Traditional Chinese medicine composition for treating cancerous anorexia and pharmaceutical preparation

Abstract

In order to overcome the defects in the prior art, the invention provides a traditional Chinese medicine composition for treating cancerous anorexia, which is prepared from the following components in percentage by mass: 10 to 15 percent of poria cocos, 5 to 10 percent of codonopsis pilosula, 5 to 10 percent of radix glehniae, 5 to 10 percent of radix pseudostellariae, 5 to 10 percent of roasted astragalus membranaceus, 5 to 10 percent of roasted malt, 5 to 10 percent of roasted endothelium corneum gigeriae galli, 5 to 10 percent of potentilla discolor and 4 to 7 percent of roasted rhizoma atractylodis macrocephalae. The traditional Chinese medicine composition is prepared from the following raw materials in percentage by weight: 4-7% of radix bupleuri, 4-7% of elsholtzia rugulosa, 2-5% of American ginseng, 2-5% of hawthorn, 2-5% of ligusticum wallichii, 2-5% of angelica sinensis, 1-3% of sun-dried ginseng and 1-3% of liquorice. The invention also discloses a pharmaceutical preparation prepared from the traditional Chinese medicine composition for treating cancerous anorexia. The traditional Chinese medicine composition is guided by basic theories of Yi medicine, comprehensively intervenes and treats cancerous anorexia by ascending lucidity and descending turbidity, strengthening spleen and stomach, benefiting qi and nourishing blood, strengthening body resistance and regulating body and regulating yin and yang balance of human body, is definite in clinical curative effect, free of obvious toxic and side effects and good in patient adaptability, and can be used for cancerous anorexia patients caused by various reasons for a long time.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition and a pharmaceutical preparation for treating cancer-related anorexia. Background Art

[0002] Cancer-related anorexia (CACS) is a condition characterized by decreased or even loss of appetite, with or without weight loss, associated with cancer or anticancer treatment. The incidence rate exceeds 40% in newly diagnosed cancer patients and reaches 80% in advanced patients. CACS can persist throughout the cancer disease course and is easily overlooked. Among patients with advanced cancer, CACS is the fourth most common symptom, second only to fatigue, pain, and weakness.

[0003] Treatment for cancer-related anorexia primarily involves psychological and nutritional support, as well as medication. Regarding medication, Western medicine currently focuses on improving patients' quality of life through appetite stimulants. These can, to a certain extent, increase food intake and alleviate clinical symptoms in patients with cancer-related anorexia, thereby prolonging survival and slowing the progression of the disease. Megestrol acetate and glucocorticoids are the most commonly used medications to stimulate appetite in cancer patients. Additionally, glucocorticoids such as dexamethasone, antidepressants such as metoclopramide and olanzapine, anamorelin, and cannabis preparations also have some efficacy in improving cancer-related anorexia. However, long-term use can lead to a high incidence of adverse reactions, making them intolerant to treatment. Side effects of hormones such as megestrol acetate and dexamethasone include edema, thrombosis, gastrointestinal ulcers, infection, and osteoporosis. Severe adverse reactions can offset the benefits of increased appetite, preventing patients from benefiting. Summary of the Invention

[0004] In order to solve the deficiencies in the prior art, the present invention provides a traditional Chinese medicine composition for treating cancer-related anorexia, which comprises, by mass percentage, 10-15% of Poria cocos, 5-10% of Codonopsis pilosula, 5-10% of Glehnia littoralis, 5-10% of Pseudostellaria pseudoginseng, 5-10% of roasted Astragalus membranaceus, 5-10% of stir-fried malt, 5-10% of stir-fried Gallus gallus domesticus, 5-10% of Psoralea corylifolia, 4-7% of stir-fried Atractylodes macrocephala, 4-7% of Bupleurum chinense, 4-7% of Wild Bamboo shoots, 2-5% of American ginseng, 2-5% of Crataegus pinnatifida, 2-5% of Chuanxiong rhizome, 2-5% of Chinese angelica sinensis, 1-3% of raw sun-dried ginseng, and 1-3% of liquorice.

