CN110680805A - Method for preparing polyethylene glycol 4000 powder - Google Patents
Method for preparing polyethylene glycol 4000 powder Download PDFInfo
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- CN110680805A CN110680805A CN201911163653.0A CN201911163653A CN110680805A CN 110680805 A CN110680805 A CN 110680805A CN 201911163653 A CN201911163653 A CN 201911163653A CN 110680805 A CN110680805 A CN 110680805A
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- polyethylene glycol
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- essence
- saccharin sodium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/74—Synthetic polymeric materials
- A61K31/765—Polymers containing oxygen
- A61K31/77—Polymers containing oxygen of oxiranes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/10—Laxatives
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Abstract
The invention discloses a preparation method of polyethylene glycol 4000 powder, wherein the formula of the polyethylene glycol 4000 powder comprises an active component polyethylene glycol 4000, a non-active component saccharin sodium and essence, and the method comprises the following steps: firstly, dissolving saccharin sodium and essence into a solution form by using a proper solvent, then uniformly mixing with polyethylene glycol 4000 in a spray feeding manner, and finally, packaging to obtain the polyethylene glycol 4000 powder. The method well solves the technical problem of uneven mixing of the auxiliary materials in the preparation process of the polyethylene glycol 4000 powder, and improves the clinical application compliance of the product.
Description
Technical Field
The invention belongs to the field of pharmaceutical preparations, and particularly relates to a method for preparing polyethylene glycol 4000 powder.
Background
Constipation is the most common disease of digestive dysfunction in clinic, and mainly refers to dry stool, difficult or endless defecation and reduction of defecation frequency. One survey shows that the incidence rate of chronic constipation in the old aged over 60 years old in Beijing, Tianjin, Xian and other areas is as high as 15-20%. In the Beijing area, an investigation of adults aged 18 to 70 years showed that the incidence of chronic constipation was 6.07%, while women were more than 4 times as many as men. Constipation occurs at about 10% of the general population, and is particularly common among women.
The polyethylene glycol 4000 powder has the active ingredient of a macromolecular linear long-chain polymer polyethylene glycol 4000, can be used for treating constipation, has an action mechanism of retaining water in a colon cavity through local penetration of an intestinal tract, softens excrement, increases the volume and weight of the excrement to be normal, generates unobstructed defecation, and can be used for treating constipation caused by various reasons of adults and children. The comments of the "gastrointestinal tract local acting drugs, the imitated drugs for electrolyte balance, the evaluation of the quality of the drugs and the consistency of the curative effect of the drugs and the special drugs bioequivalence test application (request for comments) issued by the office of the national SFDA Central office in 5 and 16 months in 2017 are mentioned: the action mechanism of the polyethylene glycol 4000 powder is that water molecules are fixed through hydrogen bonds, so that the water content of excrement in intestines is increased, the constipation symptom of adults and children over 8 years old is relieved, and the pharmacokinetics research proves that the polyethylene glycol 4000 powder is not absorbed in vivo and is discharged out of the body in the form of original medicine. Therefore, the action mechanism of the polyethylene glycol 4000 powder is physical, is not absorbed by intestinal tracts, does not enter blood and has extremely high safety for human bodies.
Polyethylene glycol 4000 powder is generally used for treating constipation, and a preoperative preparation medicament for intestinal examination and cleaning the intestinal tract before operation is reported in documents, and the polyethylene glycol 4000 powder is generally dissolved in a proper amount of water and then taken. The polyethylene glycol 4000 has astringent taste, so the polyethylene glycol 4000 powder prescription generally contains flavoring essence to improve the taste, thereby helping patients to take and treat diseases. However, the active ingredients of the product usually account for about 98% of the total amount of the whole prescription, and the total amount of the auxiliary materials only account for about 2% of the total amount of the prescription, so that the total quality control of the product usually only concerns the content uniformity and content range of the main drug polyethylene glycol 4000, but the conventional mixing mode cannot ensure the good mixing of the flavoring essence and the auxiliary materials, and the occurrence of an event that the taste of a patient is influenced due to the uneven mixing of the auxiliary materials is likely to occur, and finally the clinical use compliance is poor. For example, the conventional mixing method, i.e., the equivalent addition method, cannot obtain a product with uniform content of the auxiliary materials, and the method is complicated to operate and is not beneficial to industrial mass production.
Therefore, there is a need for an improved new preparation method, which is mainly a mixing manner of the auxiliary materials and the main drug, so as to overcome the defect of uneven mixing of the auxiliary materials in the prior art and achieve the purpose of improving the clinical use compliance of the product.
