fluid, resulting in consumptive disease of patients.

[0003] Consumptive disease is a general term for various chronic debilitating diseases caused by severe deficiency of zang-fu organs, yin-yang, qi and blood due to various reasons, and long-term deficiency without recovery. Its pathological nature is mainly the depletion of qi, blood, yin and yang. At present, the treatment methods for consumptive disease of the syndrome type of deficiency of both heart and kidney qi and yin include food therapy and traditional Chinese medicine treatment. The time for food therapy conditioning is too long, and traditional Chinese medicine treatment is a better treatment method. However, the treatment of consumptive disease has always been a difficult problem that is relatively chaotic and controversial. People have tried many treatment methods. To this day, methods such as food therapy and traditional Chinese medicine conditioning have slow food therapy effects and should be combined with medicine for conditioning. There are defects such as low cure rate and poor pertinence.

[0004] For the treatment of consumptive disease in Western medicine, mainly nutritional, vasodilating, corticosteroid and other treatments are applied. Although the effect of controlling symptoms can be achieved, due to large toxic and side effects and long treatment cycles, for example, glucocorticoids may limit their clinical use due to their own side effects and possible promoting effects on certain malignant tumors, and patients are difficult to accept. While controlling tumors, traditional Chinese medicine can improve the healthy qi of the human body, promote qi and blood circulation, adjust the functions of zang-fu organs, resist exogenous pathogens, and quickly restore the body of postoperative patients, effectively shortening their postoperative recovery period, which is a favorable condition for treating diseases, especially resisting the further differentiation and spread of tumors.

[0005] In the traditional Chinese medicine composition of the present invention, a large number of traditional Chinese medicines for tonifying the spleen and kidney are selected to adjust the body. In the formula, the spleen-strengthening formula composed of stir-fried Atractylodes macrocephala, stir-fried three immortals, Poria cocos, stir-fried Paeonia lactiflora, etc. is used as the main medicine, and the qi-tonifying and spleen-benefiting medicines such as Astragalus membranaceus and Pseudostellaria heterophylla are used as auxiliary medicines. In addition, Glossy Privet Fruit, Chinese Wolfberry Fruit and Angelica sinensis are used to tonify the liver and kidney, benefit essence and blood, and Dendrobium officinale has the effects of benefiting the stomach to promote the production of body fluid and clearing away heat and nourishing yin. Agrimony can detoxify and tonify deficiency to boost the power of strengthening healthy qi. Adjuvants such as Tangerine Peel, Japanese Apricot Flower and Fructus Citri Sarcodactylis all enter the spleen and stomach meridians and have the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. The formula of this traditional Chinese medicine composition is scientific and rigorous, and has a good therapeutic effect on consumptive disease, especially consumptive disease caused by radiotherapy and chemotherapy. Summary of the Invention

[0006] The main purpose of the present invention is to give full play to the characteristics of Chinese medicine in combining drugs and comprehensively adjusting human body functions, and to provide a Chinese medicine composition for preparing the treatment of fatigue syndrome.

[0007] The traditional Chinese medicine composition of the present invention is prepared from the following raw materials: Radix Pseudostellariae, Radix Astragali, Rhizoma Atractylodis Macrocephalae, Rhizoma Poriae, Radix Paeoniae Alba, Radix Angelicae Sinensis, Fructus Lycii, Fructus Ligustri Lucidi, Herba Agrimoniae, Pericarpium Citri Reticulatae, Plum Blossom, Rhizoma Citrus Grandis, Fructus Hawthorne, Malt, Fructus Citrus Grandis, Dendrobium Officinale and Rice Sprout.

[0008] In some embodiments, the Chinese medicine composition is prepared from the following raw materials:

[0009]

[0010] In a more preferred embodiment, the Chinese medicine composition is prepared from the following raw materials:

[0011]

[0012] In a more preferred embodiment, the Chinese medicine composition is prepared from the following raw materials:

[0013]

[0014] According to some embodiments, the Atractylodes macrocephala is fried Atractylodes macrocephala with bran, the Fructus Ligustri Lucidi is fried Fructus Ligustri Lucidi with wine, the Ligustrum lucidum is roasted Ligustrum lucidum, the Hawthorn is roasted Hawthorn, the malt is roasted malt, and the rice sprouts are roasted rice sprouts.

[0015] Another object of the present invention is to provide a method for preparing the above-mentioned composition: (1) removing impurities from raw astragalus, tuckahoe, white peony root, angelica, wolfberry, glossy privet, herb agrimony, tangerine peel, plum blossom, liushenqu, hawthorn, bergamot, and dendrobium officinale, washing, drying, crushing into granules, soaking in water for 2-3 hours, boiling the soaked raw materials with water for 2-4 times, adding 5-10 times the amount of water of the total amount of medicinal materials for the first time, boiling for 1-3 hours, taking the decoction, filtering, adding 4-6 times the amount of water of the total amount for the second time, boiling for 1-1.5 hours, mixing the two decoctions, and filtering;

[0016] (2) decompressing and concentrating the filtered filtrate to a concentrate having a relative density of 1.10-1.50 at 60-80° C., refrigerating at 0-5° C. for 20-24 h, filtering, decompressing and concentrating the filtrate, and drying it into powder;

[0017] (3) Grinding Pseudostellariae Radix, Atractylodes macrocephala, malt and rice sprout into fine powder, sieving, mixing with the powder of step (2), and preparing a clinically acceptable dosage form directly or by adding pharmaceutically acceptable excipients through conventional procedures.

