CN103006682A - Preparation method of granules for diminishing inflammation, relieving pain and promoting gastric mucosa repair - Google Patents
Preparation method of granules for diminishing inflammation, relieving pain and promoting gastric mucosa repair Download PDFInfo
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- CN103006682A CN103006682A CN2012105799543A CN201210579954A CN103006682A CN 103006682 A CN103006682 A CN 103006682A CN 2012105799543 A CN2012105799543 A CN 2012105799543A CN 201210579954 A CN201210579954 A CN 201210579954A CN 103006682 A CN103006682 A CN 103006682A
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- granule
- granules
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- procaine hydrochloride
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Abstract
The invention relates to a preparation method of granules for diminishing inflammation, relieving pain and promoting gastric mucosa repair. The preparation method comprises the following steps of: crushing procaine hydrochloride and cane sugar till the particle sizes of the two components can be 80 meshes; dosing and weighing, wherein gelatin is taken, and the weight ratio of gentamycin sulfate (calculated by anhydride) to procaine hydrochloride (calculated by anhydride) to vitamin B12 to the cane sugar is 20mg: 0.1g: 0.02mg: 4.81g; preparing a binding agent; granulating, wherein the procaine hydrochloride and the cane sugar are sequentially poured into a fluidized bed drying granulator, solution of the gentamycin sulfate and the vitamin B12 is sprayed into the mixture after the procaine hydrochloride and the cane sugar are fully mixed for 15 minutes, then aqueous solution of the gelatin is taken as the binding agent for spraying fluidized granulation, the granulation temperature is controlled in a range of 50+/-5 DEG C, the drying temperature is controlled in a range of 65+/-5 DEG C, the drying lasts for 20 minutes and stops after the granules are formed and then the granules are obtained; granulating; and totally mixing the granules. The preparation method has the advantage of obtaining the granules with good quality.
Description
Technical field
The present invention relates to a kind of manufacture method of granule, relate in particular to the manufacture method of a kind of antiinflammatory, pain relieving, promotion gastric mucosa reparation granule.
Background technology
A large amount of sale gentamycin procaine dimension B are arranged in the market
12Granule (Gentamycin Sulfatc, procaine Hydrochloride and Vitamin B
12Granules), however the gentamycin procaine of different plates dimension B
12Its medical effect of granule is different greatly, and proportioning is had any different on the one hand, there are differences in the processing technology process on the other hand.The invention provides the better gentamycin procaine dimension B of a kind of quality of production
12The manufacture method of granule, gentamycin procaine dimension B
12But granule antiinflammatory, pain relieving, promotion gastric mucosa are repaired, and are mainly used in chronic, superficial gastritis, also are used for other gastritis.
Summary of the invention
In view of this, be necessary to provide a kind of quality of production better be used for the manufacture method that granule is repaired in antiinflammatory, pain relieving, promotion gastric mucosa.
The present invention is achieved in that a kind of manufacture method for antiinflammatory, pain relieving, promotion gastric mucosa reparation granule, and it may further comprise the steps:
1, pulverizes: procaine hydrochloride and sucrose are pulverized respectively to reach the requirement of 80 mesh sieves;
2, batch weighing: get the gentamycin sulfate that gelatin and weight ratio are 20mg: 0.1g: 0.02mg:4.81g (pressing anhydride calculates), procaine hydrochloride (pressing anhydride calculates), vitamin B
12, sucrose;
3, the preparation of adhesive: with gelatin purified water alveolation, boiled 20 minutes; Add again purified water and be configured to gelatin solution;
4, granulate: procaine hydrochloride and sucrose are poured in the fluidized drying pelletizer one by one, fully mix 15 minutes after, with gentamycin sulfate and vitamin B
12Solution sprays into, and granulates take aqueous gelatin solution as the binding agent spray-fluidized again, and pelleting temperature is controlled at 50 ± 5 ℃, and baking temperature is controlled at 65 ± 5 ℃, and dry 20 minutes, behind the grain forming, can stop drying, receive to get granule;
5, granulate: with dried granule with whirlpool vibration type screening machine granulate, can be by 12 mesh sieves and can not be by the qualified granule of being of 60 mesh sieves, bulky grain that can not be by 12 mesh sieves and fine powder that can be by 60 mesh sieves are for expecting end to end;
6, total mixed: as the qualified granule behind the granulate to be put into mixer, mix after 8 minutes, granule is taken out.
As the further improvement of such scheme,, the said preparation operation is further comprising the steps of: the ball after the dripping is carried out inner packing and outer package.
As the further improvement of such scheme, during granulation, the adhesive temperature is controlled at 40~50 ℃.
Manufacture method for antiinflammatory, pain relieving, promotion gastric mucosa reparation granule of the present invention, the granular mass of making is good, composition good, good effect.
Description of drawings
Fig. 1 repairs the flow chart of the manufacture method of granule for what preferred embodiments of the present invention provided for antiinflammatory, pain relieving, promotion gastric mucosa.
The specific embodiment
In order to make purpose of the present invention, technical scheme and advantage clearer, below in conjunction with drawings and Examples, the present invention is further elaborated.Should be appreciated that specific embodiment described herein only in order to explain the present invention, is not intended to limit the present invention.
The granule that the present invention is used for the manufacture method making of antiinflammatory, pain relieving, promotion gastric mucosa reparation granule also is gentamycin procaine dimension B
12Granule (Gentamycin Sulfatc, procaine Hydrochloride and Vitamin B
12Granules), the below enumerates a detailed embodiment and is described in detail.
One, ××× System Description (V1.0):
1, name of product: gentamycin procaine dimension B
12Granule (Gentamycin Sulfatc, procaine Hydrochloride and Vitamin B
12Granules)
2, main component: gentamycin sulfate, procaine hydrochloride, vitamin B
12
3, dosage form: granule
4, character: this product is sol particle; Sweet, little hardship of distinguishing the flavor of.
5, specification: every packed 5g (sulfur acid gentamycin 20mg (20000 unit), procaine hydrochloride 0.1g, vitamin B
120.02mg)
6, usage and dosage: oral.One time 1 bag, 3 times on the one, chew ante cibum clothes or warm boiled water.6 courses for the treatment of Monday or follow the doctor's advice.
7, indication: be used for antiinflammatory, pain relieving promotes the gastric mucosa reparation, is mainly used in chronic, superficial gastritis, also is used for other gastritis.
8, untoward reaction: loss of appetite can occur, feel sick, the reaction such as diarrhea, a few patients can have renal hypofunction, hematuria, oliguria, auditory dysesthesia, tinnitus or in ear satiety (ototoxicity).
9, points for attention:
(1) the careful usefulness of anemia of pregnant woman.
(2) the careful usefulness of renal insufficiency person.
(3) vestibular function or the careful usefulness of auditory dysesthesia person.
10, taboo:
(1) the gentamycin anaphylaxis person is forbidden.
(2) severe renal functional lesion person forbidding.
11, storage: sealing, (lucifuge also is no more than 20 ℃) preserves in cool dark place.
12, effect duration: tentative 24 months
Two, prescription and foundation thereof and batch:
1, prescription:
Every packed 5g (sulfur acid gentamycin 20mg (20000 unit), procaine hydrochloride 0.1g, vitamin B
120.02mg)
2, foundation: WS-10001-(HD-0547)-2002 the gentamycin procaine is tieed up B
12Stipulate under the granule item.
3, criticize inventory: 120,000 bags.
Three, production technological process as shown in Figure 1, removes outsourcing, product inspection, warehouse-in in general production area, and all the other are all at 300,000 grades of clean areas.
Four, operating process and process conditions:
1, pulverizes: the material of required pulverizing is put into pulverizer, machine, and control certain charging rate to reach the requirement of 80 mesh sieves.Pulverize complete after, between will pulverizing, cloth bag is cleaned out, and fine powder is packed in the clean container, and is labelled, indicates the name of an article, lot number, quantity etc., delivers the material intermediate station.
2, batch weighing: check the supplementary material of having got according to producing the preparation instruction sheet, be divided into five parts by batch inventory, after batch weighing finishes, pack in the clean container, labelled, indicate the name of an article, lot number, quantity etc., weighing is calculated should be accurate, and deliver lower operation after having the special messenger to check.
3, the preparation of adhesive: with an amount of gelatin purified water alveolation, put into jacketed pan and boil about 20 minutes.Add again an amount of purified water and be configured to the gelatin solution of suitable concentration.During granulation, the adhesive temperature is controlled at about 40~50 ℃.
4, granulate: load weighted fine powder is poured in the fluidized drying pelletizer one by one, fully mix 15 minutes after, with gentamycin sulfate and vitamin B
12Solution sprays into, granulate take aqueous gelatin solution as the binding agent spray-fluidized, pelleting temperature is controlled at 50 ± 5 ℃ again, and baking temperature is controlled at 65 ± 5 ℃, dry about 20 minutes, behind the grain forming, can stop drying, receive to get granule, put into clean container, labelled, indicate the name of an article, lot number etc., transfer lower operation.
5, granulate: with dried granule with whirlpool vibration type screening machine granulate, can be by 12 mesh sieves and can not be by the qualified granule of being of 60 mesh sieves, labelled in the clean container of packing into, indicate the name of an article, lot number, quantity etc., transfer lower operation.The fine powder that can not pass through the bulky grain of 12 mesh sieves and can pass through 60 mesh sieves is for expecting end to end, and is labelled in the clean container of should packing into, indicates the name of an article, lot number, quantity etc., as recycling material, transfers terminal.
6, total mixed: the granule behind the granulate is put into mixer, mix after 8 minutes, granule is taken out, then put into clean container, sealing, labelled, indicate the name of an article, lot number, quantity etc., transfer intermediate station, censorship.
7, inner packing: get midbody particle and aluminium-plated bag according to inner packing instruction sheet and material requistion, be packaged into aluminium-plated bag with automatic granular packaging machine by definite loading amount and scope, and every 10 minutes inspection loading amounts, at last packaged pouch is put into clean container, labelled, indicate the name of an article, lot number, quantity, operator etc., transfer intermediate station.Check at any time the name of an article, lot number, loading amount etc. during operation.
8, outer package: the packaging material such as cover box, carton, description of singly getting supporting quantity according to packaging directive.Standard in accordance with regulations and require packing will be checked the name of an article, lot number, specification, quantity of product etc. at any time when packing, enter warehouse for finished product after the QA passed examination.
The above only is preferred embodiment of the present invention, not in order to limiting the present invention, all any modifications of doing within the spirit and principles in the present invention, is equal to and replaces and improvement etc., all should be included within protection scope of the present invention.
Claims (3)
1. one kind is used for the manufacture method that granule is repaired in antiinflammatory, pain relieving, promotion gastric mucosa, it is characterized in that it may further comprise the steps:
1, pulverizes: procaine hydrochloride and sucrose are pulverized respectively to reach the requirement of 80 mesh sieves;
2, batch weighing: get the gentamycin sulfate that gelatin and weight ratio are 20mg: 0.1g: 0.02mg:4.81g (pressing anhydride calculates), procaine hydrochloride (pressing anhydride calculates), vitamin B
12, sucrose;
3, the preparation of adhesive: with gelatin purified water alveolation, boiled 20 minutes; Add again purified water and be configured to gelatin solution;
4, granulate: procaine hydrochloride and sucrose are poured in the fluidized drying pelletizer one by one, fully mix 15 minutes after, with gentamycin sulfate and vitamin B
12Solution sprays into, and granulates take aqueous gelatin solution as the binding agent spray-fluidized again, and pelleting temperature is controlled at 50 ± 5 ℃, and baking temperature is controlled at 65 ± 5 ℃, and dry 20 minutes, behind the grain forming, can stop drying, receive to get granule;
5, granulate: with dried granule with whirlpool vibration type screening machine granulate, can be by 12 mesh sieves and can not be by the qualified granule of being of 60 mesh sieves, bulky grain that can not be by 12 mesh sieves and fine powder that can be by 60 mesh sieves are for expecting end to end;
6, total mixed: as the qualified granule behind the granulate to be put into mixer, mix after 8 minutes, granule is taken out.
2. the manufacture method for antiinflammatory, pain relieving, promotion gastric mucosa reparation granule as claimed in claim 1 is characterized in that the said preparation operation is further comprising the steps of: the ball after the dripping is carried out inner packing and outer package.
3. the manufacture method for antiinflammatory, pain relieving, promotion gastric mucosa reparation granule as claimed in claim 1 is characterized in that during granulation, the adhesive temperature is controlled at 40~50 ℃.
Priority Applications (1)
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CN2012105799543A CN103006682A (en) | 2012-12-27 | 2012-12-27 | Preparation method of granules for diminishing inflammation, relieving pain and promoting gastric mucosa repair |
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CN2012105799543A CN103006682A (en) | 2012-12-27 | 2012-12-27 | Preparation method of granules for diminishing inflammation, relieving pain and promoting gastric mucosa repair |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105147638A (en) * | 2015-10-30 | 2015-12-16 | 成都通德药业有限公司 | Method for producing compound procaine hydrochloride capsules |
CN113143866A (en) * | 2021-04-25 | 2021-07-23 | 河南省食品药品检验所 | Gentamicin sulfate granules for preventing main drug from degrading |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1244393A (en) * | 1998-08-11 | 2000-02-16 | 苏乐群 | Gastritis treating tablet |
CN1679616A (en) * | 2005-02-01 | 2005-10-12 | 海南康力元药业有限公司 | Compound tablet for treating gastritis and preparation thereof |
CN1712012A (en) * | 2004-06-23 | 2005-12-28 | 毛友昌 | Preparation containing compound gentamicin procaine |
-
2012
- 2012-12-27 CN CN2012105799543A patent/CN103006682A/en active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1244393A (en) * | 1998-08-11 | 2000-02-16 | 苏乐群 | Gastritis treating tablet |
CN1712012A (en) * | 2004-06-23 | 2005-12-28 | 毛友昌 | Preparation containing compound gentamicin procaine |
CN1679616A (en) * | 2005-02-01 | 2005-10-12 | 海南康力元药业有限公司 | Compound tablet for treating gastritis and preparation thereof |
Non-Patent Citations (3)
Title |
---|
国家药典委员会: "《国家药品标准》", 31 December 2002 * |
朱民等: "对流化床喷雾制粒工艺过程控制的研究", 《化工装备技术》 * |
胡容峰等: "《工业药剂学》", 30 October 2010, 中国中医药出版社 * |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105147638A (en) * | 2015-10-30 | 2015-12-16 | 成都通德药业有限公司 | Method for producing compound procaine hydrochloride capsules |
CN113143866A (en) * | 2021-04-25 | 2021-07-23 | 河南省食品药品检验所 | Gentamicin sulfate granules for preventing main drug from degrading |
CN113143866B (en) * | 2021-04-25 | 2023-08-04 | 河南省食品药品检验所 | Gentamicin sulfate particles capable of preventing degradation and deterioration of main medicine |
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Application publication date: 20130403 |