Disclosure of Invention
The invention aims to provide a preparation method of polyethylene glycol 4000 powder, which is to dissolve all auxiliary materials of the powder into a proper solvent and then uniformly mix the auxiliary materials with an active ingredient polyethylene glycol 4000 in a spray feeding mode. The method can effectively avoid the technical problem of uneven mixing of auxiliary materials in the production process of the product, thereby improving the clinical application compliance of the product.
To this end, the present inventors have tried to investigate many material mixing methods commonly used in the production of formulations: for example, the essence and the active ingredient polyethylene glycol 4000 are premixed in an equivalent progressive manner, and then saccharin sodium is added for final total mixing, but because the content of the auxiliary materials of the product is extremely low (only accounting for about 2.0% of the total amount of the prescription), the final result is that the aim of uniformly mixing the auxiliary materials cannot be achieved (part of finished products contain too high, too low or even no auxiliary materials); for example, the essence is mixed with the saccharin sodium, and then the essence is finally and totally mixed with the polyethylene glycol 4000 serving as the active ingredient, so that the aim of uniformly mixing the auxiliary materials cannot be achieved; for example, the essence or the essence plus saccharin sodium and polyethylene glycol 4000 are mixed by adopting a wet granulation mode, and the aim of uniformly mixing the auxiliary materials cannot be achieved;
the inventor unexpectedly finds that the auxiliary materials are uniformly mixed with the polyethylene glycol 4000 serving as the active ingredient in a spray feeding mode, but the following technical problems are encountered in the specific experimental process: 1) saccharin sodium is solid, essence or solid or liquid, and a proper solvent is required to be well dissolved into a solution form; 2) although an appropriate solvent- -water or aqueous ethanol capable of dissolving saccharin sodium and essence simultaneously is finally found through experiments, polyethylene glycol 4000 is soluble in both water and ethanol, so the amount of the solvent and the spray feeding rate of the adjuvant solution must be strictly controlled through experiments so that polyethylene glycol 4000 is not dissolved in the spray feeding process. Through repeated tests, the problem is finally solved.
To achieve the object of the present invention, the following embodiments are provided.
In one embodiment, the present invention provides a method for preparing polyethylene glycol 4000 powder, comprising the steps of:
1) weighing and mixing the saccharin sodium and the essence which are auxiliary materials according to the prescription amount, and dissolving the mixture into a uniform auxiliary material solution by using a selected solvent;
2) uniformly mixing the auxiliary material solution obtained in the step 1) with polyethylene glycol 4000 at a set rate in a spray feeding manner to obtain a polyethylene glycol 4000 powder intermediate;
3) and (3) packaging the uniformly mixed polyethylene glycol 4000 powder intermediate obtained in the step 2) to obtain the finished product polyethylene glycol 4000 powder.
In the above embodiment, the method of the present invention, step 1), first weighing saccharin sodium and essence according to the prescription amount into a container for dissolution, then adding the selected solvent, stirring to dissolve them into a solution form, and finally transferring the material into the material liquid cavity of the spray gun. The selected solvent is selected from water and aqueous ethanol. The water content of the hydrous ethanol is 60-80%, and preferably 70-80%. The dosage of the solvent is 5-8 times, preferably 5-6 times of the total mass of the saccharin sodium and the essence.
In the above specific embodiment, in step 2), firstly, weighing the active ingredient polyethylene glycol 4000 according to the formula amount into the mixing equipment, starting stirring, then opening the valve of the spray gun, spraying the adjuvant solution in step 1) to the polyethylene glycol 4000 in the mixing equipment at a set speed, and finally, uniformly mixing the adjuvant and the polyethylene glycol 4000 to obtain the polyethylene glycol 4000 powder intermediate. The D90 of the polyethylene glycol 4000 particle size is 100-200 μm, preferably 100-150 μm. The set rate of the spray feeding of the auxiliary material solution is 10-20% of the total volume of the auxiliary material solution sprayed every minute, preferably 15-20%.
In the above embodiment, in step 3), the method of the present invention completes packaging of the uniformly mixed polyethylene glycol 4000 powder intermediate obtained in step 2), so as to obtain the finished polyethylene glycol 4000 powder.
In the method, the auxiliary materials are dissolved into a solution and are uniformly mixed with the main medicine polyethylene glycol 4000 in a spray feeding mode, so that the content of the saccharin sodium in each bag of the finished product can reach 90-110%, preferably 95-105% of the amount of the prescription (because the essence components are complex, no proper analysis method is used for detection, but the essence and the saccharin sodium are sprayed and fed into the polyethylene glycol 4000 in a solution mode so as to be uniformly mixed, and therefore, the content of the saccharin sodium in each bag of the finished product is measured to verify the uniformity of mixing of the auxiliary materials).
