Traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention provides a composition for treating qi and blood deficiency and a preparation method and application thereof, and relates to the technical field of traditional Chinese medicine. The invention discloses a composition for treating qi and blood deficiency. The composition is prepared from the following raw materials: astragalus membranaceus, salvia miltiorrhiza, codonopsis pilosula, fructus lycii, hairyvein agrimony, caulis spatholobi, radix rehmanniae recen, fried malt, fried rhizoma atractylodis macrocephalae, angelica sinensis, fried endothelium corneum gigeriae galli, wine-processed glossy privet fruit, herba epimedii, coptis chinensis, deer-horn glue, tortoise-shell glue and pseudo-ginseng powder. The composition for treating qi and blood deficiency is prepared from a plurality of traditional Chinese medicinal materials with mild properties, not only can tonify yang qi, essence and blood, but also can treat anemia symptoms such as aplastic anemia and the like, myelosuppression caused by platelet, leucopenia and tumor radiotherapy and chemotherapy, and can treat diseases causing qi and blood deficiency. In addition, the invention further provides a preparation method of the composition for treating the qi and blood deficiency, the preparation method of the composition for treating the qi and blood deficiency not only improves the medicine property of the composition for treating the qi and blood deficiency, but also is simple in process, easy to operate and convenient to master.

Description

[0001] This application is a divisional application filed on February 1, 2021, with patent number "202110139024.5" and invention title "A composition for treating qi and blood deficiency and its preparation method and application". Technical Field

[0002] This invention relates to the field of traditional Chinese medicine technology, and more specifically, to a composition for treating qi and blood deficiency, its preparation method, and its application. Background Technology

[0003] In Traditional Chinese Medicine (TCM), Qi and Blood deficiency often refers to both Qi deficiency and Blood deficiency. Qi and Blood deficiency can lead to decreased organ function, causing a sub-healthy state and even premature aging. Qi deficiency, characterized by weakened organ function and poor disease resistance, manifests as aversion to cold, cold limbs, spontaneous sweating, dizziness, tinnitus, lethargy, fatigue, weakness, palpitations, shortness of breath, and developmental delays. Blood deficiency can present as a pale, sallow complexion, dry skin, brittle hair, cracked nails, blurred vision, numbness in the hands and feet, insomnia, dreaminess, forgetfulness, palpitations, and mental confusion. Qi and Blood deficiency are considered simultaneous diseases of both Qi and Blood. Qi and Blood deficiency can also lead to malnourishment of the body, with common symptoms including fatigue, weakness, shortness of breath, reluctance to speak, pale or sallow complexion, dizziness, pale lips and nails, palpitations, insomnia, pale tongue, and weak pulse.

[0004] Qi deficiency and blood deficiency can occur alone or together. Qi and blood deficiency is often caused by insufficient rest and excessive fatigue, which is relatively easy to recover from. Taking common Chinese herbal supplements to replenish qi and blood can improve the condition. However, qi and blood deficiency caused by diseases or chemotherapy, radiotherapy, etc., resulting in impaired hematopoietic function or reduced blood cells is more troublesome.

[0005] Nowadays, most Chinese medicines on the market that claim to replenish qi and blood are health supplements. They can only improve qi and blood deficiency caused by insufficient rest or excessive fatigue. They are helpless for qi and blood deficiency caused by diseases or radiotherapy and chemotherapy, which lead to loss of hematopoietic function or reduction of blood cells. Although taking qi and blood replenishing Chinese medicine health supplements can temporarily relieve the symptoms of qi and blood deficiency, it cannot completely eradicate the above-mentioned symptoms. In the long run, the symptoms of qi and blood deficiency will only become more and more serious, causing greater damage to the body. Summary of the Invention

[0006] The purpose of this invention is to provide a composition for treating qi and blood deficiency. This composition is made by combining a variety of mild Chinese medicinal herbs. It can not only replenish yang qi and essence and blood, but also treat symptoms of anemia such as aplastic anemia, as well as thrombocytopenia, leukopenia, bone marrow suppression caused by radiotherapy and chemotherapy for tumors, and diseases that cause qi and blood deficiency, thus treating qi and blood deficiency from the root cause.

[0007] Another object of the present invention is to provide the use of a composition for treating blood and qi deficiency in the preparation of a medicament for treating anemia and thrombocytopenia, leukopenia and restoring blood counts.

[0008] Another objective of this invention is to provide a method for preparing a composition for treating qi and blood deficiency. This method improves the medicinal properties of the composition by concentration and astringent processing, and the process is simple, easy to operate, and user-friendly.

[0009] The technical problem solved by this invention is achieved by the following technical solution.

[0010] On one hand, this application provides a composition for treating qi and blood deficiency, mainly prepared from the following raw materials in parts by weight: 75-85 parts of Astragalus membranaceus, 25-35 parts of Salvia miltiorrhiza, 55-65 parts of Codonopsis pilosula, 40-50 parts of Lycium barbarum, 85-95 parts of Agrimonia pilosa, 85-95 parts of Spatholobus suberectus, 45-55 parts of Rehmannia glutinosa, 25-35 parts of stir-fried malt, 35-45 parts of stir-fried Atractylodes macrocephala, 55-65 parts of Angelica sinensis, 15-25 parts of stir-fried chicken gizzard lining, 40-50 parts of wine-processed Ligustrum lucidum, 15-25 parts of Epimedium brevicornu, 10-20 parts of Coptis chinensis, 25-35 parts of deer antler glue, 25-35 parts of tortoise shell glue, and 5-15 parts of Panax notoginseng powder.

[0011] On the other hand, embodiments of this application provide the use of a composition for treating blood and qi deficiency in the preparation of a medicament for treating anemia and thrombocytopenia, leukopenia and restoring blood counts.

[0012] On the other hand, embodiments of this application provide a method for preparing a composition for treating qi and blood deficiency, comprising the following steps: soaking the remaining raw materials, except for Panax notoginseng powder, deer antler glue and tortoise shell glue, in water and then decocting them to obtain a decoction; concentrating the decoction to obtain a concentrated liquid; and then adding Panax notoginseng powder, tortoise shell glue and deer antler glue to the concentrated liquid to form an ointment, thereby obtaining the composition for treating qi and blood deficiency.

[0013] The preparation method of this composition for treating qi and blood deficiency involves decoction, concentration, and paste formation, which reduces the volume of the composition, making it easier to take and enhancing its medicinal properties. Furthermore, the preparation method is simple to operate, easy to learn, and convenient for operators.

[0014] Compared with the prior art, the embodiments of the present invention have at least the following advantages or beneficial effects:

[0015] The composition for treating qi and blood deficiency provided by this invention uses a variety of blood-tonifying and qi-boosting medicinal materials. Among them, the cold and warm properties of the medicinal materials are mutually balanced and restrained in a certain proportion, which achieves the effect of yin-yang harmony. In addition, the medicinal materials are combined in a reasonable principal-assistant-adjuvant relationship. Therefore, the composition for treating qi and blood deficiency provided by this invention has a good therapeutic effect on the symptoms of anemia caused by qi and blood deficiency, such as aplastic anemia and the reduction of blood cells caused by radiotherapy and chemotherapy. Furthermore, the composition for treating qi and blood deficiency can also clear heat and dry dampness, nourish yin and tonify yang, strengthen the stomach and promote digestion, and astringe essence and stop seminal emission, thus regulating the body's condition from multiple aspects.

[0016] The principal ingredients include Astragalus membranaceus, deer antler glue, and tortoise shell glue. Astragalus membranaceus, primarily using its root, is sweet and slightly warm in nature, entering the spleen and lung meridians. It replenishes qi and blood, and its sweet and warm properties benefit the spleen, treating symptoms such as qi deficiency and fatigue. Deer antler glue, made from deer antler with rock sugar, rice wine, and soybean oil, has a faint aroma and a slightly sweet taste. It warms the liver and kidneys, replenishes essence and nourishes blood, treating symptoms such as blood deficiency dizziness and general weakness. Tortoise shell glue, made from tortoise shell with rice wine and other excipients, has a slightly fishy aroma and a bland taste. It nourishes yin and blood, treating symptoms such as yin deficiency fever and blood deficiency with chlorosis. These three herbs, combined in appropriate proportions, promote qi circulation, replenish kidney essence, and nourish liver blood, achieving both innate and acquired benefits, and harmonizing qi, blood, yin, and yang. Their combined effects complement each other, making them the principal ingredients.

