CN109464406A - 2mg loperamide hydrochloride blade technolgy - Google Patents
2mg loperamide hydrochloride blade technolgy Download PDFInfo
- Publication number
- CN109464406A CN109464406A CN201811388566.0A CN201811388566A CN109464406A CN 109464406 A CN109464406 A CN 109464406A CN 201811388566 A CN201811388566 A CN 201811388566A CN 109464406 A CN109464406 A CN 109464406A
- Authority
- CN
- China
- Prior art keywords
- loperamide hydrochloride
- magnesium stearate
- added
- ludipress
- blade technolgy
- 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
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Classifications
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/451—Non condensed piperidines, e.g. piperocaine having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
-
- 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
- A61P1/12—Antidiarrhoeals
Abstract
The invention discloses 2mg loperamide hydrochloride blade technolgies, which comprises the following steps: S1 takes loperamide hydrochloride, Ludipress, magnesium stearate material respectively, carries out sieving screening with stainless steel sieve；S2, the magnesium stearate after taking sieving are added to the mixer, and open mixing machine；S3 takes out magnesium stearate, loperamide hydrochloride is added in mixing machine and is mixed with the mixture of 10kg Ludipress；S4 adds the remaining Ludipress being sieved, carries out total mix；S5 is added magnesium stearate and is mixed；S6 takes out mixed material, is added in tablet press machine, carries out tabletting；S7 obtains semi-finished product, examines, packs to obtain finished product.The present invention; make the contents such as technology, quality management and quality control, material balance and consumption, health, safety, the environmental protection of 2mg loperamide hydrochloride piece production overall process; it is produced according to the requirement of license products; meet drug licence and the requirement of GMP, stability, safety, reliability, the consistency of product quality is made to be guaranteed.
Description
Technical field
The present invention relates to loperamide hydrochloride processing technique field more particularly to 2mg loperamide hydrochloride blade technolgies.
Background technique
Loperamide hydrochloride is the crystalline powder of a kind of white or off-white color, can be used as antidiarrheal agent or long-acting
Anti-diarrheal is chiefly used in treating acute and chronic dysentery.When overdose, in fact it could happen that drowsiness, constipation, muscular tone, pupil contracting
The poisoning symptoms such as small, bradypnoea can be detoxified with naloxone, and observation at least 48 hours is carried out to patient, to send out in time
The inhibiting effect of existing central nervous system.
The prior art, loperamide hydrochloride are mostly capsule products, so we invent a kind of loperamide hydrochloride piece work
Skill, but in tableting processes, the bad control such as quality control, material balance and consumption, health, safety, environmental protection.
Summary of the invention
The purpose of the present invention is to solve disadvantages existing in the prior art, and the 2mg loperamide hydrochloride piece proposed
Technique.
To achieve the goals above, present invention employs following technical solutions:
2mg loperamide hydrochloride blade technolgy, which comprises the following steps:
S1 takes loperamide hydrochloride, Ludipress, magnesium stearate material respectively, carries out sieving screening with stainless steel sieve；
S2, the magnesium stearate after taking sieving are added to the mixer, and open mixing machine；
S3, takes out magnesium stearate, and the mixture that loperamide hydrochloride and 10kg Ludipress are added in mixing machine carries out
Mixing；
S4 adds the remaining Ludipress being sieved, carries out total mix；
S5 is added magnesium stearate and is mixed；
S6 takes out mixed material, is added in tablet press machine, carries out tabletting；
S7 obtains semi-finished product, examines, packs to obtain finished product.
Preferably, in the S1, stainless steel sieve is ZS-515 shaking screen, and specification is 15-40 mesh.
Preferably, the mixing machine is the mixing of HZD2000 type automatic lifting hopper.
Preferably, in the S2, incorporation time 3-10min.
Preferably, in the S3, incorporation time 3-10min.
Preferably, in the S4, incorporation time 15-25min.
Preferably, in the S5, incorporation time 1-3min.