Technical effects of the invention
The method of the invention dissolves the auxiliary materials into solution by controlling the solvent and the using amount of the solvent, and mixes the solution with the main medicine polyethylene glycol 4000 by adopting a spray feeding mode with a specific speed, thereby solving the technical problem of uneven mixing of the auxiliary materials and the main medicine of the polyethylene glycol 4000 powder, ensuring that the content of saccharin sodium in each bag of a finished product can reach 90-110 percent, preferably 95-105 percent of the prescription amount, finally improving the clinical use compliance of the polyethylene glycol 4000 powder and improving the industrial mass production efficiency.
Detailed Description
The following examples are intended to further illustrate the invention, but not to limit the scope of the invention in any way.
Example 1
Prescription:
the preparation process comprises the following steps:
weighing the essence and the saccharin sodium according to the prescription amount into a mixing tank, adding 16000g of purified water, stirring to fully dissolve the auxiliary materials, and transferring the auxiliary materials into a material cavity of a spray gun. 1000000g of polyethylene glycol 4000 are weighed into a double cone mixer and the stirring is switched on. And opening a valve of the spray gun, and spraying 10 percent of the total volume of the auxiliary material solution every minute. And after the spraying is finished, continuously stirring for about 10min, transferring the materials to a subpackaging and packaging machine, and packaging 100000(10 ten thousand) bags.
And (3) auxiliary material uniformity determination result: the essence and the saccharin sodium are sprayed and added into the polyethylene glycol 4000 in a solution form, so that the content uniformity index of the saccharin sodium is used for representing the mixing uniformity of the saccharin sodium. Respectively randomly taking 5 bags in the initial stage, the middle stage and the final stage in the subpackaging and packaging process, and measuring the content of the saccharin sodium, wherein the results are as follows:
example 2
Prescription:
the preparation process comprises the following steps:
weighing the essence and the saccharin sodium according to the prescription amount into a 500ml beaker, adding 256g of purified water, stirring to fully dissolve the auxiliary materials, and transferring the auxiliary materials into a material cavity of a spray gun. 10000g of polyethylene glycol 4000 are weighed into a three-dimensional cone mixer, and stirring is started. And opening a valve of the spray gun, and spraying the materials according to 20 percent of the total volume of the auxiliary material solution sprayed every minute. And after the spraying is finished, continuously stirring for about 10min, transferring the materials to a subpackaging and packaging machine, and packaging for 1000 bags.
And (3) auxiliary material uniformity determination result: the detection method is the same as that of example 1, and the results are as follows:
example 3
Prescription:
the preparation process comprises the following steps:
weighing the essence and the saccharin sodium according to the prescription amount into a 500ml beaker, adding 192g of purified water, stirring to fully dissolve the auxiliary materials, and transferring the auxiliary materials into a material cavity of a spray gun. 10000g of polyethylene glycol 4000 are weighed into a swing cone mixer, and stirring is started. And opening a valve of the spray gun, and spraying the materials according to 15 percent of the total volume of the auxiliary material solution sprayed every minute. And after the spraying is finished, continuously stirring for about 10min, transferring the materials to a subpackaging and packaging machine, and packaging for 1000 bags.
And (3) auxiliary material uniformity determination result: the detection method is the same as that of example 1, and the results are as follows:
example 4
Prescription:
the preparation process comprises the following steps:
weighing the essence and the saccharin sodium according to the prescription amount into a 500ml beaker, adding 160g of hydrous ethanol with the water content of 60%, stirring to fully dissolve the auxiliary materials, and transferring the auxiliary materials into a material cavity of a spray gun. 10000g of polyethylene glycol 4000 are weighed into a double cone mixer, and stirring is started. And opening a valve of the spray gun, and spraying 10 percent of the total volume of the auxiliary material solution every minute. And after the spraying is finished, continuously stirring for about 10min, transferring the materials to a subpackaging and packaging machine, and packaging for 1000 bags.
And (3) auxiliary material uniformity determination result: the detection method is the same as that of example 1, and the results are as follows:
example 5
Prescription:
the preparation process comprises the following steps:
weighing the essence and the saccharin sodium according to the prescription amount into a 500ml beaker, adding 256g of hydrous ethanol (the water content is 80%), stirring to fully dissolve the auxiliary materials, and transferring the auxiliary materials into a material cavity of a spray gun. 10000g of polyethylene glycol 4000 are weighed into a three-dimensional cone mixer, and stirring is started. And opening a valve of the spray gun, and spraying the materials according to 20 percent of the total volume of the auxiliary material solution sprayed every minute. And after the spraying is finished, continuously stirring for about 10min, transferring the materials to a subpackaging and packaging machine, and packaging for 1000 bags.
