CN114272842A - Preparation method of nasal spray - Google Patents
Preparation method of nasal spray Download PDFInfo
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- CN114272842A CN114272842A CN202210035891.9A CN202210035891A CN114272842A CN 114272842 A CN114272842 A CN 114272842A CN 202210035891 A CN202210035891 A CN 202210035891A CN 114272842 A CN114272842 A CN 114272842A
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Abstract
A method of preparing a nasal spray comprising: preparing and shearing suspension base liquid, comprising the following steps of firstly, weighing purified water according to the prescription amount, placing the purified water in a preparation tank A, starting stirring and keeping the rotating speed: adding anhydrous glucose at 50 rpm, stirring to dissolve, and clarifying the solution by visual inspection; secondly, stirring continuously, slowly adding microcrystalline cellulose-sodium carboxymethyl cellulose, and stirring continuously until the solution does not have the phenomena of agglomeration and wall sticking by visual observation; thirdly, opening a mixing tank A to be connected with a shearing machine, and a mixing tank B to be connected with a corresponding valve of the shearing machine and on-line shearing equipment, and performing circulating pre-shearing; the total mixing and shearing step comprises the first step of adding other dissolved components into a material preparing tank A under the condition of stirring, and continuing stirring for 10 minutes; and secondly, opening a corresponding valve of the mixing tank A connected with the shearing machine, and a corresponding valve of the mixing tank B connected with the shearing machine and the on-line shearing equipment to perform on-line circular shearing. The invention ensures that the nasal spray has high dispersion degree of components and quick production.
Description
Technical Field
The invention relates to the technical field of preparation of sprays, in particular to a preparation method of a nasal spray.
Background
As a nasal spray, the dispersion of the various ingredients therein is very important. In the production and preparation of the nasal spray, cellulose which is solid at normal temperature is a substance which needs to be used in a large amount in the production process of the nasal spray, and the dispersion is very difficult. Usually, the cellulose is put into purified water with the prescription amount, naturally swells, is stirred and is sieved, and the time is about 24 hours; the preparation period of the whole nasal spray is prolonged, the dispersion effect is poor, and the appearance is visually observed: the raw materials are not aggregated, are uniformly dispersed suspension and have thixotropy; and (3) microscopic observation: the distribution is basically uniform, trace agglomeration exists, and the raw materials are gathered in trace amount to form a flowing image. In view of the above problems, the present invention provides a solution.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a preparation method of a nasal spray. The invention ensures that the nasal spray has high dispersion degree of components and quick production.
The invention relates to a preparation method of a nasal spray, which comprises the following steps:
the preparation and shearing process of the suspension liquid comprises the following specific steps:
firstly, weighing purified water in a proportioning tank A according to the prescription amount, starting stirring to keep the rotating speed: adding anhydrous glucose at 50 rpm, stirring to dissolve, and clarifying the solution by visual inspection;
secondly, stirring continuously, slowly adding microcrystalline cellulose-sodium carboxymethyl cellulose, and stirring continuously until the solution does not have the phenomena of agglomeration and wall sticking by visual observation;
thirdly, opening a mixing tank A to be connected with a shearing machine, and a mixing tank B to be connected with a corresponding valve of the shearing machine and on-line shearing equipment, and performing circulating pre-shearing;
the total mixing and shearing process comprises the following specific steps:
firstly, adding other dissolved components into a mixing tank A under the condition of stirring, and continuously stirring for 10 minutes;
and secondly, opening a corresponding valve of the mixing tank A connected with the shearing machine, and a corresponding valve of the mixing tank B connected with the shearing machine and the on-line shearing equipment to perform on-line circular shearing.
In the preparation method of the nasal spray, in the steps of preparing and shearing the suspension base liquid, the shearing frequency is set to be 83.7Hz, which is equivalent to the rotating speed of 5000 r/min, and the circulating pre-shearing frequency is 6 times.