[0018] In a more preferred embodiment, the Chinese medicine composition is prepared by the following steps:

[0019] (1) Remove impurities from and wash raw astragalus membranaceus, poria cocos, white peony root, angelica sinensis, wolfberry fruit, glossy privet fruit, agrimony, tangerine peel, Japanese apricot flower, medicated leaven, hawthorn, fingered citron, and dendrobium officinale var. moniliforme, dry in the air, pulverize into granules, soak in water for 1.5 h: Decoct the soaked raw materials in water three times. For the first time, add 8 times the amount of water of the total medicinal materials and decoct for 1.5 - 2 h, take the decoction, and filter. For the second time, add 5 times the amount of water of the total amount and decoct for 1 - 1.2 h, take the decoctions of the two times and mix them, and filter;

[0020] (2) Concentrate the filtered filtrate under reduced pressure to a concentrated solution with a relative density of 1.20 at 70 °C, refrigerate at a low temperature of 0 - 5 °C for 24 h; filter, concentrate the filtrate under reduced pressure, and dry into a powder;

[0021] (3) Pulverize pseudostellaria heterophylla, atractylodes macrocephala, malt, and germinated rice into fine powder, sieve, mix with the powder in step (2), and directly or add pharmaceutically acceptable excipients through conventional processes to make clinically acceptable dosage forms.

[0022] In some embodiments, the preparation is an oral preparation.

[0023] In some embodiments, the oral preparation is a decoction, powder, honeyed pill, pill, tablet, capsule, oral liquid, granule, or syrup.

[0024] Another object of the present invention is to provide an application of a traditional Chinese medicine composition in the preparation of a drug for treating consumptive disease caused by radiotherapy, chemotherapy, and postoperative physical weakness.

[0025] Compared with the prior art, the present invention has achieved remarkable technical effects:

[0026] 1) The present invention uses common Chinese herbal medicines on the market as raw materials, is simple to prepare, has low cost, and has good therapeutic effects. Verified by pharmacodynamics, the traditional Chinese medicine composition of the present invention can improve the relevant blood indexes of mice, has a certain improvement effect on the reduction of bone marrow nucleated cells, and can improve the immune function of mice after chemotherapy.

[0027] 2) Verified by clinical trials, the traditional Chinese medicine composition of the present invention can enhance the immune function of patients, supplement qi and blood, and the combination of various medicines can improve the body's immunity, relieve symptoms, and make the white blood cells reach the normal level. At the same time, the traditional Chinese medicine of the present invention can have a certain therapeutic effect on consumptive disease and can be used for symptoms such as palpitation, fatigue, soreness and weakness of the waist and knees, dizziness and tinnitus, insomnia and dreaminess. Description of the Drawings

[0028] Figure 1 : Related indexes of immune organs of mice

[0029] Figure 2 : Content of IL-2 in serum in mice

[0030] Figure 3:Count of nucleated cells in mouse bone marrow Specific embodiments

[0031] The present invention is further explained below in conjunction with specific examples. It should be understood that these examples are only used to illustrate the present invention and are not used to limit the scope of the present invention. After reading the present invention, various equivalent modifications of the present invention by those skilled in the art fall within the scope defined by the claims attached to this application.

[0032] Example 1: A Chinese medicine combination for treating consumptive disease caused by radiotherapy and chemotherapy and its preparation process, as follows:

[0033] Pseudostellariae Radix 24g, raw astragalus 30g, white atractylodes 12g, poria 15g, white peony 12g, angelica 12g, wolfberry 12g, Ligustrum lucidum 12g, agrimony 12g, tangerine peel 9g, plum blossom 5g, Liushenqu 15g, hawthorn 12g, malt 15g, citron 10g, Zhejiang Dendrobium 12g, rice sprout 15g.

[0034] Preparation process: remove impurities from raw astragalus, poria, white peony root, angelica, wolfberry, Ligustrum lucidum, herbaceous agrimony, tangerine peel, plum blossom, liushenqu, hawthorn, bergamot, and dendrobium officinale, wash them, dry them, grind them into granules, and soak them in water for 1.5 hours; add water to the soaked raw materials and boil them for 3 times, add 8 times the amount of water of the total medicinal materials for the first time, boil them for 1.5 hours, take the decoction, filter it, add 5 times the amount of water of the total amount for the second time, boil them for 1.2 hours, take the two decoctions and mix them, filter them; decompress the filtered filtrate to a concentrate with a relative density of 1.20 at 70°C, and refrigerate it at 0-5°C for 24 hours; filter, decompress the filtrate and concentrate it, and dry it into powder; grind Pseudostellariae Radix, Atractylodes macrocephala, malt, and rice sprout into fine powder, sieve it, mix it with the powder in step (2), and make it into pills through conventional processes.

[0035] Example 2: A Chinese medicine combination for treating consumptive disease caused by radiotherapy and chemotherapy and its preparation process, as follows:

[0036] 10g of Pseudostellaria heterophylla, 10g of raw Astragalus, 5g of Atractylodes macrocephala, 5g of Poria, 5g of White Peony Root, 5g of Angelica sinensis, 5g of Lycium barbarum, 5g of Ligustrum lucidum, 5g of Agrimoniae scabra, 5g of Tangerine Peel, 1g of Plum Blossom, 5g of Liushenqu, 5g of Hawthorn, 5g of Malt, 4g of Citrus Hand, 5g of Dendrobium officinale, and 5g of Rice Sprout.