[0005] Furthermore, in terms of mass percentage, it includes: 12% of Poria cocos, 8% of Codonopsis pilosula, 10% of Adenophora adenophora, 10% of Pseudostellaria baicalensis, 5% of roasted Astragalus membranaceus, 8% of stir-fried malt, 6% of stir-fried Chicken Gizzard Stone, 7% of Psoralea corylifolia, 5% of stir-fried Atractylodes macrocephala, 5% of Bupleurum chinense, 5% of Wild Bazi, 4% of American ginseng, 5% of Crataegus pinnatifida, 3% of Ligusticum chuanxiong, 4% of Angelica sinensis, 2% of raw sun-dried ginseng, and 1% of Licorice.

[0006] The present invention also provides a pharmaceutical preparation, specifically comprising: directly decocting the aforementioned Chinese herbal composition for treating cancer-related anorexia to obtain a decoction liquid preparation. Alternatively, the aforementioned Chinese herbal composition for treating cancer-related anorexia may be added or not added with a pharmaceutically acceptable carrier and prepared into other pharmaceutical preparations according to conventional preparation methods.

[0007] Furthermore, the pharmaceutical preparation is one of tablets, capsules, powders, mixtures, pills, granules, oral liquids, and syrups.

[0008] Furthermore, the pharmaceutically acceptable carrier is selected from at least one of pharmaceutically acceptable solvents, solubilizers, cosolvents, emulsifiers, colorants, adhesives, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adhesives, integrators, penetration enhancers, pH regulators, buffers, plasticizers, surfactants, thickeners, packaging materials, humectants, absorbents, diluents, flocculants, deflocculants, filter aids, release retardants, polymer skeleton materials, and polymer film-forming materials.

[0009] Furthermore, the decoction is prepared by the following method:

[0010] Step 1: Crush the raw sun-dried ginseng and Pseudostellaria heterophylla to pass through a 10-mesh sieve to obtain crushed material.

[0011] Step 2: Mix the crushed material with the remaining medicinal materials, add cold water and soak for 25-45 minutes to obtain a soaking mixture.

[0012] Step 3: After adjusting the solid-liquid ratio of the soaking mixture to 1:7, the mixture is decocted for 1-2 hours and filtered to obtain filtrate A and the decoction.

[0013] Step 4: Add water to the decoction until the solid-liquid ratio reaches 1:5, decoct for 0.5-1.5 hours, and filter to obtain filtrate B.

[0014] Step 5: combining filtrate A and filtrate B to obtain the decoction liquid.

[0015] Furthermore, the decoction obtained in step 5 is concentrated to a relative density with water of 1.04±0.02 to obtain a concentrated medicinal solution, and the other pharmaceutical preparations are prepared based on the concentrated medicinal solution.

[0016] The beneficial effects of the present invention are as follows: the present invention is guided by the basic theories of Yi medicine, and the prescription comprehensively intervenes and treats cancer-related anorexia by raising the clear and lowering the turbid, strengthening the spleen and harmonizing the stomach, replenishing qi and nourishing blood, strengthening the body and regulating the yin and yang balance of the human body, has definite clinical efficacy, has no obvious toxic and side effects, has good patient adaptability, and can be used for a long time in patients with cancer-related anorexia caused by various reasons. DETAILED DESCRIPTION

[0017] The following examples are provided for a better understanding of the present invention and are not intended to limit the best mode of implementation. They do not limit the content and scope of protection of the present invention. Any product identical or similar to the present invention obtained by anyone under the guidance of the present invention or by combining the features of the present invention with other prior arts shall fall within the scope of protection of the present invention.

[0018] The present invention exemplarily provides a traditional Chinese medicine composition for treating cancer-related anorexia, which comprises, by mass percentage, 10-15% of Poria cocos, 5-10% of Codonopsis pilosula, 5-10% of Glehnia littoralis, 5-10% of Pseudostellaria baicalensis, 5-10% of roasted Astragalus membranaceus, 5-10% of stir-fried malt, 5-10% of stir-fried Gallus gallus domesticus, 5-10% of Psoralea corylifolia, 4-7% of stir-fried Atractylodes macrocephala, 4-7% of Bupleurum chinense, 4-7% of Wild Bamboo Shoots, 2-5% of American ginseng, 2-5% of Crataegus pinnatifida, 2-5% of Chuanxiong rhizome, 2-5% of Angelica sinensis, 1-3% of raw sun-dried ginseng, and 1-3% of Licorice root.