In the total mixing and shearing step, the shearing frequency is set to be 83.7Hz, which is equivalent to the rotating speed of 5000 r/min, and 5 times of circulating total mixing and shearing are carried out.
In conclusion, the invention has the following beneficial effects: the invention is sheared after the cellulose is added and all the components are added, and the materials are fully and uniformly dispersed by utilizing the shearing action; meanwhile, the dissolving time of the cellulose can be greatly shortened, so that the whole preparation period is shortened.
Detailed Description
The first embodiment is as follows: the invention provides a preparation method of a nasal spray, which comprises the following steps:
1 preparation and shearing of suspension
1.1 weighing purified water according to the prescription amount, placing the purified water in a proportioning tank A, starting the proportioning tank A to stir (the rotating speed is controlled at 50 revolutions per minute), adding anhydrous glucose, stirring to dissolve, and visually observing the solution to be clear.
1.2. And continuously stirring, slowly adding the microcrystalline cellulose-sodium carboxymethylcellulose, and continuously stirring until the solution is visually observed to have no agglomeration or wall sticking phenomenon.
1.3, opening a dosing tank A to be connected with a shearing machine, and a dosing tank B to be connected with corresponding valves and online shearing equipment of the shearing machine, carrying out online shearing, setting the shearing frequency to be 83.7Hz (equivalent to the rotating speed of 5000 r/min), and carrying out 6 times of circulating pre-shearing (namely 12 times of unidirectional pre-shearing).
2 Total shear
2.1 adding the other dissolved components into the mixing tank A under the condition of stirring, and continuing stirring for 10 minutes;
2.2, opening the corresponding valves of the mixing tank A and the shearing machine, connecting the mixing tank B and the shearing machine, and performing on-line shearing, wherein the shearing frequency is set to be 83.7Hz (equivalent to the rotating speed of 5000 r/min), and performing 5 times of circulating total mixed shearing (namely 10 times of unidirectional total mixed shearing).
Comparative example one:
the difference between the first comparative example and the first example is as follows: the cellulose is put into purified water with the prescription amount, naturally swelled, stirred and sieved to obtain a suspension liquid, and the rest steps are the same as the first embodiment.
The comparison of the first example product with the first comparative example product is as follows:
the preparation time is short:
the first method comprises placing cellulose in purified water, swelling naturally, stirring, and sieving for 24 hr;
example a method: placing the cellulose in purified water with the prescription amount, stirring uniformly, and circularly shearing by a high-shear machine without sieving for about 1.5 hours;
the dispersion effect is good:
comparative example one method effect: A. visual inspection of appearance: the raw materials are not aggregated, are uniformly dispersed suspension and have thixotropy;
B. and (3) microscopic observation: the distribution is basically uniform, trace agglomeration exists, and the raw materials are gathered in trace amount to form a flowing image with extremely small amount;
example one method effect: A. visual inspection of appearance: the raw materials are not aggregated, are white dispersion liquid and are uniformly distributed;
B. and (3) microscopic observation: the raw materials are fine particles, the raw materials are not aggregated, the raw materials are uniformly dispersed suspension liquid and have thixotropy,
no lumps and no flow phenomenon.
The present embodiment is only for explaining the novel invention, and it is not limited to the present invention, and those skilled in the art can make modifications of the present embodiment without inventive contribution as required after reading the present specification, but all of them are protected by patent law within the scope of the claims of the present invention.