[0037] Preparation process: Same as Example 1.

[0038] Example 3: A Chinese medicine combination for treating consumptive disease caused by radiotherapy and chemotherapy and its preparation process, as follows:

[0039] 10g of Pseudostellaria heterophylla, 10g of raw Astragalus, 5g of Atractylodes macrocephala, 5g of Poria, 5g of White Peony Root, 5g of Angelica sinensis, 5g of Lycium barbarum, 5g of Ligustrum lucidum, 5g of Agrimoniae scabra, 5g of Tangerine Peel, 1g of Plum Blossom, 5g of Liushenqu, 5g of Hawthorn, 5g of Malt, 4g of Citrus Hand, 5g of Dendrobium officinale, and 5g of Rice Sprout.

[0040] Preparation process: Same as Example 1.

[0041] Example 4: A Chinese medicine combination for treating consumptive disease caused by radiotherapy and chemotherapy and its preparation process, as follows:

[0042] 40g of Pseudostellaria heterophylla, 50g of raw Astragalus, 20g of Atractylodes macrocephala, 30g of Poria, 20g of White Peony Root, 20g of Angelica sinensis, 20g of Lycium barbarum, 20g of Ligustrum lucidum, 20g of Agrimoniae scabra, 20g of Tangerine Peel, 15g of Plum Blossom, 30g of Liushenqu, 20g of Hawthorn, 30g of Malt, 20g of Citrus hand, 20g of Dendrobium officinale, and 30g of Rice Sprout.

[0043] Preparation process: Same as Example 1.

[0044] Example 5: A Chinese medicine combination for treating consumptive disease caused by radiotherapy and chemotherapy and its preparation process, as follows:

[0045] 15g of Pseudostellaria heterophylla, 20g of raw Astragalus, 10g of Atractylodes macrocephala, 10g of Poria, 10g of White Peony Root, 10g of Angelica sinensis, 10g of Lycium barbarum, 10g of Ligustrum lucidum, 10g of Agrimoniae, 10g of Tangerine Peel, 3g of Plum Blossom, 10g of Liushenqu, 10g of Hawthorn, 10g of Malt, 5g of Citrus Hand, 10g of Dendrobium officinale, and 10g of Rice Sprout.

[0046] Preparation process: Same as Example 1.

[0047] Example 6: A Chinese medicine combination for treating consumptive disease caused by radiotherapy and chemotherapy and its preparation process, as follows:

[0048] 30g of Pseudostellaria heterophylla, 40g of raw Astragalus, 15g of Atractylodes macrocephala, 20g of Poria, 15g of White Peony Root, 15g of Angelica sinensis, 15g of Lycium barbarum, 15g of Ligustrum lucidum, 15g of Agrimoniae herb, 15g of Tangerine peel, 10g of Plum Blossom, 20g of Liushenqu, 15g of Hawthorn, 20g of Malt, 15g of Citrus hand, 15g of Dendrobium officinale, and 20g of Rice Sprout.

[0049] Preparation process: Same as Example 1.

[0050] Example 7: A Chinese medicine combination for treating consumptive disease caused by radiotherapy and chemotherapy and its preparation process, as follows:

[0051] Pseudostellariae Radix 24g, raw astragalus 30g, white atractylodes 12g, poria 15g, white peony 12g, angelica 12g, wolfberry 12g, Ligustrum lucidum 12g, agrimony 12g, tangerine peel 9g, plum blossom 5g, Liushenqu 15g, hawthorn 12g, malt 15g, citron 10g, Zhejiang Dendrobium 12g, rice sprout 15g.

[0052] Preparation process: remove impurities from raw astragalus, poria, white peony, angelica, wolfberry, Ligustrum lucidum, herbaceous agrimony, tangerine peel, plum blossom, liushenqu, hawthorn, bergamot, and dendrobium officinale, wash them, dry them, grind them into granules, and soak them in water for 3 hours; add water to the soaked raw materials and boil them for 4 times, add 10 times the amount of water of the total medicinal materials for the first time, boil them for 3 hours, take the decoction, filter it, add 6 times the amount of water for the second time, boil them for 3 hours, take the two decoctions and mix them, and filter them; decompress the filtered filtrate to a concentrate with a relative density of 1.50 at 80°C, and refrigerate it at 0-5°C for 24 hours; filter, decompress the filtrate and concentrate it, and dry it into powder; grind Pseudostellariae Radix, Atractylodes macrocephala, malt, and rice sprout into fine powder, sieve it, mix it with the powder in step (2), and make it into pills through conventional processes.

[0053] Comparative Example 1: A Chinese medicine combination for treating consumptive disease caused by radiotherapy and chemotherapy and its preparation process, as follows:

[0054] 45g of Pseudostellaria heterophylla, 55g of raw Astragalus, 25g of Atractylodes macrocephala, 35g of Poria, 25g of White Peony Root, 25g of Angelica sinensis, 25g of Lycium barbarum, 5g of Ligustrum lucidum, 5g of Agrimoniae scabra, 5g of Tangerine Peel, 5g of Plum Blossom, 5g of Liushenqu, 3g of Hawthorn, 5g of Malt, 5g of Citrus Hand, 5g of Dendrobium officinale, and 25g of Rice Sprout.

