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Antisense oligonucleotide injection for treating liver cancer and preparation method thereof
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A technology of antisense oligonucleotides and injections, which is applied in the application field of liver cancer treatment and combined chemotherapy with chemotherapy, can solve the problems of liver cancer without chemotherapy and poor liver cancer effect, and achieve quality control, good inhibitory effect, and good stability Effect
Inactive Publication Date: 2013-08-14
HANGZHOU TIANLONG PHARM CO LTD +1
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The effect of chemotherapy on liver cancer is poor: According to statistics, the effective rate is about 11%, but the serious side effects are almost caused by chemotherapy drugs, so in principle, chemotherapy is not used for liver cancer
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Embodiment 1
[0045] Cancer Taide 100g
[0046] Water for injection 2500ml
[0047] Make 1000 bottles (100mg / 2.5ml)
[0048] Preparation method: Weigh Aitide and dissolve it in 1000ml water for injection, stir until it is completely dissolved, add water for injection to the full amount, and mix well. Filter with a 0.22 μm microporous membrane, then fill, and freeze-dry (in the freeze dryer, turn on the freeze dryer, cool down to -45°C, and pre-freeze for 3 hours; gradually warm up to -25°C in 8 hours, and pump continuously Vacuum for 8 hours; take 5 hours to naturally heat up to -10°C, keep warm for 2 hours; take 2 hours to heat up to 0°C, keep warm for 2 hours, and continue vacuuming; take 4 hours to heat up to 25°C, continue vacuuming for 8 hours, to After the product curve and the vacuum degree curve tend to be consistent, the freeze-drying ends; the carefully filtered protective gas nitrogen is filled into the freeze dryer to protect the product; automatic plugging), and the cap is re...
Embodiment 2
[0050]
[0051] Preparation method: Weigh mannitol, dissolve it with 600ml water for injection, and set aside; then weigh Ataide, dissolve it in 1000ml water for injection, slowly add the prepared mannitol solution into Ataide solution, and keep Stir and mix well, add water for injection to the full amount. Filter with a 0.22 μm microporous membrane, then fill, freeze-dry (same as in Example 1), and crimp the cap to obtain the product.
Embodiment 3
[0053]
[0054] Preparation method: Weigh glucose, dissolve it with 600ml water for injection, and set aside; then weigh Ataide, dissolve it in 1000ml water for injection, slowly add the prepared glucose solution into Ataide solution, and keep stirring to mix Mix well, add water for injection to the full amount. Filter with a 0.22 μm microporous membrane, then fill, freeze-dry (same as in Example 1), and crimp the cap to obtain the product.
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Abstract
The purpose of the invention is to provide an injection preparation for liver cancer resistance with an antisense oligonucleotide drug Aitaide (which has a sequence of 5'-ACT CAC TCA GGC CTC AGA CT-3') as an active component, and a preparation method thereof. The injection comprises a lyophilized powder injection or a concentrated solution for preparing a solution before clinical intravenous drip, is prepared by the single-dose active component Aitaide and pharmaceutically effective additives, has a pH of 7-9, a content specification of 10 mg-500 mg; the pharmaceutically effective additives comprise 0-5% of antioxidants, 0-60% of fillers, 0-10% of stabilizers, 0-10% of pH regulators, and 0-10% of ionic strength regulators, and the above percentages are the percentage ratios of the total component mass to the solution volume. The antisense oligodeoxynucleotide injection for treating liver cancer of the invention has good inhibition effect on hepatoma cells, controllable quality, and good stability.
Description
technical field [0001] The invention belongs to the field of chemical pharmacy, and is an injection preparation with an antisense oligonucleotide drug Aitide (its sequence is: 5'-ACT CAC TCAGGC CTC AGA CT-3') as an active ingredient for the treatment of liver cancer and its application in combination with chemotherapy. Background technique [0002] At present, the main treatment methods for liver cancer are: surgical resection is the main method for small single liver cancer without metastasis, and interventional therapy and traditional Chinese medicine treatment can be considered for inoperable middle and advanced liver cancer. The effect of chemotherapy on liver cancer is relatively poor: According to statistics, the effective rate is about 11%, but the serious side effects are almost all caused by chemotherapy drugs, so chemotherapy is not used in principle for liver cancer. Antisense oligonucleotides are a new gene-targeted drug that can interfere with the production of...
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