[0017] The main ingredients include Codonopsis pilosula, stir-fried Atractylodes macrocephala, and Angelica sinensis. Codonopsis pilosula is mainly used from its dried root. It is sweet and neutral in nature, and can replenish qi and blood, and promote the production of body fluids. It is mainly used to treat symptoms such as fatigue and weakness and deficiency of both qi and blood. Atractylodes macrocephala is a perennial herb of the Asteraceae family. It is sweet and warm in nature, and can replenish qi and strengthen the spleen, and dry dampness and promote diuresis. It is mainly used to treat symptoms such as weakness of the spleen and stomach and loss of appetite. Angelica sinensis is a plant of the Apiaceae family. Its root is used to treat symptoms such as deficiency of blood and fever, and excessive blood loss. It is slightly sweet and warm in nature, and can replenish qi and blood, and promote blood circulation and moisten the intestines. It is mainly used to treat symptoms such as deficiency of blood and fever, and excessive blood loss. The combination of these three herbs with Astragalus membranaceus further enhances the effect of replenishing blood and qi. The combination of Angelica sinensis and Astragalus membranaceus is known as the Angelica sinensis blood-replenishing decoction. When combined with tortoise shell glue and deer antler glue, it can further enhance the effect of nourishing essence and blood. Moreover, Angelica sinensis can promote blood circulation while replenishing blood, so it can replenish blood without causing blood stagnation.

[0018] The adjuvant herbs include wolfberry, privet fruit (processed with wine), salvia miltiorrhiza, chicken blood vine, stir-fried chicken gizzard lining, stir-fried malt, epimedium, agrimony, coptis chinensis, rehmannia glutinosa, and notoginseng powder. Wolfberry, the mature fruit of the wolfberry plant, is sweet and neutral in nature, nourishing the liver and kidneys, and benefiting essence and vision, primarily treating symptoms such as deficiency of essence and blood and insufficiency of the liver and kidneys. Privet fruit (processed with wine), the mature fruit of the privet plant, is sweet and bitter, and neutral in nature, nourishing yin and prolonging life, and benefiting the liver and kidneys, primarily treating symptoms such as dizziness and vertigo caused by deficiency of qi and blood. Salvia miltiorrhiza, mainly using its root and stem, is bitter and slightly cold in nature, invigorating qi and promoting blood circulation, primarily treating symptoms such as chest pain, heart pain, and insomnia. Chicken blood vine, mainly using its stem, is bitter and sweet, and warm in nature, invigorating blood and replenishing blood, primarily treating symptoms such as blood deficiency and chlorosis. Stir-fried chicken gizzard lining, made by stir-frying fresh chicken gizzard lining, is sweet and neutral in nature, invigorating the stomach and aiding digestion, and astringing essence and stopping seminal emission, primarily... This medicine is used to treat symptoms such as indigestion, enuresis, and seminal emission. Roasted malt, made by roasting malt, can promote digestion, strengthen the spleen, and improve appetite, primarily treating indigestion and poor appetite due to spleen deficiency. Epimedium, mainly using its leaves, is pungent, sweet, and warm in nature, and can tonify kidney yang, primarily treating symptoms such as kidney yang deficiency. Agrimonia pilosa, mainly using its stems and leaves, is bitter and astringent, and neutral in nature, and can stop bleeding and tonify deficiency, primarily treating symptoms such as metrorrhagia and metrorrhagia. Coptis chinensis, mainly using its dried rhizome, is bitter and cold in nature, and can clear heat and dry dampness, primarily treating symptoms such as hematemesis and epistaxis due to blood heat. Rehmannia glutinosa, mainly using its dried tuberous root, is sweet and slightly warm in nature, and can nourish blood and yin, and replenish essence and marrow, primarily treating symptoms such as blood deficiency and chlorosis, and liver and kidney yin deficiency. Panax notoginseng, mainly using its dried root, is sweet, slightly bitter, and warm in nature, and can resolve blood stasis, stop bleeding, and relieve pain, primarily treating symptoms such as traumatic bleeding and hematochezia. Goji berries and wine-processed privet fruit can work synergistically with tortoise shell glue, deer antler glue, and angelica to nourish the liver and kidney essence and blood. Epimedium combined with deer antler glue can warm the kidneys and strengthen yang. When combined with various yin-nourishing and blood-nourishing herbs in the adjuvant medicines, it has the effect of seeking yin within yang. Coptis chinensis is cold in nature and can harmonize the properties of warming herbs and has the effect of synergistic hemostasis.

[0019] Furthermore, the preparation method of the composition for treating qi and blood deficiency provided by the present invention has simple operation steps, is easy to learn, facilitates operation by operators, and reduces the difficulty of operation. Attached Figure Description

[0020] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a graph showing the trend of body weight change in each group of mice in Experiment 1 of the present invention, where C is the normal group, M is the model control group, and D is the drug-treated group;

[0022] Figure 2This is a graph showing the trend of peripheral blood routine changes in mice in each group in Experiment Example 1 of this invention, where C is the normal group, M is the model control group, and D is the drug-treated group;

[0023] Figure 3 This is a graph showing the trend of changes in thymus index and spleen index in mice in each group in Experiment Example 1 of the present invention, where C is the normal group, M is the model control group, and D is the drug-treated group;

[0024] Figure 4 This is a pathological morphology image of bone marrow tissue from normal mice in Experiment Example 1 of this invention, observed under a 400x microscope after HE staining.

[0025] Figure 5 The image shows the pathological morphology of bone marrow tissue from the model control group mice in Experiment Example 1 of this invention after HE staining, observed under a 400x microscope.

[0026] Figure 6 This is a pathological morphological image of bone marrow tissue from mice in the treatment group in Experiment Example 1 of this invention, observed under a 400x microscope after HE staining.

[0027] Icons: 1-megakaryocyte; 2-segmented neutrophils; 3-blood sinusoids. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased commercially.

[0029] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other. The present invention will now be described in detail with reference to specific embodiments.

[0030] On one hand, this application provides a composition for treating qi and blood deficiency, mainly prepared from the following raw materials in parts by weight: 75-85 parts of Astragalus membranaceus, 25-35 parts of Salvia miltiorrhiza, 55-65 parts of Codonopsis pilosula, 40-50 parts of Lycium barbarum, 85-95 parts of Agrimonia pilosa, 85-95 parts of Spatholobus suberectus, 45-55 parts of Rehmannia glutinosa, 25-35 parts of stir-fried malt, 35-45 parts of stir-fried Atractylodes macrocephala, 55-65 parts of Angelica sinensis, 15-25 parts of stir-fried chicken gizzard lining, 40-50 parts of wine-processed Ligustrum lucidum, 15-25 parts of Epimedium brevicornu, 10-20 parts of Coptis chinensis, 25-35 parts of deer antler glue, 25-35 parts of tortoise shell glue, and 5-15 parts of Panax notoginseng powder. The principal ingredients include Astragalus membranaceus, deer antler glue, and tortoise shell glue. Astragalus membranaceus, primarily using its root, is sweet and slightly warm in nature, entering the spleen and lung meridians. It replenishes qi and blood, and its sweet and warm properties benefit the spleen, treating symptoms such as qi deficiency and fatigue. Deer antler glue, made from deer antler with rock sugar, rice wine, and soybean oil, has a faint aroma and a slightly sweet taste. It warms the liver and kidneys, replenishes essence and nourishes blood, treating symptoms such as blood deficiency dizziness and general weakness. Tortoise shell glue, made from tortoise shell with rice wine and other excipients, has a slightly fishy aroma and a bland taste. It nourishes yin and blood, treating symptoms such as yin deficiency fever and blood deficiency with chlorosis. These three herbs, combined in appropriate proportions, promote qi circulation, replenish kidney essence, and nourish liver blood, achieving both innate and acquired benefits, and harmonizing qi, blood, yin, and yang. Their combined effects complement each other, making them the principal ingredients.

