阅读说明：本技术 一种治疗癌症的组合物及其制备方法和用途 (Composition for treating cancer and preparation method and application thereof ) 是由 冉文华 刘华文 张亮 杨得艺 饶辉 梁艳 黄小平 于 2021-08-27 设计创作，主要内容包括：本发明提供了一种治疗癌症的药物组合物,含有如下重量份数的原料药组成：喜树果6-21份、红豆杉5-20份、肿节风5-25份、猪苓10-30份、黄芪20-50份、莪术9-30份、鳖甲9-24份、败酱草9-30份、猫爪草9-30份、川芎10-30份、当归10-30份。本发明药物组合物高效,低毒,长时期服用无明显副作用,可针对肺癌,肝癌,淋巴癌,乳腺癌,宫颈癌等多种实体瘤癌症,能够有效提高患者生存率,具有很好的临床应用前景。(The invention provides a pharmaceutical composition for treating cancer, which comprises the following raw material medicines in parts by weight: 6-21 parts of common camptotheca fruit, 5-20 parts of taxus chinensis, 5-25 parts of glabrous sarcandra herb, 10-30 parts of polyporus, 20-50 parts of astragalus membranaceus, 9-30 parts of curcuma zedoary, 9-24 parts of turtle shell, 9-30 parts of herba patriniae, 9-30 parts of radix ranunculi ternati, 10-30 parts of ligusticum wallichii and 10-30 parts of angelica sinensis. The pharmaceutical composition has high efficiency and low toxicity, has no obvious side effect after long-term administration, can be used for treating various solid tumor cancers such as lung cancer, liver cancer, lymph cancer, breast cancer, cervical cancer and the like, can effectively improve the survival rate of patients, and has good clinical application prospect.)

1. The pharmaceutical composition for treating cancer is characterized by comprising the following raw material medicines in parts by weight: 6-21 parts of common camptotheca fruit, 5-20 parts of taxus chinensis, 5-25 parts of glabrous sarcandra herb, 10-30 parts of polyporus, 20-50 parts of astragalus membranaceus, 9-30 parts of curcuma zedoary, 9-24 parts of turtle shell, 9-30 parts of herba patriniae, 9-30 parts of radix ranunculi ternati, 10-30 parts of ligusticum wallichii and 10-30 parts of angelica sinensis.

2. The pharmaceutical composition for treating cancer is characterized by comprising the following raw material medicines in parts by weight: 12 parts of common camptotheca fruit, 10 parts of taxus chinensis, 15 parts of glabrous sarcandra herb, 15 parts of polyporus umbellatus, 30 parts of astragalus root, 10 parts of zedoary, 10 parts of turtle shell, 15 parts of dahurian patrinia herb, 15 parts of ternate buttercup root, 12 parts of szechuan lovage rhizome and 12 parts of Chinese angelica.

3. The pharmaceutical composition of claim 1 or 2, which is a preparation prepared from crude drug powder of the raw drug materials, water or an organic solvent extract as active ingredients, and pharmaceutically acceptable auxiliary materials.

4. The pharmaceutical composition of claim 3, wherein the formulation is an oral formulation.

5. The pharmaceutical composition of claim 4, wherein the oral formulation is a decoction, a granule, a pill, a powder, an oral liquid, a capsule or a tablet.

6. A process for the preparation of a pharmaceutical composition according to any one of claims 1 to 5, comprising the steps of:

(1) decocting ramulus et folium taxi Cuspidatae and carapax Trionycis in water;

(2) adding the rest raw materials, and decocting to obtain decoction.

7. The preparation method of claim 6, wherein the decocting time in the step (1) is 30-60 min; the decocting time in the step (2) is 0.5-2 h.

8. Use of a pharmaceutical composition according to any one of claims 1 to 5 in the manufacture of a medicament for the treatment of cancer.

9. Use according to claim 8, wherein the medicament is a medicament for the treatment of a solid tumor cancer, preferably lung cancer, liver cancer, lymph cancer, breast cancer, cervical cancer, prostate cancer, stomach cancer, ovarian cancer or colorectal cancer, more preferably lung cancer.

10. The medicament of claim 8 or 9, wherein the medicament is a medicament for improving the efficacy and prolonging the survival of cancer patients.

Technical Field

The invention belongs to the field of medicines, and particularly relates to a composition for treating cancer, and a preparation method and application thereof.

Background

Cancer is a common disease and frequently occurring disease which seriously threatens human health, and the mortality rate of human caused by cancer is the second of all disease mortality rates and is second only to cardiovascular and cerebrovascular diseases. Currently, surgical resection, chemotherapy and radiotherapy are the main treatment methods. However, the toxic and side effects of radiotherapy and chemotherapy are often serious, and the treatment effect is difficult to further improve only by increasing the dose and the treatment course of radiotherapy and chemotherapy; the prognosis of the patient is not ideal, the life cycle is short, and the disease death rate is high. How to improve the survival rate of patients is a problem to be solved urgently at present.

