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Preparation method of paclitaxel injection

A paclitaxel and injection technology, applied in the field of biomedicine, can solve problems such as hypersensitivity, and achieve the effects of low production energy consumption, high production efficiency, and good solubility

Active Publication Date: 2018-12-21
海南卓泰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Therefore, the technical problem to be solved by the present invention is to overcome the technical defect that existing paclitaxel injections easily cause hypersensitivity reactions, thereby proposing a paclitaxel injection with low dosage of polyoxyethylene castor oil, stable product, good solubility and low side effects and preparation method

Method used

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  • Preparation method of paclitaxel injection
  • Preparation method of paclitaxel injection
  • Preparation method of paclitaxel injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Example 1: A paclitaxel injection

[0021]

[0022] The preparation method is:

[0023] A. Prepare the materials according to the production prescription, and weigh the original and auxiliary materials according to the prescription and reserve;

[0024] B. Add one-third of the prescription amount of absolute ethanol to paclitaxel, ultrasound, add four-fifths of the prescription amount of polyoxyethylene castor oil, and one-half of the prescription amount of lactic acid, and mix thoroughly;

[0025] C. Pre-freeze the solution at -50°C for 3 hours; then sublimate and dry at -15°C for 12 hours; then increase the temperature to 30°C for re-drying, for 6 hours, pre-freeze, sublimate and dry, and then Paclitaxel freeze-dried powder is obtained in the drying stage;

[0026] D. Take the paclitaxel lyophilized powder obtained in step C, add the remaining amount of absolute ethanol to ultrasonically dissolve, add the remaining amount of polyoxyethylene castor oil and the remaining amount ...

experiment example 1

[0040] Experimental Example 1 Stability Comparison Study Results

[0041] The paclitaxel injection in Example 1 of the present invention and the products prepared in Comparative Example 1 and Comparative Example 2 were subjected to accelerated tests and long-term tests to determine various indicators.

[0042] Accelerated test

[0043] Take trial samples and place them at 40℃±2℃ / RH75±5% for 6 months for accelerated test investigation. Samples were taken at the end of the first 1, 2, 3, and 6 months, and the inspection items were tested according to the inspection method of the national standard for paclitaxel injection WS1-(X-026)-2001Z, and the results were compared with those in 0 months. The results are as follows in Table 1:

[0044]

[0045] Long-term test Take trial samples and place them under the conditions of temperature 25℃±2℃ and relative humidity 60%±10% for long-term test. Samples were taken at the end of the 0th and 6th months, and the inspection items were tested acco...

experiment example 2

[0050] Experimental example 2 Allergy test

[0051] The injection prepared in Example 1 of the present invention and the injection in Comparative Examples 1-2 were used for animal experiments, and converted into the same effective amount of paclitaxel before use.

[0052] Allergy test method: Take 18 guinea pigs and randomly divide them into three groups. Inject 6mg / mL paclitaxel injection into the intraperitoneal cavity at a dose of 3mg / head, once every other day, three times in a row, on the 14th and 21st days after the first injection. The group took 3 guinea pigs each time and challenged them by intravenous injection of 6 mg / mouse, and judged the allergic reaction score according to Table 4's systemic allergic reaction rating standard.

[0053]

[0054]

[0055] The results are shown in Table 5 (average value):

[0056]

[0057] From the results in Table 5, it can be seen that the allergic reaction of paclitaxel injection of the present invention is between 0-1 grade, and the alle...

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PUM

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Abstract

The invention discloses a preparation method of paclitaxel injection. A formula comprises the following components: 30 parts by weight of paclitaxel, 1000 to 1500 parts by volume of anhydrous ethanol,18 to 24 parts by volume of lactic acid, and 1000 to 1500 parts by volume of polyoxylethylene castor oil ether (35). Compared with the prior art, the prepared paclitaxel injection is high in solubility, uniform in concentration, stable in quality, and low in acute adverse reaction, and the preparation method is simple, easy to control, high in production efficiency, and low in production energy consumption.

Description

Technical field [0001] The invention belongs to the technical field of biomedicine, and specifically relates to a preparation method of paclitaxel injection. Background technique [0002] Paclitaxel is a natural plant extract anti-tumor drug that effectively treats a variety of cancers. It is widely used in the treatment of ovarian cancer, breast cancer, lung cancer and other tumors. It has outstanding effects on breast cancer and ovarian cancer. It is effective for liver cancer, lung cancer, and esophagus. Cancer, head and neck cancer and prostate cancer also have certain curative effects, and when combined with other commonly used anti-tumor drugs, the curative effect can be further improved, because the unique anti-cancer mechanism is widely used in clinical practice. However, paclitaxel has very poor water solubility, is difficult to dissolve in water, and has low bioavailability. Therefore, it is difficult to prepare it into a preparation for intravenous injection or infusio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/337A61K47/44A61K47/12A61K47/10A61P35/00
CPCA61K9/0019A61K9/08A61K31/337A61K47/10A61K47/12A61K47/44A61P35/00
Inventor 魏雪纹陈华奇
Owner 海南卓泰制药有限公司
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