[0031] The main ingredients include Codonopsis pilosula, stir-fried Atractylodes macrocephala, and Angelica sinensis. Codonopsis pilosula is mainly used from its dried root. It is sweet and neutral in nature, and can replenish qi and blood, and promote the production of body fluids. It is mainly used to treat symptoms such as fatigue and weakness and deficiency of both qi and blood. Atractylodes macrocephala is a perennial herb of the Asteraceae family. It is sweet and warm in nature, and can replenish qi and strengthen the spleen, and dry dampness and promote diuresis. It is mainly used to treat symptoms such as weakness of the spleen and stomach and loss of appetite. Angelica sinensis is a plant of the Apiaceae family. Its root is used to treat symptoms such as deficiency of blood and fever, and excessive blood loss. It is slightly sweet and warm in nature, and can replenish qi and blood, and promote blood circulation and moisten the intestines. It is mainly used to treat symptoms such as deficiency of blood and fever, and excessive blood loss. The combination of these three herbs with Astragalus membranaceus further enhances the effect of replenishing blood and qi. The combination of Angelica sinensis and Astragalus membranaceus is known as the Angelica sinensis blood-replenishing decoction. When combined with tortoise shell glue and deer antler glue, it can further enhance the effect of nourishing essence and blood. Moreover, Angelica sinensis can promote blood circulation while replenishing blood, so that blood can be replenished without stagnation.

[0032] The adjuvant herbs include wolfberry, privet fruit (processed with wine), salvia miltiorrhiza, chicken blood vine, stir-fried chicken gizzard lining, stir-fried malt, epimedium, agrimony, coptis chinensis, rehmannia glutinosa, and notoginseng powder. Wolfberry is the mature fruit of the wolfberry plant, sweet in taste and neutral in nature, capable of nourishing the liver and kidneys, and benefiting essence and vision, mainly treating symptoms such as deficiency of essence and blood and insufficiency of the liver and kidneys. Privet fruit (processed with wine) is the mature fruit of the privet plant, sweet and bitter in taste and neutral in nature, capable of nourishing yin and prolonging life, and benefiting the liver and kidneys, mainly treating symptoms such as dizziness and vertigo caused by deficiency of qi and blood. Salvia miltiorrhiza mainly uses its root and stem, bitter in taste and slightly cold in nature, capable of invigorating qi and promoting blood circulation, mainly treating symptoms such as chest pain, heart pain, and insomnia. Chicken blood vine mainly uses its stem, bitter and sweet in taste and warm in nature, capable of invigorating blood and replenishing blood, mainly treating symptoms such as blood deficiency and chlorosis. Stir-fried chicken gizzard lining is made by stir-frying fresh chicken gizzard lining, sweet in taste and neutral in nature, capable of strengthening the stomach and aiding digestion, and astringing essence and stopping seminal emission, mainly treating... Symptoms such as indigestion, enuresis, and seminal emission; stir-fried malt, made by stir-frying malt, can promote qi circulation, aid digestion, and strengthen the spleen and stomach, and is mainly used to treat indigestion and poor appetite due to spleen deficiency; Epimedium, mainly using its leaves, is pungent and sweet in taste and warm in nature, and can tonify kidney yang, and is mainly used to treat symptoms such as kidney yang deficiency; Agrimonia pilosa, mainly using its stems and leaves, is bitter and astringent in taste and neutral in nature, and can stop bleeding and tonify deficiency, and is mainly used to treat symptoms such as metrorrhagia; Coptis chinensis, mainly using its dried rhizome, is bitter and cold in nature, and can clear heat and dry dampness, and is mainly used to treat symptoms such as hematemesis due to blood heat; Rehmannia glutinosa, mainly using its dried tuberous root, is sweet and slightly warm in nature, and can nourish blood and yin and replenish essence and marrow, and is mainly used to treat symptoms such as blood deficiency and chlorosis and liver and kidney yin deficiency; Panax notoginseng, mainly using its dried root, is sweet and slightly bitter in taste and warm in nature, and can resolve blood stasis, stop bleeding, promote blood circulation, and relieve pain, and is mainly used to treat symptoms such as traumatic bleeding and hematochezia. Goji berries and wine-processed privet fruit can work synergistically with tortoise shell glue, deer antler glue, and angelica to nourish the liver and kidney essence and blood. Epimedium combined with deer antler glue can warm the kidneys and strengthen yang. When combined with various yin-nourishing and blood-nourishing herbs in the adjuvant medicines, it has the effect of seeking yin within yang. Coptis chinensis is cold in nature and can harmonize the properties of warming herbs and has the effect of synergistic hemostasis.

[0033] In some embodiments of the present invention, the above-mentioned composition for treating qi and blood deficiency is mainly prepared from the following raw materials in parts by weight: 80 parts Astragalus membranaceus, 30 parts Salvia miltiorrhiza, 60 parts Codonopsis pilosula, 45 parts Lycium barbarum, 90 parts Agrimonia pilosa, 90 parts Spatholobus suberectus, 50 parts Rehmannia glutinosa, 30 parts stir-fried malt, 40 parts stir-fried Atractylodes macrocephala, 60 parts Angelica sinensis, 20 parts stir-fried chicken gizzard lining, 45 parts Ligustrum lucidum (processed with wine), 20 parts Epimedium brevicornu, 15 parts Coptis chinensis, 30 parts deer antler glue, 30 parts tortoise shell glue, and 10 parts Panax notoginseng powder.

[0034] The aforementioned embodiments represent the optimal formulation of this composition for treating qi and blood deficiency. It not only has significant therapeutic effects on diseases that cause qi and blood deficiency, but also clears heat and dries dampness, nourishes yin and yang, strengthens the stomach and aids digestion, and astringes essence and stops seminal emission.

[0035] On the other hand, embodiments of this application provide the use of a composition for treating blood and qi deficiency in the preparation of a medicament for treating anemia and thrombocytopenia, leukopenia and restoring blood counts.

[0036] On the other hand, embodiments of this application provide a method for preparing a composition for treating qi and blood deficiency, comprising the following steps: soaking the remaining raw materials (excluding Panax notoginseng powder, deer antler glue, and tortoise shell glue) in water and then decocting them to obtain a decoction; concentrating the decoction to obtain a concentrated liquid; and then adding Panax notoginseng powder, tortoise shell glue, and deer antler glue to the concentrated liquid to form a paste, thereby obtaining the composition for treating qi and blood deficiency. Adding Panax notoginseng powder, deer antler glue, and tortoise shell glue after decoction and concentration avoids the deer antler glue and tortoise shell glue from burning during decoction, thus preventing loss of medicinal properties. Panax notoginseng powder is easily wasted during decoction, leading to loss of medicinal properties, so it is added directly after concentration. The soaking time in water before decoction is 0.5 hours.

[0037] In some embodiments of the present invention, the above-mentioned soaking process further includes a sterilization step, which involves irradiating the raw material under ultraviolet light at 255-265 nm for 10-20 minutes. Sterilization can be performed by ultraviolet sterilization or high-pressure steam sterilization, with ultraviolet sterilization being preferred. Ultraviolet sterilization is not only simple and easy to operate, but also does not damage the medicinal properties of the medicinal materials.

[0038] In some embodiments of the present invention, the tortoise shell glue and deer antler glue were further processed before being added to the concentrate. The processing involved using a sand-scalding method to crisp the tortoise shell glue and deer antler glue. The processing could be done by stir-frying or sand-scalding, with sand-scalding being preferred. This method not only improves the taste of the medicinal materials but also does not damage their medicinal properties.

[0039] In some embodiments of the present invention, the decoction is performed twice. The first decoction lasts for 40-50 minutes, and after filtration, decoction liquid one is obtained. Water is added again for a second decoction, which lasts for 40-50 minutes. After filtration, decoction liquid two is obtained. The decoction liquid two is a mixture of decoction liquid one and decoction liquid two. By performing the two decoctions, the beneficial components in the medicinal materials are completely extracted. Adding water in two separate decoctions avoids the loss of some beneficial components due to excessive water addition and evaporation during the first decoction.

