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A kind of dry granulation method of dry suspension

A dry suspension and dry technology, applied in the field of medicine, can solve the problems of uniform particle formation of unfavorable materials, short production time, poor stability, etc., and achieve the effects of facilitating large-scale production, reducing production time, and improving stability.

Active Publication Date: 2022-02-11
北京阳光诺和药物研究股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Since the raw material of oseltamivir phosphate has viscosity itself, and the excipients xanthan gum and sorbitol used in the prescription have a relatively high viscosity when exposed to water, when wet granulation is used, it is easy to cause material sticking after adding water. It is not conducive to the uniformity of materials and particle forming, etc.
And through the investigation of the influencing factors of the raw materials, it can be known that the raw materials have poor stability under conditions such as humidity and heat, so it is necessary to provide a dry granulation process to avoid the addition of water and drying during the preparation process, and the dry granulation process is easy to operate and short production time

Method used

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  • A kind of dry granulation method of dry suspension
  • A kind of dry granulation method of dry suspension
  • A kind of dry granulation method of dry suspension

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1, dry preparation oseltamivir phosphate dry suspension

[0035] This embodiment provides the prescription and preparation method for preparing 10000 bags of oseltamivir dry suspension (specification 15mg), as follows:

[0036] The composition of the prescription is shown in Table 1:

[0037] The composition of table 1 oseltamivir phosphate dry suspension

[0038]

[0039] Adopt dry granulation process, as shown in Table 2:

[0040] Table 2 Dry granulation process steps

[0041]

[0042]

[0043] Table 3 Dry granulation process conditions

[0044] Feeding screw speed 20rpm Pressure roller speed 8rpm Roller pressure 15 bar Granulator speed 100rpm Whole grain sieve aperture 1.5mm

Embodiment 2

[0045] Embodiment 2, dry preparation oseltamivir phosphate dry suspension

[0046] This embodiment provides the prescription and preparation method for preparing 10000 bags of oseltamivir dry suspension (specification 15mg), as follows:

[0047] The composition of the prescription is as shown in Table 4:

[0048] The composition of table 4 oseltamivir phosphate dry suspension

[0049]

[0050] Adopt dry granulation process, as shown in Table 5:

[0051] Table 5 Dry granulation process steps

[0052]

[0053]

[0054] The samples prepared according to this process were investigated in different xanthan gum dosages, and the results of the dissolution assay were shown in Table 6:

[0055] The dissolution result of the oseltamivir phosphate dry suspension of prescription 1-3 of table 6

[0056] Dissolution result (%) 5min 10min 15min 20min 30min Prescription 1 95 99 99 99 99 Prescription 2 97 98 99 99 99 Prescription 3 94 ...

Embodiment 3

[0058] Embodiment 3, dry preparation oseltamivir phosphate dry suspension

[0059] This example provides the prescription and preparation method for preparing 10000 bags of oseltamivir dry suspension (specification 15 mg). Since the amount of xanthan gum in the prescription is too small, the xanthan gum in the prescription is dried until the moisture is less than 1 %,details as follows:

[0060] The composition of the prescription is as shown in Table 7:

[0061] The composition of table 7 oseltamivir phosphate dry suspension

[0062]

[0063] Adopt dry granulation process, as shown in Table 8:

[0064] Table 8 Dry granulation process steps

[0065]

[0066]

[0067] The sample of the prepared xanthan gum without drying treatment mode is carried out dissolution investigation result is as follows:

[0068] Table 10 The dissolution results of the oseltamivir phosphate dry suspension of prescription 4 and prescription 5

[0069] Dissolution result (%) 5min...

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Abstract

The invention discloses a dry suspension and its dry granulation method. Oseltamivir phosphate dry suspension consists of the following components: oseltamivir phosphate, xanthan gum, sorbitol, sodium dihydrogen citrate, essence, titanium dioxide and aspartame; the oseltamivir phosphate The mass ratio of each component in Wei dry suspension is as follows: 4 parts of oseltamivir phosphate, 1-3 parts of xanthan gum, 70-90 parts of sorbitol, 3-8 parts of sodium dihydrogen citrate, 1-3 parts of essence 3 parts, 1 to 3 parts of titanium dioxide, and 0.1 to 0.5 parts of aspartame. The invention divides the sorbitol into two parts and adds it, so as to reduce the dry granulation time and help the product dissolve quickly. The invention adopts a dry granulation process, which avoids the influence of adding water and heating and drying on product stability when using wet granulation, improves product stability, reduces production time, improves production efficiency, and facilitates large-scale production.

Description

technical field [0001] The invention relates to a dry granulation method of a dry suspension, belonging to the technical field of medicine. Background technique [0002] Since the raw material of oseltamivir phosphate has viscosity itself, and the excipients xanthan gum and sorbitol used in the prescription have a relatively high viscosity when exposed to water, when wet granulation is used, it is easy to cause material sticking after adding water. It is not conducive to the uniformity of materials and the formation of particles. And through the investigation of the influencing factors of the raw materials, it can be known that the raw materials have poor stability under conditions such as humidity and heat, so it is necessary to provide a dry granulation process to avoid the addition of water and drying during the preparation process, and the dry granulation process is easy to operate And the production time is short. Contents of the invention [0003] The object of the...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/215A61K9/10A61K47/26
CPCA61K31/215A61K9/1623A61K9/1682A61K9/10
Inventor 郑柏松韩琳琳刘宇晶佟德全罗桓谌宗永
Owner 北京阳光诺和药物研究股份有限公司
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