[0019] In the treatment of cancer-related anorexia nervosa (CACS), Western medicine currently primarily uses appetite stimulants to improve patients' quality of life. These can, to a certain extent, increase food intake and alleviate clinical symptoms, thereby prolonging survival and slowing disease progression. Megestrol acetate and glucocorticoids are the most commonly used medications to stimulate appetite in cancer patients. Studies have confirmed that megestrol acetate can effectively improve appetite and increase weight, with a positive correlation between dosage and efficacy. Additionally, glucocorticoids such as dexamethasone, antidepressants such as metoclopramide and olanzapine, anamorelin, and cannabis-based preparations also have some efficacy in improving CACS.

[0020] However, long-term use of these medications can lead to numerous adverse reactions, making them intolerant. Side effects of hormones like megestrol acetate and dexamethasone include edema, blood clots, gastrointestinal ulcers, infections, and osteoporosis. Severe side effects can offset the benefits of increased appetite. Other medications can also cause adverse reactions, including hyperglycemia and diabetes, gastrointestinal disorders, and mental disturbances such as drowsiness.

[0021] Yi medicine is an important component of ethnic medicine, accumulating rich experience in medication over thousands of years. Yi medicine is a system of medicine formed through the long-term use of medicine by the Yi people. Its core theories include the Three Qi Theory, the Two Qi and Six Paths Theory, and the Toxic and Evil Theory. Yi medicine considers the Two Qi and Six Paths Theory one of the core tenets of Yi medicine. Guided by Yi philosophy, this theory divides the body's clear and turbid qi into six pathways. These pathways connect the body's internal organs, limbs, and bones into a unified whole, circulating qi, blood, water, and food, in harmony with heaven and earth. If the body produces internal toxins, or external toxins are generated by external attacks of evil qi, or if seasonal imbalances between heaven and earth cause blockages in the six pathways, leading to organ dysfunction or abnormal sensations such as soreness, numbness, swelling, and pain in the skin, flesh, tendons, and bones, then the disease is treated by selecting medications or treatments corresponding to these pathways.

[0022] The Chinese medicine composition of the present invention is a prescription formulated with both traditional Chinese and Yi medicines under the guidance of the "Three Qi Theory" of Yi medicine. The "Three Qi Theory" (primordial qi, clear qi, and turbid qi) is one of the important theories of Yi medicine. Yi medicine believes that the physiological functions of the human body are maintained through the interaction of primordial qi, clear qi, and turbid qi through the function of qi transformation. Cancer-related anorexia is primarily a condition caused by damage to primordial qi and / or deficiency of clear qi, which develops in cancer patients after contracting cancer or undergoing anti-tumor treatment. Considering the etiology and pathogenesis, the prescription uses roasted Astragalus membranaceus, American ginseng, and raw sun-dried ginseng to replenish primordial qi. Codonopsis pilosula, Pseudostellaria pseudoginseng, and Adenophora australis to raise the clear qi of the spleen and stomach. These two groups of herbs are monarch herbs. Poria cocos and stir-fried Atractylodes macrocephala are spleen-tonifying and turbidity-clearing herbs. Stir-fried malt, stir-fried chicken's gizzard lining, radix scutellariae, hawthorn, and wild basil are spleen-tonifying and digestion-promoting herbs, supporting the clear qi of the spleen and stomach. These two groups of herbs are assistant herbs. Chuanxiong and Chinese angelica are guiding herbs, nourishing blood to nourish the clear qi. Licorice and Bupleurum are used as adjuvants to regulate the other medicines. Therefore, the Chinese medicine composition of the present invention is a prescription for replenishing vital energy, raising clear energy and regulating the spleen and stomach.

[0023] The present invention illustratively provides a pharmaceutical preparation, specifically comprising: directly decocting the aforementioned traditional Chinese medicine composition for treating cancer-related anorexia to obtain a decoction liquid preparation. Alternatively, the aforementioned traditional Chinese medicine composition for treating cancer-related anorexia may be added or not added with a pharmaceutically acceptable carrier and prepared into other pharmaceutical preparations according to conventional preparation methods.

