Pharmaceutical composition for early intervention of malignant pulmonary nodule and preparation method thereof

Abstract

The invention discloses a pharmaceutical composition for early intervention of malignant pulmonary nodules and a preparation method of the pharmaceutical composition. The pharmaceutical composition is prepared from 16 traditional Chinese medicines such as raw astragalus membranaceus and angelica sinensis through scientific compatibility. PI3K / AKT and TGF-beta / Smad signal channels are regulated and controlled through multiple targets, and the effects of tonifying qi, activating blood, reducing phlegm and resolving masses are achieved. Clinical studies show that the compound can significantly improve cough, short breath and chest pain symptoms (Plt; 0.05) of patients with qi stagnation and blood stasis syndromes, reduce GGO (ground glass sample) nodule metabolic activity (SUVmax decrease is greater than or equal to 40%), and effectively block malignant progression of pulmonary nodules. The preparation is mature in process and can be prepared into various dosage forms, and a safe and effective traditional Chinese and western medicine combined solution is provided for prevention and treatment of precancerous lesions of pulmonary nodules.

Description

Technical Field

[0001] The present invention belongs to the technical field of integrated traditional Chinese and Western medicine clinical medicine, and specifically relates to a traditional Chinese medicine composition with the effects of supplementing qi and activating blood circulation, resolving phlegm and dissipating nodules, and its application in preventing and treating precancerous lesions of malignant pulmonary nodules. Background Art

[0002] As an important biological marker for early screening of lung cancer, the malignant transformation rate of malignant nodules with a diameter ≤ 3 cm can reach 20%-40% in 5 years. Modern medicine has a treatment blind spot for sub-centimeter nodules that do not meet the surgical indications, which provides a unique time window for traditional Chinese medicine intervention. The ancient Chinese medical classic "Huangdi Neijing" first proposed the pathogenesis evolution law of "the beginning of accumulation and its formation", and "Synopsis of the Golden Chamber" more clearly pointed out that "blood stasis leads to fluid retention", laying the foundation for the theory of phlegm and blood stasis mutual binding.

[0003] Based on the treatment principle of "strengthening the healthy qi and cultivating the root, regulating qi and blood simultaneously", the inventor innovatively proposed a combined intervention strategy of "tonifying qi and expelling toxins - activating blood circulation and dredging collaterals - resolving phlegm and dissipating nodules". Through repeated clinical practice, it is found that the total effective rate of this compound prescription in improving core symptoms such as cough, shortness of breath, and chest pain is 86.7%, and the nodule stability rate at 6 months is 92.3%, which is significantly better than the conventional treatment plan. This curative effect feature highly coincides with the academic thought of "the key to treating accumulation lies in the appropriateness of attacking and tonifying" in "Introduction to Medicine". At the same time, the treatment concept of "tonifying qi and expelling toxins, removing phlegm and dredging collaterals" of this compound prescription not only inherits the classic theory of "phlegm combined with blood stasis forms a cyst" in "Danxi's Heart Method", but also innovatively integrates the modern theory of tumor microenvironment regulation, providing a new paradigm for integrated traditional Chinese and Western medicine intervention in the precancerous lesion stage. Summary of the Invention

[0004] The present invention innovatively constructs a triple action system of "tonifying qi and expelling toxins - activating blood circulation and dredging collaterals - resolving phlegm and dissipating nodules":

[0005] King drug: Astragalus membranaceus (supplementing lung qi) and Angelica sinensis (nourishing blood and promoting blood circulation) form the core of supplementing qi and blood

[0006] Ministerial drug: Salvia miltiorrhiza / Zedoary turmeric (breaking blood stasis) and Fritillaria thunbergii / Oyster (resolving phlegm and softening hardness) constitute the framework of attacking and tonifying simultaneously

[0007] Assistant and guiding drug: Lonicera japonica / Licorice (detoxifying and harmonizing drugs) and Trionyx sinensis / Prunella vulgaris (dissipating nodules and dredging collaterals) achieve microscopic regulation

[0008] Pharmacodynamic studies show that astragaloside in the composition can inhibit epithelial-mesenchymal transition (EMT) by regulating the TGF-β / Smad pathway, notoginsenoside in the ministerial drug can target and regulate the VEGF / VEGFR2 axis to improve the hypoxic state of the tumor microenvironment, and the alkaloids of Fritillaria thunbergii in the assistant and guiding drug can down-regulate the expression of MMP-9 to inhibit extracellular matrix remodeling, with definite anti-inflammatory, anti-angiogenic and immunomodulatory effects. Brief Description of the Drawings

[0009] Figure 1 This is the lung CT diagnosis report of the patient from Peking Union Medical College Hospital on January 13, 2023 for the first time.

[0010] Figure 2 This is the lung CT diagnosis report of the patient from Peking Union Medical College Hospital on July 24, 2023 after taking traditional Chinese medicine for 5 months.

[0011] Figure 3 This is the lung CT diagnosis report of the patient from Peking Union Medical College Hospital on April 22, 2024 after taking traditional Chinese medicine for 1 year.

[0012] Figure 4 This is the lung CT image of the patient from Peking Union Medical College Hospital on April 22, 2024 after taking traditional Chinese medicine for 1 year.

Claims

1. A Chinese medicine composition for early intervention in the treatment of malignant pulmonary nodules, characterized in that The invention is composed of the following raw materials in parts by weight: 25-35 parts of raw astragalus, 25-35 parts of angelica, 10-15 parts of honeysuckle, 12-18 parts of platycodon, 12-18 parts of thunbergia thunbergii, 15-25 parts of selfheal, 25-35 parts of raw oyster, 12-18 parts of trichosanthes, 12-18 parts of sapodilla thorn, 8-12 parts of turtle shell, 12-18 parts of zedoaria, 8-12 parts of salvia miltiorrhiza, 15-25 parts of scrophularia, 3-8 parts of frankincense, 3-8 parts of myrrh and 4-8 parts of liquorice.

2. The pharmaceutical composition according to claim 1, characterized in that It can be prepared into decoction, granules, pills or capsules. Here is an example: Decoction method: add 8 times the amount of water to soak for 30 minutes, boil over high heat and then keep on low heat for 40 minutes; add 6 times the amount of water to boil for 30 minutes for the second decoction.

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