A traditional Chinese medicine formula for tumor chemotherapy and its preparation method

Abstract

This invention relates to a traditional Chinese medicine formula and its preparation method for increasing platelet count during tumor chemotherapy. The formula consists of the following ingredients: ginseng, prepared rehmannia root, atractylodes macrocephala, poria cocos, astragalus membranaceus, angelica sinensis, white peony root, prepared notoginseng, licorice root, deer blood, tortoise shell, agrimony, longan pulp, chicken blood vine, paper mulberry fruit, polygonatum sibiricum, rhodiola rosea, lithospermum erythrorhizon, and callicarpa japonica. This invention incorporates nourishing ingredients to replenish blood and essence without causing stagnation. The combined herbs warm and tonify the spleen and kidneys, nourish the liver, strengthen the spleen and lungs, calm the mind, regulate the five internal organs, nourish yin and subdue yang, benefit the kidneys and strengthen bones, and powerfully promote the recovery of bone marrow function, thereby increasing platelet count. After taking the medicine, patients experience a stable increase in platelet count, demonstrating a definite therapeutic effect. Patients' mental state, appetite, and physical condition recover rapidly, and the formula is highly acceptable to patients.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a traditional Chinese medicine formula and its preparation method for increasing platelet count during tumor chemotherapy. Background Technology

[0002] To date, chemotherapy remains one of the main methods for treating malignant tumors, and even the only treatment for some malignant tumors, playing a crucial role in the treatment of malignant tumors. During chemotherapy, while chemotherapy drugs kill tumor cells, they also have certain toxic side effects on the body's bone marrow cells, causing damage to normal hematopoietic stem cells and the hematopoietic microenvironment, thus leading to bone marrow suppression, with neutropenia and thrombocytopenia being the most pronounced. Patients are often forced to reduce the dosage, shorten the course of treatment, or terminate chemotherapy as a result. In severe cases, this can lead to infection, gastrointestinal bleeding, or even death. With the widespread use of granulocyte colony-stimulating factor (GCS), neutropenia has been effectively controlled. However, there is currently no satisfactory treatment for the significant thrombocytopenia caused by drugs such as carboplatin and gemcitabine. In addition to the poor overall survival rate and increased risk of bleeding, the harm caused by thrombocytopenia may also force doctors to reduce the chemotherapy dosage, change the chemotherapy regimen, postpone the chemotherapy plan, or even terminate chemotherapy, seriously affecting the efficacy of tumor treatment and the progress of chemotherapy, increasing medical costs, and reducing quality of life.

[0003] Currently, the main clinical treatments for thrombocytopenia include component blood transfusion, recombinant interleukin, and recombinant human thrombopoietin. However, these drugs are difficult to obtain, expensive, and their efficacy is often unsatisfactory. Therefore, finding a safe, convenient, and readily acceptable treatment method for increasing platelet count, with no significant toxic side effects and that is acceptable to patients both physically and financially, has become a critical clinical issue that urgently needs to be addressed.