[0055] Preparation process: Same as Example 1.

[0056] Comparative Example 2: A Chinese medicine combination for treating consumptive disease caused by radiotherapy and chemotherapy and its preparation process, as follows:

[0057] Codonopsis pilosula 24g, Astragalus 30g, Atractylodes macrocephala 12g, Poria 15g, Polygonum multiflorum 12g, Lycium barbarum 12g, Agrimoniae 12g, Rhubarb 15g, Hawthorn 12g, Malt 15g, Citron 10g, Dendrobium officinale 12g, Rice sprout 15g.

[0058] Preparation process: Same as Example 1.

[0059] Comparative Example 3: A Chinese medicine combination for treating consumptive disease caused by radiotherapy and chemotherapy and its preparation process, as follows:

[0060] Pseudostellariae Radix 24g, raw astragalus 30g, white atractylodes 12g, poria 15g, white peony 12g, angelica 12g, wolfberry 12g, Ligustrum lucidum 12g, agrimony 12g, tangerine peel 9g, plum blossom 5g, Liushenqu 15g, hawthorn 12g, malt 15g, citron 10g, Zhejiang Dendrobium 12g, rice sprout 15g.

[0061] Preparation process: remove all impurities from all medicinal materials, wash them, dry them, crush them into granules, soak them in water for 5 hours, add water to the soaked raw materials and boil them twice, add 15 times the amount of water of the total medicinal materials for the first time, boil them for 5 hours, take the decoction, filter it, add 10 times the amount of water for the second time, boil them for 3 hours, take the two decoctions and mix them, filter them; decompress and concentrate the filtered filtrate to a concentrate with a relative density of 1.8 at 70°C, place it in a low temperature refrigerator at 0-5°C for 24 hours, filter it, decompress and concentrate the filtrate, dry it into powder, and make it into pills through conventional processes. Comparative Example 4: A Chinese medicine combination for treating consumptive disease caused by radiotherapy and chemotherapy and its preparation process, as follows:

[0062] 24g of Pseudostellaria heterophylla, 30g of raw astragalus, 30g of white peony root, 12g of angelica, 12g of wolfberry, 12g of Ligustrum lucidum, 12g of agrimony, 9g of tangerine peel, 5g of plum blossom, 15g of Liushenqu, 12g of hawthorn, 15g of malt, 10g of bergamot, 12g of Dendrobium officinale, and 15g of rice sprout.

[0063] Preparation process: as in specific embodiment 1.

[0064] Comparative Example 5: A Chinese medicine combination for treating consumptive disease caused by radiotherapy and chemotherapy and its preparation process, as follows:

[0065] Pseudostellariae Radix 24g, Atractylodes macrocephala 12g, Poria cocos 15g, White Peony Root 12g, Angelica sinensis 12g, Ligustrum lucidum 12g, Agrimoniae 12g, Tangerine Peel 9g, Plum Blossom 5g, Liushenqu 15g, Hawthorn 12g, Malt 15g, Citrus Hand 10g, Dendrobium officinale 12g.

[0066] Preparation process: Same as Example 1.

[0067] Comparative Example 6: A Chinese medicine combination for treating consumptive disease caused by radiotherapy and chemotherapy and its preparation process, as follows:

[0068] Pseudostellariae Radix 24g, raw astragalus 30g, atractylodes 12g, poria 15g, white peony root 12g, angelica 12g, wolfberry 12g, Ligustrum lucidum 12g, tangerine peel 9g, plum blossom 5g, Liushenqu 15g, hawthorn 12g, rice sprout 15g.

[0069] Preparation process: Same as Example 1.

[0070] 1. Toxicity test

[0071] 1. Half-lethal test

[0072] Twenty healthy white rats (half male and half female), weighing 200 - 400 g, were selected. 5 g of the powder of this preparation was dissolved in water and fed to the white rats once. After administration, the rats were observed for 7 days. No variations in the digestive system, respiratory system, or nervous system were found, and the rats were healthy.

[0073] 2. Long - term toxicity test

[0074] Twenty healthy white rats (half male and half female), weighing 250 - 400 g, were selected. The preparation was administered by gavage to the rats at a dose of 1 g / kg once a day for 30 consecutive days. No toxic or side effects were observed, and the rats were normal in terms of eating, activity, hair color, and body weight.

[0075] II. Pharmacodynamic experiments

[0076] The inventor wishes to state that the following experimental studies were all carried out on the basis of the above - mentioned proof of drug safety. The dosing doses in the experimental studies were all within the safe dose range. For the animal modeling methods, selection of detection indicators, etc. in the following experimental studies, relevant existing literature on animal modeling was referred to.

[0077] To verify the effect of the traditional Chinese medicine composition of the present invention in treating consumptive disease caused by radiotherapy and chemotherapy, the inventor selected the drugs obtained from some embodiments of the present invention to carry out relevant pharmacodynamic tests and clinical studies. For the drugs obtained from other formulations and preparation methods included in the present invention, the inventor also carried out pharmacodynamic experiments. The experimental results showed that the drugs obtained from other formulations and preparation methods had the same or similar effects. However, due to space limitations, they are not all listed here.

