Method for determining contents of auxiliary materials in lamivudine tablet
A technology for lamivudine tablets and lamivudine tablets, which is applied in the field of determining the content of excipients in lamivudine tablets, and can solve performance differences such as tablet dissolution, content uniformity, and drug stability, and titration methods Problems such as manual operation and low efficiency of titration method can achieve the effect of reducing the probability of defective lamivudine tablets, good quality control of drugs, and high accuracy
Pending Publication Date: 2021-06-25
HINYE PHARM CO LTD
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Problems solved by technology
In the actual production process, it is found that even if the difference of the main active ingredient is controlled to remain unchanged, when there is a slight change in the components of each auxiliary material, the dissolution, content uniformity, and drug stability of the final tablet are limited by the granulation, coating and other processes. There will be large differences in properties such as sex
[0009] For each adjuvant in the lamivudine tablet, Chinese Pharmacopoeia (2015) fourth part No. 608 and page 586 stipulate the identification and content determination methods of carboxymethyl starch sodium and magnesium stearate, but all adopt the titration method On the one hand, the titration method is inefficient, and on the other hand, most of the titration methods are manually operated, with large errors, which is not conducive to quality control in the industry
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Embodiment 1
[0073] A method for determining auxiliary auxiliary tablet in a lamifer tablet comprising the steps of:
[0074] S1 carboxymeta sodium content detection
[0075] S1.1 solution formulation
[0076] Standard curve solution : The precision amount of sodium standard solution is given, and the sodium containing sodium, 2 μg, 5 μg, 10 [mu] g, 2 μg, 5 μg, 10 μg, and 20 μg, the concentration is the abscissive, and the absorbance is longitudinally. Linear regression , Standard curve of sodium, as follows figure 1 As shown, it is a linear relationship of sodium.
[0077] by figure 1 It can be seen that sodium is in the concentration range of 0-20 μg / ml, with a concentration of a horizontal coordinate, the resulting regression curve is [A] = 0.0091 * [C] -0.0005; the correlation coefficient R is 0.99976, indicating that the analysis method has a good linear relationship in the range of 0-20 μg / ml concentration.
[0078] Test solution solution
[0079] Take 20 pieces of this product to ...
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The invention relates to the technical field of drug content detection, in particular to a method for determining the contents of auxiliary materials in a lamivudine tablet. The method comprises the following steps of: S1, measuring the content of carboxymethyl starch sodium in a lamivudine tablet core; S2, measuring the content of magnesium stearate in the lamivudine tablet core; S3, determining the content of lamivudine; and S4, calculating the content of microcrystalline cellulose according to the following formula: the content of microcrystalline cellulose = 100% - the content of lamivudine - the content of carboxymethyl starch sodium - the content of magnesium stearate. The method for determining the contents of auxiliary materials in a lamivudine tablet is simple to operate and high in accuracy, and the method is beneficial for an enterprise to reduce the defective rate of lamivudine tablets, better control the quality of drugs and realize the consistency of the quality and the curative effect of the lamivudine tablets and an original research drug.
Description
Technical field [0001] The present invention relates to the field of drug content detection, and more particularly to a method of determining an accessory content in a lamifer tablet. Background technique [0002] Lamivudine is a new type of nucleotide antiviral drug, and the structural formula is as shown in Formula I. [0003] [0004] Ramiv is synthesized by the nucleoside analog, in which it is not active, and in terms of phosphoric acid derivative in cell phosphoric acid, inhibits HBV-DNA synthesis by competitive inhibition of hepatitis B virus (HBV) polymerase. At the same time, the interruption of the chain is bonded to the newly synthetic HBV, thereby replication of HBV viruses. British Glax Operations (UK) LTD first developed and produced Ramiv, first listed in the United States in 1995. LamivudinetaBlets were developed by GlaxoWikang in 1998 and was allowed to be listed in the United States. In 1999, it entered the Chinese market in 1999, approved for chronic hepatiti...
Claims
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Login to View More IPC IPC(8): G01N30/02G01N30/06G01N30/72G01N30/74
CPCG01N30/02G01N30/06G01N30/72G01N30/74
Inventor 程雪清张海霞唐昭春刘雁鸣
Owner HINYE PHARM CO LTD