CN1180517A - Pharmaceutical technique method suitable for dispersion and granulation of solid raw material - Google Patents
Pharmaceutical technique method suitable for dispersion and granulation of solid raw material Download PDFInfo
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- CN1180517A CN1180517A CN 97118977 CN97118977A CN1180517A CN 1180517 A CN1180517 A CN 1180517A CN 97118977 CN97118977 CN 97118977 CN 97118977 A CN97118977 A CN 97118977A CN 1180517 A CN1180517 A CN 1180517A
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- medicine
- polyethylene glycol
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Abstract
A technological method used in the process of crushing raw materials and dispersing during the procedure of preparing capsules, tablets, or exterior-use drugs of hormone, mental medicine, anti-cancer medicine and acid-base medicine, which may play abverse action on normal human body, includes such steps as heating polyethylene glycol as surfactant until it is molten, addition of solid raw materials, stirring and cooling for granulating, and features less technological steps and environmental pollution.
Description
The present invention relates in making drug capsules agent, tablet and part medicine for external use process, with the process of using in solid material pulverizing, the dispersion step, particularly hormone medicine, psychotropic drugs, antitumor drug, Acidity of Aikalinity medicine etc. produce the medicine of ill effect to the normal person easily, its solid shape crude drug is disperseed, employed process in the granulation process.
Usually, when using the solid material medicine to produce medicinal tablet, capsule and part medicine for external use dosage forms such as (as unguentum), need principal agent is disperseed.Principal agent is mixed with adjuvants such as excipient, surfactant, disintegrating agents, principal agent is disperseed.Also to add wetting agent (being generally water or alcoholic solution), binding agent.Behind drying and the granulate, enter next process again.In dry run, along with moisture and alcoholic acid distillation, volatilization, ingredient also escapes in the workshop air.In the dried granulation process, drug microparticles takes place inevitably fly upward and float in the workshop air.Be in the staff in this environment, suck drug microparticles for a long time, cumulant can reach suitable level.Many medicines can cause physiological interference to the normal person, even pathological lesion.For example hormone medicine changes people's metabolism or reproductive function, and spiritual medication makes the people depressed or excited, and antitumor drug makes people's bone marrow damage, leukopenia, and the medicine of band Acidity of Aikalinity causes stimulation and infringement to respiratory mucosa and skin.The production of the contraceptive that consumption is very big on China and the international is exactly an example.The workshop woman worker because of suction estrogen drug microparticles menoxenia takes place and growing barrier is modal ill effect.Each manufacturer is perplexed by this, and the young and middle-aged women workman has to avoid using.Cross involutional middle aged and aged women even if tolerance is stronger, also will constantly change, in the hope of with the injured extent control of individuality in lower level.Therefore, seek a kind of process, solid shape crude drug is pulverized, when disperseing, can avoid or reduce the pollution of drug volatilization thing, buoyant drug microparticles to workshop air, thereby avoid or reduce infringement, become the problem that pharmaceuticals industry presses for solution the field personnel.
The purpose of this invention is to provide in a kind of pharmacy procedure the process that solid shape crude drug is pulverized, disperses, granulated.This method is applied to the multiple medicine pharmacy that may produce ill effect to the normal human of multiclass, the pollution to environment that can reduce or avoid dispersing of drug microparticles to be caused.
The technical scheme that realizes the object of the invention is, adopt one of the most frequently used adjuvant of modern pharmaceutical-Polyethylene Glycol to make the surfactant of medicine, to make its fusion be liquid in heating according to the melting temperature of Polyethylene Glycol, the solid material medicine short time is once joined in the Polyethylene Glycol that fusion is a liquid, stir, treating promptly becomes graininess or bulk after its cooling.Graininess person can carry out granulate.Bulk person goes when pulverizing again, because this medicine is firmly adsorbed by Polyethylene Glycol, also seldom produces microgranule and flies upward, and its ill effect is faint to disregarding.
When using Polyethylene Glycol to make pharmaceutical aids, be earlier Polyethylene Glycol to be dissolved in water or Different concentrations of alcohol solution in the past, and added solid material medicine and other adjuvant, drying is granulated, and enters later operation again.Substitute traditional method that makes water or dissolve with ethanol solution with the Polyethylene Glycol fusion method, saved drying and granulation process, eliminated drug volatilization substantially and microgranule disperses, and shortened man-hour.