[0078] Whether the present invention has an elevating effect on the leukopenia and reduction of nucleated bone marrow cells caused by chemotherapy in mice, and whether it can improve the general condition and immune function of mice

[0079] 1 Animal model

[0080] 100 ICR mice, male, weighing 20 ± 2 g.

[0081] 1.1 Preparation of S180 sarcoma mice

[0082] Take S180 osteosarcoma in the exponential growth phase, centrifuge and collect it. Microscopically count the cell number routinely, and adjust the cell concentration to 1×10 8 / ml. Take 3 male healthy Kunming mice, weighing about 20 g. Under sterile conditions, each mouse was intraperitoneally inoculated with 1 ml of cell suspension. Ascites tumors formed in about 10 days. Take tumor - bearing mice with S180 tumor implanted in the abdomen for 8 days. Under sterile operation, draw abdominal tumor fluid and dilute it with sterile distilled water into a tumor cell suspension with a concentration of 1:4 (microscopic examination shows that the number of tumor cells is 5×10 7( / ml), 0.2 ml per mouse was subcutaneously inoculated on the outer side of the right hind limb of healthy mice.

[0083] 1.2 Preparation of chemotherapy injury model

[0084] Except for the blank control group and the model group, the remaining groups were given the chemotherapy drug cyclophosphamide (CTX) at 10 mg / ml, with a dose of 220 mg / kg, by intraperitoneal injection once a day for 10 consecutive days.

[0085] 2 Grouping and drug administration

[0086] 2.1 Grouping

[0087] 100 mice were randomly divided into 10 groups: blank group, model group, radiotherapy group, positive control group, Example 1 group + chemotherapy, Example 2 group + chemotherapy, Example 3 group + chemotherapy, Comparative Example 1 group + chemotherapy, Comparative Example 2 group + chemotherapy, Comparative Example 3 group + chemotherapy.

[0088] 2.2 Drug administration

[0089] Blank group: Not inoculated with S180 sarcoma + not chemotherapy, gavage with 2 ml of normal saline once a day for 10 consecutive days.

[0090] Model group: Mice inoculated with S180 sarcoma, gavage with 2 ml of normal saline once a day for 10 consecutive days.

[0091] Chemotherapy group: Mice inoculated with S180 sarcoma, the chemotherapy drug was cyclophosphamide (CTX) at 10 mg / ml, with a dose of 220 mg / kg, by intraperitoneal injection once a day for 10 consecutive days.

[0092] Positive control group: Zhenqi Fuzheng Capsule was mixed with 1 ml of normal saline and then gavaged once a day for 10 consecutive days.

[0093] Example 1 group + chemotherapy: The traditional Chinese medicine composition of Example 1 group was mixed with 1 ml of normal saline and then gavaged once a day for 10 consecutive days.

[0094] Example 2 group + chemotherapy: The traditional Chinese medicine composition of Example 2 group was mixed with 1 ml of normal saline and then gavaged once a day for 10 consecutive days.

[0095] Example 3 group + chemotherapy: The traditional Chinese medicine composition of Example 3 group was mixed with 1 ml of normal saline and then gavaged once a day for 10 consecutive days.

[0096] Comparative Example 1 group + chemotherapy: The traditional Chinese medicine composition of Comparative Example 1 group was mixed with 1 ml of normal saline and then gavaged once a day for 10 consecutive days.

[0097] Comparative Example 2 group + chemotherapy: The traditional Chinese medicine composition of the Comparative Example 2 group was mixed with 1 ml of normal saline and then gavaged once a day for 10 consecutive days.

[0098] Comparative Example 3 group + chemotherapy: The traditional Chinese medicine composition of the Comparative Example 3 group was mixed with 1 ml of normal saline and then gavaged once a day for 10 consecutive days.

[0099] On the 3rd, 5th, and 10th days, blood was collected from the tail veins of the mice in each group. Peripheral blood cell counts were performed. Blood was collected from behind the eye sockets 24 hours after the last administration and the serum was separated to detect IL-2. At the same time, the mice were sacrificed, the spleen weight and thymus weight were weighed, and the number of nucleated bone marrow cells was counted.

[0100] 3 Result processing

[0101] Processing was performed using SPSS 22.0 software, and the data was expressed as , and one-way analysis of variance was used for comparison between groups and multiple comparisons were performed. P < 0.05 indicates that the difference is statistically significant.

[0102] 4 Experimental results

[0103] 4.1 Immune function of mice

[0104] The effects of the present invention on the immune function of mice after chemotherapy are shown in Table 1 and Figure 1 、 Figure 2 。

