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Injecting tanshinone II and its derivative concentrated solution and its production

A technology of tanshinone and derivatives, applied in the field of preparation of the concentrated solution for injection, can solve the problems of reducing the stability and quality of the preparation, large allergic reaction, complicated use and the like, and achieves increasing the scope of use, reducing degradation, and achieving clinical use. handy effect

Inactive Publication Date: 2007-11-21
秦长青
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently commercially available Tanshinone II A The specification of sodium sulfonate injection is only 2ml: 10mg, which is mainly due to the fact that Tanshinone II A The sodium sulfonate structure still contains larger non-polar groups, and the solubility of aqueous solution at room temperature is relatively small, so the unit dose of commercially available products cannot be improved, resulting in commercially available tanshinone II A The unit dosage of sodium sulfonate injection is on the low side. From the perspective of pharmaceutical preparations, the design is unreasonable, and more than 4 to 8 times of packaging materials are wasted, more labor resources are consumed, and it is also a great harm to social wealth. waste, also caused the clinical use of Tanshinone II A For sodium sulfonate injection, 4 to 8 injections must be used each time, which increases the chance of drug contamination, affects the safety of drugs, and is cumbersome to use, increasing the workload of medical staff
At the same time, due to the highly oxidized polyphenyl ring in the structure, Tanshinone II A Sodium Sulfonate and Tanshinone II A In the aqueous solution state, it is extremely unstable to light and heat, and it is prone to oxidation, polymerization and decomposition reactions, which reduces the stability and quality of the preparation, causes adverse reactions, and even serious medical accidents, especially as the preparation is placed for a long time. Prolonged, the greater the probability of allergic reactions, seriously affecting its clinical application

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1: Tanshinone II for injection A Preparation of sodium sulfonate concentrated solution (2ml: 40mg)

[0037] Prescription: Tanshinone II A Sodium sulfonate (as C 19 h 17 NaO 6 S gauge) 40g

[0038] Tween-80 1000ml (about 2160g)

[0039] Propylene glycol 1000ml

[0040] Make 1000 pieces

[0041] Preparation:

[0042] (1) Accurately weigh the sodium tanshinone IIA sulfonate (in C) of the prescription amount in the aseptic operation room 19 h 17 NaO 6 S) 40g, 900ml of propylene glycol through depyrogenation treatment and 1000ml of Tween-80 through depyrogenation treatment are placed in a suitable aseptic, non-pyrogenic container, and stirred to mix evenly;

[0043] (2) The above solution is sterilized by fine filtration (0.22 μm), and after filtration, add propylene glycol to make up the full amount (2000ml / 1000 bottles);

[0044] (3) The solution is submitted for inspection (assay);

[0045] (4) ...

Embodiment 2

[0048] Embodiment 2: Tanshinone II for injection A Preparation of sodium sulfonate concentrated solution (2ml: 40mg)

[0049] Prescription: Tanshinone II A Sodium sulfonate (as C 19 h 17 NaO 6 S gauge) 40g

[0050] Tween-80 1000ml Absolute Ethanol 1000ml

[0051] Make 1000 pieces

[0052] The preparation method is the same as in Example 1.

Embodiment 3

[0053] Embodiment 3: Tanshinone II for injection A Preparation of sodium sulfonate concentrated solution (2ml: 40mg)

[0054] Prescription: Tanshinone II A Sodium sulfonate (as C 19 h 17 NaO 6 S meter) 40g

[0055] Tween-80 1000m Propylene Glycol 1000ml

[0056] Sodium Calcium Edetate 0.25g

[0057] Make 1000 pieces

[0058] Preparation method is the same as embodiment 1, wherein step (1) is to accurately weigh the sodium tanshinone IIA sulfonate (in C) of prescription quantity in aseptic operation room 19 h 17 NaO 6 S) 40g, 0.25g of sodium calcium edetate, 900ml of depyrogenated propylene glycol and 1000ml of depyrogenated Tween-80 were placed in a suitable aseptic and pyrogen-free container, and stirred to make the mixture even ;

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PUM

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Abstract

The invention is concerned with the injecting thick solution and the preparation method that prepares by Tanshinone IIA or Sodium Tanshinone IIA.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, more specifically, a tanshinone II A , Tanshinone II A One of the sodium sulfonates is a concentrated solution for injection prepared as a raw material, and the invention also relates to a preparation method of the concentrated solution for injection. Background technique [0002] Tanshinone II A It is one of the main active ingredients in Salvia miltiorrhiza, which has excellent anti-inflammatory and antibacterial effects, as well as promoting blood circulation and removing blood stasis. Tanshinone II A It is almost insoluble in water, which greatly limits its application in the pharmaceutical industry, especially in the field of medical injections. Currently, only Tanshinone II is clinically used as an injection A Sodium sulfonate injection, which is Tanshinone II A Small-volume injection made after sulfonation to increase water solubility. According to clinically used Tanshino...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/343A61K47/10A61K47/32A61P9/00A61P31/04
Inventor 秦长青
Owner 秦长青
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