CN109620911B

CN109620911B - Traditional Chinese medicine composition capable of improving neutropenia after chemotherapy and application thereof

Info

Publication number: CN109620911B
Application number: CN201910091633.0A
Authority: CN
Inventors: 王一飞
Original assignee: Guangzhou Tianrui Biotechnology Co ltd
Current assignee: Guangzhou Tianrui Biotechnology Co ltd
Priority date: 2019-01-30
Filing date: 2019-01-30
Publication date: 2021-08-31
Anticipated expiration: 2039-01-30
Also published as: CN109620911A

Abstract

The invention relates to a traditional Chinese medicine composition for improving neutropenia after chemotherapy and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-40 parts of ginseng, 30-50 parts of prepared aconite, 10-20 parts of ganoderma lucidum, 40-60 parts of radix glehniae, 20-40 parts of eucommia bark, 20-40 parts of Chinese herbaceous peony, 20-40 parts of dwarf lilyturf tuber, 15-30 parts of baical skullcap root, 15-30 parts of white mulberry root-bark, 15-30 parts of philippine violet herb and 10-25 parts of honey-fried licorice root, has the effects of tonifying qi and supporting yang, nourishing yin and clearing heat, and strengthening body resistance and consolidating constitution, and can be used for improving neutropenia after chemotherapy. In the traditional Chinese medicine composition provided by the invention, the compatibility of medicines is precise, and the synergistic effect is realized, so that the traditional Chinese medicine decoction prepared by applying the traditional Chinese medicine composition provided by the invention has an obvious effect on improving the neutropenia after chemotherapy, is convenient to apply, has small side effect, and has a wide application prospect.

Description

Traditional Chinese medicine composition capable of improving neutropenia after chemotherapy and application thereof

Technical Field

The invention relates to a traditional Chinese medicine composition and application thereof, in particular to a traditional Chinese medicine composition for improving neutropenia after chemotherapy and application thereof, and belongs to the field of traditional Chinese medicines.

Background

Neutrophils (neutrophiles) are the most common granulocytes, constituting up to 70% of the circulating leukocytes that are primarily resistant to pathogen infection. One group of syndromes that arise due to a decrease in the absolute value of the peripheral blood neutrophils is Neutropenia (Neutropenia), and the risk of a patient developing an infection is closely related to the time to decrease, the rate of decrease, of the neutrophil count. Chemotherapy (Chemotherapy) is one of the conventional methods for treating malignant tumors in modern medicine, and when cancer cells are killed directly, it often damages cells, tissues and organs of the body and affects their physiological functions. Neutropenia (Neutropenia after Chemotherapy) is a common side effect of Chemotherapy, and Neutropenia occurs due to bone marrow suppression after Chemotherapy of most cancer patients, and then resistance is reduced, susceptibility is increased, if serious infection is combined, life is threatened, and execution, clinical effect and survival expectation of a Chemotherapy cycle scheme are affected.

For neutropenia after chemotherapy, granulocyte colony stimulating factor type leukogenic drugs such as rhG-CSF are generally adopted clinically for adjuvant therapy at present, although the rapid leukogenic effect is obvious, the leucogenic drugs are often insufficient in the aspects of stably and continuously leukogenic, synchronously improving clinical symptoms, physical conditions and the like; in addition, the colony stimulating factor can not only cause bone pain, flu-like symptoms, fever, leucocyte reduction after drug withdrawal and other side effects, but also stimulate the growth of certain malignant cells, so that the clinical application of the colony stimulating factor has certain limitation. On the other hand, relevant clinical researches find that before and during chemotherapy, when western medicines have poor leukocyte increasing effect and even severe myelosuppression, the traditional Chinese medicine is applied to prevent and treat granulocytopenia, so that the traditional Chinese medicine clinical symptoms of chemotherapy patients can be improved, a plurality of adverse reactions caused by chemotherapy can be reduced, and the chemotherapy compliance of the patients can be improved. Therefore, the traditional Chinese medicine has unique advantages in improving the neutropenia after chemotherapy.