[0024] The present invention illustratively provides a pharmaceutical preparation that is one of tablets, capsules, powders, mixtures, pills, granules, oral liquids, and syrups.

[0025] The present invention illustratively provides a pharmaceutically acceptable carrier, which is selected from at least one of pharmaceutically acceptable solvents, solubilizers, cosolvents, emulsifiers, colorants, adhesives, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adhesives, integrities, penetration enhancers, pH regulators, buffers, plasticizers, surfactants, thickeners, encapsulating agents, humectants, absorbents, diluents, flocculants, deflocculants, filter aids, release retardants, polymer skeleton materials, and polymer film-forming materials.

[0026] The traditional Chinese medicine composition for treating cancer-related anorexia of the present invention can be prepared into a preparation that is convenient for patients to take by the above method.

[0027] The present invention illustratively provides a decoction liquid, which is prepared by the following method:

[0028] Step 1: Crush the raw sun-dried ginseng and Pseudostellaria heterophylla to pass through a 10-mesh sieve to obtain crushed material.

[0029] Step 2: Mix the crushed material with the remaining medicinal materials, add cold water and soak for 25-45 minutes to obtain a soaking mixture.

[0030] Step 3: After adjusting the solid-liquid ratio of the soaking mixture to 1:7, the mixture is decocted for 1-2 hours and filtered to obtain filtrate A and the decoction.

[0031] Step 4: Add water to the decoction until the solid-liquid ratio reaches 1:5, decoct for 0.5-1.5 hours, and filter to obtain filtrate B.

[0032] Step 5: combining filtrate A and filtrate B to obtain the decoction liquid.

[0033] By adopting this method, the effective ingredients in the traditional Chinese medicine composition can be decocted into the medicinal liquid, thereby facilitating patients to take the decocted medicine with better effectiveness.

[0034] The present invention illustratively provides another pharmaceutical preparation, specifically comprising: concentrating the decoction obtained in step 5 to a relative density with water of 1.04±0.02 to obtain a concentrated medicinal solution. The concentrated medicinal solution is used as a basis for preparing the other pharmaceutical preparation.

[0035] By decoction, the active ingredients of the drug are reduced to a liquid form, which is then concentrated. This allows for convenient processing of the concentrated liquid into other formulations as needed. For example, granules require only freeze-drying or spray-drying the concentrated liquid. Oral solutions require only the addition of pharmaceutically acceptable carriers, such as preservatives, flavoring agents, and suspending agents, to the concentrated liquid form, mixing thoroughly, and then adjusting to the desired concentration.

[0036] The present invention will be further described below with reference to specific embodiments.

[0037] Example 1

[0038] A traditional Chinese medicine composition for treating cancer-related anorexia comprises, by mass percentage, 12% of Poria cocos, 8% of Codonopsis pilosula, 10% of Glehnia littoralis, 10% of Radix Pseudostellariae, 5% of roasted Astragalus membranaceus, 8% of stir-fried malt, 6% of stir-fried Gallus gallus domesticus, 7% of Radix Polygoni Multiflori, 5% of stir-fried Atractylodes macrocephala, 5% of Bupleurum chinense, 5% of Radix yeloceae, 4% of American ginseng, 5% of Crataegus pinnatifida, 3% of Ligusticum chuanxiong, 4% of Radix Angelicae sinensis, 2% of raw sun-dried ginseng, and 1% of Licorice root.

[0039] The Chinese medicine composition for treating cancer-related anorexia is prepared into a decoction liquid by the following method and then used:

[0040] Step 1: Crush the raw sun-dried ginseng and Pseudostellaria heterophylla to pass through a 10-mesh sieve to obtain crushed material.

[0041] Step 2: Mix the crushed material with the remaining medicinal materials, add cold water and soak for 25-45 minutes to obtain a soaking mixture.

[0042] Step 3: After adjusting the solid-liquid ratio of the soaking mixture to 1:7, the mixture is decocted for 1-2 hours and filtered to obtain filtrate A and the decoction.