And (3) auxiliary material uniformity determination result: the detection method is the same as that of example 1, and the results are as follows:
example 6
Prescription:
the preparation process comprises the following steps:
weighing the essence and the saccharin sodium according to the prescription amount into a 500ml beaker, adding 192g of hydrous ethanol (the water content is 70%), stirring to fully dissolve the auxiliary materials, and transferring the auxiliary materials into a material cavity of a spray gun. 10000g of polyethylene glycol 4000 are weighed into a swing mixer, and stirring is started. And opening a valve of the spray gun, and spraying the materials according to 15 percent of the total volume of the auxiliary material solution sprayed every minute. And after the spraying is finished, continuously stirring for about 10min, transferring the materials to a subpackaging and packaging machine, and packaging for 1000 bags.
And (3) auxiliary material uniformity determination result: the detection method is the same as that of example 1, and the results are as follows:
comparative example 1
Prescription:
the preparation process comprises the following steps:
weighing the essence and the saccharin sodium according to the prescription amount into a 500ml beaker, adding 160g of purified water, stirring to fully dissolve the auxiliary materials, and transferring the auxiliary materials into a material cavity of a spray gun. 10000g of polyethylene glycol 4000 are weighed into a double cone mixer, and stirring is started. And opening a valve of the spray gun, and spraying the materials according to 5 percent of the total volume of the auxiliary material solution sprayed every minute. And after the spraying is finished, continuously stirring for about 10min, transferring the materials to a subpackaging and packaging machine, and packaging for 1000 bags.
And (3) auxiliary material uniformity determination result: the detection method is the same as that of example 1, and the results are as follows:
comparative example 2
Prescription:
the preparation process comprises the following steps:
weighing the essence and the saccharin sodium according to the prescription amount into a 500ml beaker, adding 160g of purified water, stirring to fully dissolve the auxiliary materials, and transferring the auxiliary materials into a material cavity of a spray gun. 10000g of polyethylene glycol 4000 are weighed into a double cone mixer, and stirring is started. And opening a valve of the spray gun, and spraying the materials according to 25 percent of the total volume of the auxiliary material solution sprayed every minute. And after the material spraying is finished, continuously stirring for about 10min, opening the mixer to find that the material is seriously caked and can not be subpackaged. Therefore, subsequent dispensing and measurement of the homogeneity of the auxiliary materials were not carried out.
Comparative example 3
Prescription:
the preparation process comprises the following steps:
weighing the essence and the saccharin sodium according to the prescription amount into a 500ml beaker, adding 160g of absolute ethyl alcohol, stirring until the auxiliary materials are not dissolved (in a suspension state), and transferring the auxiliary materials into a material cavity of a spray gun. 10000g of polyethylene glycol 4000 are weighed into a double cone mixer, and stirring is started. Open the spray gun valve, just appear the spray gun very fast and block up unable normal material that spouts, the experiment once more after the clearance spray gun continues the condition that the spray gun blockked up to appear. Repeating for many times, finally directly feeding the residues blocking the spray gun into a mixer, continuously stirring and mixing for about 10min, transferring the materials into a subpackaging and packaging machine, and packaging for 1000 bags.
And (3) auxiliary material uniformity determination result: the detection method is the same as that of example 1, and the results are as follows:
comparative example 4
Prescription:
the preparation process comprises the following steps:
weighing the essence and the polyethylene glycol 4000 according to the prescription amount, premixing for about 10min in a double-cone mixer in an equivalent progressive manner, then adding the saccharin sodium to perform total mixing for about 10min, and finally transferring the materials to a subpackaging packaging machine to complete packaging for 1000 bags.
And (3) auxiliary material uniformity determination result: the detection method is the same as that of example 1, and the results are as follows:
comparative example 5
Prescription:
the preparation process comprises the following steps:
weighing the essence and the saccharin sodium according to the prescription amount, fully mixing, then weighing the polyethylene glycol 4000 according to the prescription amount, totally mixing for about 10min in a double-cone mixer in an equivalent progressive manner, and finally transferring the materials to a subpackaging packaging machine to complete packaging for 1000 bags.
And (3) auxiliary material uniformity determination result: the detection method is the same as that of example 1, and the results are as follows:
comparative example 6
Prescription:
the preparation process comprises the following steps:
weighing the essence and the saccharin sodium according to the prescription amount, adding 160g of purified water, stirring to fully dissolve the auxiliary materials, adding the auxiliary materials and 10000g of polyethylene glycol 4000 into a wet granulator together for mixing, sieving by a 120-mesh sieve, wherein the sieving total amount is not less than 90%, finally uniformly mixing again, transferring the materials to a subpackaging and packaging machine, and packaging by 1000 bags.