The Chinese medicine has rich Chinese herbal medicine resources, various Chinese herbal medicines contain strong anti-cancer active substances, and the Chinese medicine has the unique advantages of small toxic and side effects and the like on cancer treatment. At present, a plurality of anticancer traditional Chinese medicine compositions are reported, but the defects of complex formula, poor curative effect and the like still exist. For example, patent CN104083728B discloses a preparation method of concentrated pill for treating cancer and tumor, which is composed of dozens of drugs such as stir-fried toad skin, etc., and has high cost, complex preparation process, small number of clinically verified cases and uncertain actual curative effect. Therefore, by applying the theory of traditional Chinese medicine and combining the pathological characteristics and pathogenesis of cancer, the Chinese medicinal composition with the anticancer and cancer-inhibiting effects is developed, and the cancer treatment by combining the treatment mode of western medicine has excellent clinical application prospect.

Disclosure of Invention

The invention aims to provide a composition for treating cancer, a preparation method and application thereof.

The invention provides a pharmaceutical composition for treating cancer, which comprises the following raw material medicines in parts by weight: 6-21 parts of common camptotheca fruit, 5-20 parts of taxus chinensis, 5-25 parts of glabrous sarcandra herb, 10-30 parts of polyporus, 20-50 parts of astragalus membranaceus, 9-30 parts of curcuma zedoary, 9-24 parts of turtle shell, 9-30 parts of herba patriniae, 9-30 parts of radix ranunculi ternati, 10-30 parts of ligusticum wallichii and 10-30 parts of angelica sinensis.

Furthermore, the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight: 12 parts of common camptotheca fruit, 10 parts of taxus chinensis, 15 parts of glabrous sarcandra herb, 15 parts of polyporus umbellatus, 30 parts of astragalus root, 10 parts of zedoary, 10 parts of turtle shell, 15 parts of dahurian patrinia herb, 15 parts of ternate buttercup root, 12 parts of szechuan lovage rhizome and 12 parts of Chinese angelica.

Furthermore, the traditional Chinese medicine composition is composed of the following raw material medicines in parts by weight: 6-21 parts of common camptotheca fruit, 5-20 parts of taxus chinensis, 5-25 parts of glabrous sarcandra herb, 10-30 parts of polyporus, 20-50 parts of astragalus membranaceus, 9-30 parts of curcuma zedoary, 9-24 parts of turtle shell, 9-30 parts of herba patriniae, 9-30 parts of radix ranunculi ternati, 10-30 parts of ligusticum wallichii and 10-30 parts of angelica sinensis.

Furthermore, the traditional Chinese medicine composition is composed of the following raw material medicines in parts by weight: 12 parts of common camptotheca fruit, 10 parts of taxus chinensis, 15 parts of glabrous sarcandra herb, 15 parts of polyporus umbellatus, 30 parts of astragalus root, 10 parts of zedoary, 10 parts of turtle shell, 15 parts of dahurian patrinia herb, 15 parts of ternate buttercup root, 12 parts of szechuan lovage rhizome and 12 parts of Chinese angelica.

Furthermore, the traditional Chinese medicine composition is a preparation prepared by taking crude drug powder of the raw drug materials, water or organic solvent extract as active ingredients and adding pharmaceutically acceptable auxiliary materials.

Further, the above preparation is an oral preparation.

Furthermore, the oral preparation is decoction, granules, pills, powder, oral liquid, capsules or tablets.

The invention also provides a preparation method of the pharmaceutical composition, which comprises the following steps:

(1) decocting ramulus et folium taxi Cuspidatae and carapax Trionycis in water;

(2) adding the rest raw materials, and decocting to obtain decoction.

Further, the decocting time in the step (1) is 30-60 min; the decocting time in the step (2) is 0.5-2 h.

The invention also provides application of the pharmaceutical composition in preparing a medicament for treating cancer.

Further, the above-mentioned drug is a drug for treating solid tumor cancer, preferably a drug for treating lung cancer, liver cancer, lymphoma, breast cancer, cervical cancer, prostate cancer, stomach cancer, ovarian cancer or colorectal cancer, more preferably a drug for treating lung cancer.

Furthermore, the medicine is used for improving the curative effect of cancer patients and/or prolonging the survival time of the cancer patients.