[0040] In some embodiments of the present invention, the amount of water added during the first decoction and the second decoction is 12 times the weight of the added medicinal materials. Both the first and second decoctions are first brought to a boil over high heat, then simmered over low heat. Adding the same amount of water in both decoctions ensures that the beneficial components of the medicinal materials are extracted to the maximum extent during both decoctions. Furthermore, simmering over low heat avoids damaging the medicinal properties of the herbs due to excessive heat.

[0041] In some embodiments of the present invention, the relative density of the concentrate is controlled to be 1.02-1.1 at 60°C during concentration. Ensuring the density of the concentrate is within a reasonable range guarantees the content of beneficial components in each gram of concentrate.

[0042] In some embodiments of the present invention, the relative density of the composition for treating qi and blood deficiency is controlled to be 1.1-1.2 at 60°C during the paste-forming process. This ensures that the relative density of the composition for treating qi and blood deficiency is within a reasonable range during paste-forming, thereby guaranteeing the content of beneficial components in each gram of the composition.

[0043] The features and performance of the present invention will be further described in detail below with reference to embodiments.

[0044] Example 1

[0045] The purpose of this embodiment is to provide a composition for treating qi and blood deficiency.

[0046] The ingredients of this composition are: Astragalus membranaceus 75g, Salvia miltiorrhiza 25g, Codonopsis pilosula 55g, Lycium barbarum 40g, Agrimonia pilosa 85g, Spatholobus suberectus 85g, Rehmannia glutinosa 45g, stir-fried malt 25g, stir-fried Atractylodes macrocephala 35g, Angelica sinensis 55g, stir-fried chicken gizzard lining 15g, Ligustrum lucidum 40g, Epimedium brevicornu 15g, Coptis chinensis 10g, deer antler glue 25g, tortoise shell glue 25g, and Panax notoginseng powder 5g.

[0047] The composition is prepared by the following steps: After irradiating the medicinal materials with 255nm ultraviolet light for 10 minutes, add the medicinal materials except for Panax notoginseng powder, deer antler glue and tortoise shell glue to the decoction pot and add 7260mL of water. After soaking for 0.5h, start the first decoction. First, bring to a boil over high heat, then reduce the heat to low heat and simmer for 40min to obtain decoction one. Then add 7260mL of water for the second decoction. First, bring to a boil over high heat, then reduce the heat to low heat and simmer for 40min to obtain decoction two. Combine decoction one and decoction two to obtain decoction. Concentrate the decoction to a relative density of 1.02 (60℃) to obtain concentrated liquid. Then, treat the tortoise shell glue and deer antler glue with sand scalding until crisp. Then add Panax notoginseng powder, tortoise shell glue and deer antler glue to the concentrated liquid and reduce to a relative density of 1.1 (60℃) to obtain the composition for treating qi and blood deficiency.

[0048] Example 2

[0049] The purpose of this embodiment is to provide a composition for treating qi and blood deficiency.

[0050] The ingredients of this composition are: Astragalus membranaceus 85g, Salvia miltiorrhiza 35g, Codonopsis pilosula 65g, Lycium barbarum 50g, Agrimonia pilosa 95g, Spatholobus suberectus 95g, Rehmannia glutinosa 55g, stir-fried malt 35g, stir-fried Atractylodes macrocephala 45g, Angelica sinensis 65g, stir-fried chicken gizzard lining 25g, Ligustrum lucidum 50g, Epimedium brevicornu 25g, Coptis chinensis 20g, deer antler glue 35g, tortoise shell glue 35g, and Panax notoginseng powder 15g.

[0051] The composition is prepared by the following steps: After irradiating the medicinal materials with 265nm ultraviolet light for 20 minutes, add the medicinal materials except for Panax notoginseng powder, deer antler glue and tortoise shell glue to the decoction pot and add 8940mL of water. After soaking for 0.5h, start the first decoction. First, bring to a boil over high heat, then reduce the heat to low heat and simmer for 50min to obtain decoction one. Then add 8940mL of water for the second decoction. First, bring to a boil over high heat, then reduce the heat to low heat and simmer for 50min to obtain decoction two. Combine decoction one and decoction two to obtain decoction. Concentrate the decoction to a relative density of 1.1 (60℃) to obtain concentrated liquid. Then, treat the tortoise shell glue and deer antler glue with sand scalding until crisp. Then add Panax notoginseng powder, tortoise shell glue and deer antler glue to the concentrated liquid and reduce to a relative density of 1.2 (60℃) to obtain the composition for treating qi and blood deficiency.

[0052] Example 3

[0053] The purpose of this embodiment is to provide a composition for treating qi and blood deficiency.

[0054] The ingredients of this composition are: Astragalus membranaceus 80g, Salvia miltiorrhiza 30g, Codonopsis pilosula 60g, Lycium barbarum 45g, Agrimonia pilosa 90g, Spatholobus suberectus 90g, Rehmannia glutinosa 50g, stir-fried malt 30g, stir-fried Atractylodes macrocephala 40g, Angelica sinensis 60g, stir-fried chicken gizzard lining 20g, Ligustrum lucidum 45g, Epimedium brevicornu 20g, Coptis chinensis 15g, deer antler glue 30g, tortoise shell glue 30g, and Panax notoginseng powder 10g.

[0055] The composition is prepared by the following steps: After irradiating the medicinal materials with 260nm ultraviolet light for 15 minutes, add the medicinal materials except for Panax notoginseng powder, deer antler glue and tortoise shell glue to the decoction pot and add 8100mL of water. After soaking for 0.5h, start the first decoction. First, bring to a boil over high heat, then reduce the heat to low heat and simmer for 45min to obtain decoction one. Then add 8100mL of water for the second decoction. First, bring to a boil over high heat, then reduce the heat to low heat and simmer for 45min to obtain decoction two. Combine decoction one and decoction two to obtain decoction. Concentrate the decoction to a relative density of 1.06 (60℃) to obtain concentrated liquid. Then, treat the tortoise shell glue and deer antler glue with sand scalding until crisp. Then add Panax notoginseng powder, tortoise shell glue and deer antler glue to the concentrated liquid and reduce to a relative density of 1.15 (60℃) to obtain the composition for treating qi and blood deficiency.

[0056] Example 4

[0057] The purpose of this embodiment is to provide a composition for treating qi and blood deficiency.

[0058] The ingredients of this composition are: Astragalus membranaceus 75g, Salvia miltiorrhiza 32g, Codonopsis pilosula 60g, Lycium barbarum 40g, Agrimonia pilosa 85g, Spatholobus suberectus 86g, Rehmannia glutinosa 46g, stir-fried malt 32g, stir-fried Atractylodes macrocephala 35g, Angelica sinensis 54g, stir-fried chicken gizzard lining 15g, Ligustrum lucidum 40g, Epimedium brevicornu 15g, Coptis chinensis 17g, deer antler glue 24g, tortoise shell glue 31g, and Panax notoginseng powder 5g.

[0059] The composition is prepared by the following steps: After irradiating the medicinal materials with 258nm ultraviolet light for 13 minutes, add the medicinal materials except for Panax notoginseng powder, deer antler glue and tortoise shell glue to the decoction pot and add 7584mL of water. After soaking for 0.5h, start the first decoction. First, bring to a boil over high heat. After boiling, reduce the heat to low heat and simmer for 44min to obtain decoction one. Then add 7584mL of water for the second decoction. First, adjust the heat to high heat. After boiling, reduce the heat to low heat and simmer for 44min to obtain decoction two. Combine decoction one and decoction two to obtain decoction. Concentrate the decoction to a relative density of 1.05 (60℃) to obtain concentrated liquid. Then, treat the tortoise shell glue and deer antler glue with sand scalding until crisp. Then add Panax notoginseng powder, tortoise shell glue and deer antler glue to concentrated liquid and reduce to a relative density of 1.14 (60℃) to obtain composition for treating qi and blood deficiency.

