A traditional Chinese medicine compound preparation for treating cancer and a preparation method and application thereof

Abstract

The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine compound preparation for treating cancer and a preparation method and application thereof. The application has high disease mechanism fitting degree: the compound is based on the core disease mechanism of the internal retention of damp-heat in colorectal cancer, and is combined with spleen-strengthening and heat-clearing and knot-removing, which is in line with the theory of diagnosis and treatment in traditional Chinese medicine. In addition, the antitumor activity of the compound is clear, and the safety is excellent: the compound can significantly inhibit the growth of colorectal tumors, and has no obvious toxicity to the main organs such as heart, liver, spleen, lung and kidney, and the drug safety window is wide. On this basis, the dosage form of the flavored Huangqin-Huopo composition is optimized, and in addition to the traditional decoction, a standardized granule preparation process is established. The granules and the traditional decoction have no significant difference in the antitumor effect and safety, the traditional decoction is retained, the problems of inconvenience of carrying and poor controllability of quality are solved, and the granules are more suitable for clinical promotion and industrial production.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine compound preparation for treating cancer, its preparation method, and its application. Background Technology

[0002] Colorectal cancer (CRC) is a malignant tumor of the digestive system with a high incidence and mortality rate worldwide. Currently, clinical interventions for CRC mainly include comprehensive approaches such as surgery, chemotherapy, radiotherapy, targeted therapy, and immunotherapy. Although these therapies have prolonged patient survival to some extent, their clinical application still faces many bottlenecks: the risk of recurrence and metastasis is significantly increased in patients with advanced stages after surgery; chemotherapy drugs easily induce multidrug resistance (MDR) and are often accompanied by severe systemic toxic side effects, seriously affecting patients' quality of life and treatment adherence. Therefore, finding safe, effective, and synergistically sensitizing and toxicity-reducing strategies for treating CRC has become an urgent clinical challenge in the field of oncology treatment.

[0003] In recent years, the value of Traditional Chinese Medicine (TCM) in the comprehensive treatment of cancer has received increasing attention. TCM theory classifies colorectal cancer under the categories of "intestinal masses," "accumulations," and "visceral toxins," with its pathogenesis rooted in spleen deficiency and manifested by internal damp-heat and blood stasis. Clinically, core syndromes commonly identified include spleen deficiency, internal damp-heat, and blood stasis. Epidemiological surveys and clinical observations show a high prevalence of internal damp-heat syndrome in colorectal cancer patients, with these patients exhibiting faster tumor progression, higher metastasis rates, and worse prognoses, suggesting that damp-heat accumulation is a key pathological factor driving the development of colorectal cancer. Therefore, developing compound preparations with clear TCM theoretical guidance, well-defined components, and relatively clear mechanisms of action, targeting this core pathogenesis of internal damp-heat, is of significant practical importance for improving the clinical outcomes of colorectal cancer patients. Summary of the Invention

[0004] The purpose of this invention is to provide a modified Scutellaria baicalensis and Magnolia officinalis compound preparation and its application in the treatment of colorectal cancer. This invention provides modified Scutellaria baicalensis and Magnolia officinalis decoction and granules, and both dosage forms of the modified Scutellaria baicalensis and Magnolia officinalis compound preparation have good therapeutic or ameliorative effects on colorectal cancer.

[0005] This invention provides a flavored Scutellaria baicalensis and Magnolia officinalis composition, comprising the following raw materials in parts by weight: Astragalus membranaceus 10-60 parts, Codonopsis pilosula 10-60 parts, Atractylodes macrocephala 9-30 parts, Poria cocos 10-60 parts, Scutellaria baicalensis 3-30 parts, Magnolia officinalis 3-30 parts, Codonopsis pilosula 10-60 parts, Hedyotis diffusa 15-60 parts, Actinidia chinensis root 15-90 parts, Coix lacryma-jobi 10-100 parts, Patrinia scabiosaefolia 9-30 parts, and Glycyrrhiza uralensis 9-30 parts.

[0006] Preferably, the dosage form of the flavored Scutellaria baicalensis and Magnolia officinalis composition includes decoctions and / or granules.