[0105] Table 1 Indexes related to the immune function of mice

[0106] Grouping Quantity (n) Spleen index (mg / g) Thymus index (mg / g) IL-2 (PG / ml) Blank group 10 2.79±0.51 5.44±0.53 100.65±17.29 Model group 10 <![CDATA[7.88±1.02 ## > 5.23±0.46 <![CDATA[88.17±13.51 # > Chemotherapy group 10 <![CDATA[3.72±0.69 ** > <![CDATA[1.84±0.53 ##** > <![CDATA[68.56±13.28 ##** > Positive control group 10 <![CDATA[5.91±0.90 ##*^ > <![CDATA[3.34±0.52 ##**^^ > <![CDATA[115.91±17.21 #**^^ > Example 1 group 10 <![CDATA[6.17±1.14 ##*^ > <![CDATA[4.32±0.51 #*^^& > <![CDATA[134.45±20.29 ##**^^&& > Example 2 group 10 <![CDATA[5.85±1.06 ##*^ > <![CDATA[4.21±0.40 #*^^ > <![CDATA[125.78±19.62 ##**^^& > Example 3 group 10 <![CDATA[5.90±1.07 ##*^ > <![CDATA[4.07±0.38 #*^^ > <![CDATA[124.50±21.23 ##**^^& > Comparative example 1 group 10 <![CDATA[4.61±0.73 #**&$ > <![CDATA[2.28±0.36 ##**&$$ > <![CDATA[106.09±22.74 *^^ > Comparative example 2 group 10 <![CDATA[4.97±1.21 #**&$ > <![CDATA[2.52±0.42 ##**&$$ > <![CDATA[104.41±19.22 *^^& > Comparative example 3 group 10 <![CDATA[5.04±1.09 #**&$ > <![CDATA[2.40±0.41 ##**&$$ > <![CDATA[100.40±23.11 *^^& >

[0107] # Compared with the blank group # P < 0.05, ## P < 0.01

[0108] * Compared with the model group * P < 0.05, ** P < 0.01

[0109] ^ Compared with the chemotherapy group ^ P < 0.05, ^^ P < 0.01

[0110] & Compared with the positive control group & P < 0.05, && P < 0.01

[0111] $ Compared with Example 1 group $$ P < 0.05, $$ P < 0.01

[0112] As can be seen from the results in the above table, chemotherapy has a greater impact on the thymus of mice. After chemotherapy, the thymus of mice is significantly smaller than that of the blank group (P < 0.01). Tumors have a greater impact on the spleens of mice. The spleen index of the model group is significantly higher than that of the blank group (P < 0.01). The spleen indices of each group of mice after taking the medicine are higher than those of the chemotherapy group (P < 0.05). Among them, the traditional Chinese medicine composition of the present invention has the effect of significantly increasing the spleen index of mice. The positive control group and each group of the examples of the present invention have the effect of increasing the thymus index of mice, and the effect is significantly better than that of the simple radiotherapy group (P < 0.05). In terms of increasing the thymus index, the effect of the present invention is significantly better than that of the positive control group and each group of the comparative examples (P < 0.05).

[0113] After chemotherapy, the content of IL-2 in the serum of mice decreased significantly. The traditional Chinese medicine composition of the present invention can significantly increase the IL-2 in the serum, which is significantly different from the simple tumor-bearing radiotherapy group (P < 0.05) and significantly different from the positive control group (P < 0.05), and the effect is better.

[0114] 4.2 Results of nucleated bone marrow cells in mice

[0115] The nucleated bone marrow cells of mice are shown in Figure 3 , and it can be seen from Figure 3 that the values of nucleated bone marrow cells in each treatment group are higher than those of the chemotherapy group and lower than those of the model group. There are significant differences between groups 1-3 of the examples of the present invention and the chemotherapy group (P < 0.05), and the effect is better than that of the positive control group and each group of the comparative examples. This shows that chemotherapy drugs can clearly damage bone marrow hematopoietic tissue, and the present invention has a protective effect on the parenchymal cells of bone marrow hematopoietic tissue after chemotherapy and can significantly inhibit the reduction of nucleated bone marrow cells.

[0116] 4.3 Peripheral blood cell count

[0117] Table 2 Changes in the number of red blood cells in the peripheral blood of mice (1×10 12 / l)

[0118] Grouping Quantity (n) 3d 7d 14d Blank group 10 9.96±1.13 12.49±1.29 13.38±1.16 Model group 10 9.52±1.07 <![CDATA[10.43±1.51 # > <![CDATA[11.42±1.85 # > Chemotherapy group 10 9.34±0.77 <![CDATA[11.75±0.84 * > <![CDATA[9.42±1.13 ##** > Positive control group 10 9.79±1.27 <![CDATA[11.63±1.34 * > <![CDATA[14.27±1.31 **^^ > Example 1 group 10 9.71±1.32 <![CDATA[12.84±1.43 **^ > <![CDATA[14.67±1.36 **^^ > Example 2 group 10 9.52±1.76 <![CDATA[12.36±1.67 * > <![CDATA[13.73±1.73 *^^ > Example 3 group 10 9.58±1.26 <![CDATA[12.70±1.04 **^ > <![CDATA[13.12±1.23 *^ > Comparative example 1 group 10 9.03±1.50 <![CDATA[11.56±1.15 * > <![CDATA[10.08±1.39 #&& > Comparative example 2 group 10 9.71±1.43 <![CDATA[10.89±1.54 # > <![CDATA[9.12±0.65 ##&& > Comparative example 3 group 10 9.61±1.49 <![CDATA[10.68±1.31 # > <![CDATA[9.23±1.77 ##&& >

[0119] # Compared with the blank group # P < 0.05, ## P < 0.01

[0120] * Compared with the model group * P < 0.05, ** P < 0.01

[0121] ^ Compared with the chemotherapy group ^ P < 0.05, ^^ P < 0.01

[0122] & Compared with the positive control group & P < 0.05, && P < 0.01

[0123] $ Compared with group 1 of the example $$ P < 0.05, $$ P < 0.01

[0124] Table 3 Changes in the number of white blood cells in the peripheral blood of mice (1×10 9 / l)

[0125]