[0060] Example 5

[0061] The purpose of this embodiment is to provide a composition for treating qi and blood deficiency.

[0062] The ingredients of this composition are: Astragalus membranaceus 77g, Salvia miltiorrhiza 33g, Codonopsis pilosula 63g, Lycium barbarum 42g, Agrimonia pilosa 87g, Spatholobus suberectus 87g, Rehmannia glutinosa 47g, stir-fried malt 33g, stir-fried Atractylodes macrocephala 37g, Angelica sinensis 57g, stir-fried chicken gizzard lining 17g, wine-processed Ligustrum lucidum 42g, Epimedium brevicornu 17g, Coptis chinensis 18g, deer antler glue 27g, tortoise shell glue 33g, and Panax notoginseng powder 7g.

[0063] The composition is prepared by the following steps: After irradiating the medicinal materials with 262nm ultraviolet light for 18 minutes, add the medicinal materials except for Panax notoginseng powder, deer antler glue and tortoise shell glue to the decoction pot and add 7884mL of water. After soaking for 0.5h, start the first decoction. First, bring to a boil over high heat, then reduce the heat to low heat and simmer for 41min to obtain decoction one. Then add 7884mL of water for the second decoction. First, bring to a boil over high heat, then reduce the heat to low heat and simmer for 41min to obtain decoction two. Combine decoction one and decoction two to obtain decoction. Concentrate the decoction to a relative density of 1.03 (60℃) to obtain concentrated liquid. Then, treat the tortoise shell glue and deer antler glue with sand scalding until crisp. Then add Panax notoginseng powder, tortoise shell glue and deer antler glue to the concentrated liquid and reduce to a relative density of 1.16 (60℃) to obtain the composition for treating qi and blood deficiency.

[0064] Example 6

[0065] The purpose of this embodiment is to provide a composition for treating qi and blood deficiency.

[0066] The ingredients of this composition are: Astragalus membranaceus 78g, Salvia miltiorrhiza 34g, Codonopsis pilosula 64g, Lycium barbarum 43g, Agrimonia pilosa 88g, Spatholobus suberectus 88g, Rehmannia glutinosa 48g, stir-fried malt 34g, stir-fried Atractylodes macrocephala 38g, Angelica sinensis 58g, stir-fried chicken gizzard lining 18g, Ligustrum lucidum 43g, Epimedium brevicornu 18g, Coptis chinensis 19g, deer antler glue 28g, tortoise shell glue 34g, and Panax notoginseng powder 8g.

[0067] The composition is prepared by the following steps: After irradiating the medicinal materials with 259nm ultraviolet light for 17 minutes, add the medicinal materials except for Panax notoginseng powder, deer antler glue and tortoise shell glue to the decoction pot and add 8052mL of water. After soaking for 0.5h, start the first decoction. First, bring to a boil over high heat, then reduce the heat to low heat and simmer for 46min to obtain decoction one. Then add 8052mL of water for the second decoction. First, bring to a boil over high heat, then reduce the heat to low heat and simmer for 46min to obtain decoction two. Combine decoction one and decoction two to obtain decoction. Concentrate the decoction to a relative density of 1.08 (60℃) to obtain concentrated liquid. Then, treat the tortoise shell glue and deer antler glue with sand scalding until crisp. Then add Panax notoginseng powder, tortoise shell glue and deer antler glue to the concentrated liquid and reduce to a relative density of 1.17 (60℃) to obtain the composition for treating qi and blood deficiency.

[0068] Experimental Example 1

[0069] Six-week-old ICR mice were prepared for the experiment. They were SPF-grade male mice purchased from Shanghai Xipuer-Bikai Laboratory Animal Co., Ltd., with the experimental animal license number: SCXK(Shanghai)2018-0006. The mice were raised in an environment with a temperature of 20±2°C and a humidity of 60±2%RH for one week to adapt to the environment, and they had free access to food and water during the raising process.

[0070] Acetylphenylhydrazine (APH, produced by Shanghai Aladdin Biochemical Technology Co., Ltd., purity 98%), cyclophosphamide (CTX, produced by Jiangsu Hengrui Medicine Co., Ltd.), the composition for treating qi and blood deficiency prepared in Examples 1-4, normal saline, paraformaldehyde, and disodium ethylenediaminetetraacetate (EDTA-2Na, produced by Sinopharm Chemical Reagent Co., Ltd., batch number: T20120311) were prepared.

[0071] A fully automatic blood analyzer (manufacturer: HORIBA Medical; instrument model: ABX Pentra XL80); an ice maker (manufacturer: PANASONIC; instrument model: SIM-F140AY65-PC); a centrifuge (manufacturer: Beijing Boyaa Innovation Technology Development Co., Ltd.; instrument model: Micofuge 22R Centrifuge) were prepared.

[0072] The prepared ICR mice were randomly divided into three groups according to body weight: 10 mice in the normal group, 10 mice in the model control group, and 10 mice in the drug administration group. Among them, the mice in the drug administration group were intragastrically administered with Example 1; the administration dose was 0.4 ml·20 g -1 ·d -1 , and the administration was continued for 13 days. The normal group and the model control group were given an equal amount of drinking water.

[0073] Among them, the mice in the model control group and the drug administration group were respectively subcutaneously injected with APH-normal saline solution on the 7th and 10th days of the experiment. The dose on the 7th day was 20 mg·kg -1 , and the dose on the 10th day was 10 mg·kg -1 . On the 10th, 11th, 12th, and 13th days, they were intraperitoneally injected with CTX-normal saline solution, and the dose each time was 20 mg·kg -1 ; among them, on the 10th day, they were first subcutaneously injected with APH-normal saline solution, and 2 hours later, they were intraperitoneally injected with CTX-normal saline solution.

[0074] The mice in each group were weighed every other day, and the body weight was recorded and a curve was plotted. All the mice in each group were bled from the fundus venous plexus 30 minutes after administering the drug or an equal amount of drinking water on the last day of the experimental period, and a peripheral blood routine test was performed (mainly including white blood cell count (WBC / 10 9 ·L -1 ), red blood cell count (RBC / 10 12 ·L-1 ), hemoglobin (HGB / g·L) -1 ), Hematocrit (HCT / %), Reticulocyte count (RTC / 10) 12 ·L -1 The mice were then euthanized by cervical dislocation, and the thymus and spleen were weighed. The TI (thymus index, TI) and SI (spleen index, SI) were calculated using the formulas: TI = thymus weight (mg) / mouse weight (g), SI = spleen weight (mg) / mouse weight (g). The femurs of the mice were also examined pathologically. (Experimental data were statistically analyzed using Descriptives in SPSS 16.0 software, and experimental results were presented using...) (This indicates that the comparison with the model group was performed using the Dunnett method in the software's analysis of variance); the changes in mouse body weight are as follows. Figure 1 As shown, the changes in the peripheral blood routine of mice are as follows: Figure 2 As shown, the changes in the thymus index and spleen index of mice are as follows: Figure 3 As shown, in the comparison between the normal group and the model control group, "*" indicates P < 0.05, and "**" indicates P < 0.01. In the comparison between the model control group and the drug-treated group, "#" indicates P < 0.05, and "##" indicates P < 0.01.

[0075] According to Experiment 1, the normal group mice showed a slow weight gain trend, the model group mice showed a slow weight gain trend before modeling, and a weight loss trend after modeling. The drug-treated group showed a rapid weight gain from day 1 to 7, and a slow weight gain after modeling. After modeling, WBC, RBC, HGB, HCT, and RTC all decreased significantly (P < 0.05, P < 0.01), indicating successful modeling. After drug administration, all indicators except WBC increased significantly (P < 0.05, P < 0.01), indicating that the composition prepared in Example 1 for treating qi and blood deficiency has a significant effect on erythroid cells. After modeling, the thymus index decreased significantly, while the spleen index increased significantly, indicating that acetylphenylhydrazine and cyclophosphamide can cause damage to the thymus and spleen, mainly manifested as thymic atrophy and splenomegaly (P < 0.05, P < 0.01), indicating successful modeling. Drug administration can significantly improve splenomegaly (P < 0.05).