[0043] Step 4: Add water to the decoction until the solid-liquid ratio reaches 1:5, decoct for 0.5-1.5 hours, and filter to obtain filtrate B.

[0044] Step 5: combining filtrate A and filtrate B to obtain the decoction liquid.

[0045] 1. Treatment group and control group settings, including:

[0046] The control group received conventional anticancer treatment, during which time they took megestrol acetate and glucocorticoids to treat CACS.

[0047] Treatment regimen for the treatment group: Based on the control group, the patients were given the decoction of Example 1 of the present invention, 1 dose per day, divided into 3 doses, to treat CACS.

[0048] 2. Patient classification:

[0049] A total of 82 patients were randomly divided into a treatment group and a control group. The changes in serum leptin, orexin A, and appetite CACSSQ scores before and after treatment were observed to evaluate the therapeutic effect.

[0050] 3. Clinical trial data:

[0051] The present invention mainly examines the following indicators to characterize the therapeutic effects of the Chinese medicine composition of the present invention.

[0052] (1) Comparison of serum leptin and orexin

[0053] When the patient's serum leptin decreases and serum orexin A increases after treatment, it means that the patient's CACS is relieved.

[0054] (2) Comparison of appetite scores

[0055] The present invention scores the appetite of patients in the treatment group and the control group based on the CASQ scale. The scale contains 12 items, each of which has five options ae, with scores of 1-5 respectively. The lower the score, the worse the appetite.

[0056] 4. The present invention determines the therapeutic effect of the patient based on the appetite score results combined with the clinical symptoms and signs of traditional Chinese medicine, wherein:

[0057] Clinical recovery: TCM clinical symptoms and signs disappear or basically disappear, and appetite score increases by ≥95%;

[0058] Markedly effective: Clinical symptoms and signs of TCM are significantly improved, with points increased by ≥70%.

[0059] Effective: TCM clinical symptoms and signs have improved, and the score has increased by ≥30%

[0060] Ineffective: There is no significant improvement in TCM clinical symptoms and signs, or they may even worsen, and the score increases by less than 30%.

[0061] Calculation method: Appetite score increase = [(post-treatment score - pre-treatment score) ÷ pre-treatment score] × 100%.

[0062] 5. Result analysis:

[0063] Table 1. Clinical trial data of treatment groups

[0064]

[0065]

[0066] Table 2. Clinical trial data of control group

[0067]

[0068]

[0069] The above clinical trial results show that:

[0070] (1) Comparative analysis of serum leptin and orexin:

[0071] The changes in serum leptin levels in the treatment group and the control group were compared, as shown in Table 3:

[0072] Table 3. Comparison of serum leptin levels between the treatment group and the control group

[0073]

[0074] The changes in serum orexin A between the treatment group and the control group were compared, as shown in Table 4:

[0075] Table 4. Comparison of serum orexin A between the treatment group and the control group

[0076]

[0077] It can be seen from Table 3 and Table 4 that:

[0078] In the treatment group, serum leptin decreased and serum orexin A increased before and after treatment, with the difference being statistically significant. In the control group, there was no statistically significant change in serum leptin before and after treatment, but serum orexin A increased after treatment, with the difference being statistically significant. A comparison of the differences in serum leptin and orexin A before and after treatment between the two groups was statistically significant, demonstrating that the treatment group was superior to the control group in lowering serum leptin and increasing serum orexin A.

[0079] (2) Comparison of appetite scores

[0080] In terms of appetite scores, there was no difference in the scores before treatment between the treatment group and the control group. After treatment, the scores of both groups increased, but the degree of increase in the treatment group was greater than that in the control group, and the difference was statistically significant. According to the appetite efficacy evaluation criteria, 1 case in the treatment group was clinically cured, 2 cases were significantly effective, and 15 cases were effective, with an overall effective rate of 48.65%. In the control group, there was no clinical cure, 1 case was significantly effective, 2 cases were effective, and the overall effective rate was 10%. It can be seen that the Chinese medicine composition of the present invention can significantly improve patients' CACS compared to the existing technology, with the overall effective rate increased from 10% in the existing technology to 48.65% in the present invention, and some patients achieved clinical cure.

