CN101664556A - Lactose-polyvidone-crospolyvidone premixed agent and preparation method thereof - Google Patents
Lactose-polyvidone-crospolyvidone premixed agent and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a lactose-polyvidone-crospolyvidone premixed agent which is prepared form the following components in proportion by weight: 93-93.8 parts of lactose, 3.0-3.4 parts of polyvidone, 3.2-3.6 parts of crospolyvidone and 198-203 parts of water. A preparation method comprises the following steps: mixing the water, the lactose, the polyvidone and the crospolyvidone, stirring for 2-3 hours to prepare an emulsified serous fluid; discharging the serous fluid accounting for 1.5-3 percent of the gross weight from an outlet of a reaction pot, then re-adding the serous fluid into thereaction pot, continuing to stir for 30-50 minutes until the sampling inspection serous fluid is milky and uniform colloid, and then spraying and drying and packaging to obtain the lactose-polyvidone-crospolyvidone premixed agent. The lactose-polyvidone-crospolyvidone premixed agent product not only has the functions of figuration, binding, filling, disintegration and adsorption, but also can be used as an adhesive, a filling agent and a disintegrant for direct tablet compression in medicine manufacture.
Description
Technical field
The present invention relates to a kind of lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent and preparation method thereof, belong to the pharmaceutical technology field.
Background technology
Pharmaceutic adjuvant is meant and keeps its stability, safety or homogeneity when the medicine preparation molding, or for the characteristic that adapts to preparation is the material that purpose is added with promotion dissolving, slow release etc., is the necessary basis of medicament development." Chinese pharmacopoeia version in 2005 is divided into 15 classes by the pharmaceutic adjuvant purposes, is respectively: acidulant, anti-foam agent, adsorbent, anti-microbial preservative, antioxidant, coloring agent, ointment base, sweeting agent, correctives, solvent, basifier, dermal osmosis accelerator, excipient, surfactant, pharmaceutic adjuvant.According to incompletely statistics, the actual adjuvant that uses is nearly 1,000 kinds in domestic and international preparation research and the production, and the research and development of adjuvant being described and using has become an important ring in the modern preparation production.Good adjuvant can strengthen the stability of principal agent, prolongs the effect duration of medicament; Can regulate and control principal agent rate of release in vivo and in vitro; Can change the medicine absorption in vivo, increase bioavailability.
Along with the birth of numerous novel drugs, the physicochemical property that it is changeable and to the requirement of stability; The new equipment and the appearance of production technology; New rules are to the requirement of stability, safety; All the function to adjuvant has proposed more higher standards, makes existing adjuvant not have anyly can satisfy all demands fully.
Premixing auxiliary material is as the novel adjuvant of developing in recent years, by designing the prescription of premixing auxiliary material neatly, can make it constantly represent new characteristic, promptly carry out the compatibility research between adjuvant, the designing optimal composite auxiliary material, as microcrystalline Cellulose cooperate with lactose, microcrystalline Cellulose cooperates with sodium carboxymethyl cellulose etc.Reasonably use premixing auxiliary material, made things convenient for the research and development and the production of medicine widely, make the production operation of formulation products or prevent that microbial contamination is greatly improved.Promoted the fast development of preparation technique.The premixing auxiliary material that more and more has advanced function must promote the progress that preparation industry is bigger.
Lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent (external trade name Ludipress) product is used widely in the preparation industry, promote at home as the Germany happy company of U.S. agent, German BASF AG, for domestic novel form, novel formulation provide quality product, and obtain certainly.But because the premixing auxiliary material production technology is very complicated, each used adjuvant all must be through strict screening, its stability and safety, chemical inertness whether between the adjuvant, all need to carry out strictness and investigate, careful selection, the consumption proportion of each raw material also needs strict calculating.Therefore, the production and the popularization of lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent are restricted.
Summary of the invention
At above-mentioned prior art, the invention provides a kind of lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, its disintegration and dissolution are good, and the present invention also provides its preparation method.
The present invention is achieved by the following technical solutions:
A kind of lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, make by lactose, polyvidone, hinge polyvidone and water, wherein, the weight ratio of each component is: lactose: polyvidone: polyvinylpolypyrrolidone: water=(93～93.8): (3.0～3.4): (3.2～3.6): (198～203), preferred lactose: polyvidone: polyvinylpolypyrrolidone: water=93.4: 3.2: 3.4: 200.