[0076] The pathological morphology of bone marrow tissue in each group of mice was observed under a microscope, and the results are as follows: Figure 4-6 As shown, where Figure 4 This is a histopathological image of bone marrow tissue from normal mice. The bone marrow shows abundant, tightly packed hematopoietic cells distributed between sinus 3 and sinus 3, with normal ratios of the three cell lines. Nucleated cells and megakaryocytes (Type 1) are abundant in the bone marrow. Figure 5 This is a histopathological morphology image of bone marrow tissue from the model control group mice, compared with... Figure 4In contrast, most bone marrow tissue showed necrosis, edema, and sinusoidal dilation, with a significant decrease in the number of bone marrow cells, and the granulocytic lineage was dominated by intermediate and late myeloid granulocytes and segmented neutrophils. Figure 6 The image shows the histopathological morphology of bone marrow tissue from the treated mice, compared with... Figure 5 In contrast, the bone marrow tissue showed some repair, with minimal sinusoidal dilation. The number of nucleated cells and megakaryocytes 1 in the bone marrow significantly increased, and the ratio of the three cell lines remained roughly normal. Therefore, it can be concluded that this composition for treating qi and blood deficiency can effectively improve the hematopoietic function of mouse bone marrow.

[0077] Experimental Example 2

[0078] According to the inclusion criteria ((1) patients diagnosed with malignant tumors by pathology or histology and who are scheduled to undergo “paclitaxel + platinum” chemotherapy according to the “Handbook of Medical Oncology”; (2) patients aged 18 to 80 years with an expected survival of >3 months; (3) patients in good general condition with a Karnofsky Performance Status score ≥60; (4) patients with no obvious contraindications to chemotherapy and whose blood count and liver and kidney function were basically normal before chemotherapy) and the exclusion criteria ((1) patients with damage to the function of important organs such as liver, kidney, and blood system; (2) patients with a history of chemotherapy; (3) patients who received targeted therapy, immunotherapy or other treatments during chemotherapy; (4) patients whose tumors have metastasized to or invaded the bone marrow; (5) pregnant or lactating women; (6) patients with intellectual and mental disorders, language expression disorders, etc.; (7) patients who stopped taking the medication without authorization and had poor medication compliance), 60 volunteers who were hospitalized in the Department of Oncology of the First Affiliated Hospital of Soochow University from January 2018 to May 2020 were selected as research cases. The 60 participants were randomly divided into an experimental group and a control group. The experimental group consisted of 24 males and 6 females, with a mean age of 61.37 ± 9.27 years. The diseases included: esophageal cancer (12 cases), lung cancer (9 cases), ovarian cancer (5 cases), laryngeal cancer (2 cases), gastric cancer (1 case), and thymic carcinoma (1 case). The control group consisted of 19 males and 11 females, with a mean age of 63.57 ± 9.08 years. The diseases included: lung cancer (20 cases), ovarian cancer (9 cases), and esophageal cancer (1 case).

[0079] Dosage Regimen: Sixty volunteers underwent their first chemotherapy session with a regimen of paclitaxel combined with platinum-based chemotherapy (cisplatin / carboplatin / nedaplatin), administered at standard doses based on body weight and body surface area. The observation period was from the start of the first chemotherapy session to the next. The experimental group received oral administration of the composition for treating qi and blood deficiency prepared in Example 3, 20 mL twice daily with warm water, starting from the first day of chemotherapy. The control group received routine chemotherapy, taking the same amount of warm water twice daily. Relevant indicators were compared between the two groups before chemotherapy and from the end of the current chemotherapy cycle to the beginning of the next cycle to evaluate the clinical efficacy and safety of the composition for treating qi and blood deficiency prepared in Example 3 against chemotherapy-induced myelosuppression.

[0080] Incidence and severity of myelosuppression: Referring to the World Health Organization's grading criteria for acute and subacute adverse reactions to chemotherapy drugs (as shown in Table 1), blood routine tests were recorded for patients in the experimental and control groups before the start of this chemotherapy cycle. The time of the first occurrence of myelosuppression during this chemotherapy cycle, the percentage of patients experiencing myelosuppression within each group, and the severity of myelosuppression were observed. An intervention window was established; when a certain degree of myelosuppression occurred, symptomatic treatment to increase white blood cell count, platelet count, and hemoglobin was administered as needed, based on the patient's blood routine indicators and mental state. When symptoms such as fever or infection occurred, anti-infective treatment was administered as needed. The total amount of therapeutic drugs used in each group during this chemotherapy cycle was recorded.

[0081] Table 1. Grading Criteria for Myelosuppression

[0082]

[0083] Remedial medication: An intervention window is established, meaning that when a certain degree of bone marrow suppression occurs, appropriate doses of medications to increase white blood cells, platelets, and hemoglobin are administered as needed, based on the patient's blood routine indicators and mental state. When symptoms such as fever or infection occur, anti-infective treatment is administered as needed. The total amount of treatment drugs used in each group during this chemotherapy cycle is recorded.

[0084] Performance status assessment: The scores of patients in the experimental and control groups were recorded before the start of chemotherapy, referring to the Karnofsky Performance Status Scale (as shown in Table 2). The scores of the two groups at their worst point during chemotherapy were compared. Higher scores indicate better health and greater tolerance for treatment side effects, thus increasing the likelihood of receiving complete treatment. Lower scores indicate poorer health; scores below 60 indicate inability to undergo chemotherapy.

[0085] Table 2 Karl von Schereschewsky Functional Status Rating Criteria

[0086]

[0087] Traditional Chinese Medicine (TCM) syndrome scoring: Referring to the relevant content in the "Technical Guidelines for Clinical Research of New TCM Drugs Based on Syndrome Differentiation" (2018), and combining clinical practice, a self-formulated TCM syndrome scoring system was developed (as shown in Table 3). Scores were assigned based on the presence and severity of symptoms: 1 point for no symptoms, 2 points for mild symptoms, 3 points for moderate symptoms, and 4 points for severe symptoms. The scores of patients in the experimental and control groups before the start of this chemotherapy regimen were recorded, and the scores of the two groups at their worst condition during this chemotherapy regimen were compared.

[0088] Table 3 Traditional Chinese Medicine Syndrome Scoring Table

[0089]

[0090] Safety indicators: The incidence of liver and kidney damage and other adverse events after chemotherapy was compared between the two groups of patients using indicators such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), and creatinine, to evaluate the clinical safety of the traditional Chinese medicine composition.

[0091] Comparison of peripheral blood routine tests before chemotherapy: Before chemotherapy, there were no statistically significant differences in white blood cell, neutrophil, platelet and hemoglobin values ​​between the two groups of patients (P>0.05), and they were comparable. The results are shown in Table 4.

[0092] Table 4 Comparison of peripheral blood samples before chemotherapy between the two groups (x±S)

[0093]

[0094] Comparison of peripheral blood routine tests after chemotherapy: After chemotherapy, the white blood cell, neutrophil, platelet, and hemoglobin levels in the control group were all lower than before chemotherapy, with statistically significant differences (P < 0.05). In the experimental group, the white blood cell and neutrophil levels were also lower than before chemotherapy, with statistically significant differences (P < 0.05), while the platelet and hemoglobin levels showed no statistically significant difference compared to before chemotherapy. After chemotherapy, there were statistically significant differences in white blood cell and neutrophil levels between the experimental and control groups (P < 0.05), with the experimental group showing higher white blood cell and neutrophil levels than the control group. The results are shown in Table 5 (for intra-group comparisons before and after chemotherapy, "△" indicates p < 0.05, "△△" indicates p < 0.01; for inter-group comparisons after chemotherapy, "*" indicates p < 0.05).

