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A kind of preparation method of phosphate-ligustrazine microporous osmotic pump controlled-release tablet

A technology of osmotic pump controlled release and ligustrazine, applied in the field of osmotic pump, can solve the problems of complex technology of osmotic pump preparation, difficult industrialization and the like

Active Publication Date: 2022-01-07
GUANGDONG PHARMA UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the multi-layer osmotic pump preparation technology is complex and difficult to industrialize

Method used

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  • A kind of preparation method of phosphate-ligustrazine microporous osmotic pump controlled-release tablet
  • A kind of preparation method of phosphate-ligustrazine microporous osmotic pump controlled-release tablet
  • A kind of preparation method of phosphate-ligustrazine microporous osmotic pump controlled-release tablet

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Experimental program
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Effect test

Embodiment 1

[0029] A preparation method of phosphoric acid-ligustrazine microporous osmotic pump controlled-release tablet, comprising the steps of:

[0030] S1. Preparation of the tablet core: the prescription composition of the tablet core is as follows:

[0031] Prescription A tablet core: Ligustrazine phosphate 100mg, sodium citrate 40mg (30mg, 40mg, 50mg, 60mg), lactose monohydrate 320mg (330mg, 320ng, 310mg, 300mg), 20% of the prescription amount of PVPK30 (15%, 18%, 20%, 22%), magnesium stearate 4.6mg;

[0032] Prescription B tablet core: Ligustrazine phosphate 100mg, sodium tartrate 60mg (40mg, 60mg, 80mg, 100mg), lactose monohydrate 300mg (320mg, 300mg, 280mg, 260mg), PVP K30 20% 20% (15% , 18%, 20%, 22%), magnesium stearate 4.6mg.

[0033] Preparation method: Mix phosphoric acid-ligustrazine, sodium citrate or sodium tartrate, and lactose monohydrate through a 60-mesh sieve, add 20% PVP K30 (95% ethanol) solution binder, make soft material, and dry at 4°C , adding whole granu...

Embodiment 2

[0040] Measure the drug release capacity of the phosphoric acid-ligustrazine microporous osmotic pump controlled-release tablet prepared in Example 1 according to the routine test method in this area, and its drug release curve is as follows figure 1 with 2 shown. In addition, the fitting results of the in vitro release model are shown in Table 1 and Table 2.

[0041] Table 1. In vitro release model fitting results (formulation A)

[0042]

[0043] Table 2. In vitro release model fitting results (formulation B)

[0044]

[0045] Three batches of samples were prepared in the pilot scale-up test, and the reproducibility of the 24h release in vitro was investigated, and the release curves were fitted. Results The similarity of the release curves of two formulations and three batches of samples f 2 Between 84 and 97, the batch-to-batch reproducibility is good. The drug release model was fitted to the release curves of the same batch of preparations. The zero-order relea...

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Abstract

The invention discloses a preparation method of Ligustrazine Phosphate-Ligustrazine microporous osmotic pump controlled-release tablet, which comprises the following steps: S1. Preparation of tablet core: the prescription of Ligustrazine Phosphate-Ligustrazine 100mg, sodium citrate 30-60mg , 300-330mg of lactose monohydrate, 15-22% of the prescription amount of PVPK30, 4.6mg of magnesium stearate; or 100mg of ligustrazine phosphate, 40-100mg of sodium tartrate, 260-320mg of lactose monohydrate, of the prescription amount of PVP K30 15~22%; Magnesium stearate 4.6mg; S2. Preparation of coating: The prescription of the coating corresponding to the tablet core containing sodium citrate is as follows, coating solution 1000mL: cellulose acetate 30g, polyethylene glycol‑ 400 27mL, triethyl citrate 6mL, acetone 774 mL, isopropanol 193 mL; the prescription of the coating corresponding to the tablet core containing sodium tartrate is as follows, coating solution 1000mL: cellulose acetate 30g, polyethylene glycol‑400 24 mL, 6 mL of triethyl citrate, 776 mL of acetone, and 194 mL of isopropanol. The microporous osmotic pump prepared by the invention can realize 24-hour drug controlled release.

Description

technical field [0001] The invention relates to the technical field of osmotic pumps, in particular to a method for preparing phosphate-ligustrazine microporous osmotic pump controlled-release tablets. Background technique [0002] Ligustrazine is an alkaloid extracted from the rhizome of Ligusticum chuanxiong, a Chinese medicinal material, and has been artificially synthesized. It has various effects such as inhibiting platelet aggregation, dilating blood vessels, preventing thrombosis, and improving cerebral ischemia. Molecular formula C 8 h 12 N 2 , the chemical structure is tetramethylpyrazine. Ligustrazine has a melting point of 22°C, is easily sublimated at room temperature, has a special odor, and is accompanied by hygroscopicity. It is easily soluble in organic solvents and insoluble in water, which is not conducive to storage and application. It is often made into phosphoric acid-Ligustrazine or Ligustrazine Hydrochloride. Compared with phosphoric acid-ligust...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K9/22A61K31/4965A61P7/02A61P9/10
CPCA61P7/02A61P9/10A61K9/2072A61K9/2866A61K31/4965
Inventor 高崇凯沈慧芬李宁
Owner GUANGDONG PHARMA UNIV
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