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Composition containing glucosamine as well as preparation method and detection method thereof

A technology of glucosamine sulfate and sodium chloride, which is applied in the direction of medical preparations containing active ingredients, drug combinations, and pharmaceutical formulas, to achieve the effects of reducing side effects, reliable application, and satisfying industrial production

Active Publication Date: 2014-07-16
任金山 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] CN201010270516 discloses glucosamine freeze-drying and injection preparations and production methods thereof, but the freeze-drying preparations and production methods also have the following defects: because the freeze-drying preparations are After the scale-up production of the preparation process, the temperature and vacuum degree of the freeze dryer are different at different positions, resulting in differences in the ice crystal form and drying speed of the same batch of drugs, and the drying time is determined by the product with the slowest drying rate. Therefore, the current glucosamine The freeze-dried preparations of the above-mentioned lyophilized preparations have a long freeze-drying time and high energy consumption, which is not conducive to actual production, and the same batch of freeze-dried preparations has large differences in morphology and reconstitution; in addition, the injection preparations are heat-sterilized and stored. The process easily produces degradation products such as 5-hydroxymethylfurfural, N-acetylglucosamine and 2,6-dimethylaniline, and these degradation substances not only affect the curative effect of the drug, but also bring various toxic and side effects. Affect the safety and effectiveness of the injection

Method used

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  • Composition containing glucosamine as well as preparation method and detection method thereof
  • Composition containing glucosamine as well as preparation method and detection method thereof
  • Composition containing glucosamine as well as preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1 Glucosamine sulfate injection (0.4g in terms of glucosamine sulfate)

[0052]

[0053] Preparation process: Take 80% of water to make 0.001mol / L hydrochloric acid solution, add glucosamine sulfate sodium chloride double salt and stir at 55°C to dissolve completely, then add 0.02% activated carbon, stir at 75°C for 20min, After decarbonization, add 0.01% activated carbon and lidocaine hydrochloride in the prescribed amount to the solution, stir at 45°C for 10 minutes, decarbonize, filter through 0.45 μm and 0.22 μm microporous membranes until clear, and the liquid is cooled Add water to a sufficient amount at 20°C, then adjust the pH value of the solution to 4.6, fill with 2ml, and finally sterilize at 121°C for 17 minutes.

[0054] Separately prepare a special solvent, as follows: 20g of diethanolamine plus 1000ml of water for injection to make 1000 vials. Preparation process: Weigh the above prescription amount of alkaline regulator diethanolamine, add...

Embodiment 2

[0055] Embodiment 2 Glucosamine sulfate injection (0.4g in terms of glucosamine sulfate)

[0056]

[0057] Preparation process: Take 80% water to prepare 0.001mol / L hydrochloric acid solution, add glucosamine sulfate sodium chloride double salt and stir to dissolve completely, then add 0.02% activated carbon, stir at room temperature for 20min, decarbonize, and then pour into the solution Add 0.01% activated carbon and lidocaine hydrochloride in the prescription amount, stir at room temperature for 10 minutes, decarbonize, filter through 0.45 μm, 0.22 μm microporous membranes until clarification, add water to a sufficient amount when the liquid is cooled to 20°C , and then adjust the pH value of the solution to 4.6, fill with 2ml, and finally sterilize at 121°C for 17min.

[0058] Special solvent is prepared with the method of embodiment 1.

experiment example 1

[0059] Experimental example 1: Due to the reaction process of 5-hydroxymethylfurfural, it is considered that this process is composed of a series of elementary reactions such as protonation, dehydration and deprotonation, among which protonation is relatively easy, and the energy barrier of deprotonation reaction is relatively low. High, is the rate-determining step of the conversion process. Therefore, changes in temperature have a greater effect on the decomposition of glucosamine than changes in pH. According to the preparation method of Example 4 in the CN201010270516 patent application, take 80% water to prepare hydrochloric acid solution, after the active ingredient is dissolved and add enough water, the pH reaches 5.5, 5.0, 4.7, 4.4, 4.2, 4.0, 3.5, 3.0 , 2.0, 1.0, and finally sterilized at 121°C for 17min. Simultaneously, the pH of Comparative Example 1 reached 5.5, 5.0, 4.7, 4.6, 4.4, 4.2, 4.0, and 3.5 before sterilization, and finally sterilized at 121° C. for 17 min...

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Abstract

The invention discloses an injection containing glucosamine sulfate double salt, the active ingredients of which are glucosamine sulfate double salt and lidocaine hydrochloride. The injection described in the invention is preferably a small-volume injection, and the injection further includes antioxidants, pH regulator and alkaline solvent, the injection of the present invention overcomes the long freeze-drying time of the freeze-dried preparation of glucosamine in the prior art, high energy consumption, and is unfavorable for production, and the freeze-dried preparation of the same batch is different in form and recombination. The defect that there is a large difference in solubility has realized the control of the stability of the injection and related substances, and reduced the side effects caused by the degradation products, thereby meeting the requirements of the safety and stability of the injection. Therefore, the amino acid provided by the present invention The glucose injection can satisfy industrial production, and can be safely and reliably applied in the field of medicine.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and particularly relates to injections containing glucosamine sulfate double salts and the detection of components therein. Background technique [0002] Amino dextran is a natural sugar derived from chitin, which is the main component of the cartilage matrix. By changing its side chain structure, it is easier to combine with water in the articular cartilage to maintain the lubrication of the joint cavity and buffer pressure. It has a certain protective effect on damaged chondrocytes and can be artificially synthesized. Currently, glucosamine, glucosamine hydrochloride, glucosamine sulfate sodium chloride double salt or potassium chloride double salt are commonly used. Glucosamine is one of the smallest units that make up polyglucosamine, and it forms polyglucosamine with uronic acid, including chondroitin sulfate, keratan sulfate, dermatan sulfate and hyaluronic acid. [0003] Amino ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7008A61K31/167A61K9/08A61P29/00A61P19/02G01N30/02
Inventor 任金山俞嘉林权晓丹丛艳张瑾邹爱峰吴晶晶
Owner 任金山
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