[0095] Table 5 Comparison of peripheral blood after chemotherapy between the two groups of patients (x±S)

[0096]

[0097] Comparison of bone marrow suppression after chemotherapy: In the control group, 18 cases of bone marrow suppression occurred after chemotherapy, including 5 cases of grade I, 3 cases of grade II, 1 case of grade III, and 9 cases of grade IV, with an incidence rate of 60% and an average onset time of 7.3 days. In the experimental group, 11 cases of bone marrow suppression occurred, including 2 cases of grade I, 5 cases of grade II, 1 case of grade III, and 3 cases of grade IV, with an incidence rate of 37% and an average onset time of 10 days. The results are shown in Table 6.

[0098] Table 6. Comparative analysis of bone marrow suppression in the experimental and control groups after chemotherapy.

[0099]

[0100] Comparison of salvage therapy between the control and experimental groups: From the end of chemotherapy to the next chemotherapy session, 13 patients in the control group received leukocyte-stimulating drugs, and 1 patient received thrombopoietin-stimulating drugs. In the experimental group, 5 patients received leukocyte-stimulating drugs, and 1 patient received thrombopoietin-stimulating drugs. The number of patients receiving salvage therapy in the experimental group was significantly less than that in the control group, as shown in Table 7.

[0101] Table 7. Use of remedial medication in the control and experimental groups.

[0102]

[0103] Comparison of physical condition between the control and experimental groups: Before chemotherapy, the mean Karnofsky Performance Status (KPS) score of patients in the control group was 92.2, and that of the experimental group was 91.1. The specific score distribution is shown in Table 8. There was no significant difference between the two groups, making them comparable. After chemotherapy, the mean KPS score of patients in the control group was 75.2, and that of the experimental group was 83.1. The experimental group's score was significantly higher than that of the control group. The specific score distribution is shown in Table 9.

[0104] Table 8 Comparison of KPS scores before chemotherapy in the two groups of patients

[0105] Group Total number of cases 90-100 80-89 70-79 60-69 50-59 40-49 average value control group 30 20 10 0 0 0 0 92.2+4.0 experimental group 30 21 9 0 0 0 0 91.1±6.0

[0106] Table 9 Comparison of KPS scores after chemotherapy in the two groups of patients

[0107] Group Total number of cases 90-100 80-89 70-79 60-69 50-59 40-49 average value control group 30 8 9 2 1 7 3 <![CDATA[75.2±17.7 ΔΔ ]]> experimental group 30 19 2 2 4 2 1 <![CDATA[83.1±14.7 Δ ]]>

[0108] Comparison of TCM syndrome scores between the control and experimental groups: Before chemotherapy, there were no significant differences in the scores of "fatigue," "poor appetite," "dizziness and palpitations," "nausea and vomiting," and "spontaneous sweating and night sweats" between the experimental and control groups, making them comparable, as shown in Table 10. After chemotherapy, the scores of all aspects in both the experimental and control groups were higher than before chemotherapy, and the scores of all aspects in the experimental group were slightly lower than those in the control group. Among them, the score of "spontaneous sweating and night sweats" in the experimental group was significantly lower than that in the control group, with a significant difference (P < 0.05), as shown in Table 11.

[0109] Table 10 Comparison of TCM syndrome scores before chemotherapy in the two groups of patients

[0110] Group Total number of cases Feeling tired and weak Poor appetite Dizziness and palpitations nausea and vomiting spontaneous sweating and night sweats control group 30 1.13±0.35 1.10±0.31 1.0±0.0 1.03±0.18 1.07±0.25 experimental group 30 1.10±0.31 1.07±0.25 1.03±0.18 1.0±0.0 1.10±0.31

[0111] Table 11 Comparison of TCM syndrome scores after chemotherapy in the two groups of patients

[0112] Group Total number of cases Feeling tired and weak Poor appetite Dizziness and palpitations nausea and vomiting spontaneous sweating and night sweats control group 30 <![CDATA[2.37±1.19 ΔΔ ]]> <![CDATA[2.17±1.12 ΔΔ ]]> <![CDATA[2.13±1.04 ΔΔ ]]> <![CDATA[1.47±0.57 ΔΔ ]]> <![CDATA[1.73±0.78 ΔΔ ]]> experimental group 30 <![CDATA[1.9±0.88 ΔΔ ]]> <![CDATA[1.73±0.87 ΔΔ ]]> <![CDATA[1.7±0.88 ΔΔ ]]> <![CDATA[1.3±0.60 Δ ]]> <![CDATA[1.37±0.56 Δ* ]]>

[0113] Comparison of liver and kidney function between the control and experimental groups: Before chemotherapy, the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), urea, and creatinine in the experimental group were all normal and showed no significant difference from those in the control group, making them comparable, as shown in Table 12. After chemotherapy, the values ​​of various indicators in both the experimental and control groups changed slightly compared with those before chemotherapy, but there were no significant differences between the two groups, as shown in Table 13.

[0114] Table 12 Comparison of liver and kidney function before chemotherapy in the two groups of patients

[0115] Group Total number of cases Alanine aminotransferase AST urea Creatinine control group 30 28.9±26.92 26.08±15.28 5.48±1.85 62.19±12.65 experimental group 30 25.78±16.44 22.76±13.06 5.31±1.22 66.2±13.91

[0116] Table 13 Comparison of liver and kidney function after chemotherapy in the two groups of patients

[0117] Group Total number of cases Alanine aminotransferase AST urea Creatinine control group 30 32.62±22.28 29.59±1.53 5.37±10.3 62.08±17.69 experimental group 30 42.32±51.98 29.49±22.2 5.62±1.6 66.21±15.06

[0118] Based on the results of Example 2, the composition for treating qi and blood deficiency prepared in Example 3 can effectively alleviate the decrease in blood counts caused by chemotherapy in cancer patients, reduce the incidence of bone marrow suppression during chemotherapy, and delay the onset of bone marrow suppression. It also has a strong effect on alleviating chemotherapy-induced leukopenia and neutropenia. Furthermore, the composition for treating qi and blood deficiency prepared in Example 3 can also alleviate the aggravation of TCM syndromes caused by chemotherapy, especially for spontaneous sweating and night sweats. In addition, no significant liver or kidney damage toxicity was observed in this TCM composition.

[0119] In summary, the composition for treating qi and blood deficiency provided in this embodiment of the invention uses a variety of blood-tonifying and qi-boosting medicinal materials. Furthermore, the cold and warm properties of the medicinal materials are balanced and restrained according to a certain ratio, achieving a yin-yang balance. In addition, the various medicinal materials are combined according to a reasonable principal-assistant-adjuvant relationship. Therefore, the composition for treating qi and blood deficiency provided by this invention has a good therapeutic effect on treating symptoms of anemia such as aplastic anemia, which causes qi and blood deficiency. Moreover, this composition for treating qi and blood deficiency can also clear heat and dry dampness, nourish yin and tonify yang, strengthen the stomach and promote digestion, and astringe essence and stop seminal emission, thus regulating the body's condition from multiple aspects.

[0120] The principal ingredients include Astragalus membranaceus, deer antler glue, and tortoise shell glue. Astragalus membranaceus, primarily using its root, is sweet and slightly warm in nature, entering the spleen and lung meridians. It replenishes qi and blood, and its sweet and warm properties benefit the spleen, treating symptoms such as qi deficiency and fatigue. Deer antler glue, made from deer antler with rock sugar, rice wine, and soybean oil, has a faint aroma and a slightly sweet taste. It warms the liver and kidneys, replenishes essence and nourishes blood, treating symptoms such as blood deficiency dizziness and general weakness. Tortoise shell glue, made from tortoise shell with rice wine and other excipients, has a slightly fishy aroma and a bland taste. It nourishes yin and blood, treating symptoms such as yin deficiency fever and blood deficiency with chlorosis. These three herbs, combined in appropriate proportions, promote qi circulation, replenish kidney essence, and nourish liver blood, achieving both innate and acquired benefits, and harmonizing qi, blood, yin, and yang. Their combined effects complement each other, making them the principal ingredients.