Described water selection process water.
The preparation method of a kind of lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent may further comprise the steps:
1) add entry in reactor, Steam Heating to 100 ℃ also is incubated 15～20 minutes, is cooled to then below 50 ℃ or 50 ℃, and is standby;
2) in weight ratio, in lactose: polyvidone: polyvinylpolypyrrolidone: water=(93～93.8): (3.0～3.4): (3.2～3.6): the ratio of (198～203), in retort, drop into lactose, polyvidone and polyvinylpolypyrrolidone, stirred 2～3 hours, make emulsive serosity;
3) export the serosity of emitting gross weight 1.5%～3% from retort, return and be added back to retort, continue to stir 30～50 minutes, serosity promptly stops to stir for milky white, even colloid to taking a sample to check;
4) use spray drying device, under 100～120 ℃ of conditions of temperature, the product of step 3) is carried out drying, connect material every 30 minutes once and change the screening packaging process over to;
5) after product is crossed 100 eye mesh screens, be the finished product of lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent.
In the preparation method of above-mentioned lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, water is process water in the step 1), the preferred formulation purified water.
In the preparation method of above-mentioned lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, temperature retention time is 15 minutes in the step 1).
In the preparation method of above-mentioned lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, step 2) mixing time is 2 hours in.
In the preparation method of above-mentioned lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, the serosity amount of emitting from the retort outlet in the step 3) is 2%～2.5% of a serosity gross weight.
In the preparation method of above-mentioned lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, mixing time is 30 minutes in the step 3).
In the preparation method of above-mentioned lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, baking temperature is 110 ℃ in the step 4).
In the preparation method of above-mentioned lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, the finished product packing amount is every packing 20kg in the step 5).
Among the present invention, the ratio of three kinds of adjuvants is very crucial, and the applicant has passed through up to a hundred times test, has selected this prescription.After processing compound is determined, be not that simple mixing can reach standard, on manufacture method, the applicant has tested plurality of devices, has determined mulser and press atomization equipment, solved three kinds of adjuvants in conjunction with problem.In preparation method of the present invention, the combination of lactose, polyvidone, polyvinylpolypyrrolidone is: lactose, polyvidone, polyvinylpolypyrrolidone by emulsifying, spraying special handling after, make lactose stick to polyvidone equably, the polyvinylpolypyrrolidone particle surface forms community.
Lactose-polyvidone of the present invention-polyvinylpolypyrrolidone pre-mixing agent product except that having figuration, bonding, filling, disintegrate and adsorption, it in medicament is made mainly as adhesive, filler, the disintegrating agent of direct compression.In recent years along with the improving constantly of preparation technique, the effect of adjuvant has also been proposed new requirement, use this product can optimize technology, saved the loaded down with trivial details program of wet granulation, saved cost, improved working condition.
Lactose-polyvidone of the present invention-polyvinylpolypyrrolidone pre-mixing agent target level of product quality is as shown in table 1.
Table 1
In preparation method of the present invention, raw materials used standard is shown in table 2, table 3, table 4, table 5.
Table 2 lactose is carried out enterprise's inner quality standard
| Inspection item | Index |
| Specific optical rotation | ??+52.0°～+52.6° |
| Clarity of solution | Should be up to specification |
| Protein | Should be up to specification |
| Acidity | ??4.0～7.0 |
| Residue on ignition % | ??≤0.1 |
| Heavy metal % | ??≤0.0005 |
Table 3 polyvidone is carried out enterprise's inner quality standard
Table 4 polyvinylpolypyrrolidone is carried out enterprise's inner quality standard
| Inspection item | Index |
| Acidity | ??5.0～8.0 |
| Loss on drying % | ??≤5.0 |
| Peroxide % | ??≤0.04 |
| Residue on ignition % | ??≤0.4 |
| Hydrotrope % | ??≤1.5 |
| Heavy metal % | ??≤0.001 |
| Vinylpyrrolidone % | ??≤0.1 |
| Nitrogen content | ??11.0％-12.8％ |
Table 5 process water is carried out enterprise's inner quality standard
| Inspection item | Index |
| Calcium salt | Must not detect |
| Sulfate | Must not detect |
| Chloride | Must not detect |
| Acidity | ??5.5～7.0 |
| Non-volatile matter mg | ??≤1 |
Lactose-polyvidone of the present invention-polyvinylpolypyrrolidone pre-mixing agent has the advantages that former lactose, polyvidone, polyvinylpolypyrrolidone three do not possess: the disintegration and the dissolution that have improved preparation.