In traditional Chinese medicine, neutropenia can be classified into "deficiency syndrome", "consumptive disease", "malnutrition" and "blood syndrome", which are related to factors such as deficient innate qi, deficiency of spleen, stomach, liver and kidney, chronic diseases, malnutrition or toxic toxin invasion. Chemotherapy drugs are attached to the exogenous pathogenic factors, and neutrophilic granulocytopenia after chemotherapy is regarded as the sign of "drug toxicity septicemia" in chemotherapy. The toxic and internal invasion of the chemotherapy drugs can easily damage healthy qi, blood vessels, liver and kidney and bone marrow, so that the source of hematopoiesis is inhibited, and the deficiency of primordial qi causes the dysfunction of marrow not producing blood and blood not nourishing marrow. It is worth confirming that, with the theory of traditional Chinese medicine as guidance, following the combination of syndrome differentiation and disease differentiation, traditional Chinese medicine has had great effect in preventing, treating, improving neutropenia after chemotherapy, and improving immunity of the organism, such as relaxation and the like, the related research and analysis are developed aiming at the clinical curative effect of the stilbene gum leucocyte rising capsule on improving neutropenia caused by chemotherapy of non-small cell lung cancer patients, and the result shows that the stilbene gum stilbene leucocyte rising capsule can improve the chemotherapy effect, reduce the incidence rate of neutropenia, the application is safe, the adverse reaction is small, and the stilbene gum leucocyte rising capsule is worthy of clinical popularization (relaxation, tonia, childhood, etc.. the research and analysis of the clinical curative effect of the stilbene leucocyte reducing capsule on improving neutropenia caused by chemotherapy of non-small cell lung cancer patients [ J ]. southeast national defense medicine, 2018, 20 (1): 26-29.); zhang Ping also uses eleven ginseng and astragalus tablets combined with recombinant human granulocyte stimulating factor to treat neutropenia after chemotherapy, obtains better clinical curative effect, can improve the life quality and the body function state of a patient, and has certain clinical popularization and application value (Zhang Ping. curative effect observation of neutropenia after chemotherapy by eleven ginseng and astragalus tablets combined with recombinant human granulocyte stimulating factor [ J ] modern medicine and clinic, 2018, 33 (6): 1472-one 1475.). The traditional Chinese medicine is characterized in that the method is based on the principle, the method is based on the syndrome, the medicines have special characteristics and have combined wonderful functions, so that the formula of the traditional Chinese medicine composition is preferably determined according to the compatibility theory of the monarch, minister, assistant and guide prescription in the traditional Chinese medicine, and the medicines achieve the purposes of precise compatibility, complementary and synergistic effect.

Disclosure of Invention

The traditional Chinese medicine composition comprises ginseng, prepared aconite, ganoderma lucidum, radix glehniae, eucommia, peony, radix ophiopogonis, scutellaria baicalensis, cortex mori radicis, herba violae and honey-fried licorice root, has the effects of tonifying qi and yang, nourishing yin and clearing heat, and supporting the healthy energy, can obviously improve the neutrophilic granulocytopenia after chemotherapy and improve the immunity of the organism, and is used for improving the neutrophilic granulocytopenia after chemotherapy, and the symptoms of mental fatigue and weakness, palpitation and short breath, dizziness, shortness of breath and no talk, lassitude, anorexia, poor appetite, deep and fine pulse and the like. Meanwhile, the traditional Chinese medicine composition for improving the neutropenia after chemotherapy provided by the invention has the advantages of sufficient medicinal material source, low price, simple preparation process and lower treatment cost.

The technical scheme of the invention is as follows:

a traditional Chinese medicine composition for improving neutropenia after chemotherapy comprises the following raw materials in parts by weight:

preferably, the traditional Chinese medicine composition for improving the neutropenia after chemotherapy comprises the following raw materials in parts by weight:

more preferably, the traditional Chinese medicine composition for improving the neutropenia after chemotherapy comprises the following raw materials in parts by weight:

according to the syndrome differentiation theory of traditional Chinese medicine, neutropenia after chemotherapy is more manifested as 'deficiency syndrome', which is called 'deficiency caused by deprivation of essential qi'. In the early stage of the disease, deficiency of both qi and blood and spleen-qi are the main factors, and the liver and kidney are injured for a long time, resulting in deficiency of kidney-yin, kidney-yang or yin-yang, so it is indicated for the treatment of the disease by tonifying qi and supporting yang, nourishing yin to clear heat, and strengthening body resistance to consolidate the constitution. In the formula, ginseng can tonify primordial qi, tonify spleen and lung, consolidate and promote fluid production, soothe nerves and promote intelligence, and is called as "the king of tonics" to treat consumptive disease, deficiency of qi, exhaustion of body fluid and all the syndromes of qi, blood and body fluid deficiency. Modern pharmacological research also shows that ginseng can resist fatigue, aging, shock and cancer, enhance the immune function of the organism, promote the biosynthesis of protein RNA and DNA, regulate the metabolism of cholesterol, promote the function of a hematopoietic system, relieve the damage of radiation to the hematopoietic system and the like. The prepared aconite is a processed product of the Chinese medicinal material aconite, has the effects of strongly tonifying primordial yang, benefiting fire and eliminating yin, enters kidney meridian to supplement true yang, is known as a vital gate main drug, is honest as the theory of ' main drug for the minghan ' of ' medicine, uses the traditional Chinese medicine for meridian running, uses little supplementary drug as a guide and has the effect of strengthening primordial qi and regenerating. The ginseng and the prepared aconite are mutually reinforced, the ginseng can greatly tonify primordial qi, the prepared aconite can tonify fire and strengthen yang, and the ginseng can be directly treated by the prepared aconite without hardness breaking; the monkshood can be successfully completed by the ginseng and the blood vessels are not damaged (Qing & Chen & Wu & Shi' Xin Shu & ao), the two can mutually help, complement each other and have more remarkable effects of tonifying qi and tonifying yang, and the monkshood and the Mongolian monkshood are monarch drugs together.

Ganoderma lucidum is sweet in flavor and neutral in nature, and can tonify heart blood, benefit heart qi and tranquilize mind, so it is a good herb for treating consumptive disease. Modern pharmacological studies show that ganoderma lucidum polysaccharide has wide immunoregulation capability, can improve the immune function of organisms, and can antagonize the low immune function caused by immunosuppressant, antitumor agent, stress and the like to recover or approach to normal. The ganoderma lucidum is compatible with ginseng, and the ganoderma lucidum nourishes qi and blood to help the ginseng to greatly tonify vitality and achieve the purpose of tonifying qi and blood, so the ganoderma lucidum is a ministerial drug. Eucommia bark, cortex Eucommiae, sweet in taste and warm in nature, enters liver and kidney meridians, and can tonify liver and kidney, strengthen tendons and bones, and tonify liver and kidney, which is the key herb (Ming & Ni He Huo & Ben Cao Hui Yan). Modern pharmacological studies also show that the eucommia bark has the functions of enhancing the adrenal cortex of animals, enhancing the immunologic function of organisms and calming. The eucommia bark is combined with the prepared accessory piece, and the eucommia bark accessory piece which is used for tonifying the liver and kidney and assisting the preparation of the accessory piece is used for tonifying fire and supporting yang, and is also used as a ministerial drug for reinforcing the functions of nourishing the liver and the kidney and strengthening the muscles and bones. Bei Sha Shen and Mai Dong are sweet and cold in nature. Bei Sha Shen can tonify lung yin, clear lung heat, nourish stomach and promote fluid production, which is called as "tonify yin to control yang and clear gold to nourish water" from De Cang Ben Cao (de Bo Cao); ophiopogon root, radix Ophiopogonis has the effects of nourishing yin, moistening lung, nourishing stomach yin, nourishing heart yin, clearing away heart heat, so it is called from Jingyue quan Shu that it ascends heart and lung, tonifies body fluids of upper energizer, clears thirst and restlessness of chest and diaphragm, relieves vomiting of inflammation, and relieves asthenic fever of blood dryness; to replenish vital essence and nourish yin. The two are mutually reinforced, so the functions of nourishing yin, clearing heat, benefiting stomach and promoting fluid production are enhanced, and the two are used as ministerial drugs.

