CN102247330B - Sustained release tablet prepared from raw material of safflower yellow and preparation method thereof - Google Patents
Sustained release tablet prepared from raw material of safflower yellow and preparation method thereof Download PDFInfo
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- CN102247330B CN102247330B CN2010101762574A CN201010176257A CN102247330B CN 102247330 B CN102247330 B CN 102247330B CN 2010101762574 A CN2010101762574 A CN 2010101762574A CN 201010176257 A CN201010176257 A CN 201010176257A CN 102247330 B CN102247330 B CN 102247330B
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Abstract
The invention aims to provide a sustained release tablet prepared from raw material of safflower yellow and a preparation method thereof. The sustained release tablet is characterized by being a gastric floating sustained release tablet and comprising components in a weight ratio of a medicament raw material to accessories equal to 30-50%:50-70%. The medicament raw material is safflower yellow, and the accessories comprise components in a weight ratio of hydroxypropyl methyl cellulose to carboxymethylcellulose sodium to ethyl cellulose to polyvinyl alcohol to vinylpyrrolidone equal to 35-55:4-8:1-3:3-5:1-3. According to the preparation technology, a secondary granulation and an internal and external accessory adding method are employed to mix the medicament raw material and the accessories; and 95% ethanol liquid of polyvinylpyrrolidone and 95% ethanol are used as adhesives respectively.
Description
Technical field
The present invention relates to the preparation field of the modern drug-supplying system of Chinese medicine, particularly a kind of extract-Carthamus yellow with Flos Carthami of Chinese medicine is feedstock production in-stomach floating type sustained-release tablet prescription is formed and method for preparing.
Background technology
The Along with people's growth in the living standard, people are also improving the requirement of medicine, and little, the taking convenience of side effect when requiring pharmaceutical effectiveness good, compliance is good, price is suitable, requires market to produce the drug-supplying system novel form of hommization more.For this reason; The dosage form research of modern drug-supplying system has obtained develop rapidly, by the ordinary tablet of first generation regular dosage form, ball, granule, injection etc. develop into second filial generation sustained-release administration dosage form, third generation slow/controlled release form of administration, the 4th generation the target administration dosage form and the 5th generation reply the formula drug-supplying system.Wherein, third generation slow/controlled release preparation variety receives widely with suitable price with its significant advantage and paying close attention to.The chemistry medicine is the medicine slow/controlled release preparation of raw material; At aspects such as prescription design, adjuvant and moulding processs; Chinese scholars has all been done number of research projects, has obtained many patents, and sophisticated kind example hydrochloric acid diltiazem etc. is widely used clinically.
The gastric floating slow-release preparation is a third generation slow/controlled release preparation, is modern advanced administering mode and drug-supplying system.It is the positioning and slow release preparation of processing by medicine and one or more hydrophilic gel matrix materials and additives.Its dosage form has tablet, capsule and microcapsule etc.Its design key of success of floating in stomach preparation is that it is that medicine, adjuvant are formed and proportioning that suitable prescription is selected in (1), the method for preparing that (2) are suitable.Select suitably just can make preparation to produce lasting floating, the release effect of expection at gastric for these 2.Different drug prepares the prescription difference of gastric floating slow-release preparation, and method for making has different, and the prescription of the gastric floating slow-release preparation that same medication preparation is identical or inequality also has difference.
Flos Carthami is the dried floral of feverfew Carthamus tinctorius L..Be traditional Chinese medical science common drug, its function is with to cure mainly be promoting blood circulation to restore menstrual flow, and eliminating stasis to stop pain " is recording in 2005 editions one one of the Chinese pharmacopoeia.The main active component of modern study proof Flos Carthami is the Carthamus yellow of flavonoid, has coronary artery dilating, coronary blood flow increasing; Antioxidation, anticoagulant, protection cardiac muscle; Blood pressure lowering, antiinflammatory, effects such as immunosuppressant and brain protection; And evident in efficacy, be widely used in treating cardiovascular and cerebrovascular disease clinically.