[0007] This invention also provides a method for preparing a modified Scutellaria baicalensis and Magnolia officinalis decoction, comprising the following steps: The modified Scutellaria baicalensis and Magnolia officinalis composition described in the above technical solution is mixed with water and soaked. The soaked raw materials are then mixed with water and decocted. The decoctions are combined to obtain the modified Scutellaria baicalensis and Magnolia officinalis decoction.

[0008] Preferably, the decoction is performed 2 to 3 times; each decoction lasts for 40 to 50 minutes; and the amount of water used in each decoction is 8 to 12 times the weight of the flavored Scutellaria baicalensis and Magnolia officinalis composition.

[0009] Preferably, the decoction step includes: mixing the soaked raw materials with 10 times the amount of water of the modified Scutellaria baicalensis and Magnolia officinalis composition and decocting for 45 minutes to obtain a first decoction and a first dregs; The dregs were mixed with 10 times the amount of water of the modified Scutellaria baicalensis and Magnolia officinalis composition and decocted for 45 minutes to obtain a second decoction and a second dregs. The first and second decoctions were combined to obtain the modified Scutellaria baicalensis and Magnolia officinalis decoction.

[0010] The present invention also provides a modified Scutellaria baicalensis and Magnolia officinalis decoction, which is prepared by the preparation method described in the above technical solution.

[0011] This invention also provides a method for preparing flavored Scutellaria baicalensis and Magnolia officinalis granules, comprising the following steps: The modified Scutellaria baicalensis and Magnolia officinalis decoction described in the above technical solution is concentrated under reduced pressure to obtain a thick extract, wherein the relative density of the thick extract at 60°C is 1.20~1.30. The thick extract was mixed with dextrin and then wet granulated. The resulting granules were then post-processed to obtain the flavored Scutellaria baicalensis and Magnolia officinalis granules.

[0012] Preferably, the temperature for vacuum concentration is 55~65℃ and the vacuum degree is 0.06~0.10 MPa.

[0013] The present invention also provides a flavored Scutellaria baicalensis and Magnolia officinalis granule, which is prepared by the preparation method described in the above technical solution; the particle size of the flavored Scutellaria baicalensis and Magnolia officinalis granule is not greater than 1.40 mm.

[0014] The present invention also provides the application of the modified Scutellaria baicalensis and Magnolia officinalis composition, the modified Scutellaria baicalensis and Magnolia officinalis decoction, or the modified Scutellaria baicalensis and Magnolia officinalis granules described in the above-mentioned technical solutions in the preparation of drugs for treating colorectal cancer.

[0015] Beneficial effects: This invention provides a modified Scutellaria baicalensis and Magnolia officinalis composition, comprising the following raw materials in parts by weight: Astragalus membranaceus 10-60 parts, Codonopsis pilosula 10-60 parts, Atractylodes macrocephala 9-30 parts, Poria cocos 10-60 parts, Scutellaria baicalensis 3-30 parts, Magnolia officinalis 3-30 parts, Panax quinquefolius 10-60 parts, Hedyotis diffusa 15-60 parts, Actinidia chinensis root 15-90 parts, Coix lacryma-jobi 10-100 parts, Patrinia scabiosaefolia 9-30 parts, and Glycyrrhiza uralensis 9-30 parts. The composition of this invention has a rigorous formulation and high degree of alignment with the pathogenesis: the formulation is based on the core pathogenesis of damp-heat accumulation syndrome in colorectal cancer, combining spleen-strengthening and qi-tonifying with heat-clearing and nodule-dispersing effects, conforming to the theory of syndrome differentiation and treatment in traditional Chinese medicine, and possessing a solid foundation for clinical application. In addition, the composition has clear antitumor activity and excellent safety: in vivo animal experiments have confirmed that the formula can significantly inhibit the growth of colorectal tumors and has no obvious toxicity to major organs such as the heart, liver, spleen, lungs and kidneys, with a wide safety window.

[0016] Based on this, the present invention optimizes the dosage form of the modified Scutellaria baicalensis and Magnolia officinalis composition. In addition to the traditional decoction, a standardized granule preparation process has been established. Experiments have shown that there is no significant difference between the granule and the traditional decoction in terms of tumor suppression effect and safety. It retains the efficacy characteristics of the traditional decoction and solves the problems of inconvenience in carrying and poor quality control of the decoction, making it more suitable for clinical promotion and industrial production. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the accompanying drawings used in the embodiments will be briefly introduced below.

[0018] Figure 1 This refers to the inhibitory effect of the modified Scutellaria baicalensis decoction and granules on the growth of colorectal tumors in Example 4. In A, the tumors in the same group from left to right represent tumors obtained from 5 mice in the same group. In C, " "and" "respectively represent" P <0.001 and P <0.0001.

[0019] Figure 2 The effects of the modified Scutellaria baicalensis decoction and granules on the function of major organs and tissues in Example 4; Figure 3 The figure shows the effect of the influence of the major organ tissue structure on the major organ tissue structure in Example 4. The scale bar in the figure is 50 μm. Detailed Implementation

[0020] This invention provides a flavored Scutellaria baicalensis and Magnolia officinalis composition, comprising the following raw materials in parts by weight: Astragalus membranaceus 10-60 parts, Codonopsis pilosula 10-60 parts, Atractylodes macrocephala 9-30 parts, Poria cocos 10-60 parts, Scutellaria baicalensis 3-30 parts, Magnolia officinalis 3-30 parts, Codonopsis pilosula 10-60 parts, Hedyotis diffusa 15-60 parts, Actinidia chinensis root 15-90 parts, Coix lacryma-jobi 10-100 parts, Patrinia scabiosaefolia 9-30 parts, and Glycyrrhiza uralensis 9-30 parts.

[0021] In one embodiment, by weight, the Astragalus membranaceus of this invention comprises 20-50 parts, more preferably 30-40 parts; the Codonopsis pilosula comprises 20-50 parts, more preferably 20-40 parts; the Atractylodes macrocephala comprises 12-25 parts, more preferably 15-20 parts; the Poria cocos comprises 15-45 parts, more preferably 15-30 parts; the Scutellaria baicalensis comprises 8-20 parts, more preferably 10-15 parts; and the Magnolia officinalis comprises 5-25 parts, more preferably 10-20 parts. The following ingredients are listed: 20-50 parts of the cat ginseng, more specifically 30-40 parts; 20-50 parts of the white flower snake tongue grass, more specifically 30-40 parts; 20-70 parts of the vine pear root, more specifically 30-50 parts; 20-60 parts of the coix seed, more specifically 30-50 parts; 10-25 parts of the patrinia scabiosifolia, more specifically 15-20 parts; and 10-20 parts of the raw licorice root, more specifically 10-15 parts.

[0022] The modified Scutellaria baicalensis and Magnolia officinalis composition of this invention adheres to the principle of "strengthening the body's resistance and eliminating pathogens, addressing both the root cause and the symptoms," and establishes a rigorous structure of "five principal herbs, four assistant herbs, two adjuvant herbs, and one guiding herb." The principal herbs are Astragalus membranaceus, Codonopsis pilosula, Panax ginseng, Hedyotis diffusa, and Actinidia chinensis root, used in combination. Among them, Astragalus membranaceus and Codonopsis pilosula greatly tonify the spleen and stomach qi to strengthen the body's resistance, while Panax ginseng, Hedyotis diffusa, and Actinidia chinensis root specifically target clearing heat and detoxifying, reducing swelling and dissipating nodules to directly counteract cancer toxins. Together, they support the body's resistance and fight cancer. The key to treating cancer lies in the combination of herbs: *Patrinia scabiosaefolia* and *Coix lacryma-jobi* assist the principal herb in clearing intestinal heat and purging pus and toxins; *Scutellaria baicalensis* and *Magnolia officinalis* assist the principal herb in clearing damp-heat in the large intestine and promoting qi circulation and relieving bloating, preventing the tonifying herbs from obstructing the flow of qi and facilitating the downward movement of damp-heat. *Atractylodes macrocephala* and *Poria cocos* are used as adjuvant herbs to strengthen the spleen and dry dampness, assisting the principal herb in promoting digestion and balancing the bitter and cold properties of the principal and adjuvant herbs to protect the spleen yang. *Glycyrrhiza uralensis* is used as the guiding herb to harmonize the various herbs, moderate the harshness of the bitter and cold herbs, and protect the stomach qi. The entire formula is well-balanced, combining tonification and purgation, and using both warming and cooling herbs, perfectly matching the underlying pathogenesis of colorectal cancer—"deficiency of spleen and stomach qi, and internal accumulation of damp-heat and toxicity"—and is suitable for postoperative rehabilitation, toxicity reduction of radiotherapy and chemotherapy, and intervention in the late-stage survival stage with the tumor.

[0023] As one embodiment, the dosage form of the modified Scutellaria baicalensis and Magnolia officinalis composition of the present invention can be a decoction and / or granules.

[0024] This invention also provides a method for preparing a modified Scutellaria baicalensis and Magnolia officinalis decoction, comprising the following steps: The modified Scutellaria baicalensis and Magnolia officinalis composition described in the above technical solution is mixed with water and soaked. The soaked raw materials are then mixed with water and decocted. The decoctions are combined to obtain the modified Scutellaria baicalensis and Magnolia officinalis decoction.

[0025] In this invention, the modified Scutellaria baicalensis and Magnolia officinalis composition is mixed with water and soaked to obtain the soaked raw material. As one embodiment, the soaking time is 25-35 minutes, and more specifically, 30 minutes.

[0026] After soaking, the soaked raw materials are mixed with water and decocted. The decoctions are combined to obtain the modified Scutellaria baicalensis and Magnolia officinalis decoction. In one embodiment, the decoction is performed 2-3 times, more preferably 2 times; each decoction lasts 40-50 minutes, more preferably 45 minutes; and the amount of water used in each decoction is 8-12 times the weight of the modified Scutellaria baicalensis and Magnolia officinalis composition, more preferably 10 times.

[0027] As one embodiment, the decoction step of the present invention can be as follows: the soaked raw materials are mixed with 10 times the amount of water of the modified Scutellaria baicalensis and Magnolia officinalis composition and decocted for 45 minutes to obtain the first decoction and the first dregs; The dregs were mixed with 10 times the amount of water of the modified Scutellaria baicalensis and Magnolia officinalis composition and decocted for 45 minutes to obtain a second decoction and a second dregs; the first decoction and the second decoction were combined to obtain the modified Scutellaria baicalensis and Magnolia officinalis decoction.

[0028] As one implementation method, in each simmering process, the mixture is first brought to a boil over high heat, and then simmered over low heat for 45 minutes. This invention does not specifically limit the degree of high or low heat; any conventional high or low heat method used in the art will suffice.

[0029] The present invention also provides a modified Scutellaria baicalensis and Magnolia officinalis decoction, which is prepared by the preparation method described in the above technical solution.

[0030] This invention also provides a method for preparing flavored Scutellaria baicalensis and Magnolia officinalis granules, comprising the following steps: The modified Scutellaria baicalensis and Magnolia officinalis decoction described in the above technical solution is concentrated under reduced pressure to obtain a thick extract, wherein the relative density of the thick extract at 60°C is 1.20~1.30. The thick extract was mixed with dextrin and then wet granulated. The resulting granules were then post-processed to obtain the flavored Scutellaria baicalensis and Magnolia officinalis granules.

[0031] In one embodiment, the temperature for vacuum concentration is 55~65℃, more specifically 60℃; the vacuum degree is 0.06~0.10 MPa, more specifically 0.08 MPa. In another embodiment, the weight ratio of the viscous extract to dextrin can be 1:(1.6~1.8), further preparing a soft material that can be formed into a ball by hand and dispersed upon light pressure. In another embodiment, during the wet granulation process, the soft material is extruded through a 14-mesh pharmaceutical sieve to obtain wet granules.

[0032] In one embodiment, the post-processing step of the present invention includes: drying the wet granules and sizing the dried granules through a 14-mesh sieve to obtain the flavored Scutellaria baicalensis and Magnolia officinalis granules. In another embodiment, the drying step of the present invention involves transferring the wet granules into a drying oven and drying them at 60°C for 3 hours.

[0033] The present invention also provides a flavored Scutellaria baicalensis and Magnolia officinalis granule, which is prepared by the preparation method described in the above technical solution; the particle size of the flavored Scutellaria baicalensis and Magnolia officinalis granule is not greater than 1.40 mm.

[0034] This invention also provides the application of the modified Scutellaria baicalensis and Magnolia officinalis composition, the modified Scutellaria baicalensis and Magnolia officinalis decoction, or the modified Scutellaria baicalensis and Magnolia officinalis granules described in the above-mentioned technical solutions in the preparation of a drug for treating colorectal cancer. As one embodiment, the colorectal cancer described in this invention can be a case of colorectal cancer with damp-heat retention. As another embodiment, the drug described in this invention can exert its effects through multiple pathways, including inhibiting colorectal tumor proliferation, inducing colorectal tumor cell apoptosis, regulating the immune microenvironment of colorectal tumors, and inhibiting colorectal tumor invasion and metastasis, and possesses good in vivo safety.

[0035] This invention relates to a modified Scutellaria baicalensis and Magnolia officinalis composition and its various dosage forms as a traditional Chinese medicine compound preparation for the intervention of colorectal cancer with spleen and stomach qi deficiency and internal accumulation of damp-heat and toxic stasis. This disease falls under the categories of "intestinal fungus" and "abdominal masses" in traditional Chinese medicine. The core pathogenesis is deficiency of the root and excess of the branch. Spleen deficiency and impaired transport function and deficiency of vital qi are the root causes of the disease, while dampness and turbidity stagnate and transform into heat, damp-heat and toxic stasis obstruct the intestines and viscera, and accumulate into tumors as the branch. Clinically, it often presents with symptoms such as fatigue, poor appetite and emaciation, sticky stools with mucus and blood, abdominal distension and dull pain, burning sensation in the anus, pale and swollen tongue with teeth marks, yellow and greasy tongue coating, and thready and slippery pulse. The formulation follows the principles of tonifying qi and strengthening the spleen, clearing heat and resolving dampness, and detoxifying and dispersing masses. The formula heavily utilizes Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, and Coix lacryma-jobi to invigorate qi, strengthen the spleen, and eliminate dampness, thereby tonifying the middle jiao to protect the body's vital energy, blocking the source of dampness caused by spleen deficiency, and improving the weakened state of the body in cancer patients. It is combined with Scutellaria baicalensis and Magnolia officinalis to clear heat, dry dampness, promote qi circulation, and relieve bloating, clearing the stagnation of qi in the intestines, clearing damp heat in the large intestine, and relieving symptoms of damp heat stagnation such as abdominal distension, burning sensation in the anus, and sticky stools. With Codonopsis pilosula as the main ingredient, it is combined with Hedyotis diffusa, Actinidia chinensis root, Patrinia scabiosaefolia, and other heat-clearing, detoxifying, and mass-dispersing herbs to directly clear intestinal toxins and resolve local masses and lumps. Glycyrrhiza uralensis harmonizes the various herbs, is sweet and mild, and reduces the irritation of cold herbs on the gastrointestinal tract. This formula combines tonification and detoxification, balancing cold and heat, supporting the body's vital energy without suppressing pathogens, and attacking toxins without harming the body's vital energy. It can improve clinical symptoms such as abdominal distension, mucus and bloody stools, and physical weakness in patients with colorectal cancer who have spleen and stomach qi deficiency combined with damp-heat and blood stasis. It can also synergistically regulate the body's state and improve the root cause of spleen and qi deficiency. It is suitable for postoperative rehabilitation of colorectal cancer, reduction of radiotherapy and chemotherapy toxicity, and intervention in the late stage of cancer survival.

[0036] To further illustrate the present invention, the technical solutions provided by the present invention will be described in detail below with reference to the accompanying drawings and embodiments, but these should not be construed as limiting the scope of protection of the present invention.