The pharmaceutical composition can enhance the anti-cancer curative effect when being taken during the radiotherapy and chemotherapy, has low toxic and side effects, can be taken for a long time after the radiotherapy and chemotherapy is finished, enhances the immune function while inhibiting cancer, realizes a long-term and continuous anti-cancer effect, thereby improving the survival rate of cancer patients and having very good clinical application prospect.

The monarch drugs of the composition of the invention, namely the yew and the camptotheca acuminata fruit, the yew has the functions of strengthening heart, helping digestion, strengthening brain, refreshing mind, tranquilizing mind, warming stomach and benefiting liver; fructus Camptothecae Acuminatae has effects of resisting cancer, resolving hard mass, removing blood stasis; the ministerial drugs of glabrous sarcandra herb, astragalus and angelica, the glabrous sarcandra herb has the effects of clearing heat and cooling blood, promoting blood circulation and removing blood stasis, and dispelling wind and dredging collaterals; astragalus root, radix astragali, radix angelicae sinensis, herba patriniae, radix ranunculi ternati, carapax amydae and rhizoma ligustici wallichii, which have the effects of tonifying spleen and qi and promoting blood circulation, are used as adjuvant drugs for promoting blood circulation and removing blood stasis; herba Patriniae and radix Ranunculi Ternati have heat and toxic materials clearing away effects; removing blood stasis from Curcumae rhizoma; bie Jia soften hardness to dissipate nodulation and Zhu Ling induce diuresis and drain dampness. The medicines are used together to exert the effects of strengthening body resistance and banking up root and eliminating evil together so as to achieve the effects of tonifying qi and enriching blood, activating blood and dissolving stasis, clearing heat and detoxicating, and dissipating stagnation and reducing swelling, thereby realizing the anticancer effect.

Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.

The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.

Detailed Description

The raw materials and equipment used in the invention are known products and are obtained by purchasing commercial products.

Example 1 preparation of a pharmaceutical composition of the invention

6 parts of common camptotheca fruit, 5 parts of taxus chinensis, 5 parts of glabrous sarcandra herb, 10 parts of polyporus umbellatus, 20 parts of astragalus mongholicus, 9 parts of curcuma zedoary, 9 parts of turtle shell, 9 parts of herba patriniae, 9 parts of ternate buttercup root, 10 parts of ligusticum wallichii and 10 parts of angelica sinensis.

Decocting Taxus chinensis and carapax Trionycis in water for 30-60 min, adding the other materials, and decocting with slow fire for 0.5-2 hr to obtain decoction.

Example 2 preparation of a pharmaceutical composition of the invention

21 parts of common camptotheca fruit, 20 parts of taxus chinensis, 25 parts of glabrous sarcandra herb, 30 parts of polyporus, 50 parts of astragalus mongholicus, 30 parts of curcuma zedoary, 24 parts of turtle shell, 30 parts of herba patriniae, 30 parts of radix ranunculi ternati, 30 parts of ligusticum wallichii and 30 parts of angelica sinensis.

Decocting Taxus chinensis and carapax Trionycis in water for 30-60 min, adding the other materials, and decocting with slow fire for 0.5-2 hr to obtain decoction.

Example 3 preparation of a pharmaceutical composition of the invention

12 parts of common camptotheca fruit, 10 parts of taxus chinensis, 15 parts of glabrous sarcandra herb, 15 parts of polyporus umbellatus, 30 parts of astragalus root, 10 parts of zedoary, 10 parts of turtle shell, 15 parts of dahurian patrinia herb, 15 parts of ternate buttercup root, 12 parts of szechuan lovage rhizome and 12 parts of Chinese angelica.

Decocting Taxus chinensis and carapax Trionycis in water for 30-60 min, adding the other materials, and decocting with slow fire for 0.5-2 hr to obtain decoction.

The following experimental examples demonstrate the beneficial effects of the pharmaceutical composition of the present invention.

Experimental example 3, results of clinical tests

1. Clinical data

60 cases of the wide-term small cell lung cancer patients admitted by the Hospital of the three gorges Hospital affiliated to Chongqing university in 2016 and 1 to 2018 are clearly diagnosed through pathological and cytological examination, and are randomly divided into 2 groups according to the treatment sequence: study group: the traditional Chinese medicine anti-cancer treatment of the embodiment 3 is simultaneously taken orally during the period of the conventional radiotherapy treatment; control group: conventional radiotherapy treatment. Study group 32, 20 men and 12 women, mean age 60 ± 9.5 years; the control group had 28 cases, 18 men and 10 women, and the average age was 59. + -. 9.2 years. All cases have a score of more than or equal to 50 according to the health condition (Karnofsky), and are estimated to survive for more than 3 months without severe primary diseases and mental diseases of organs such as the center of gravity, brain, liver, kidney and the like, and hemogram, liver and kidney functions are in a normal range without surgical treatment.