Peony root, radix Paeoniae alba, bitter and sour in flavor, slightly cold in nature, is a blood component medicine, can ascend and descend, and can tonify blood, purge liver, benefit spleen, and astringe liver yin, and is called as "liver-inhibiting, middle-jiao-relieving, yang-supporting, yin-nourishing, qi-tonifying and blood-enriching holy medicine" (Ming & Fang Gu "materia Medica of materia Medica); baikal skullcap root, bitter in taste and cold in nature, is mainly used for clearing heat and drying dampness, purging fire and removing toxicity, cooling blood and arresting bleeding, and removing heat and preventing abortion, and can regulate qi, so it can be used for clearing heat due to qi stagnation in any zang-fu organs (Zhang Xi Chun is recorded in Zhong Can xi Lu of medicine). Modern pharmacological studies show that the scutellaria decoction has a wide antibacterial spectrum in vitro and has an inhibitory effect on staphylococcus, streptococcus, pneumococcus, typhoid bacillus, dysentery bacillus and the like. The peony is combined with the scutellaria, and the peony is taken to disperse blood clots and assist the scutellaria to urge to discharge heat of blood clots, and also assist ministerial drugs in nourishing yin and clearing heat. Sang Bai Pi is sweet and cold in nature and special for lung meridian and can purge lung and relieve dyspnea, induce diuresis to alleviate edema, recorded in compendium of materia Medica: it is advisable for the lung to contain water and qi and the rest of lung fire. Viola Yedoensis Makino is bitter and cold in property, enters heart and liver meridians and blood, and has the effects of clearing away heat and toxic materials, eliminating carbuncle and dissipating stagnation. Modern pharmacological studies also show that the Chinese violet has inhibition effects on pneumococcus, staphylococcus aureus, dysentery bacillus, tubercle bacillus and the like, and has antipyretic, detumescence, anti-inflammatory and other effects. The four medicines of the peony root and the like play an assisting role in the treatment of the formula and are used as adjuvant medicines together. Licorice root, radix Glycyrrhizae is a guiding drug because it can regulate the middle warmer, tonify, and harmonize the effects of other drugs in the recipe.

The above 11 medicines such as ginseng, prepared aconite and the like are formulated based on the traditional Chinese medicine clinical syndrome expression of neutropenia after chemotherapy according to the compatibility theory of the monarch, minister, assistant and guide ' prescription in traditional Chinese medicine and following the treatment and regulation concepts of ' strengthening body resistance and consolidating foundation ', ' tonifying yin and yang and supplementing qi ' and ' taking the peaceful period ', and the medicines are combined to play the functions of tonifying qi and strengthening yang, nourishing yin and clearing heat, and strengthening body resistance and consolidating foundation, so that the reduction of neutropenia after chemotherapy can be obviously improved, the immunity of the organism is improved, and the medicine is used for improving the neutropenia after chemotherapy and has each good effect.

The invention also aims to provide a traditional Chinese medicine oral decoction containing the traditional Chinese medicine composition, and the preparation method comprises the following steps:

1) 11 raw materials of ginseng, prepared aconite, red ganoderma lucidum, radix glehniae, eucommia bark, peony, dwarf lilyturf tuber, baical skullcap root, white mulberry root-bark, Chinese violet and honey-fried licorice root are weighed according to the weight part ratio, mixed and filled into a medicine boiling bag and put into a medicine decocting machine, distilled water which is 6 to 10 times of the total weight of the raw materials is added, the power supply is not switched on, and the raw materials are soaked for 30 to 60 minutes.

2) Setting the decocting temperature of the decocting machine to 100 ℃, and setting the decocting time to 2 h; and the power supply is switched on, and the decoction is started.

3) After the medicine is decocted, the power supply is cut off; taking out the residue, filtering the medicinal liquid, packaging, and storing at 4 deg.C.

Detailed Description

The present invention is further illustrated by the following specific examples, but it will be understood by those skilled in the art that the examples are given for illustrative purposes only and do not limit the scope of the present invention in any way.

Example 1A Chinese medicinal composition for improving neutropenia after chemotherapy

The traditional Chinese medicine composition for improving the neutropenia after chemotherapy comprises the following raw materials in parts by weight: 20 parts of ginseng, 30 parts of prepared aconite root, 10 parts of ganoderma lucidum, 40 parts of radix glehniae, 20 parts of eucommia bark, 20 parts of Chinese herbaceous peony, 20 parts of dwarf lilyturf tuber, 15 parts of baical skullcap root, 15 parts of white mulberry root-bark, 15 parts of Chinese violet and 10 parts of honey-fried licorice root.