The clinical Carthamus yellow of injection lyophilized powder is used to treat the angina pectoris that stagnation of heart-blood causes; " Chinese medicine is promulgated by the ministries or commissions of the Central Government " the 20th is loaded with Flos Carthami injection, treatment obliterated cerebral vascular disease and treatment coronary heart disease, intravenous drip.Safflower oral liquid treatment cerebrovascular disease and treatment coronary heart disease." contemporary Chinese Chinese medicine " the 2nd phase in 2009, the sustained-release matrix tablets of the main effective ingredient Carthamus yellow development of report Flos Carthami; The preparation of " Chinese patent medicine " 2009 the 1st phases report safflower yellow phosphatide complexes osmotic pump capsule.But; Injection is used inconvenient in the existing Carthamus yellow preparation; Higher side effect has caused widely to be paid close attention to: the oral sustained release matrix tablet of report and phosphatide complexes osmotic pump capsule have been avoided the inconvenience and the side effect of injection; But consider the mechanism of Carthamus yellow in oral post-absorption position and absorption, the gastric slow releasing preparation is best administering mode, the absorption of more favourable Carthamus yellow and performance curative effect.
Summary of the invention
The object of the present invention is to provide a kind of is the slow releasing tablet and preparation method thereof of feedstock production with the Carthamus yellow, specifically be a kind ofly with the Carthamus yellow be that the prescription of medicine and adjuvant of the intragastric floating slowly releasing tablet of preparation raw material preparation is formed, composition proportioning and preparation method thereof.
For realizing the best administering mode of Carthamus yellow, the technical problem that solve is:
1, guarantee that Carthamus yellow prolonged in the Gastrointestinal time of staying: the clear and definite and main active ingredient of Carthamus yellow is a S-A Hydroxysafflor yellow A; S-A Hydroxysafflor yellow A degree of absorption in animal body is followed successively by from high to low: jejunum, duodenum, ileum, the S-A Hydroxysafflor yellow A stability in gastrointestinal tract is followed successively by from big to small: ileum, stomach, jejunum.Therefore, for guaranteeing that S-A Hydroxysafflor yellow A has absorption maximum in vivo, the performance better therapeutic must guarantee that S-A Hydroxysafflor yellow A has better absorption at jejunum, duodenum, just needs to prolong the time of staying of S-A Hydroxysafflor yellow A at above-mentioned position.
2, the prescription of intragastric floating tablets is formed and preparation technology: the gastric floating slow-release tablet all has special and higher requirement because of its effect characteristics have determined prescription compositions, preparation technology etc. to required medicine of its preparation and adjuvant, needs the various technology of integrated use to reach the purpose of gastric location, lasting release medicine.
It is the slow releasing tablet of feedstock production with the Carthamus yellow that the present invention specifically provides a kind of, it is characterized in that, this slow releasing tablet is the intragastric floating slowly releasing tablet, and its composition and percentage by weight are medicine material: adjuvant=30-50%: 50-70%;
Wherein medicine material is a Carthamus yellow, and the composition of adjuvant and weight ratio are hydroxypropyl emthylcellulose: sodium carboxymethyl cellulose: ethyl cellulose: polyvinyl alcohol: polyvinylpyrrolidone=35-55: 3-6: 1-3: 2-5: 1-3.
The present invention also provides the optimizing prescriptions and the proportioning of this kind slow releasing tablet, it is characterized in that: medicine material: adjuvant=40-50%: 50-60%; The composition of adjuvant and weight ratio are: hydroxypropyl emthylcellulose: sodium carboxymethyl cellulose: ethyl cellulose: polyvinyl alcohol: polyvinylpyrrolidone=45-55: 3-5: 1-2: 2-4: 1-2.Through experimental verification, adopt its slow release effect of slow releasing tablet of this optimizing prescriptions preparation better, the oral observation tablet of volunteer can be detained more than 7 hours under one's belt.
It is the method for preparing of the slow releasing tablet of feedstock production with the Carthamus yellow that the present invention also provides this kind; It is characterized in that: adopt the method hybrid medicine raw material and the adjuvant that add in 2 granulations, the adjuvant, 95% ethanol liquid and 95% ethanol with polyvinylpyrrolidone is adhesive respectively; The polyvinylpyrrolidone of preparation amount is dissolved in 95% ethanol, and Carthamus yellow, the hydroxypropyl emthylcellulose with 1/2 preparation amount, ethyl cellulose, the polyvinyl alcohol of getting preparation amount mix the system soft material, cross 60 mesh sieves, drying, granulate; The sodium carboxymethyl cellulose mix homogeneously that adds remaining hydroxypropyl emthylcellulose, ethyl cellulose, polyvinyl alcohol, preparation amount 1/2-1/3 again; With 95% ethanol system soft material; Cross 60 mesh sieves; Drying adds remaining sodium carboxymethyl cellulose mix homogeneously, and tabletting promptly gets slow releasing tablet according to the invention.