2. Method of treatment

The control group and the study group are treated with standard EP regimen comprising etoposide (VP-16) + cisplatin (DDP) for 4 cycles, VP-16100 mg/m² d1、2、3+DDP 60mg/m²d1, 1 cycle × 4 times every 21 d. Radiotherapy is not a conventional treatment method, and palliative radiotherapy is considered only when the control group and the research group have local symptoms such as severe superior vena cava compression syndrome, spinal cord compression syndrome and the like.

The control group was treated with the above-described chemotherapeutic and radiotherapeutic regimen only.

The study group adopts the traditional Chinese medicine combined chemotherapy, and the chemotherapy scheme is the same as that of the control group; the main prescription of the medicine prescription comprises: 12 parts of common camptotheca fruit, 10 parts of taxus chinensis, 15 parts of glabrous sarcandra herb, 15 parts of polyporus umbellatus, 30 parts of astragalus root, 10 parts of zedoary, 10 parts of turtle shell, 15 parts of dahurian patrinia herb, 15 parts of ternate buttercup root, 12 parts of szechuan lovage rhizome and 12 parts of Chinese angelica. Decocting Taxus chinensis and carapax Trionycis in water for 30-60 min, adding the other materials, decocting with slow fire for 0.5-2 hr to obtain decoction, and decocting to obtain decoction 600ml for three times (example 3).

Starting on the first day of chemotherapy, continuously taking medicine for 2 weeks, then resting for 1 week, taking 200ml each time, 3 times daily, taking 0.5h before meal, and total treatment course is 4 cycles.

And (5) carrying out follow-up observation after the treatment of the control group and the research group is finished, and evaluating the curative effect.

3. Criteria for efficacy assessment

Before and after treatment, chest CT examination, liver and kidney function and blood routine detection are carried out on all patients. According to the evaluation standard of objective curative effect of Resist solid tumor, the method is divided into Complete Remission (CR), Partial Remission (PR), Stability (SD) and Progression (PD), the total effective rate is calculated by CR + PR, and adverse reaction is judged according to WHO standard.

4. Follow-up visit

The follow-up time of the patient is 1 year, the patient is rechecked 1, 3, 6, 9 and 12 months after treatment, the detection of enhanced CT, tumor markers and blood biochemical indexes is carried out, the change condition of the disease state is observed, and the curative effect is evaluated. All patients completed follow-up in 6 months of 2020.

5. Statistical analysis

Analysis was performed using SPSS13.0 statistical software. All measurements are expressed as median and count as percentage. The comparison of the rates among the groups adopts a Chi 2 test, a rank sum test, a survival analysis, a logrank test and the like, and the difference with P less than 0.05 has statistical significance.

6. Clinical effects

1. The effective rate is as follows: the total effective rates of the control group and the study group were 53.6% (15/28) and 75.0% (24/32), respectively, and the two groups were statistically different (χ 2 ═ 5.275, and P ═ 0.022). The above results show that the pharmaceutical composition of the present invention can effectively eliminate or reduce the target focus of cancer, treat cancer and improve the effective rate.

2. Survival analysis: median survival time. Study group: 11.6 months (95% CI: 10.9-12.5); control group: 7.8 months (95% CI: 7.2-8.6), and the two groups have significant statistical significance by log-rank test (x 2 is 27.903, P is less than 0.001); the 1-year survival rate of the control group was 32.1% (9/28), the study group was 53.3% (17/32), and the comparative differences between the two groups were statistically significant (χ 2 ═ 5.763, P < 0.05).

The above results demonstrate that the pharmaceutical composition of the present invention can increase median survival time and prolong the survival time of cancer patients.

3. Adverse reactions: myelosuppression is its major adverse reaction, all well tolerated, no treatment-related deaths. Bone marrow suppression: 5 samples (17.9%) of I degree, 8 samples (28.6%) of II degree, 5 samples (16.7%) of III degree and 3 samples (10.7%) of IV degree in a control group; the study groups were 4 degree I (12.5%), 8 degree II (25%), 6 degree III (18.8%), 2 degree IV (6.3%), and the two groups compared had no statistical significance (P > 0.05).

The results show that the pharmaceutical composition has small toxic and side effects and slight adverse reaction, and can be well tolerated by patients.

In conclusion, the invention provides the pharmaceutical composition for treating the cancer, which can enhance the anti-cancer curative effect when being taken during the radiotherapy and chemotherapy, has low toxic and side effects, can be taken for a long time after the radiotherapy and chemotherapy is finished, can inhibit the cancer and enhance the immune function at the same time, and realizes the long-term and continuous anti-cancer effect, thereby improving the survival rate of cancer patients and having very good clinical application prospect.