[0121] The main ingredients include Codonopsis pilosula, stir-fried Atractylodes macrocephala, and Angelica sinensis. Codonopsis pilosula is mainly used from its dried root. It is sweet and neutral in nature, and can replenish qi and blood, and promote the production of body fluids. It is mainly used to treat symptoms such as fatigue and weakness and deficiency of both qi and blood. Atractylodes macrocephala is a perennial herb of the Asteraceae family. It is sweet and warm in nature, and can replenish qi and strengthen the spleen, and dry dampness and promote diuresis. It is mainly used to treat symptoms such as weakness of the spleen and stomach and loss of appetite. Angelica sinensis is a plant of the Apiaceae family. Its root is used to treat symptoms such as deficiency of blood and fever, and excessive blood loss. It is slightly sweet and warm in nature, and can replenish qi and blood, and promote blood circulation and moisten the intestines. It is mainly used to treat symptoms such as deficiency of blood and fever, and excessive blood loss. The combination of these three herbs with Astragalus membranaceus further enhances the effect of replenishing blood and qi. The combination of Angelica sinensis and Astragalus membranaceus is known as the Angelica sinensis blood-replenishing decoction. When combined with tortoise shell glue and deer antler glue, it can further enhance the effect of nourishing essence and blood. Moreover, Angelica sinensis can promote blood circulation while replenishing blood, so that blood can be replenished without stagnation.

[0122] The auxiliary herbs include wolfberry, privet fruit (processed with wine), salvia miltiorrhiza, chicken blood vine, stir-fried chicken gizzard lining, stir-fried malt, epimedium, agrimony, coptis chinensis, rehmannia glutinosa, and notoginseng powder. Wolfberry, the mature fruit of the wolfberry plant, is sweet and neutral in nature, nourishing the liver and kidneys, and benefiting essence and eyesight; it is mainly used to treat symptoms such as deficiency of essence and blood and insufficiency of the liver and kidneys. Privet fruit (processed with wine) is mainly the mature fruit of the privet plant; it is sweet and bitter, and neutral in nature, nourishing yin and prolonging life, and benefiting the liver and kidneys; it is mainly used to treat symptoms such as dizziness and vertigo caused by deficiency of qi and blood. Salvia miltiorrhiza mainly uses its root and stem; it is bitter and slightly cold in nature, invigorating qi and promoting blood circulation; it is mainly used to treat symptoms such as chest pain, heart pain, and insomnia. Chicken blood vine mainly uses its stem; it is bitter and sweet, and warm in nature, invigorating blood and replenishing blood; it is mainly used to treat symptoms such as blood deficiency and chlorosis. Stir-fried chicken gizzard lining is made by stir-frying fresh chicken gizzard lining; it is sweet and neutral in nature, invigorating the stomach and promoting digestion, and astringing essence and stopping seminal emission. It is used to treat symptoms such as indigestion, enuresis, and seminal emission; stir-fried malt is made by stir-frying malt, which can promote qi circulation, aid digestion, and strengthen the spleen and stomach, and is used to treat symptoms such as indigestion and poor appetite due to spleen deficiency; Epimedium mainly uses its leaves as medicine, which is pungent and sweet in taste and warm in nature, and can tonify kidney yang, and is used to treat symptoms such as kidney yang deficiency; Agrimonia pilosa mainly uses its stems and leaves as medicine, which is bitter and astringent in taste and neutral in nature, and can stop bleeding and tonify deficiency, and is used to treat symptoms such as metrorrhagia and menorrhagia; Coptis chinensis mainly uses its dried rhizome as medicine, which is bitter in taste and cold in nature, and can clear heat and dry dampness, and is used to treat symptoms such as hematemesis and epistaxis due to blood heat; Rehmannia glutinosa mainly uses its dried tuberous root as medicine, which is sweet in taste and slightly warm in nature, and can nourish blood and yin and replenish essence and marrow, and is used to treat symptoms such as blood deficiency and chlorosis and liver and kidney yin deficiency; Panax notoginseng mainly uses its dried root as medicine, which is sweet and slightly bitter in taste and warm in nature, and can resolve blood stasis, stop bleeding, promote blood circulation, and relieve pain, and is used to treat symptoms such as traumatic bleeding and hematochezia. Goji berries and privet fruit, in combination with tortoise shell glue, deer antler glue, and angelica, nourish the liver and kidneys, replenishing essence and blood. Epimedium combined with deer antler glue warms the kidneys and strengthens yang. When combined with other yin-nourishing and blood-tonifying herbs in the adjuvant formula, it achieves a yin-nourishing effect within yang. Coptis chinensis, being cold in nature, harmonizes the properties of the warming herbs and has a synergistic hemostatic effect. Furthermore, this combination for treating qi and blood deficiency significantly improves erythroid cells, strengthens the body's hematopoietic function and blood transport function; and it also has a significant therapeutic effect on splenomegaly.

[0123] The present invention also provides a method for preparing a composition for treating qi and blood deficiency. The method for preparing the composition for treating qi and blood deficiency adopts the steps of decoction, concentration and paste formation, which can reduce the volume of the composition for treating qi and blood deficiency, making it convenient to take, and improving the medicinal properties of the composition. Moreover, the preparation method is simple to operate, easy to learn and convenient for operators to operate.

[0124] The embodiments described above are some, but not all, embodiments of the present invention. The detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a drug for treating complications caused by radiotherapy and chemotherapy for tumors, characterized in that, The traditional Chinese medicine composition is mainly prepared from the following raw materials in parts by weight: Astragalus membranaceus 75-85 parts, Salvia miltiorrhiza 25-35 parts, Codonopsis pilosula 55-65 parts, Lycium barbarum 40-50 parts, Agrimonia pilosa 85-95 parts, Spatholobus suberectus 85-95 parts, Rehmannia glutinosa 45-55 parts, stir-fried malt 25-35 parts, stir-fried Atractylodes macrocephala 35-45 parts, Angelica sinensis 55-65 parts, stir-fried chicken gizzard lining 15-25 parts, wine-processed Ligustrum lucidum 40-50 parts, Epimedium brevicornu 15-25 parts, Coptis chinensis 10-20 parts, deer antler glue 25-35 parts, tortoise shell glue 25-35 parts, and Panax notoginseng powder 5-15 parts.

2. The application according to claim 1, characterized in that, The traditional Chinese medicine composition is mainly prepared from the following raw materials in parts by weight: 80 parts Astragalus membranaceus, 30 parts Salvia miltiorrhiza, 60 parts Codonopsis pilosula, 45 parts Lycium barbarum, 90 parts Agrimonia pilosa, 90 parts Spatholobus suberectus, 50 parts Rehmannia glutinosa, 30 parts stir-fried malt, 40 parts stir-fried Atractylodes macrocephala, 60 parts Angelica sinensis, 20 parts stir-fried chicken gizzard lining, 45 parts Ligustrum lucidum (processed with wine), 20 parts Epimedium brevicornu, 15 parts Coptis chinensis, 30 parts deer antler glue, 30 parts tortoise shell glue, and 10 parts Panax notoginseng powder.

3. The application according to claim 1 or 2, characterized in that, The complications mentioned are bone marrow suppression after radiotherapy and chemotherapy for tumors, and recovery of blood counts after radiotherapy and chemotherapy.

4. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for treating anemia-related diseases.

5. The application according to claim 4, characterized in that, The anemia-related diseases mentioned are aplastic anemia and hemolytic anemia.

6. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for treating thrombocytopenia.

7. The application according to claim 6, characterized in that, The blood cell reduction disorders mentioned are thrombocytopenia and leukopenia.

8. A method for preparing a traditional Chinese medicine composition as described in claim 1 or 2, characterized in that, The process includes the following steps: soaking the remaining ingredients (excluding Panax notoginseng powder, deer antler glue, and tortoise shell glue) in water and then decocting them to obtain a decoction; concentrating the decoction to obtain a concentrated liquid; and then adding Panax notoginseng powder, tortoise shell glue, and deer antler glue to the concentrated liquid to form a paste, thus obtaining the composition for treating qi and blood deficiency.

9. The preparation method according to claim 8, characterized in that, Before being added to the concentrated liquid, the tortoise shell glue and deer antler glue underwent a processing treatment, which involved using a sand-scalding method to process the tortoise shell glue and deer antler glue until they became crispy.

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