[0004] In response, we conducted research from the perspective of Traditional Chinese Medicine (TCM). TCM theory holds that malignant tumors are fundamentally deficient in nature but excessive in manifestation. The internal cause of tumor development is a deficiency of vital energy (Qi), which is also an inevitable consequence of tumors, especially in patients with mid-to-late stage tumors. A large amount of vital energy is depleted by the cancer toxins, leading to deficiency due to cancer itself. Excessive or prolonged use of both Western and Chinese anti-cancer drugs further depletes Qi, blood, Yin, and Yang, resulting in a more pronounced decline in organ function. Deficiency of vital energy can lead to excess of pathogenic factors, which in turn further exacerbates the deficiency. Weakened vital energy reduces the body's ability to fight cancer, thus deepening the disease. Chemotherapy-related thrombocytopenia is indeed a "deficiency syndrome," often diagnosed as "deficiency of both spleen and kidney, and insufficiency of Qi and blood." If the spleen is deficient and unable to control blood, blood will not follow its normal course and will overflow from the vessels, resulting in subcutaneous or visceral bleeding. Asthenia is characterized by the decline of organ function, deficiency of Qi, blood, Yin, and Yang, which persists over time, manifesting as various chronic weakness symptoms. The main sites of damage in asthenia are the five internal organs, with the spleen and kidneys being particularly important. The spleen governs transformation and transportation, specifically the transformation of essential nutrients and fluids. The kidneys govern the storage of essence, water, and the intake of vital energy, serving as the foundation of postnatal health. The connection between the spleen and kidneys is primarily manifested in their mutually reinforcing relationship between prenatal and postnatal factors, as well as their shared use in fluid metabolism. The spleen transforms the essence of food and water into vital energy and blood, acting as the "wood" element of postnatal health; the kidneys store prenatal essence, the source of life. Prenatal essence and postnatal essence from food and water form the body's essence, vital energy, and blood, hence the saying "essence and blood share the same origin." Prenatal nourishment stimulates postnatal energy, while postnatal supplementation nurtures prenatal energy, resulting in a strong and robust spleen and kidneys, leading to overall health. Physiologically, prenatal and postnatal factors mutually nourish each other, playing a vital role in the transformation of vital energy and blood, warming the internal organs, and nourishing the whole body. Pathologically, prolonged spleen deficiency inevitably damages the kidneys, and kidney deficiency weakens the fire of the gate of life (mingmen), causing the spleen to lose its ability to warm the uterus, thus exacerbating spleen deficiency. Therefore, the TCM treatment for chemotherapy-related thrombocytopenia should adhere to the principles of strengthening the body's resistance, invigorating the spleen and stomach, replenishing qi and blood, stopping bleeding, and nourishing the liver and kidneys. In addition to following the principles of "eighteen incompatibilities," "nineteen ingredients," and the "principal, assistant, adjuvant, and guide" in TCM formulation, there are also some empirical formulas that have shown significant clinical efficacy.

[0005] Based on the pathological analysis of thrombocytopenia caused by chemotherapy for malignant tumors using traditional Chinese medicine, and through long-term clinical practice, we have proposed a traditional Chinese medicine formula that can increase platelet count during chemotherapy for malignant tumors. This aims to address the shortcomings of existing technologies in increasing platelet count and thus reduce the toxic side effects of chemotherapy. Summary of the Invention

[0006] To address the above problems, this invention provides a traditional Chinese medicine formula and its preparation method suitable for increasing platelet count during tumor chemotherapy.

[0007] The specific technical solution is: a traditional Chinese medicine formula suitable for increasing platelet count during tumor chemotherapy, the traditional Chinese medicine formula being composed of the following raw materials: ginseng, prepared rehmannia root, atractylodes macrocephala, poria cocos, astragalus membranaceus, angelica sinensis, white peony root, prepared notoginseng, licorice, deer blood, tortoise shell, agrimony, longan pulp, chicken blood vine, paper mulberry fruit, polygonatum sibiricum, rhodiola rosea, gromwell root, and purple pearl grass.

[0008] Furthermore, the traditional Chinese medicine formula consists of the following ingredients in parts by weight: ginseng 10g, prepared rehmannia root 20g, atractylodes macrocephala 15g, poria cocos 15g, astragalus membranaceus 20g, angelica sinensis 15g, white peony root 15g, prepared notoginseng 10g, licorice root 6g, deer blood 5g, tortoise shell 6g, agrimony 15g, longan pulp 15g, chicken blood vine 15g, paper mulberry fruit 15g, polygonatum sibiricum 15g, rhodiola rosea 15g, gromwell root 5g, and calla lily 10g.

[0009] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine formula for increasing platelet count in tumor chemotherapy, wherein the above-mentioned mass fractions of traditional Chinese medicine are weighed and made into granules.

[0010] The herbal formula of this invention contains detailed records of each herb in the Chinese Pharmacopoeia, the Chinese Dictionary, and the Chinese Herbal Medicine, and the pharmacological effects of each herb are as follows:

[0011] Ginseng: It is slightly warm in nature and has a sweet and slightly bitter taste. It has the effects of replenishing qi and consolidating the body, strengthening the spleen and benefiting the lungs, calming the mind and improving intelligence, nourishing blood and promoting body fluids. It is mainly used to treat serious illness, chronic illness, blood loss, and dehydration that lead to the depletion of vital energy.

[0012] Rehmannia glutinosa (Shu Di): It is slightly warm in nature and has the effects of nourishing yin and tonifying the kidneys, nourishing blood and replenishing deficiency. It is used to treat various diseases caused by blood deficiency and is a very commonly used blood-tonifying medicine.

[0013] Atractylodes macrocephala: It is warm in nature and bitter and sweet in taste. It has the effect of tonifying qi and strengthening the spleen, and is used to treat spleen and stomach qi deficiency syndrome.