Claims (3)
1. A method of preparing a nasal spray, comprising:
the preparation and shearing process of the suspension liquid comprises the following specific steps:
firstly, weighing purified water in a proportioning tank A according to the prescription amount, starting stirring to keep the rotating speed: adding anhydrous glucose at 50 rpm, stirring to dissolve, and clarifying the solution by visual inspection;
secondly, stirring continuously, slowly adding microcrystalline cellulose-sodium carboxymethyl cellulose, and stirring continuously until the solution does not have the phenomena of agglomeration and wall sticking by visual observation;
thirdly, opening a mixing tank A to be connected with a shearing machine, and a mixing tank B to be connected with a corresponding valve of the shearing machine and on-line shearing equipment, and performing circulating pre-shearing;
the total mixing and shearing process comprises the following specific steps:
firstly, adding other dissolved components into a mixing tank A under the condition of stirring, and continuously stirring for 10 minutes;
and secondly, opening a corresponding valve of the mixing tank A connected with the shearing machine, and a corresponding valve of the mixing tank B connected with the shearing machine and the on-line shearing equipment to perform on-line circular shearing.
2. The method of claim 1, wherein the suspension is formulated and sheared at a shear frequency of 83.7Hz corresponding to 5000 rpm, and the number of cycles of pre-shearing is 6.
3. The method for preparing a nasal spray according to claim 1, wherein in the total mixing and shearing step, the shearing frequency is set to 83.7Hz, which is equivalent to 5000 r/min, and 5 cycles of total mixing and shearing are performed.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210035891.9A CN114272842A (en) | 2022-01-13 | 2022-01-13 | Preparation method of nasal spray |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210035891.9A CN114272842A (en) | 2022-01-13 | 2022-01-13 | Preparation method of nasal spray |
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| Publication Number | Publication Date |
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| CN114272842A true CN114272842A (en) | 2022-04-05 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202210035891.9A Pending CN114272842A (en) | 2022-01-13 | 2022-01-13 | Preparation method of nasal spray |
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Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009140887A1 (en) * | 2008-05-22 | 2009-11-26 | 昆明制药集团股份有限公司 | A scutellarin derivative, the preparing process, the pharmaceutical composition and the use thereof |
| CN103588846A (en) * | 2012-08-15 | 2014-02-19 | 重庆华邦制药有限公司 | Preparation method of fluticasone propionate particles and applications of the particle |
| CN104606139A (en) * | 2014-05-16 | 2015-05-13 | 沈阳药科大学 | Preparation and application of drug powder |
| CN106074387A (en) * | 2016-08-15 | 2016-11-09 | 辽宁大学 | There is thixotropic triamcinolone acetonide nasal spray and preparation method thereof |
| CN107320449A (en) * | 2017-08-07 | 2017-11-07 | 武汉武药科技有限公司 | Fluticasone propionate nasal spray and preparation method thereof |
| CN108096408A (en) * | 2016-11-17 | 2018-06-01 | 中国科学院大连化学物理研究所 | A kind of nasal spray and its preparation and application |
| CN112516087A (en) * | 2020-12-24 | 2021-03-19 | 四川普锐特药业有限公司 | Budesonide nasal spray and preparation method thereof |
-
2022
- 2022-01-13 CN CN202210035891.9A patent/CN114272842A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009140887A1 (en) * | 2008-05-22 | 2009-11-26 | 昆明制药集团股份有限公司 | A scutellarin derivative, the preparing process, the pharmaceutical composition and the use thereof |
| CN103588846A (en) * | 2012-08-15 | 2014-02-19 | 重庆华邦制药有限公司 | Preparation method of fluticasone propionate particles and applications of the particle |
| CN104606139A (en) * | 2014-05-16 | 2015-05-13 | 沈阳药科大学 | Preparation and application of drug powder |
| CN106074387A (en) * | 2016-08-15 | 2016-11-09 | 辽宁大学 | There is thixotropic triamcinolone acetonide nasal spray and preparation method thereof |
| CN108096408A (en) * | 2016-11-17 | 2018-06-01 | 中国科学院大连化学物理研究所 | A kind of nasal spray and its preparation and application |
| CN107320449A (en) * | 2017-08-07 | 2017-11-07 | 武汉武药科技有限公司 | Fluticasone propionate nasal spray and preparation method thereof |
| CN112516087A (en) * | 2020-12-24 | 2021-03-19 | 四川普锐特药业有限公司 | Budesonide nasal spray and preparation method thereof |
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