The inventor through lot of test, comprise orthogonal experiment; Having obtained above-mentioned is the prescription design and the technology of preparing scheme of the intragastric floating sustained-release tablet agent of feedstock production with the Carthamus yellow; Solved with the Chinese medicine extraction component that contains complicated physical property be feedstock production modern slow/technical barrier of controlling agent; And preparation technology provided by the invention is fit to common pharmaceutical manufacturing enterprise and preparation production equipment, and making with the Chinese crude drug extract is that preparation raw material also can carry out suitability for industrialized production by the production technology of conventional tablet.
Utilize the Chinese medicine intragastric floating sustained-release tablet of prescription according to the invention and method for making preparation, through experiment showed, external visible tablet corrosion gradually, slowly dissolve, unfused interior layer segment remains drying regime.The oral observation tablet of volunteer can be detained more than 5 hours under one's belt, has filled up the blank of the modern preparation administration of Chinese medicine novel form.
The specific embodiment
The present invention is under the situation without sign, and percentage ratio and proportionate relationship all refer to weight ratio.
Embodiment 1
Preparation prescription is formed: medicine material: adjuvant=50%: 50%; Wherein adjuvant is made up of hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone; Their proportionate relationship is a hydroxypropyl emthylcellulose: sodium carboxymethyl cellulose: ethyl cellulose: polyvinyl alcohol: polyvinylpyrrolidone=55: 4: 3: 5: 1, medicine material was a Carthamus yellow.
Method for making: the polyvinylpyrrolidone of preparation amount is dissolved in 95% ethanol, gets hydroxypropyl emthylcellulose, ethyl cellulose, the mixed soft material of polyvinyl alcohol adjuvant of Carthamus yellow and 1/2 preparation amount, cross 60 mesh sieves, drying, granulate.Get the sodium carboxymethyl cellulose mix homogeneously of remaining hydroxypropyl emthylcellulose, ethyl cellulose, polyvinyl alcohol, 2/3 preparation amount; With 95% ethanol system soft material, cross 60 mesh sieves, drying; Add 1/3 remaining sodium carboxymethyl cellulose mix homogeneously, tabletting promptly gets this medicine.Be detained under one's belt 7 hours through the oral observation tablet of volunteer.
Embodiment 2
Preparation prescription is formed: medicine material: adjuvant=40%: 60%; Wherein adjuvant is made up of hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone; Their proportionate relationship is a hydroxypropyl emthylcellulose: sodium carboxymethyl cellulose: ethyl cellulose: polyvinyl alcohol: polyvinylpyrrolidone=35: 6: 1: 2: 2, medicine material was a Carthamus yellow.
Method for making: the polyvinylpyrrolidone of preparation amount is dissolved in 95% ethanol, gets hydroxypropyl emthylcellulose, ethyl cellulose, the mixed soft material of polyvinyl alcohol adjuvant of Carthamus yellow and 1/2 preparation amount, cross 60 mesh sieves, drying, granulate.Get the sodium carboxymethyl cellulose mix homogeneously of remaining hydroxypropyl emthylcellulose, ethyl cellulose, polyvinyl alcohol, 1/2 preparation amount; With 95% ethanol system soft material, cross 60 mesh sieves, drying; Add remaining sodium carboxymethyl cellulose mix homogeneously, tabletting promptly gets this medicine.Be detained under one's belt 6 hours through the oral observation tablet of volunteer.
Embodiment 3
Preparation prescription is formed: medicine material: adjuvant=30%: 70%; Wherein adjuvant is made up of hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, and their proportionate relationship is a hydroxypropyl emthylcellulose: sodium carboxymethyl cellulose: ethyl cellulose: polyvinyl alcohol: polyvinylpyrrolidone=35: 3: 1: 5: 3; Medicine material is a Carthamus yellow.
Method for making: the polyvinylpyrrolidone of preparation amount is dissolved in 95% ethanol, gets hydroxypropyl emthylcellulose, ethyl cellulose, the mixed soft material of polyvinyl alcohol adjuvant of Carthamus yellow and 1/2 preparation amount, cross 60 mesh sieves, drying, granulate.Get the sodium carboxymethyl cellulose mix homogeneously of remaining hydroxypropyl emthylcellulose, ethyl cellulose, polyvinyl alcohol, 1/2 preparation amount; With 95% ethanol system soft material, cross 60 mesh sieves, drying; Add 1/2 remaining sodium carboxymethyl cellulose mix homogeneously, tabletting promptly gets this medicine.Be detained under one's belt 6 hours through the oral observation tablet of volunteer.
