CN102258482A - Osalmid for suspension and preparation method thereof - Google Patents

Osalmid for suspension and preparation method thereof Download PDF

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Publication number
CN102258482A
CN102258482A CN2011102518238A CN201110251823A CN102258482A CN 102258482 A CN102258482 A CN 102258482A CN 2011102518238 A CN2011102518238 A CN 2011102518238A CN 201110251823 A CN201110251823 A CN 201110251823A CN 102258482 A CN102258482 A CN 102258482A
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CN
China
Prior art keywords
osalmide
dry suspension
correctives
osalmid
suspension
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN2011102518238A
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Chinese (zh)
Inventor
徐园
祝瑞章
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Yangzhou Sanyao Pharmaceutical Co Ltd
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Yangzhou Sanyao Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Yangzhou Sanyao Pharmaceutical Co Ltd filed Critical Yangzhou Sanyao Pharmaceutical Co Ltd
Priority to CN2011102518238A priority Critical patent/CN102258482A/en
Publication of CN102258482A publication Critical patent/CN102258482A/en
Pending legal-status Critical Current

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  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention discloses osalmid for suspension and a preparation method thereof, relating to the technical field of medicaments. The preparation method comprises the following steps of: firstly crushing the osalmid, a flavoring agent, a suspending agent and a filling agent respectively, and sieving by 100-120 meshes; then mixing the osalmid, the filling agent, the suspending agent, the flavoring agent and a binding agent, granulating, and then drying at the temperature of 55+/-5 DEG C; and then packaging. According to the invention, the process is simple and reasonable, the production is convenient, low-energy-consumption and low-cost production is beneficial, and the stability of a product is good. The method in the invention adopts a novel auxiliary material (sodium carboxymethylcellulose-microcrystalline cellulose, after water is added for the osalmid for suspension, the mixed suspension with uniform distribution can be rapidly formed, the product has sweat smell, after administration, the product is almost not absorbed by a human body, has higher concentration only at the intestinal canal, and the adverse reaction is low in incidence rate and slight. According to the invention, the application range of the osaimid is expanded, and the defect of poor compliance when a patient takes solid osalmid is made up.

Description

A kind of osalmide dry suspension and preparation method thereof
Technical field
The present invention relates to medical technical field, particularly relating to a kind of is the pharmaceutical technology field of raw material with the osalmide.
Background technology
Osalmide is a choleretic.This product promotes bile secretion, can make choleresis increase several times, and not change its composition, acts on similarly to dehydrocholic acid, can increase hepatic blood flow, improves liver function, makes that moisture significantly increases in the bile, and choleretic effect is strong than dehydrocholic acid.The atropinic spasmolysis of this product tool can make the Oddi sphincter dilatation, is applicable to syndrome behind cholecystitis, biliary tract inflammation, cholelithiasis and the operation on gallbladder.The effect of the cholesterolemia of reduction is still arranged in addition.
After osalmide is oral, mainly be the little intestinal absorption of alkaline environment, this product is discharged with feces after metabolism.Life-time service can increase the periphery platelet counts.
Be the Japan and the former Soviet Union to osalmide research, use than morning abroad, these product once recorded in Pharmacopeia of Japan.Also there is the bibliographical information of research this product in state such as Finland in addition.
According to the literature, domesticly begin one's study and use osalmide, Sichuan Province's drug standard (1992), Jilin Province's drug standard (1986) once to record osalmide and tablet thereof, capsule from the seventies.This product initial stage Ceng Zuowei is used for the treatment of the medicinal application of acute or chronic hepatitis and cholecystitis, biliary tract inflammation, cholelithiasis in clinical.Now be mainly used in syndrome behind treatment cholecystitis, biliary tract inflammation, cholelithiasis and the operation on biliary tract.But this product can not be dissolved bile pigment calculus, combination calculus and not saturating X ray calculus.This product is applied to clinical always, after medication idol urticaria sample sebum reaction is arranged or digestive tract reaction such as feel sick, do not see that so far these product have the report of serious adverse reaction, its preparation has osalmide sheet and osalmide capsule, is all one of clinical choleretic.
From the situation analysis of osalmide clinical application for many years, curative effect has obtained having document osalmide to be treated the report of hepatitis, cholecystitis, calculus curative effect certainly.Osalmide has dosage form tablet, capsule now.
Summary of the invention
The object of the invention is to provide a kind of compliance of dysphagia patients, osalmide dry suspension of expansion osalmide range of application of improving.
The present invention includes osalmide, filler, suspending agent, correctives and binding agent; Described osalmide accounts for 1~40% of described dry suspension gross mass.
The present invention adopts novel adjuvant sodium carboxymethyl cellulose microcrystalline Cellulose, after product adds water, can form the suspension that is evenly distributed rapidly, product has fragrant and sweet abnormal smells from the patient, and after taking, human body absorbs hardly, only at intestinal higher concentration is arranged, adverse reaction rate is low, and slight.The present invention is a novel form, has enlarged the range of application of osalmide, has remedied the defective that the patient takes the compliance difference of solid system, is particularly suitable for child and gerontal patient and uses.
Filler of the present invention, suspending agent, correctives and binding agent account for 10~50%, 20~60%, 20~60% and 1~10% of described dry suspension gross mass respectively.Form suspension rapidly after adopting this proportioning can make medicine add water.
In order to promote that the described filler of medicine suspendible is a dextrin.
In like manner, form the suspendible shape in order to impel medicine, described suspending agent is the sodium carboxymethyl cellulose microcrystalline Cellulose.
Described correctives is stevioside, sucrose and essence, and the mass ratio of described stevioside and sucrose is 1 ︰ 200~300.Adopt this correctives can cover the bad smell of medicine, improve the compliance of drug administration.
Be convenient to form granule when medicine is granulated, described binding agent is a 30 POVIDONE K 30 BP/USP 30.
Another object of the present invention is a kind of preparation method that proposes this osalmide dry suspension.
1) osalmide is pulverized the back and cross 100~120 mesh sieves; Correctives suspending agent, filler pulverize separately, and cross 100~120 mesh sieves;
2) preparation binder solution;
3) osalmide, filler, suspending agent, correctives and binder solution are mixed the back and granulate, again through 55 ± 5 ℃ of oven dry; When feeding intake, described osalmide accounts for 1~40% of the quality that always feeds intake;
4) packing.
Technology of the present invention is simple, reasonable, and convenient production is beneficial to low energy consumption, low-cost production, and product stability is good.
Described binder solution is that mass percent is 5% 30 POVIDONE K 30 BP/USP 30 alcoholic solution.
In addition, when described system material fed intake, described filler, suspending agent, correctives and binding agent accounted for 10~50%, 20~60%, 20~60% and 1~10% of the described quality that always feeds intake respectively.
The specific embodiment
One, production technology:
Osalmide is pulverized, crossed 120 mesh sieves, sucrose is pulverized the back and is crossed 100 mesh sieves respectively with sodium carboxymethyl cellulose microcrystalline Cellulose, dextrin, and press recipe quantity and mix, be 5% 30 POVIDONE K 30 BP/USP 30 alcoholic solution system soft materials with mass percent, the granulation of 18 orders.After 55 ± 5 ℃ of oven dry, reuse 16 mesh sieves are removed coarse granule then, add an amount of essence and mix the back packing.
Two, raw materials for production prescription:
Example 1:
Osalmide 125g
Sodium carboxymethyl cellulose microcrystalline Cellulose 400g
Dextrin 200g
Sucrose 500g
The about 200ml of 5% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution
Essence 5ml
Example 2:
Osalmide 150g
Sodium carboxymethyl cellulose microcrystalline Cellulose 400g
Dextrin 200g
Sucrose 500g
Stevioside 2.5g
The about 200ml of 5% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution
Essence 5ml
Annotate: the used sodium carboxymethyl cellulose microcrystalline Cellulose of the present invention is the import adjuvant, is produced by Asahi Kasel Corporation, and its specification is RC-A-591NF.

Claims (10)

1. an osalmide dry suspension is characterized in that comprising osalmide, filler, suspending agent, correctives and binding agent; Described osalmide accounts for 1~40% of described dry suspension gross mass.
2. according to the described osalmide dry suspension of claim 1, it is characterized in that described filler, suspending agent, correctives and binding agent account for 10~50%, 20~60%, 20~60% and 1~10% of described dry suspension gross mass respectively.
3. according to claim 1 or 2 described osalmide dry suspension, it is characterized in that described filler is a dextrin.
4. according to claim 1 or 2 described osalmide dry suspension, it is characterized in that described suspending agent is the sodium carboxymethyl cellulose microcrystalline Cellulose.
5. according to claim 1 or 2 described osalmide dry suspension, it is characterized in that described correctives is stevioside and essence.
6. according to claim 1 or 2 described osalmide dry suspension, it is characterized in that described correctives is stevioside, sucrose and essence, the mass ratio of described stevioside and sucrose is 1 ︰ 200~300.
7. according to claim 1 or 2 described osalmide dry suspension, it is characterized in that described binding agent is a 30 POVIDONE K 30 BP/USP 30.
8. the preparation method of osalmide dry suspension according to claim 1 is characterized in that may further comprise the steps:
1) osalmide is pulverized the back and cross 100~120 mesh sieves; Correctives suspending agent, filler pulverize separately, and cross 100~120 mesh sieves;
2) preparation binder solution;
3) osalmide, filler, suspending agent, correctives and binder solution are mixed the back and granulate, again through 55 ± 5 ℃ of oven dry; Described osalmide accounts for 1~40% of the quality that always feeds intake;
4) packing.
9. the preparation method of described according to Claim 8 osalmide dry suspension is characterized in that described binder solution is that mass percent is 5% 30 POVIDONE K 30 BP/USP 30 alcoholic solution.
10. the preparation method of described according to Claim 8 osalmide dry suspension, when it is characterized in that described system material feeds intake, described filler, suspending agent, correctives and binding agent account for 10~50%, 20~60%, 20~60% and 1~10% of the described quality that always feeds intake respectively.
CN2011102518238A 2011-08-30 2011-08-30 Osalmid for suspension and preparation method thereof Pending CN102258482A (en)

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Application Number Priority Date Filing Date Title
CN2011102518238A CN102258482A (en) 2011-08-30 2011-08-30 Osalmid for suspension and preparation method thereof

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Application Number Priority Date Filing Date Title
CN2011102518238A CN102258482A (en) 2011-08-30 2011-08-30 Osalmid for suspension and preparation method thereof

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105693546A (en) * 2014-11-27 2016-06-22 中国科学院上海药物研究所 Uses of 2-hydroxy-N-(4-hydroxyphenyl)-benzamide compounds in preparation of tyrosinase inhibitors

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105693546A (en) * 2014-11-27 2016-06-22 中国科学院上海药物研究所 Uses of 2-hydroxy-N-(4-hydroxyphenyl)-benzamide compounds in preparation of tyrosinase inhibitors
CN105693546B (en) * 2014-11-27 2019-05-31 中国科学院上海药物研究所 4- hydroxyl Salicylanilide compounds are preparing the application in tyrosinase inhibitor

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Application publication date: 20111130