The dosage form of the traditional Chinese medicine composition for improving the neutropenia after chemotherapy is traditional Chinese medicine oral decoction.

The preparation method of the traditional Chinese medicine composition oral decoction for improving the neutropenia after chemotherapy comprises the following steps:

1) weighing ginseng, prepared aconite, ganoderma lucidum, radix glehniae, eucommia bark, peony, radix ophiopogonis, scutellaria baicalensis, cortex mori radicis, philippine violet herb and honey-fried licorice root according to the weight part ratio, mixing, filling into a medicine boiling bag, putting into a medicine decocting machine, adding distilled water 6 times of the total weight of the medicinal materials, not switching on a power supply, and soaking for 30 min.

2) Setting the decocting temperature of the decocting machine to 100 ℃, and setting the decocting time to 2 h; 2, the power is switched on, and the decoction is started.

Example 2A Chinese medicinal composition for improving neutropenia after chemotherapy

The traditional Chinese medicine composition for improving the neutropenia after chemotherapy comprises the following raw materials in parts by weight: 40 parts of ginseng, 50 parts of prepared aconite root, 20 parts of red ganoderma lucidum, 60 parts of radix glehniae, 40 parts of eucommia bark, 40 parts of Chinese herbaceous peony, 40 parts of dwarf lilyturf tuber, 30 parts of baical skullcap root, 30 parts of white mulberry root-bark, 30 parts of Chinese violet and 25 parts of honey-fried licorice root.

1) weighing ginseng, prepared aconite, red ganoderma, radix glehniae, eucommia bark, peony, ophiopogon root, scutellaria baicalensis, cortex mori radicis, philippine violet herb and honey-fried licorice root according to the weight part ratio, mixing, filling into a medicine boiling bag, putting into a medicine decocting machine, adding distilled water which is 10 times of the total weight of the medicinal materials, not switching on a power supply, and soaking for 60 min.

Example 3A Chinese medicinal composition for improving neutropenia after chemotherapy

The traditional Chinese medicine composition for improving the neutropenia after chemotherapy comprises the following raw materials in parts by weight: 30 parts of ginseng, 40 parts of prepared aconite root, 15 parts of red ganoderma, 50 parts of radix glehniae, 30 parts of eucommia bark, 30 parts of Chinese herbaceous peony, 30 parts of dwarf lilyturf tuber, 20 parts of baical skullcap root, 20 parts of white mulberry root-bark, 20 parts of Chinese violet and 16 parts of honey-fried licorice root.

1) weighing ginseng, prepared aconite, ganoderma lucidum, radix glehniae, eucommia bark, peony, radix ophiopogonis, scutellaria baicalensis, cortex mori radicis, philippine violet herb and honey-fried licorice root according to the weight part ratio, mixing, filling into a medicine boiling bag, putting into a medicine decocting machine, adding distilled water with the weight 8 times of the total weight of the medicinal materials, not switching on a power supply, and soaking for 45 min.

Example 4A Chinese medicinal composition for improving neutropenia after chemotherapy

The traditional Chinese medicine composition for improving the neutropenia after chemotherapy comprises the following raw materials in parts by weight: 35 parts of ginseng, 45 parts of prepared aconite root, 12 parts of red ganoderma, 45 parts of radix glehniae, 20 parts of eucommia bark, 20 parts of Chinese herbaceous peony, 40 parts of dwarf lilyturf tuber, 30 parts of baical skullcap root, 15 parts of white mulberry root-bark, 15 parts of Chinese violet and 20 parts of honey-fried licorice root.

1) weighing ginseng, prepared aconite, ganoderma lucidum, radix glehniae, eucommia bark, peony, radix ophiopogonis, scutellaria baicalensis, cortex mori radicis, philippine violet herb and honey-fried licorice root according to the weight part ratio, mixing, filling into a medicine boiling bag, putting into a medicine decocting machine, adding distilled water which is 10 times of the total weight of the medicinal materials, not switching on a power supply, and soaking for 30 min.

Comparative example 1 an incomplete Chinese medicinal composition for ameliorating neutropenia after chemotherapy

The incomplete traditional Chinese medicine composition for improving the neutropenia after chemotherapy comprises the following raw materials in parts by weight: 20 parts of ginseng, 30 parts of prepared aconite, 10 parts of ganoderma lucidum, 40 parts of radix glehniae and 20 parts of radix ophiopogonis.

The dosage form of the incomplete traditional Chinese medicine composition for improving the neutropenia after chemotherapy is traditional Chinese medicine oral decoction.

The preparation method of the incomplete traditional Chinese medicine composition oral decoction for improving the neutropenia after chemotherapy is similar to that in example 1.

Comparative example 2 an incomplete Chinese medicinal composition for improving neutropenia after chemotherapy

The incomplete traditional Chinese medicine composition for improving the neutropenia after chemotherapy comprises the following raw materials in parts by weight:

15 parts of scutellaria baicalensis, 15 parts of cortex mori radicis, 15 parts of Chinese violet, 20 parts of eucommia ulmoides, 20 parts of Chinese herbaceous peony and 10 parts of honey-fried licorice root.

In order to verify the effect of the traditional Chinese medicine composition on improving neutropenia after chemotherapy, the inventor carries out animal experiments and typical case research. It should be noted that the drugs selected for the animal experiments and typical case studies of the present invention are the representative formulations and the preparations thereof, and the other formulations and preparations thereof involved in the present invention relate to the experiments and the results thereof, which are not intended to be exhaustive due to space limitations.

Experimental example 1 animal experiments

1 Material

1.1 Experimental animals 80 cynomolgus monkeys of 3-5 years old, half male and female, body weight 3.0-5.0kg, provided by Guangdong island Biotechnology Co., Ltd, license number: SCXK (Yue) 2014-. The animals are raised in special laboratories in cages with the specification of 90 multiplied by 70 cm; the temperature is 22-24 ℃, the relative humidity is 40-60%, the noise is less than or equal to 60dB, the ventilation frequency is 10 times/h, and the natural illumination is carried out; the complete granulated feed for monkeys is used for feeding fruits regularly, and drinking water is boiled and sterilized.

1.2 instruments, reagents and drugs AU480 model full-automatic biochemical analyzer, Beckman Coulter, USA; PE-6800VET model full-automatic animal blood cell analyzer, Shenzhen Shanpu kang electronic Limited; paclitaxel injection (national Standard H20058719) is provided by Yangziang pharmaceutical industry group, Inc. and is used for establishing animal models; the tested drugs were oral decoctions of the Chinese medicinal compositions prepared according to examples 1, 2, 3 and 4 and comparative examples 1 and 2.

2 method

2.1 grouping and modeling 80 cynomolgus monkeys were randomly divided into 8 groups, i.e., a normal control group, a model control group, an example 1 group, an example 2 group, an example 3 group, an example 4 group, a comparative example 1 group, and a comparative example 2 group, each of which was 10, according to male and female halves. Taking a paclitaxel injection, and diluting the paclitaxel injection with normal saline until the concentration is 1.2mg/mL for later use; except for the normal control group, 7 groups of paclitaxel injection after intravenous drip dilution are respectively used for constructing a cynomolgus monkey model simulating neutropenia after clinical chemotherapy. And (4) venous blood collection, wherein biochemical and conventional blood indexes of the animal blood of the model are detected, and the success of modeling is determined.

2.2 administration after successful modeling, the gavage administration is started, 2 times a day, 100mL each time, and 7 days are 1 course of treatment. Wherein the normal control group and the model control group are given drinking water sterilized by boiling in the same volume; the example 1 group, the example 2 group, the example 3 group, the example 4 group, the comparative example 1 group and the comparative example 2 group were administered with the respective test drugs.

2.3 index detection venous blood of animals in each test group is collected respectively before administration (Day0) and 24h after administration (Day7) after successful modeling, the blood sample amount is 2mL, EDTA-K is used₂Performing anticoagulation treatment; and (3) detecting the percentage of the neutrophils and the absolute value of the neutrophils in each test group by adopting a PE-6800VET type full-automatic animal blood cell analyzer.