Simultaneously, the process operation of the suitable some drugs of the melting temperature of Polyethylene Glycol.For example salicylic acid distils in the time of 76 ℃.If a certain link in the technical process surpasses 76 ℃, will cause the ease of salicylic acid composition to lose.The melting temperature of Polyethylene Glycol-6000 is 60-63 ℃, uses Polyethylene Glycol-6000 fusion method to produce the salicylic acid tablet, at the temperature operation below 76 ℃, has avoided the distillation of this medicine, makes the preparation effective ingredient avoid loss.
The invention will be further described by the following examples.
Embodiment 1 produces 1000 of tamoxifen (tamoxifen) 10mg capsules
Get
Tamoxifen 10g Polyethylene Glycol-6000 100g
Starch 180g magnesium stearate 6g
1. tamoxifen, starch are crossed 100 mesh sieves respectively, standby.
2. Polyethylene Glycol-6000 is heated to 60-63 ℃, treat that its complete fusion is a liquid, add above-mentioned tamoxifen of getting ready and starch, stir, place room temperature about 5 hours, 40 mesh sieves are crossed in the cooling back, add magnesium stearate again, stir evenly, divide after chemical examination content meets the requirements and pack 1000 capsules into promptly.
Embodiment 2 produces salicylic acid powder 1000g
Get
Salicylic acid 1000g Polyethylene Glycol-6000 2000g
1. salicylic acid is crossed 100 mesh sieves, standby.
2. Polyethylene Glycol-6000 is heated to 60-63 ℃, treats that its complete fusion is a liquid, adds the above-mentioned salicylic acid of getting ready, stir, place 5 hours postcooling of room temperature and become block, be ground into powdery after the chemical examination content conformance with standard, in order to making ointment, or the soaked immersion focus of direct packaging patients.
Claims (1)
- A kind of in the agent of making drug capsules; in tablet and the part medicine for external use process; solid material is pulverized; disperse; the process of using in the granulation process; hormone medicine particularly; psychotropic drugs; antitumor drug; Acidity of Aikalinity medicine etc. produces the medicine of ill effect to the normal person easily; its solid shape crude drug is being disperseed; employed process in the granulation process; select for use Polyethylene Glycol to make surfactant; it is characterized in that; it is liquid by its melting temperature heating it to be melt into Polyethylene Glycol earlier; once add the solid material medicine; the postcooling that stirs is in order to granulate or granulate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 97118977 CN1180517A (en) | 1997-10-09 | 1997-10-09 | Pharmaceutical technique method suitable for dispersion and granulation of solid raw material |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 97118977 CN1180517A (en) | 1997-10-09 | 1997-10-09 | Pharmaceutical technique method suitable for dispersion and granulation of solid raw material |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1180517A true CN1180517A (en) | 1998-05-06 |
Family
ID=5175102
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 97118977 Pending CN1180517A (en) | 1997-10-09 | 1997-10-09 | Pharmaceutical technique method suitable for dispersion and granulation of solid raw material |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1180517A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102885788A (en) * | 2011-07-22 | 2013-01-23 | 重庆华邦制药股份有限公司 | Linezolid tablets in stable crystal form and preparation method thereof |
| CN102988181A (en) * | 2012-12-31 | 2013-03-27 | 广州白云山天心制药股份有限公司 | Granulating method and application for oral solid preparation |
| CN112656690A (en) * | 2021-01-29 | 2021-04-16 | 南京科技职业学院 | Pharmaceutical process method suitable for dispersing and granulating solid raw materials |
-
1997
- 1997-10-09 CN CN 97118977 patent/CN1180517A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102885788A (en) * | 2011-07-22 | 2013-01-23 | 重庆华邦制药股份有限公司 | Linezolid tablets in stable crystal form and preparation method thereof |
| CN102885788B (en) * | 2011-07-22 | 2016-06-29 | 重庆华邦制药有限公司 | A kind of Linezolid sheet of stable crystal form and preparation method thereof |
| CN102988181A (en) * | 2012-12-31 | 2013-03-27 | 广州白云山天心制药股份有限公司 | Granulating method and application for oral solid preparation |
| CN112656690A (en) * | 2021-01-29 | 2021-04-16 | 南京科技职业学院 | Pharmaceutical process method suitable for dispersing and granulating solid raw materials |
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| SE01 | Entry into force of request for substantive examination | ||
| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |