Pharmaceutical composition for treating small cell lung cancer and application, kit and package thereof

A small cell lung cancer and kit technology, applied in drug combination, packaging, drug delivery, etc., can solve problems such as unsatisfactory curative effect, second-line treatment, patient recurrence, etc., and achieve excellent therapeutic effect and less toxic and side effects

Active Publication Date: 2011-09-07
海南长安国际制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the effective rate of small cell lung cancer radiotherapy and chemotherapy is high at the initial stage, most patients relapse and need second-line tre...

Method used

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  • Pharmaceutical composition for treating small cell lung cancer and application, kit and package thereof
  • Pharmaceutical composition for treating small cell lung cancer and application, kit and package thereof
  • Pharmaceutical composition for treating small cell lung cancer and application, kit and package thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1 This experiment compared and observed the effectiveness and safety of lobaplatin freeze-dried combined with etoposide injection and lobaplatin freeze-dried single product in the treatment of extensive-stage small cell lung cancer.

[0036] Drugs used:

[0037] 1. Lobaplatin (LBP) for injection: 10mg / bottle, white lyophilized powder, batch number 20070101, each bottle contains 10mg lobaplatin in anhydrous form; produced by Hainan Changan International Pharmaceutical Co., Ltd.;

[0038] 2. Etoposide injection (VP-16): the specification is 5ml: 100mg, colorless to light yellow clear liquid, excipients are polyethylene glycol 400, absolute ethanol, Tween-80, citric acid, each A 5ml injection contains 100mg etoposide; produced by Qilu Pharmaceutical Co., Ltd.

[0039] Treatment plan and treatment effect evaluation plan:

[0040] 1. General Information

[0041] 120 patients with extensive stage SCLC were diagnosed by pathology and randomly divided into two groups...

Embodiment 2

[0073] Example 2 This experiment compared and observed the effectiveness and safety of lobaplatin freeze-dried combined with etoposide injection and cisplatin freeze-dried combined with etoposide injection for the first-line treatment of small cell lung cancer.

[0074] Drugs used:

[0075] 1. Lobaplatin (LBP) for injection: 10mg / bottle, white lyophilized powder, batch number 20070101, each bottle contains 10mg lobaplatin in anhydrous form; produced by Hainan Changan International Pharmaceutical Co., Ltd.;

[0076] 2. Etoposide injection (VP-16): 5ml: 100mg / bottle, colorless to light yellow clear liquid, excipients are polyethylene glycol 400, absolute ethanol, Tween-80, citric acid, each 5ml injection contains 100mg etoposide; produced by Qilu Pharmaceutical Co., Ltd.

[0077] 3. Cisplatin (DDP) for injection: 10mg / bottle; yellow powder, batch number 36-014050304, excipients: mannitol, sodium chloride. Each bottle contains cisplatin 10mg in anhydrous form, produced by Jiang...

experiment example 3

[0111] Experimental example 3 Evaluation experiment of the effect of changes in the dosage of lobaplatin and etoposide on the therapeutic effect

[0112] Select 40 patients with extensive-stage SCLC diagnosed by pathology, with an average weight of (70.0±0.5) KG, an average height of (1.66±0.15) meters, and an average body surface area of ​​(1.61±0.22) m 2 , by dose escalation (dose climbing) test, determine the optimal dose of LBP combined with VP-16 for the treatment of SCLC (the LBP and VP-16 used are the same as in Example 1), evaluate the effective rate of treatment, disease control rate, and safety as Check indicators. Dose-limiting toxicity (DLT) is defined as: ANC (neutropenia), PLT (thrombocytopenia) or anemia of CTCAE grade 4 in the first cycle of the subject, or CTCAE grade 3 or 4 (except nausea, vomiting and alopecia) Hematological toxicity. VP-16 and LBP are increased from low doses respectively, divided into 4 grades, VP-16 respectively: 90mg / m 2 (average dail...

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Abstract

The invention relates to a pharmaceutical composition for treating small cell lung cancer and application, a kit and package thereof. The pharmaceutical composition, kit and package contain a treatment effective dose of lobaplatin and a treatment effective dose of etoposide as a combination for simultaneous, separated or sequential use. When used for treating the small cell lung cancer, the pharmaceutical composition, kit and package provided by the invention can obtain excellent treatment effect and have small toxic side effect.

Description

technical field [0001] The invention relates to an anticancer pharmaceutical composition, in particular to a pharmaceutical composition for treating small cell lung cancer and its application. Background technique [0002] In recent years, the incidence of lung cancer, primary liver cancer, colorectal cancer, and gynecological malignant tumors has increased year by year, and has become the most common malignant tumor that seriously endangers human health, bringing many changes to our society, economy, and life. . [0003] Lung cancer is a tumor with a high incidence rate at present. Small cell lung cancer (SCLC) is an undifferentiated cancer type of lung cancer, accounting for about 20-25% of lung cancer. Small cell lung cancer is divided into limited stage and extensive stage. Most small cell lung cancers have been diagnosed as extensive stage, and limited stage accounts for up to 1 / 3. It is derived from the malignant transformation of lung Kulchitsky cells (Kulchitsky ce...

Claims

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Application Information

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IPC IPC(8): A61K31/282A61K31/7048A61K9/08A61K9/48A61K9/20A61P35/00B65D77/00B65D77/24
Inventor 秦叔逵窦啟玲隋东虎冯志刚
Owner 海南长安国际制药有限公司
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