[0081] In addition, after clinical observation, the patients in the treatment group did not experience any adverse reactions that were clearly related to the treatment with the Chinese medicine composition of the present invention, which proves that the Chinese medicine composition of the present invention has good safety in clinical treatment.

[0082] With the above-described preferred embodiments of the present invention as a guide, and with reference to the above description, relevant personnel are fully capable of making various changes and modifications without departing from the technical scope of this invention. The technical scope of this invention is not limited to the contents of the specification and must be determined according to the scope of the claims.

Claims

1. A Chinese medicine composition for treating cancer-related anorexia, characterized in that: Calculated by mass percentage, it includes: 10-15% of Poria cocos, 5-10% of Codonopsis pilosula, 5-10% of Adenophora acuta, 5-10% of Pseudostellaria heterophylla, 5-10% of roasted Astragalus membranaceus, 5-10% of stir-fried malt, 5-10% of stir-fried Chicken Gizzard Stone, 5-10% of Polygonum multiflorum leaf, 4-7% stir-fried Atractylodes macrocephala, 4-7% of Bupleurum chinense, 4-7% of Wild Basil, 2-5% of American ginseng, 2-5% of Crataegus pinnatifida, 2-5% of Ligusticum chuanxiong, 2-5% of Angelica sinensis, 1-3% of raw sun-dried ginseng, and 1-3% of Licorice.

2. The Chinese medicine composition for treating cancer-related anorexia according to claim 1, characterized in that: Calculated by mass percentage, it includes: 12% Poria cocos, 8% Codonopsis pilosula, 10% Adenophora adenophora, 10% Pseudostellaria heterophylla, 5% roasted Astragalus membranaceus, 8% stir-fried malt, 6% stir-fried Chicken gizzard lining, 7% Polygonum multiflorum leaf, 5% stir-fried Atractylodes macrocephala, 5% Bupleurum chinense, 5% Wild basil, 4% American ginseng, 5% Crataegus pinnatifida, 3% Ligusticum chuanxiong, 4% Angelica sinensis, 2% raw sun-dried ginseng, and 1% Licorice.

3. A pharmaceutical preparation, characterized in that The Chinese medicine composition for treating anorexia due to cancer as claimed in any one of claims 1 to 2 is directly decocted to obtain a decoction liquid preparation, or the Chinese medicine composition for treating anorexia due to cancer as claimed in any one of claims 1 to 2 is added with or without a pharmaceutically acceptable carrier and prepared into other pharmaceutical preparations according to conventional preparation preparation methods.

4. The pharmaceutical preparation according to claim 3, characterized in that: The pharmaceutical preparation is one of tablets, capsules, powders, mixtures, pills, granules, oral liquids and syrups.

5. The pharmaceutical preparation according to claim 3, characterized in that: The pharmaceutically acceptable carrier is selected from at least one of pharmaceutically acceptable solvents, solubilizers, cosolvents, emulsifiers, colorants, adhesives, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adhesives, integrities, penetration enhancers, pH regulators, buffers, plasticizers, surfactants, thickeners, inclusion bodies, humectants, absorbents, diluents, flocculants, deflocculating agents, filter aids, release retardants, polymer skeleton materials, and polymer film-forming materials.

6. The pharmaceutical preparation according to claim 3, characterized in that: The decoction liquid is prepared by the following method: Step 1: Crush the raw sun-dried ginseng and Radix Pseudostellariae Radix to pass through a 10-mesh sieve to obtain crushed products; Step 2: Mix the crushed material with the remaining medicinal materials and soak them in cold water for 25-45 minutes to obtain a soaking mixture; Step 3: adjusting the solid-liquid ratio of the soaking mixture to 1:7, boiling for 1-2 hours, and filtering to obtain filtrate A and decoction; Step 4: adding water to the decoction until the solid-liquid ratio is 1:5, boiling for 0.5-1.5 hours, and filtering to obtain filtrate B; Step 5: combining filtrate A and filtrate B to obtain the decoction solution.

7. The pharmaceutical preparation according to claim 6, characterized in that: The decoction obtained in step 5 is concentrated to a relative density with water of 1.04±0.02 to obtain a concentrated medicinal solution; and the other pharmaceutical preparations are prepared based on the concentrated medicinal solution.

Images