[0126] # Compared with the blank group # P < 0.05, ## P < 0.01

[0127] * Compared with the model group * P < 0.05, ** P < 0.01

[0128] ^ Compared with the chemotherapy group ^ P < 0.05, ^^ P < 0.01

[0129] & Compared with the positive control group & P < 0.05, && P < 0.01

[0130] $ Compared with the group of Example 1 $$ P < 0.05, $$ P < 0.01

[0131] Table 4 Changes in the number of platelets in the peripheral blood of mice (1×10 12 / l)

[0132]

[0133] # Compared with the blank group # P < 0.05, ## P < 0.01

[0134] * Compared with the model group * P < 0.05, ** P < 0.01

[0135] ^ Compared with the chemotherapy group ^ P < 0.05, ^^ P < 0.01

[0136] & Compared with the positive control group & P < 0.05, && P < 0.01

[0137] $ Compared with the group of Example 1 $$ P < 0.05, $$ P < 0.01

[0138] It can be seen from Tables 2-4 that the effects of each group in the embodiments of the present invention are superior to those of each group in the embodiments. Chemotherapy has a greater impact on the number of peripheral blood cells in mice. Among them, the white blood cells decreased significantly after chemotherapy. The traditional Chinese medicine composition of the present invention can delay the decrease of white blood cells after chemotherapy and recover quickly, having an obvious effect of increasing white blood cells, with a statistical difference from the chemotherapy group. The positive control drug has an insignificant effect on increasing white blood cells. The effect of the present invention is significantly superior to the positive control group and each group in the embodiments. Each group in the embodiments of the present invention and the positive control group have an obvious effect of increasing red blood cells and platelets, with a statistical difference from the chemotherapy group, the model group and each group in the comparative examples. In terms of the effect of increasing red blood cells, the effect of the present invention is equivalent to that of the positive control group, and the effect of increasing platelets is superior to that of the positive control group, and the effects are all superior to each group in the comparative examples.

[0139] III. Clinical effect verification

[0140] (1) Observation on the effect of the present invention on leukopenia in chemotherapy patients

[0141] In order to verify the positive effect of the drug of the present invention, the inventor conducted a clinical efficacy observation on 74 patients with leukopenia in the hospital.

[0142] 1. Basic information

[0143] There were 74 patients receiving chemotherapy, including 49 males and 25 females; aged 23 - 80 years old, with an average age of 56.5 years old, and Karnofsky (KPS) score ≥ 60 points. There were 33 cases of lung cancer, 15 cases of gastric cancer, 13 cases of colon cancer, 10 cases of breast cancer, and 3 cases of ovarian cancer.

[0144] Chemotherapy regimens: for gastric cancer, EP or CAP regimens were given; for gastric cancer, LFP, LAFP or ELFAP regimens were given; for colon cancer, LFP regimen was given; for breast cancer, CMF, CAF or CAF regimens were given; for ovarian cancer, EP or CAP regimens were given. The patients were randomly divided into two groups, group A and group B, with 37 people in each group.

[0145] 2. Treatment methods

[0146] After chemotherapy, leukopoietic drugs were given to the patients in each group. Group A, as the control group, was given leucogen, batilol, and vitamin B4 orally, while group B was given the traditional Chinese medicine preparation of the present invention. After the end of chemotherapy, blood routine was tested once a week. If the white blood cells were normal two weeks after the end of chemotherapy, the medication was stopped. After two weeks of treatment, the white blood cell examination results of the two groups are shown in Table 5.

[0147] Table 5 Comparison of peripheral blood white blood cell counts between the two groups (×10 9 L -1 )

[0148] Grouping n Before treatment 1 week later 2 weeks later Control group of Group A 37 5.15±1.14 2.33±1.32 2.56±2.1 Treatment group of Group B 37 5.08±1.26 4.32±2.27# 4.5±1.6#

[0149] #Compared with the control group# P < 0.05

[0150] 3. Results

[0151] It can be seen from Table 5 that there are significant differences in the white blood cell counts after 1 week and 2 weeks of treatment between the present invention and the control group. The present invention can effectively treat and prevent leukopenia in patients. In this group of prescriptions, the combination of various drugs can improve the body's immunity, improve symptoms, and make the white blood cells reach the normal level. In clinical practice, the present invention can not only treat leukopenia caused by chemotherapy, but also play a preventive role in the decrease of white blood cells during chemotherapy, so that patients will not be affected by the decrease of white blood cells and affect subsequent treatment.

[0152] (2) Clinical treatment effect of the present invention on consumptive disease

[0153] It is verified that the preparation of the present invention has a therapeutic effect on patients with general asthenia syndrome, and has the efficacy of supplementing qi and blood, strengthening the spleen and tonifying the kidney.

[0154] 1. Basic information

[0155] 120 patients with asthenia syndrome were selected, including 59 males and 61 females; aged 19 - 65 years old, with an average age of 44.8 years old, and were divided into two groups, with 60 cases in each group.

[0156] 2. Treatment method: The control group took Shengui Yangxue Tablets, and the treatment group took the traditional Chinese medicine composition of the present invention. Three weeks was one course of treatment.

[0157] 3. Scoring and judgment criteria

[0158] 3.1 Symptom scoring criteria

[0159] According to the severity of symptoms, they were divided into severe, moderate, mild, and asymptomatic, and were recorded as 3 - 2 - 1 - 0 respectively.