[0037] Example 1 A modified Scutellaria baicalensis tonic composition, comprising the following raw materials: The formula consists of 30 g Astragalus membranaceus, 20 g Codonopsis pilosula, 15 g Atractylodes macrocephala, 15 g Poria cocos, 10 g Scutellaria baicalensis, 10 g Magnolia officinalis, 30 g Panax quinquefolius, 30 g Hedyotis diffusa, 30 g Actinidia chinensis root, 30 g Coix lacryma-jobi, 15 g Patrinia scabiosaefolia, and 10 g Glycyrrhiza uralensis.

[0038] Example 2 A method for preparing a modified Scutellaria baicalensis and Magnolia officinalis decoction, comprising the following steps: Weigh the raw materials from Example 1 according to the specified weight, mix the above-mentioned medicinal materials, add 10 times the total weight of the raw materials in purified water and soak for 30 minutes, bring to a boil over high heat and then simmer over low heat for 45 minutes, filter out the liquid; add 10 times the amount of purified water to the dregs and simmer for 45 minutes, filter out the liquid, combine the two decoctions to obtain the modified Scutellaria baicalensis and Magnolia officinalis decoction, and store it in a sealed container at 4℃ for later use.

[0039] Example 3 The preparation method of the modified Huangqin Houpu Decoction granules is as follows: The modified Scutellaria baicalensis and Magnolia officinalis decoction prepared in Example 2 was transferred to a rotary evaporator for vacuum concentration. The water bath temperature was set to 60°C and the vacuum degree to 0.08 MPa, concentrating the decoction to a thick extract with a relative density of 1.20~1.30 (measured at 60°C). Dextrin was gradually added to the thick extract and mixed thoroughly until it reached the standard of a soft material that could be formed into a ball by hand but crumbled easily upon light pressure. The soft material was extruded through a 14-mesh pharmaceutical sieve for granulation. The resulting wet granules were evenly spread on an enamel tray and dried in a drying oven at 60°C for 3 hours. After drying, the granules were removed and sieved through a 14-mesh sieve to remove fine powder and lumps, thus obtaining the modified Scutellaria baicalensis and Magnolia officinalis granules.

[0040] Example 4 The efficacy and safety evaluation of modified Scutellaria and Magnolia officinalis decoction and modified Scutellaria and Magnolia officinalis granules in the treatment of colorectal cancer were carried out as follows: 1. Experimental Materials Laboratory animals: SPF-grade 3-5 week old female C57BL / 6J mice, purchased from Shanghai Silex Laboratory Animal Co., Ltd. All animal experimental procedures were reviewed and approved by the Research Ethics Committee of Hangzhou Normal University, and the experimental process strictly followed relevant ethical and welfare guidelines for laboratory animals.

[0041] Cell line: Mouse colorectal cancer MC38 cell line, routinely cultured in DMEM medium containing 10% fetal bovine serum, passaged in a 37℃, 5% CO2 incubator, and used for modeling with logarithmic growth phase cells.

[0042] Main reagents and instruments: serum biochemical test kit, 4% paraformaldehyde, hematoxylin-eosin (HE) staining kit; vernier calipers, rotary evaporator, benchtop centrifuge, fully automated biochemical analyzer, paraffin microtome, slide scanner, etc.

[0043] 2. Experimental Methods Subcutaneous xenograft model construction: MC38 cells in logarithmic growth phase were collected, and the cell suspension concentration was adjusted to 5 × 10⁻⁶. 6 0.1 mL of cell suspension (containing 5 × 10⁶ cells / mL) was subcutaneously injected into the right flank of mice. 5 (One), to construct a mouse subcutaneous xenograft model of colorectal cancer.

[0044] Grouping and administration: When the mouse tumors grew to a suitable size for measurement, the mice were randomly divided into 7 groups of 5 mice each: control group (saline by gavage), low-dose decoction group (LD-Decoction), medium-dose decoction group (MD-Decoction), high-dose decoction group (HD-Decoction), low-dose granule group (LD-Granules), medium-dose granule group (MD-Granules), and high-dose granule group (HD-Granules).