Claims (3)
1. one kind is the slow releasing tablet of feedstock production with the Carthamus yellow, it is characterized in that, this slow releasing tablet is the intragastric floating slowly releasing tablet, and its composition and percentage by weight are medicine material: adjuvant=30-50%:50-70%;
Wherein medicine material is a Carthamus yellow, and the composition of adjuvant and weight ratio are: hydroxypropyl emthylcellulose: sodium carboxymethyl cellulose: ethyl cellulose: polyvinyl alcohol, polyvinylpyrrolidone=35-55:3-6:1-3:2-5:1-3;
Its preparation method is: adopt the method hybrid medicine raw material and the adjuvant that add in 2 granulations, the adjuvant; The polyvinylpyrrolidone of preparation amount is dissolved in 95% ethanol, gets the Carthamus yellow of preparation amount,, cross 60 mesh sieves, drying, granulate with hydroxypropyl emthylcellulose, ethyl cellulose, the polyvinyl alcohol mixing system soft material of 1/2 preparation amount; The sodium carboxymethyl cellulose mix homogeneously that adds hydroxypropyl emthylcellulose, ethyl cellulose, polyvinyl alcohol and 1/2～2/3 preparation amount of residue 1/2 preparation amount again; With 95% ethanol system soft material, cross 60 mesh sieves, drying; Add remaining sodium carboxymethyl cellulose mix homogeneously, tabletting promptly gets.
2. said according to claim 1 is the slow releasing tablet of feedstock production with the Carthamus yellow, it is characterized in that medicine material: adjuvant=40-50%:50-60%; The composition of adjuvant and weight ratio are: hydroxypropyl emthylcellulose: sodium carboxymethyl cellulose: ethyl cellulose: polyvinyl alcohol: polyvinylpyrrolidone=45-55:3-5:1-2:2-4:1-2.
3. a claim 1 is said is the method for preparing of the slow releasing tablet of feedstock production with the Carthamus yellow, it is characterized in that: adopt the method hybrid medicine raw material and the adjuvant that add in 2 granulations, the adjuvant; The polyvinylpyrrolidone of preparation amount is dissolved in 95% ethanol, gets the Carthamus yellow of preparation amount,, cross 60 mesh sieves, drying, granulate with hydroxypropyl emthylcellulose, ethyl cellulose, the polyvinyl alcohol mixing system soft material of 1/2 preparation amount; The sodium carboxymethyl cellulose mix homogeneously that adds hydroxypropyl emthylcellulose, ethyl cellulose, polyvinyl alcohol and 1/2～2/3 preparation amount of residue 1/2 preparation amount again; With 95% ethanol system soft material, cross 60 mesh sieves, drying; Add remaining sodium carboxymethyl cellulose mix homogeneously, tabletting promptly gets.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101762574A CN102247330B (en) | 2010-05-19 | 2010-05-19 | Sustained release tablet prepared from raw material of safflower yellow and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2010101762574A CN102247330B (en) | 2010-05-19 | 2010-05-19 | Sustained release tablet prepared from raw material of safflower yellow and preparation method thereof |
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| CN102247330A CN102247330A (en) | 2011-11-23 |
| CN102247330B true CN102247330B (en) | 2012-11-21 |
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| CN2010101762574A Expired - Fee Related CN102247330B (en) | 2010-05-19 | 2010-05-19 | Sustained release tablet prepared from raw material of safflower yellow and preparation method thereof |
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| CN107164092B (en) * | 2017-06-16 | 2020-06-16 | 云南中烟工业有限责任公司 | Preparation method of high-boiling-point radix puerariae fragrant particles and high-boiling-point radix puerariae fragrant particles |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1947707A (en) * | 2006-09-14 | 2007-04-18 | 郑州三创释药技术有限公司 | Floated in staomach type slow-release tablets contg. berberine hydrochloide and its prepn. method |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1947707A (en) * | 2006-09-14 | 2007-04-18 | 郑州三创释药技术有限公司 | Floated in staomach type slow-release tablets contg. berberine hydrochloide and its prepn. method |
Non-Patent Citations (2)
| Title |
|---|
| 刘忠垒等.红花黄色素缓释骨架片的研制.《药用植物化学与中药有效成分分析研讨会论文集（上）》.2008,391-393. * |
| 徐晓宏等.胃内滞留漂浮型缓释片的研究线现状及在中药制剂中应用展望.《中草药》.2007,第38卷(第5期),779-782. * |
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