Below in conjunction with contrast test the effect of product of the present invention is further elaborated (the experiment details are seen specific embodiment part).
Test is compared: the lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent product (hereinafter to be referred as Germany) of lactose-polyvidone of the present invention-polyvinylpolypyrrolidone pre-mixing agent (hereinafter to be referred as the present invention) and import (German BASF AG produces) carries out the dissolving out capability contrast test of disintegrative and medicine, and with the relatively poor medicine atenolol of dissolubility in better medicine spectinomycin hydrochloride of water solublity and the water as model drug, adopt direct compression process, investigate disintegration, the dissolution of tablet.
Pilot project:
The disintegration result of the test: during as model drug, disintegration of tablet order from fast to slow is the present invention＞Germany with spectinomycin hydrochloride; With atenolol during as model drug, disintegration of tablet order from fast to slow is, the present invention＞Germany, and both are all in critical field.
The dissolution result of the test: during as model drug, tablet stripping order from fast to slow is the present invention＞Germany with spectinomycin hydrochloride; During as model drug, tablet stripping order from fast to slow is the present invention＞Germany with atenolol.
Conclusion (of pressure testing): lactose-polyvidone of the present invention-polyvinylpolypyrrolidone pre-mixing agent is compared with the product of import, and every index no significant difference under the prerequisite of ensuring the quality of products, can contend with external product.
Lactose-polyvidone of the present invention-polyvinylpolypyrrolidone pre-mixing agent is the three-in-one system by lactose, polyvidone, three kinds of special uniquenesses that process of compositions process of polyvinylpolypyrrolidone, be white or off-white color, odorless, tasteless runny powder, product of the present invention reacts to the medicine of moisture-sensitive such as aspirin, penicillin and amphetamine, amino acids, almost with all compatibility of drugss.
Attention: the easy moisture absorption of product of the present invention goes bad with absorbing abnormal smells from the patient, so will be stored in the hermetic container.
The specific embodiment
The present invention is further illustrated with experiment below in conjunction with embodiment:
Embodiment 1: preparation lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, and step is as follows:
1) in reactor, add process water 1200kg, Steam Heating to 100 ℃ insulation 15 minutes, be cooled to 50 ℃ standby;
2) in retort, drop into lactose 560.4kg, polyvidone 19.2kg, polyvinylpolypyrrolidone 20.4kg, stirred 2 hours, and emitted the 30-50kg serosity from outlet and return retort again, continue to stir 30 minutes, the serosity of taking a sample to check changes next procedure for milky white, even colloid;
3) the debugging spray drying device is at normal condition, and the control baking temperature carries out drying in 100～120 ℃ of scopes, connect material once every 30 minutes, and change the screening packaging process over to;
4) after product was crossed 100 eye mesh screens, every packing 20kg was lactose-polyvidone-polyvinylpolypyrrolidone finished product.
Embodiment 2: preparation lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, and step is as follows:
1) in reactor, add process water 1188kg, Steam Heating to 100 ℃ insulation 20 minutes, be cooled to 45 ℃ standby;
2) in retort, drop into lactose 562.6kg, polyvidone 18kg, polyvinylpolypyrrolidone 21.6kg, stirred 3 hours, and emitted the 30-50kg serosity from outlet and return retort again, continue to stir 50 minutes, the serosity of taking a sample to check changes next procedure for milky white, even colloid;
3) the debugging spray drying device is at normal condition, and the control baking temperature carries out drying in 100～120 ℃ of scopes, connect material once every 30 minutes, and change the screening packaging process over to;
4) after product was crossed 100 eye mesh screens, every packing 20kg was lactose-polyvidone-polyvinylpolypyrrolidone finished product.