[0045] The dosage was calculated based on the daily adult clinical dosage, using the human-to-mouse body surface area coefficient to obtain the equivalent dosage for mice: the medium-dose group received 15.21 g crude drug / kg body weight, the low-dose group received 7.605 g crude drug / kg body weight, and the high-dose group received 30.42 g crude drug / kg body weight. All groups received the same volume of medication via gavage once daily, while the control group received an equal volume of physiological saline. The administration was continued for 15 consecutive days.

[0046] General condition and tumor volume monitoring: The long diameter (a) and short diameter (b) of the tumor were measured every 2 days using calipers, according to the formula V = 0.5 × a × b. 2 The tumor volume was calculated; at the same time, the body weight of mice in each group was recorded, and the general condition of the mice, such as their mental state, diet, and activity, was observed.

[0047] Sample Collection and Processing: At the experimental endpoint, whole blood was collected from mice using the ocular blood sampling method. After standing at room temperature for 2 hours, the serum was separated by centrifugation at 3500 rpm for 15 minutes and stored at -80℃ for subsequent serum biochemical index detection. Mice were euthanized by cervical dislocation, and tumor tissue was completely dissected and photographed. Simultaneously, major organs such as the heart, liver, spleen, lungs, and kidneys were collected and fixed in 4% paraformaldehyde solution for histopathological examination.

[0048] Serum biochemical index detection: Serum from each group of mice was collected, and eight biochemical indexes, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase (CK), α-amylase (A-AMY), α-hydroxybutyrate dehydrogenase (HBDH), creatinine (CR), total protein (TP), and cholinesterase (CHE), were detected using a fully automated biochemical analyzer to assess the functional status of each organ.

[0049] Histopathological examination: After fixation with 4% paraformaldehyde, organ tissues were dehydrated in a gradient manner, embedded in paraffin, sectioned, and stained with hematoxylin and eosin (HE). The tissue structure and cell morphology of each organ were observed using a slide scanner to assess the pathological effects of the drug on the organs.

[0050] 3. Experimental Results 1) Inhibitory effect on the growth of colorectal tumors The experimental results showed that with prolonged administration time, the tumor volume in the control group increased rapidly; the tumor growth rate in each administration group was slower than that in the control group to varying degrees, and showed a certain dose-dependent effect, with the high-dose group showing a more significant tumor-suppressing effect. At the experimental endpoint, the tumor volume in each administration group was significantly smaller than that in the control group. Figure 1 (A~B)

[0051] Comparison of tumor-suppressing effects between decoction and granules at the same dosage level: At low, medium, and high dosage gradients, there was no statistically significant difference in tumor volume between the decoction group and the corresponding granule group (ns). Figure 1 The results (C~E) indicate that the antitumor activities of the two are comparable. Throughout the experiment, there were no significant differences in body weight among the groups of mice, and no abnormalities were observed in the mice's mental state, diet, or activity level, indicating that the preparation had no adverse effects on the general growth of the mice.

[0052] 2) Effects on the function of major organs Serum biochemical tests showed that, compared with the control group, there were no statistically significant differences in ALT, AST, CK, A-AMY, HBDH, CR, TP, and CHE levels among the drug-treated groups, and all indicators were within the normal physiological range for mice. Figure 2 The above results indicate that this traditional Chinese medicine compound preparation did not have significant adverse effects on the function of major organs such as the liver, heart, kidneys, and pancreas, and did not exhibit obvious organ toxicity.

[0053] 3) Effects on the structure of major organs and tissues HE staining microscopic observation showed that the heart, liver, spleen, lung, and kidney tissues of mice in both the control group and the drug-treated groups had clear structures, normal cell morphology, and no obvious pathological changes such as cell degeneration, necrosis, or inflammatory cell infiltration. Figure 3 This result further confirms from a histopathological perspective that both the modified Huangqin Houpu Decoction decoction and granules exhibit good in vivo safety at the experimental doses.

[0054] 4) Equivalence evaluation between decoction and granules The combined efficacy and safety results show that, under the same dosage conditions, both the modified Huangqin Houpu Decoction granules and the traditional decoction can significantly inhibit the growth of colorectal tumors, with no significant difference in their tumor-inhibiting effects. Furthermore, both showed consistent performance in serum biochemical indicators and organ tissue morphology, with no obvious toxic reactions. This confirms that the granules prepared in this invention are equivalent to the traditional decoction in terms of efficacy and safety, and can be promoted and applied as an alternative dosage form to the decoction.

[0055] Although the above embodiments have provided a detailed description of the present invention, they are only some embodiments of the present invention, and not all embodiments. People can obtain other embodiments based on these embodiments without creative effort, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A flavored Scutellaria baicalensis and Magnolia officinalis composition, characterized in that, The raw materials include the following parts by weight: Astragalus membranaceus 10-60 parts, Codonopsis pilosula 10-60 parts, Atractylodes macrocephala 9-30 parts, Poria cocos 10-60 parts, Scutellaria baicalensis 3-30 parts, Magnolia officinalis 3-30 parts, Codonopsis pilosula 10-60 parts, Hedyotis diffusa 15-60 parts, Actinidia chinensis root 15-90 parts, Coix lacryma-jobi 10-100 parts, Patrinia scabiosaefolia 9-30 parts, and Glycyrrhiza uralensis 9-30 parts.

2. The modified Scutellaria baicalensis and Magnolia officinalis composition according to claim 1, characterized in that, The dosage forms of the modified Scutellaria baicalensis and Magnolia officinalis composition include decoctions and / or granules.

3. A method for preparing a modified Scutellaria baicalensis and Magnolia officinalis decoction, characterized in that, Includes the following steps: The modified Scutellaria baicalensis and Magnolia officinalis composition of claim 1 is mixed with water and soaked. The soaked raw materials are then mixed with water and decocted. The decoctions are combined to obtain the modified Scutellaria baicalensis and Magnolia officinalis decoction.

4. The preparation method according to claim 3, characterized in that, The decoction is performed 2 to 3 times; each decoction lasts for 40 to 50 minutes; and the amount of water used for each decoction is 8 to 12 times the weight of the flavored Scutellaria baicalensis and Magnolia officinalis composition.

5. The preparation method according to claim 3 or 4, characterized in that, The decoction step includes: mixing the soaked raw medicinal materials with 10 times the amount of water of the modified Scutellaria baicalensis and Magnolia officinalis composition and decocting for 45 minutes to obtain the first decoction and the first dregs. The dregs were mixed with 10 times the amount of water of the modified Scutellaria baicalensis and Magnolia officinalis composition and decocted for 45 minutes to obtain a second decoction and a second dregs. The first and second decoctions were combined to obtain the modified Scutellaria baicalensis and Magnolia officinalis decoction.

6. A modified Scutellaria baicalensis and Magnolia officinalis decoction, characterized in that, It is prepared by the preparation method described in any one of claims 3 to 5.

7. A method for preparing a flavored Scutellaria baicalensis and Magnolia officinalis granule, characterized in that, Includes the following steps: The modified Scutellaria baicalensis and Magnolia officinalis decoction according to claim 6 is concentrated under reduced pressure to obtain a thick extract, wherein the relative density of the thick extract at 60°C is 1.20~1.

30. The thick extract was mixed with dextrin and then wet granulated. The resulting granules were then post-processed to obtain the flavored Scutellaria baicalensis and Magnolia officinalis granules.

8. The preparation method according to claim 7, characterized in that, The vacuum concentration temperature is 55~65℃, and the vacuum degree is 0.06~0.10 MPa.

9. A flavored Scutellaria baicalensis and Magnolia officinalis granule formulation, characterized in that, The granules are prepared using the preparation method described in claim 7 or 8; the particle size of the flavored Scutellaria baicalensis and Magnolia officinalis granules is not greater than 1.40 mm.

10. The use of the modified Scutellaria baicalensis and Magnolia officinalis composition of claim 1, the modified Scutellaria baicalensis and Magnolia officinalis decoction of claim 6, or the modified Scutellaria baicalensis and Magnolia officinalis granules of claim 9 in the preparation of a medicament for treating colorectal cancer.

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