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Large-sized ligustrazine phosphate drop pill

A Ligustrazine Phosphate, large-scale technology, applied in the field of large-scale Ligustrazine Phosphate dripping pills, can solve the problems of less drug loading, more pills to take, and incapable of industrial production, and achieve strong controllability of quality indicators and high technological efficiency. Good reproducibility and large drug loading effect

Inactive Publication Date: 2019-12-20
BEIJING JIUFA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Now commercially available Ligustrazine Phosphate Dropping Pills, the specification is 12.5mg / pill, the matrix is ​​polyethylene glycol 4000, the main and auxiliary ratio is 1:3, and the dosage is 8 pills each time. Many, bring inconvenience to the patient, according to the preparation method of existing Ligustrazine Phosphate Dropping Pills, prepare large-scale dripping pills, its roundness, pill weight difference unqualified rate is as high as about 60%, and there is tailing in the dripping process Phenomenon, unable to carry out industrial production

Method used

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  • Large-sized ligustrazine phosphate drop pill

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] In order to investigate Ligustrazine Phosphate: the difference in quality of the drop pills made when the ratio of base is 1:1, according to the ratio of 1:1, Ligustrazine Phosphate was mixed with polyethylene glycol respectively. 1500 , polyethylene glycol 2000 , polyethylene glycol 4000 , polyethylene glycol 6000 , polyoxyl 40 stearate, poloxamer, sodium carboxymethyl starch, sodium lauryl sulfate, stearic acid, glycerin, gelatin and pharmaceutically acceptable carriers, according to the provisions in the "preparation method" According to the steps of preparation, 11 pharmaceutical composition experiments containing ligustrazine phosphate and different substrates can be obtained, and 11 groups of different experimental results are obtained, as shown in Table 1.

[0032] Table 1 Combination experiment of ligustrazine phosphate and single matrix

[0033] (Ligustrazine Phosphate: Matrix = 1:1)

[0034] serial number Matrix name Rounding rate (%) Dissol...

Embodiment 2

[0036] In order to investigate Ligustrazine Phosphate and the difference in quality of Ligustrazine Phosphate Dropping Pills prepared when the ratio of different substrates is 1: 3, according to the ratio of 1: 3, the ratio is carried out with the substrate described in Example 1, according to The preparation was carried out according to the steps specified in the "preparation method", and 11 groups of different experimental results were obtained, as shown in Table 2.

[0037] Table 2 Combination experiment of ligustrazine phosphate and single matrix

[0038] (Ligustrazine Phosphate: Matrix = 1:3)

[0039] serial number Matrix name Rounding rate (%) Dissolution time limit (minutes) Pill Weight Difference (%) hardness 1 polyethylene glycol 1500

Embodiment 3

[0041] In order to investigate Ligustrazine Phosphate and the difference in quality of Ligustrazine Phosphate Dropping Pills made when the ratio of different substrates is 1:5, according to the ratio of 1:5, the ratio is carried out with the substrate described in Example 1, according to The preparation was carried out according to the steps specified in the "preparation method", and 11 groups of different experimental results were obtained, as shown in Table 3.

[0042] Table 3 Combination experiment of ligustrazine phosphate and single matrix

[0043] (Ligustrazine Phosphate: Matrix = 1:5)

[0044]

[0045]

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Abstract

The present invention discloses a large-sized ligustrazine phosphate drop pill. The large-sized ligustrazine phosphate drop pill consists of a raw material to a matrix at a ratio of 1:1 to 1:5 in parts by weight, and is prepared by an air pressure pulse type dropping method. Weight of the pill can be controlled at about 300 mg, during production processes, process reproducibility is good, controllability of quality indicators of roundness, dissolution, etc. is strong, a pass rate can reach 96% or more, and the large-sized ligustrazine phosphate drop pill meets requirements of quality standardsand can be subjected to industrialized production. Due to large drug load, only 1 pill is taken at a time, which brings convenience to patients.

Description

technical field [0001] The invention belongs to the field of pharmaceutical technology research and development, in particular to a large-scale ligustrazine phosphate dripping pill. Background technique [0002] Ischemic cerebrovascular disease has the characteristics of high morbidity, high mortality and disability rate, and high recurrence rate. In my country, its incidence rate is increasing year by year, such as cerebral thrombosis, cerebral infarction, cerebral vasospasm, and transient ischemic attack. [0003] Ligustrazine is the active ingredient in the rhizome of Ligusticum chua-nxiong Hort., a traditional Chinese medicine Umbelliferae plant. It has the characteristics of definite curative effect, rapid action and small side effects. Clinically, it is mainly used for the treatment of occlusive vascular disease, coronary heart disease, angina pectoris, vasculitis, and for the acute phase, recovery phase and sequelae of ischemic cerebrovascular disease, such as cerebr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4965A61K47/10A61K47/38A61P9/10
CPCA61K9/2031A61K9/2059A61K31/4965A61P9/10
Inventor 柏吉哲刘玉泉
Owner BEIJING JIUFA PHARMA
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