Embodiment 3: preparation lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, and step is as follows:
1) in reactor, add process water 1212kg, Steam Heating to 100 ℃ insulation 18 minutes, be cooled to 40 ℃ standby;
2) in retort, drop into lactose 558kg, polyvidone 20.4kg, polyvinylpolypyrrolidone 19.2kg, stirred 2.5 hours, and emitted the 30-50kg serosity from outlet and return retort again, continue to stir 40 minutes, the serosity of taking a sample to check changes next procedure for milky white, even colloid;
3) the debugging spray drying device is at normal condition, and the control baking temperature carries out drying at 110 ℃, connects material once every 30 minutes, and changes the screening packaging process over to;
4) after product is crossed 100 eye mesh screens, be lactose-polyvidone-polyvinylpolypyrrolidone finished product.
Embodiment 4: preparation lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, and step is as follows:
1) in reactor, add process water 1200kg, Steam Heating to 100 ℃ insulation 18 minutes, be cooled to 50 ℃ standby;
2) in retort, drop into lactose 560.4kg, polyvidone 19.2kg, polyvinylpolypyrrolidone 20.4kg, stirred 2.5 hours, and emitted the 30-50kg serosity from outlet and return retort again, continue to stir 30 minutes, the serosity of taking a sample to check changes next procedure for milky white, even colloid;
3) the debugging spray drying device is at normal condition, and the control baking temperature carries out drying in 100～120 ℃ of scopes, connect material once every 30 minutes, and change the screening packaging process over to;
4) after product was crossed 100 eye mesh screens, every packing 20kg was lactose-polyvidone-polyvinylpolypyrrolidone finished product.
Experiment: the comparison of product technology performance level and similar products at home and abroad
The stripping of the particle diameter of product of the present invention, flowability, swellability, disintegrative and tablet etc. experiment showed, that this product has reached or is better than foreign level.Do the contrast experiment through pharmaceutical college of Shandong University with external like product partial properties, experimental result is as follows: (the A-U.S..B-Germany BASF AG, C product of the present invention)
The granularity percent of experiment 1. each producer's lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agents, the result is as shown in table 6.
Table 6
| Particle diameter/order | ??A | ??B | ??C |
| ??＞140 ??140-120 ??120-100 ??100-80 ??80-60 ??＜60 | ??2.10 ??95.68 ??1.19 ??1.13 ??0 ??0 | ??3.20 ??85.50 ??2.00 ??5.55 ??3.75 ??0 | ??1.00 ??98.0 ??0.80 ??0.20 ??0 ??0 |
Experiment 2. each producer's lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent angle of repose (α), as shown in table 7.
Table 7
Test the experiment of 3. swellabilities
Take by weighing lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent 2.0 grams that are dried to constant weight, put in the tool plug test tube.Measure the height h of powder
1, add water 10ml, jolting, at interval jolting was once again in 10 minutes.Static 48 hours, the powder height h after the mensuration swelling
2Calculate the swelling volume ratio h of powder
2/ h
1, as shown in table 8.
The swellability experimental result of each producer's lactose-polyvidone of table 8-polyvinylpolypyrrolidone pre-mixing agent
| Producer | ??A | ??B | ??C |
| ??H 2/h 1SD | ??1.55±0.14 | ??1.59±3.19 | ??1.65±2.8 |
Experiment 4: disintegrative experiment
Get each producer's lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent 70 ℃ of dryings 2 hours.Hardness Control is about 8.5kg.Direct powder compression supports diameter 8mm, and the scrobicula shape sheet of the heavy 200mg of sheet is by " two disintegrations to the operational approach comparative tablet of disintegration experiment of Chinese pharmacopoeia version in 2005, the result is as shown in table 9.
The disintegrative experimental result of each producer's lactose-polyvidone of table 9-polyvinylpolypyrrolidone pre-mixing agent
| Manufacturer | Spectinomycin hydrochloride disintegration time (min) | Atenolol disintegration time (min) |
| ??A ??B ??C | ?34.44±4.26 ?39.17±3.06 ?19.11±1.06 | ?5.00±2.41 ?＞60min ?＞60min |
Test the experiment of 5. dissolutions
Get 6 of spectinomycin hydrochloride sheets, is dissolution medium according to dissolution experimental technique (2005 editions two appendix XD first methods of Chinese Pharmacopoeia) with the 500ml distilled water, rotating speed is that 100 rev/mins of temperature are 37 ± 0.5 ℃, operation in accordance with the law, in 10,25, the 45min 5ml{ that takes a sample respectively adds synthermal distilled water 5ml} simultaneously, use the 0.8um filtering with microporous membrane, getting subsequent filtrate is need testing solution; In addition precision takes by weighing through 60 ℃ of drying under reduced pressure in right amount to the tartaric acid Tuo Luoer reference substance of constant weight, accurately claims surely, and the solution of making about 100ug/ml with distilled water is liquid in contrast.Get above-mentioned two kinds of solution, measure trap in 274nm wavelength place according to ultraviolet spectrometry light method (two appendix IVA of Chinese Pharmacopoeia version in 2005), ask content with trap than ratio method, calculate the percentage composition that each time point stripping is equivalent to labelled amount, the result is as shown in table 10.
The spectinomycin hydrochloride stripping experimental result (n=5) that each producer's lactose-polyvidone of table 10-polyvinylpolypyrrolidone pre-mixing agent is made
From experimental result as can be seen: the external stripping of the particle diameter of this product, flowability, swellability, disintegrative and tablet etc. are all approaching even more excellent with external product of the same race.So domestic have a lot of producers progressively with my this product of company like product use of import as an alternative.
Claims (10)
1. lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent, it is characterized in that: make by lactose, polyvidone, hinge polyvidone and water, wherein, the weight ratio of each component is: lactose: polyvidone: polyvinylpolypyrrolidone: water=(93～93.8): (3.0～3.4): (3.2～3.6): (198～203).
2. will remove 1 described a kind of lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent according to right, it is characterized in that: the weight ratio of described each component is 93.4: 3.2: 3.4: 200.
3. will remove 1 described a kind of lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent according to right, it is characterized in that: described water is process water.
4. the preparation method of lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent is characterized in that, may further comprise the steps:
1) add entry in reactor, Steam Heating to 100 ℃ also is incubated 15～20 minutes, is cooled to then below 50 ℃ or 50 ℃, and is standby;
2) in weight ratio, in lactose: polyvidone: polyvinylpolypyrrolidone: water=(93～93.8): (3.0～3.4): (3.2～3.6): the ratio of (198～203), in retort, drop into lactose, polyvidone and polyvinylpolypyrrolidone, stirred 2～3 hours, make emulsive serosity;
3) export the serosity of emitting gross weight 1.5%～3% from retort, return and be added back to retort, continue to stir 30～50 minutes, serosity promptly stops to stir for milky white, even colloid to taking a sample to check;
4) use spray drying device, under 100～120 ℃ of conditions of temperature, the product of step 3) is carried out drying, connect material every 30 minutes once and change the screening packaging process over to;
5) after product is crossed 100 eye mesh screens, be the finished product of lactose-polyvidone-polyvinylpolypyrrolidone pre-mixing agent.
5. the preparation method of lactose-polyvidone according to claim 4-polyvinylpolypyrrolidone pre-mixing agent is characterized in that: water is process water in the described step 1).
6. the preparation method of lactose-polyvidone according to claim 4-polyvinylpolypyrrolidone pre-mixing agent is characterized in that: mixing time is 2 hours described step 2).
7. the preparation method of lactose-polyvidone according to claim 4-polyvinylpolypyrrolidone pre-mixing agent is characterized in that: the serosity amount of emitting from the retort outlet in the described step 3) is 2%～2.5% of a serosity gross weight.
8. the preparation method of lactose-polyvidone according to claim 4-polyvinylpolypyrrolidone pre-mixing agent is characterized in that: mixing time is 30 minutes in the described step 3).
9. the preparation method of lactose-polyvidone according to claim 4-polyvinylpolypyrrolidone pre-mixing agent is characterized in that: baking temperature is 110 ℃ in the described step 4).
10. the preparation method of lactose-polyvidone according to claim 4-polyvinylpolypyrrolidone pre-mixing agent is characterized in that: the finished product packing amount is every packing 20kg in the described step 5).
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| CN102614519A (en) * | 2012-04-06 | 2012-08-01 | 安徽山河药用辅料股份有限公司 | Preparation method of premixed auxiliary material for dispersible tablet |
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Address after: 252000 Shandong Province, Liaocheng city Dongchangfu District Wei Weiyu Road No. 1 Patentee after: Shandong Liaocheng A Hua Pharmaceutical Co., Ltd. Address before: 252000 Shandong Province, Liaocheng city Dongchangfu District Wei Weiyu Road No. 1 Patentee before: Ahua Pharmaceutical Co., Ltd., Liaocheng, Shandong |