[0014] Poria cocos: It is neutral in nature and sweet and bland in taste. It has the effects of strengthening the spleen and stomach, calming the mind and soothing the nerves, and enhancing immunity.

[0015] Astragalus: It is warm in nature and sweet in taste. It is the source of tonifying qi and raising yang, and nourishing blood. It is used to treat qi deficiency and blood deficiency, qi deficiency and blood loss, and qi deficiency and blood stasis. When combined with Angelica sinensis, it can tonify qi and nourish blood. When combined with ginseng, longan pulp and other ingredients, it can form Gui Pi Tang, which can treat hematochezia and metrorrhagia caused by spleen qi deficiency and loss of control.

[0016] Angelica sinensis: It is warm in nature and sweet and pungent in taste. It has a good effect of nourishing blood and promoting blood circulation. The polysaccharide contained in Angelica sinensis can increase white blood cells and reticulocytes, and has a significant promoting effect on the recovery of red blood cells and hemoglobin. It can enhance hematopoietic function and can be used to treat many diseases caused by blood deficiency.

[0017] White peony root: It is cool in nature and bitter and sour in taste. It has the effects of nourishing blood and regulating menstruation, soothing the liver and relieving pain. It can treat blood deficiency symptoms.

[0018] Roasted Panax notoginseng: This is the dried product of Panax notoginseng rhizome, which is roasted or steamed to turn it red. It has the effects of stopping bleeding, promoting blood circulation and removing blood stasis, dispelling wind and relieving pain, and tonifying the liver and kidneys. It can be used to treat various diseases such as traumatic bleeding, dysmenorrhea, and rheumatoid arthritis. In the past, it was mainly used externally for tissue damage.

[0019] Licorice: It is neutral in nature and sweet in taste. It has the effects of tonifying the spleen and replenishing qi, and harmonizing the properties of various medicines.

[0020] Deer blood: It tastes sweet and salty, and is warm in nature. It has the effect of greatly replenishing essence and blood and benefiting qi.

[0021] Tortoise shell: It has the effects of nourishing yin and suppressing yang, tonifying the kidneys and strengthening bones;

[0022] Agrimony: It is neutral in nature and bitter and astringent in taste. It has the effects of tonifying deficiency and strengthening the body, astringing and stopping bleeding. It is also a commonly used medicine in traditional Chinese medicine for treating tumors. It can be used to treat various tumors such as lung cancer, stomach cancer, liver cancer, and uterine cancer. Agrimony is different from chemotherapy drugs. It can not only kill cancer cells, but also promote the growth of normal cells instead of killing them.

[0023] Longan pulp: It is warm in nature and sweet in taste. It has the effects of tonifying the spleen, heart and lungs, nourishing blood and calming the mind. It belongs to the category of qi-tonifying medicine under the category of tonifying deficiency medicine.

[0024] Chicken blood vine: It is warm in nature and has a bitter and slightly sweet taste. It has the effects of nourishing blood, promoting blood circulation, and activating blood vessels. It can improve anemia and promote blood regeneration.

[0025] Paper mulberry fruit: slightly cold in nature, sweet in taste, can nourish the liver and kidneys, and make the liver essence and blood sufficient;

[0026] Polygonatum: neutral in nature, sweet in taste, replenishes qi and nourishes yin, strengthens the spleen and kidneys and nourishes blood;

[0027] Rhodiola rosea: It can improve the transformation rate of T-lymphocytes and enhance the activity of phagocytes, and can play a role in resisting microwave radiation, fighting tumors, and increasing the body's immunity.

[0028] Purple gromwell: It is cold in nature and sweet and salty in taste. It has the effect of clearing heat and detoxifying.

[0029] Purple Callicarpa: It is neutral in nature and has a pungent and bitter taste. It has the effect of clearing heat and detoxifying.

[0030] The efficacy principle of the traditional Chinese medicine formula of this invention is as follows: Ginseng in the formula tonifies the spleen and replenishes qi, while Rehmannia glutinosa greatly replenishes yin and blood, serving as the principal herbs. Atractylodes macrocephala and Poria cocos assist ginseng in tonifying the spleen and replenishing qi, and also dispel dampness; Astragalus membranaceus is added to tonify qi and strengthen the middle jiao; Angelica sinensis and Paeonia lactiflora assist Rehmannia glutinosa in replenishing blood and nourishing the heart and liver. Panax notoginseng (processed) is added to invigorate blood and replenish blood, treating anemia, ensuring the tonification is not stagnant. Licorice root is used as the guiding herb to replenish qi and harmonize the formula. Deer blood is sweet and salty in taste, and hot in nature; it can benefit essence and blood, replenish yang qi, and stop bleeding. Tortoise shell has the effects of nourishing yin and suppressing yang, tonifying the kidneys and strengthening bones, and nourishing blood and replenishing the heart. Longan pulp tonifies the heart and spleen, and nourishes blood and calms the mind. Agrimonia pilosa enters the heart, liver, and spleen meridians, and has the effects of astringing and stopping bleeding, and tonifying deficiency. Spatholobus suberectus is bitter and sweet in taste, and warm in nature. It enters the liver and kidney meridians, and functions to replenish blood, invigorate blood, and unblock the meridians. Polygonatum sibiricum (processed) tonifies the spleen and moistens the lungs, replenishes qi and nourishes yin, and generates fluids and quenches thirst. Paper mulberry fruit nourishes the kidneys, clears the liver, and improves eyesight. Rhodiola rosea replenishes and invigorates blood. The addition of blood-nourishing ingredients in the formula replenishes essence and blood without causing stagnation. The combined effects of these herbs warm and tonify the spleen and kidneys, nourish the kidneys and clear the liver, tonify the spleen and moisten the lungs, nourish the heart and calm the mind, regulate the five internal organs, nourish yin and subdue yang, benefit the kidneys and strengthen bones, powerfully promote the recovery of bone marrow function, and increase platelet count.

[0031] In particular, the prepared Panax notoginseng is usually used for external injuries, while Broussonetia papyrifera and Rhodiola rosea are usually used to tonify the liver and kidneys. Lithospermum erythrorhizon and Callicarpa japonica are usually used to clear heat and detoxify, and are rarely used in terms of nourishing blood. The addition of these herbs to this formula can synergize with other herbs in the formula to enhance the effect of increasing platelet count, which is beneficial to the patient's recovery.

[0032] The beneficial effects of this invention are as follows: The traditional Chinese medicine formula for increasing platelet count incorporates ingredients rich in blood and flesh, replenishing essence and blood without causing stagnation. The combined effects of these herbs warm and tonify the spleen and kidneys, nourish the liver, strengthen the lungs, calm the mind, regulate the five internal organs, nourish yin and subdue yang, benefit the kidneys and strengthen bones, and powerfully promote the recovery of bone marrow function, thus increasing platelet count. After taking this medicine, patients experience a stable increase in platelet count, demonstrating a definite therapeutic effect. Patients' spirit, appetite, and physical condition recover rapidly, resulting in high patient acceptance. Furthermore, this traditional Chinese medicine formula incorporates unique ethnic medicine from Yunnan, featuring a unique combination different from other platelet-increasing formulas. This addresses the shortcomings of existing technologies in increasing platelet count, reduces the toxic side effects of chemotherapy in cancer patients, improves long-term efficacy, and enhances the quality of life for patients. Attached Figure Description

[0033] Figure 1 This is a comparison chart of platelet counts before and after treatment with the platelet-boosting formula in the example. Detailed Implementation

[0034] To make the technical problems and solutions solved by the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely for explaining the present invention and are not intended to limit the present invention. Example

[0035] This embodiment provides a traditional Chinese medicine formula suitable for increasing platelet count during tumor chemotherapy, which consists of the following ingredients in parts by weight: ginseng 10g, prepared rehmannia root 20g, atractylodes macrocephala 15g, poria cocos 15g, astragalus membranaceus 20g, angelica sinensis 15g, white peony root 15g, prepared notoginseng 10g, licorice root 6g, deer blood 5g, tortoise shell 6g, agrimony 15g, longan pulp 15g, chicken blood vine 15g, paper mulberry fruit 15g, polygonatum sibiricum 15g, rhodiola rosea 15g, gromwell root 5g, and purple pearl grass 10g.

[0036] The preparation method and administration method of the traditional Chinese medicine formula described in this embodiment are as follows: Weigh the above-mentioned proportions of traditional Chinese medicine and make them into granules. Take one dose daily, three times a day.

[0037] Experimental verification:

[0038] To verify the clinical efficacy of the traditional Chinese medicine formula described in the examples, a comparative experiment was conducted. By comparing the platelet counts of 75 patients before and after treatment with the platelet-boosting formula, the results showed that the platelet counts of all 75 patients increased after treatment. After 5 days of medication, the platelet count increased from 124.69±90.52*10⁻⁶ before treatment. 9 / L (mean) rose to 183.52 ± 105.21 * 10 9 / L (mean), the difference was statistically significant, see Table 1 and Figure 1 .

[0039] Table 1: Patient General Information and Platelet Counts Before and After Treatment

[0040]

[0041] Typical Cases

[0042] Typical Case 1:

[0043] Patient Li, male, 69 years old, presented with a low platelet count after chemotherapy. His platelet count at the time of presentation was 30*10^6. 9 / L, after 7 days of medication, the platelet count rose to 198*10. 9 / L.

[0044] Typical Case 2:

[0045] Patient Li, male, 65 years old, with left lung cancer, presented with a low platelet count after chemotherapy. His platelet count at the time of consultation was 69*10^6. 9 / L, after 6 days of medication, the platelet count rose to 214*10. 9 / L.

[0046] Typical Case 3:

[0047] Patient Zhang, male, 71 years old, with right lung cancer, presented with a low platelet count after chemotherapy. At the time of consultation, his platelet count was 66*10^6. 9 / L, after 7 days of medication, the platelet count rose to 353*10. 9 / L.

[0048] Typical Case 4:

[0049] Patient Yang, female, 40 years old, ovarian cancer, presented with a low platelet count after chemotherapy. At the time of consultation, her platelet count was 76*10^6. 9 / L, after 6 days of medication, the platelet count had risen to 114*10. 9 / L.

[0050] Typical Case 5:

[0051] Patient Wang, female, 50 years old, with stomach cancer, presented to the hospital due to low platelet count after chemotherapy. At the time of consultation, her platelet count was 35*10^6. 9 / L, after 6 days of medication, the platelet count rose to 265*10. 9 / L.

[0052] Typical Case 6:

[0053] Patient Hong, female, 51 years old, breast cancer, presented to the hospital due to low platelet count after chemotherapy. At the time of consultation, her platelet count was 59*10^6. 9 / L, after 6 days of medication, the platelet count rose to 253*10. 9 / L.

[0054] Typical Case 7:

[0055] Patient Yang, male, 65 years old, esophageal cancer, presented with low platelet count after chemotherapy; his platelet count at the time of consultation was 49*10. 9 / L, after 7 days of medication, the platelet count increased to 109*10. 9 / L.

[0056] Typical Case 8:

[0057] Patient Li, female, 54 years old, ovarian cancer, presented with low platelet count after chemotherapy; her platelet count at the time of consultation was 50*10^6. 9 / L, after 6 days of medication, the platelet count had risen to 429*10. 9 / L.

[0058] Typical Case 9:

[0059] The patient, Ms. Liu, 72 years old, with lymphoma, presented with a low platelet count after chemotherapy. At the time of consultation, her platelet count was 69*10^6. 9 / L, after 6 days of medication, the platelet count rose to 199*10.9 / L.

[0060] Typical Case 10:

[0061] Patient Chen, male, 54 years old, with right lung cancer, presented with a low platelet count after chemotherapy. At the time of consultation, his platelet count was 29*10^6. 9 / L, after 7 days of medication, the platelet count rose to 109*10. 9 / L.

[0062] The present invention has been described in detail above through specific and preferred embodiments. However, those skilled in the art should understand that the present invention is not limited to the embodiments described above. Any modifications, equivalent substitutions, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine suitable for increasing platelet count during tumor chemotherapy, characterized in that, Made from the following ingredients in parts by weight: ginseng 10g, prepared rehmannia root 20g, atractylodes macrocephala 15g, poria cocos 15g, astragalus membranaceus 20g, angelica sinensis 15g, white peony root 15g, prepared notoginseng 10g, licorice root 6g, deer blood 5g, tortoise shell 6g, agrimony 15g, longan pulp 15g, chicken blood vine 15g, paper mulberry fruit 15g, polygonatum sibiricum 15g, rhodiola rosea 15g, gromwell root 5g, and callicarpa japonica 10g.

2. The preparation method of a traditional Chinese medicine suitable for increasing platelet count in tumor chemotherapy as described in claim 1, characterized in that, Weigh out the above-mentioned proportions of Chinese herbal raw materials and prepare them into granules.

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