Preferably, in the S6, tablet press machine is PG65 Highspeedrotarytabletpress, is checked in tableting processes every 30 minutes
The appearance of primary piece, 20 gross weights, 20 be averaged slice weights and friabilities, every the weight differential of inspection in 1 hour, diameter,
Thickness, hardness and disintegration time limited.
Compared with prior art, the beneficial effects of the present invention are:
1. the present invention establishes 2mg loperamide hydrochloride tablet recipe and technological procedure, keep the production of 2mg loperamide hydrochloride piece complete
The contents such as the technology of process, quality management and quality control, material balance and consumption, health, safety, environmental protection, are pressed
Requirement according to license products is produced, and drug licence and the requirement of GMP are met, and makes stability, the safety of product quality
Property, reliability, consistency are guaranteed.
2. it is of the invention, in mixing machine mixed process, magnesium stearate is added, lubricates mixer wall, raw material is avoided to glue machine wall.
Specific embodiment
It is clearly and completely described below in conjunction with the technical solution in the embodiment of the present invention, it is clear that described reality
Applying example is only a part of the embodiment of the present invention, instead of all the embodiments.
Embodiment 1:2mg loperamide hydrochloride blade technolgy, which comprises the following steps: S1 takes hydrochloric acid Lip river respectively
Piperazine butylamine, Ludipress, magnesium stearate material carry out sieving screening with stainless steel sieve；S2, the magnesium stearate after taking sieving add
Enter in mixing machine, opens mixing machine；S3 takes out magnesium stearate, loperamide hydrochloride and 10kg is added in mixing machine
The mixture of Ludipress is mixed；S4 adds the remaining Ludipress being sieved, carries out total mix；S5 is added stearic
Sour magnesium is mixed；S6 takes out mixed material, is added in tablet press machine, carries out tabletting；S7 obtains semi-finished product, examine, pack at
Product.
In the S1, stainless steel sieve is ZS-515 shaking screen, and specification is 15 mesh；The mixing machine is that HZD2000 type is automatic
Promote hopper mixing；In the S2, incorporation time 3min；In the S3, incorporation time 3min；In the S4, when mixing
Between be 15min；In the S5, incorporation time 1min；In the S6, tablet press machine is PG65 Highspeedrotarytabletpress, tabletting
Appearance, 20 gross weights, 20 average slice weights and the friability for checking primary piece every 30 minutes in the process, were examined every 1 hour
Cha Yici weight differential, diameter, thickness, hardness and disintegration time limited.
Item controlled, inspection method and the control limit at the present embodiment workshop QA quality of production control point:
Embodiment 2:2mg loperamide hydrochloride blade technolgy, which comprises the following steps: S1 takes hydrochloric acid Lip river respectively
Piperazine butylamine, Ludipress, magnesium stearate material carry out sieving screening with stainless steel sieve；S2, the magnesium stearate after taking sieving add
Enter in mixing machine, opens mixing machine；S3 takes out magnesium stearate, loperamide hydrochloride and 10kg is added in mixing machine
The mixture of Ludipress is mixed；S4 adds the remaining Ludipress being sieved, carries out total mix；S5 is added stearic
Sour magnesium is mixed；S6 takes out mixed material, is added in tablet press machine, carries out tabletting；S7 obtains semi-finished product, examine, pack at
Product.
In the S1, stainless steel sieve is ZS-515 shaking screen, and specification is 40 mesh；The mixing machine is that HZD2000 type is automatic
Promote hopper mixing；In the S2, incorporation time 10min；In the S3, incorporation time 10min；In the S4, mixing
Time is 25min；In the S5, incorporation time 3min；In the S6, tablet press machine is PG65 Highspeedrotarytabletpress, pressure
Appearance, 20 gross weights, 20 average slice weights and the friability for checking primary piece during piece every 30 minutes, every 1 hour
Check a weight differential, diameter, thickness, hardness and disintegration time limited.
Item controlled, inspection method and the control limit at the present embodiment workshop quality of production control point:
Integrated embodiment one and embodiment two, invention establish 2mg loperamide hydrochloride tablet recipe and Process Planning
Journey, make the 2mg loperamide hydrochloride piece production technology of overall process, quality management and quality control, material balance and consumption,
The contents such as health, safety, environmental protection are produced according to the requirement of license products, meet wanting for drug licence and GMP
It asks, stability, safety, reliability, the consistency of product quality is made to be guaranteed.
The foregoing is only a preferred embodiment of the present invention, but scope of protection of the present invention is not limited thereto,
Anyone skilled in the art in the technical scope disclosed by the present invention, according to the technique and scheme of the present invention and its
Inventive concept is subject to equivalent substitution or change, should be covered by the protection scope of the present invention.
Claims (8)
1.2mg loperamide hydrochloride blade technolgy, which comprises the following steps:
S1 takes loperamide hydrochloride, Ludipress, magnesium stearate material respectively, carries out sieving screening with stainless steel sieve；
S2, the magnesium stearate after taking sieving are added to the mixer, and open mixing machine；
S3 takes out magnesium stearate, loperamide hydrochloride is added in mixing machine and is mixed with the mixture of 10kg Ludipress；
S4 adds the remaining Ludipress being sieved, carries out total mix；
S5 is added magnesium stearate and is mixed；
S6 takes out mixed material, is added in tablet press machine, carries out tabletting；
S7 obtains semi-finished product, examines, packs to obtain finished product.
2. 2mg loperamide hydrochloride blade technolgy according to claim 1, which is characterized in that in the S1, stainless steel sieve is
ZS-515 shaking screen, specification are 15-40 mesh.
3. 2mg loperamide hydrochloride blade technolgy according to claim 1, which is characterized in that the mixing machine is HZD2000
The mixing of type automatic lifting hopper.
4. 2mg loperamide hydrochloride blade technolgy according to claim 1, which is characterized in that in the S2, incorporation time is
3-10min。
5. 2mg loperamide hydrochloride blade technolgy according to claim 1, which is characterized in that in the S3, incorporation time is
3-10min。
6. 2mg loperamide hydrochloride blade technolgy according to claim 1, which is characterized in that in the S4, incorporation time is
15-25min。
7. 2mg loperamide hydrochloride blade technolgy according to claim 1, which is characterized in that in the S5, incorporation time is
1-3min。
8. 2mg loperamide hydrochloride blade technolgy according to claim 1, which is characterized in that in the S6, tablet press machine is
PG65 Highspeedrotarytabletpress, checked every 30 minutes in tableting processes the appearance of primary piece, 20 gross weights, 20 it is average
Slice weight and friability, every a 1 hour inspection weight differential, diameter, thickness, hardness and disintegration time limited.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811388566.0A CN109464406A (en) | 2018-11-21 | 2018-11-21 | 2mg loperamide hydrochloride blade technolgy |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811388566.0A CN109464406A (en) | 2018-11-21 | 2018-11-21 | 2mg loperamide hydrochloride blade technolgy |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109464406A true CN109464406A (en) | 2019-03-15 |
Family
ID=65674029
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811388566.0A Pending CN109464406A (en) | 2018-11-21 | 2018-11-21 | 2mg loperamide hydrochloride blade technolgy |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109464406A (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20080020047A1 (en) * | 2006-07-24 | 2008-01-24 | Alexander Thomas A | Method for distributing a pharmaceutically active compound in an excipient |
-
2018
- 2018-11-21 CN CN201811388566.0A patent/CN109464406A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20080020047A1 (en) * | 2006-07-24 | 2008-01-24 | Alexander Thomas A | Method for distributing a pharmaceutically active compound in an excipient |
Non-Patent Citations (2)
| Title |
|---|
| 无: "Norimode Tablets", 《IMEDI网页，网址：HTTPS://IMEDI.CO.UK/NORIMODE-TABLETS》 * |
| 潘卫三: "《工业药剂学》", 31 August 2015, 中国医药科技出版社 * |
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|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20190315 |