2.4 statistical processing analysis was performed using SPSS16.0 statistical software. Experimental data are expressed as mean ± sd

Formally, comparison of differences between groups was performed using one-way anova. P < 0.05 indicates that the difference is statistically significant.

3 results

After 7 days of administration, the change of the percentage of neutrophils and the absolute number of neutrophils in each test group can be observed by detecting the blood routine. The analysis results are shown in tables 1 and 2:

TABLE 1 percentage change of neutrophils in animals of each test group (1)

％)

Note: comparison with normal control group: # P < 0.01; comparison with model control group: p < 0.01; comparison with example 1 group: p < 0.01.

TABLE 2 Absolute Change in neutrophil value in animals of each test group ((

10⁹·L^-1)

As is clear from tables 1 and 2, the test drugs for the groups of example 1, example 2, example 3 and example 4 all improved the neutropenia in venous blood of the cynomolgus monkey model with neutropenia after chemotherapy, were significantly different from the model control group, and the best example of the present invention was found to be the group of example 3, which had the best improvement effect. Meanwhile, experimental data of the comparative example group and the comparative example group show that the traditional Chinese medicine composition for improving the neutropenia after chemotherapy provided by the invention is scientific and reasonable in formula and component proportion, obvious in synergistic effect and capable of remarkably improving the neutropenia after chemotherapy.

Experimental example 2 typical case study

Case 1: a patient is Zhang-a, male, and 64 years old, the lung cancer is diagnosed, and after the patient receives the gemcitabine and cisplatin chemotherapy scheme in a hospital for 1 week, the symptoms of mental fatigue, hypodynamia, dizziness, palpitation, insomnia, inappetence and deep and thready pulse appear. The indexes such as neutrophils and the like are obviously reduced (the absolute value of the neutrophils is 1.16 multiplied by 10^9/L) in the conventional detection of blood. After the oral traditional Chinese medicine decoction prepared in the embodiment 3 of the invention is taken for 4 weeks, 1 time in the morning and at night and 200mL each time, each index of the routine blood detection basically returns to normal (the absolute value of the neutrophil is 3.79 multiplied by 10^9/L), and can be maintained to be stable.

Case 2: patients were Song in, female, 51 years old, confirmed to be ovarian cancer, treated in the hospital for 2 weeks on a "paclitaxel + carboplatin" chemotherapy regimen, and blood was routinely tested: the absolute value of the neutrophil is 1.22 x 10^ 9/L. Patients complain of the recent symptoms of lassitude, palpitation, shortness of breath, insomnia, anorexia, sallow complexion, white and greasy tongue coating, and thready and weak pulse. After the oral traditional Chinese medicine decoction prepared in the embodiment 3 of the invention is taken for 4 weeks, 1 time in the morning and at night and 200mL each time, each index of the blood routine test basically returns to normal (the absolute value of the neutrophil is 4.03 multiplied by 10^ 9/L). No obvious discomfort reaction occurs during the taking period.

Claims

1. A traditional Chinese medicine composition for improving neutropenia after chemotherapy is characterized by comprising the following raw materials in parts by weight:

2. the traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight:

3. the traditional Chinese medicine composition according to claim 2, which is prepared from the following raw materials in parts by weight:

4. the pharmaceutical composition according to any one of claims 1 to 3, for the preparation of a medicament for ameliorating neutropenia after chemotherapy.

5. A Chinese medicinal oral decoction, which comprises the Chinese medicinal composition as claimed in any one of claims 1 to 3.

6. The traditional Chinese medicine oral decoction according to claim 5, which is prepared by the following steps:

1) weighing 11 raw materials of ginseng, prepared aconite, ganoderma lucidum, radix glehniae, eucommia bark, peony, ophiopogon root, scutellaria baicalensis, cortex mori radicis, philippine violet herb and honey-fried licorice root according to the weight part ratio, mixing, filling into a medicine boiling bag, putting into a medicine decocting machine, adding distilled water 6-10 times of the total weight of the raw materials, not switching on a power supply, and soaking for 30-60 min;

2) setting the decocting temperature of the decocting machine to 100 ℃, and setting the decocting time to 2 h; switching on a power supply, and starting decoction;