[0160] 3.2 Efficacy judgment criteria

[0161] Cure: The symptoms completely disappeared, and the symptom score decreased by more than 90%; Marked effect: The main symptoms were significantly alleviated, and the symptom score decreased by more than 70%; Effective: The main symptoms were alleviated, and the symptom score decreased by more than 30%; Ineffective: The symptoms had no obvious change, and the symptom score decreased by less than 30%.

[0162] 4. Results

[0163] Table 6 Efficacy judgment of the two groups after taking medicine

[0164] Group Number of cases Cured N (%) Markedly effective N (%) Effective N (%) Ineffective N (%) Total effective rate N (%) Control group 60 10(16.7) 20(33.3) 22(36.7) 8(13.3) 52(86.7) Treatment group 60 19(31.7) 26(43.3) 11(18.3) 4(6.7) 56(93.3)

[0165] As can be seen from the above table, the present invention has a good curative effect, and the treatment effect is significantly better than that of the control group.

[0166] Table 7 Symptom changes before and after treatment

[0167]

[0168]

[0169] As can be seen from Table 7, the present invention has a good improvement effect on palpitations, dizziness, insomnia and dreaminess, and fatigue in patients with asthenia syndrome.

Claims

1. A Chinese medicine composition for treating asthenia, characterized in that: The Chinese medicine composition mainly comprises Radix Pseudostellariae Radix, Radix Astragali Radix, Rhizoma Atractylodis Macrocephalae, Rhizoma Poriae, Radix Paeoniae Alba, Radix Angelicae Sinensis, Fructus Lycii, Fructus Ligustri Lucidi, Herba Agrimoniae, Pericarpium Citri Reticulatae, Plum Blossom, Herba Ligustici Chuanxiong, Fructus Hawthorne, Malt, Fructus Citron, Dendrobium Officinale and Rice Sprout.

2. The use according to claim 1, characterized in that The Chinese medicine composition is prepared from the following raw materials:

3. The use according to claim 2, characterized in that The Chinese medicine composition is prepared from the following raw materials:

4. The use according to claim 3, characterized in that The Chinese medicine composition is prepared from the following raw materials:

5. The method according to any one of claims 1 to 4, characterized in that: The Atractylodes macrocephala is fried with bran, the Fructus Ligustri Lucidi is fried with wine, the Liu Shen Qu is roasted Liu Shen Qu, the Hawthorn is roasted Hawthorn, the malt is roasted malt, and the rice sprouts are roasted rice sprouts.

6. The use according to claim 1, characterized in that The Chinese medicine composition is prepared by the following steps: (1) Remove impurities from raw astragalus, Poria, white peony root, Chinese angelica, wolfberry, Ligustrum lucidum, herb agrimony, tangerine peel, plum blossom, Liushenqu, hawthorn, bergamot, and dendrobium officinale, clean them, dry them, grind them into granules, soak them in water for 2-3 hours, decoct the soaked raw materials with water for 2-4 times, add 5-10 times the amount of water of the total amount of medicinal materials for the first time, decoct for 1-3 hours, take the decoction, filter it, add 4-6 times the amount of water of the total amount for the second time, decoct for 1-1.5 hours, take the two decoctions, mix them, and filter them; (2) decompressing and concentrating the filtered filtrate to a concentrate having a relative density of 1.10-1.50 at 60-80° C., refrigerating at 0-5° C. for 20-24 h, filtering, decompressing and concentrating the filtrate, and drying it into powder; (3) Grinding Pseudostellariae Radix, Atractylodes macrocephala, malt and rice sprout into fine powder, sieving, mixing with the powder of step (2), and preparing a clinically acceptable dosage form directly or by adding pharmaceutically acceptable excipients through conventional procedures.

7. The use according to claim 6, characterized in that The Chinese medicine composition is prepared by the following steps: (1) Remove impurities from raw astragalus, Poria, white peony root, Chinese angelica, wolfberry, Ligustrum lucidum, agrimony, tangerine peel, plum blossom, Liushenqu, hawthorn, bergamot, and Dendrobium officinale, clean them, dry them, grind them into granules, and soak them in water for 1.5 hours. Then, add water to the soaked raw materials and boil them three times. For the first time, add 8 times the amount of water of the total amount of medicinal materials, boil them for 1.5 hours, take the decoction, filter it, and for the second time, add 5 times the amount of water of the total amount, boil them for 1.2 hours, take the two decoctions and mix them, and filter them; (2) decompressing and concentrating the filtered filtrate to a concentrated solution having a relative density of 1.20 at 70° C., and refrigerating at 0-5° C. for 24 h; filtering, decompressing and concentrating the filtrate, and drying it into powder; (3) Grinding Pseudostellariae Radix, Atractylodes macrocephala, malt and rice sprout into fine powder, sieving, mixing with the powder of step (2), and preparing a clinically acceptable dosage form directly or by adding pharmaceutically acceptable excipients through conventional procedures.

8. The preparation according to claim 7, characterized in that The preparation is an oral preparation.

9. The preparation according to claim 8, characterized in that The oral preparation is a decoction, a powder, a honey-refined pill, a pill, a tablet, a capsule, an oral liquid, a granule or a syrup.

10. Use of the Chinese medicine composition according to any one of claims 1 to 9 in the preparation of a medicine for treating asthenia caused by radiotherapy, chemotherapy and postoperative physical weakness.

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