And (3) auxiliary material uniformity determination result: the detection method is the same as that of example 1, and the results are as follows:
Claims (7)
1. a process for preparing a polyethylene glycol 4000 powder comprising the steps of:
1) weighing the saccharin sodium and essence serving as auxiliary materials according to the prescription amount, and dissolving the saccharin sodium and essence into an auxiliary material solution by using a selected solvent;
2) uniformly mixing the auxiliary material solution obtained in the step 1) with polyethylene glycol 4000 at a set rate by adopting a spray feeding mode to obtain a polyethylene glycol 4000 powder intermediate;
3) packaging and packaging the polyethylene glycol 4000 powder intermediate uniformly mixed in the step 2) to obtain the finished product polyethylene glycol 4000 powder.
2. The method of claim 1, wherein the selected solvent in step 1) is water or an ethanol solution.
3. The method according to claim 2, wherein the ethanol solution has a water content of 60% to 80%.
4. The method as claimed in claim 3, wherein in the step 1), the amount of the solvent is 5-8 times of the total mass of the saccharin sodium and the essence.
5. The method of claim 1, wherein the polyethylene glycol 4000 particle size D90 in step 2) is 100-200 μm.
6. The method of claim 1, wherein the set rate in step 2) is 10-20% of the total volume of the adjuvant solution sprayed per minute.
7. The method of claim 1, wherein said mixing in step 2) is uniform, and means that the content of saccharin sodium in each bag of the finished product can reach 90% -110% of the prescribed amount.
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| CN201911163653.0A CN110680805A (en) | 2019-11-25 | 2019-11-25 | Method for preparing polyethylene glycol 4000 powder |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111671911A (en) * | 2020-07-24 | 2020-09-18 | 刘艳 | Pharmaceutical composition for treating basin bottom laxity type constipation and preparation method thereof |
| CN112101701A (en) * | 2020-07-28 | 2020-12-18 | 重庆华森制药股份有限公司 | Intelligent manufacturing system and manufacturing method for producing polyethylene glycol electrolyte powder |
| CN112494511A (en) * | 2020-12-06 | 2021-03-16 | 天津康哲医药科技发展有限公司 | Preparation of polyethylene glycol sodium potassium oral pharmaceutical preparation |
| CN114432339A (en) * | 2022-02-18 | 2022-05-06 | 重庆希尔安药业有限公司 | Polyethylene glycol sodium potassium powder and preparation method thereof |
| CN116687864A (en) * | 2023-08-08 | 2023-09-05 | 成都医路康医学技术服务有限公司 | Compound polyethylene glycol electrolyte powder and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101036668A (en) * | 2007-02-15 | 2007-09-19 | 刘宇 | Grain agent including polyethylene glycol 4000 |
| CN204710135U (en) * | 2015-05-05 | 2015-10-21 | 天津巴莫科技股份有限公司 | A kind of mixer with metered dose feeding device |
-
2019
- 2019-11-25 CN CN201911163653.0A patent/CN110680805A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101036668A (en) * | 2007-02-15 | 2007-09-19 | 刘宇 | Grain agent including polyethylene glycol 4000 |
| CN204710135U (en) * | 2015-05-05 | 2015-10-21 | 天津巴莫科技股份有限公司 | A kind of mixer with metered dose feeding device |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111671911A (en) * | 2020-07-24 | 2020-09-18 | 刘艳 | Pharmaceutical composition for treating basin bottom laxity type constipation and preparation method thereof |
| CN111671911B (en) * | 2020-07-24 | 2021-08-10 | 刘艳 | Pharmaceutical composition for treating basin bottom laxity type constipation and preparation method thereof |
| CN112101701A (en) * | 2020-07-28 | 2020-12-18 | 重庆华森制药股份有限公司 | Intelligent manufacturing system and manufacturing method for producing polyethylene glycol electrolyte powder |
| CN112494511A (en) * | 2020-12-06 | 2021-03-16 | 天津康哲医药科技发展有限公司 | Preparation of polyethylene glycol sodium potassium oral pharmaceutical preparation |
| CN114432339A (en) * | 2022-02-18 | 2022-05-06 | 重庆希尔安药业有限公司 | Polyethylene glycol sodium potassium powder and preparation method thereof |
| CN116687864A (en) * | 2023-08-08 | 2023-09-05 | 成都医路康医学技术服务有限公司 | Compound polyethylene glycol electrolyte powder and preparation method thereof |
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