CN1198328A - Medicinal (health care preparation) dry sugar granular (syrup) tablet - Google Patents
Medicinal (health care preparation) dry sugar granular (syrup) tablet Download PDFInfo
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- CN1198328A CN1198328A CN 96107983 CN96107983A CN1198328A CN 1198328 A CN1198328 A CN 1198328A CN 96107983 CN96107983 CN 96107983 CN 96107983 A CN96107983 A CN 96107983A CN 1198328 A CN1198328 A CN 1198328A
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- dispersible tablet
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Abstract
The invented dispering tablet can be orally taken as candy also can be dispersed in water under specific condition to become into syrup type suspension. It is made up by adopting sugar, glucase or adjuvant with sugar-like taste as main ingredient, adding medicine in accordence with the dose of the prescription and other adjuvants according to the technological process of the dispersing tablet. It can be swallowed as tablet, drunken as syrup after dispersed in water or directly taken by chewing or sucking in mouth. The advantages are quick disintegraling, high solubility, high utilization ratio of biology and less gastrointestinal adverse reaction, etc.
Description
Medicine (health product) dried molassed granule (slurry) dispersible tablet, be main component wherein with saccharide such as multitudinous sugar, glucose or the adjuvant by preparation back mouthfeel such as saccharide, add other adjuvant etc. by recipe quantity interpolation medicine and dispersible tablet preparation technology requirement, as confection, the dispersible tablet that is dispersed into syrup formula suspension in the water under rated condition is medicine dried molassed granule (slurry) dispersible tablet to make oral (chew, contain and suck etc.).
The medicine of utility model (health product) preparation.The utility model medicine preparation (containing health product) of medical industry.It is applicable to Western medicine, Chinese medicine (containing extract), in (containing extract) western polypharmaceutic medicine.
Science and technology department of State Economic and Trade Commission, Department of Science and Technology Education of State Pharmaceutical Administration point out in JIUYUE, 1993 editor " national pharmaceutical preparation new product development guide ": " tablet is one of main dosage form of China's production; nineteen ninety is 24,256 hundred million, and 1991 is 2757.7 hundred million.The subject matter that exists is that dosage form is few, specification is few, kind is few, and wide in variety always, backward wide in variety.The tablet manufacturing plant is backward, utilization rate is low, all drops to below 60% of production capacity in recent years.The tablet kind that one tittle of domestic production is big and wide, mass discrepancy is very big between each factory, and the product dissolution of most factories does not reach criterion of acceptability, and what have is lower than 10% unexpectedly, individual product even be " 0 ".The tablet kind that 1990 editions United States pharmacopoeia specifications will be measured dissolution is 334 kinds, and 1990 editions pharmacopeia of China are only recorded 40 kinds ".So far, the problems referred to above are not resolved yet.
" guide " pointed out again simultaneously: " after China's implementation pharmaceutical patent, developing drugs novel formulation novel form is one of outlet of China's medical industry immediate development.Now, developing new drug is at human and material resources and the difficult increasing of aspect such as examine, thereby exploitation novel form, new medicine-releasing system and optimization administration cause the concern of domestic and international pharmaceuticals industry day by day.A brand-new chemical compound of exploitation (NCE) is on average expensive more than 2.3 hundred million dollars at present in the U.S., lasts 10～12 years." united states drug patent phase handbook is the novel form with consummate technology development the NCE class also to monograph, enjoys equal patent protection period.As seen, not only note developing NCE in the U.S., but also active development medicine novel formulation novel form.Therefore, new drug is formulated the exploitation that the still not strong China of ability more should pay attention to the pharmaceutical preparation new product at present ".
At present, the dosage form used of Chinese children is many based on granule (containing dry syrup granule, dry syrup suspensoid), oral liquid.Though above-mentioned two kinds of dosage forms have solved the difficulty that children is swallowed, and have certain shortcoming separately, the oral liquid volume is big, and effect duration shortens relatively; Granule need add mixing in water for oral taking, makes troubles to the patient sometimes, and the medicine that has is too high because of dashing with water temperature, reduces it and tires, as the cephalosporins medicine.For this reason, " guide " advises with regard to the direction of medicine preparation new product structural adjustment and the kind of suggestion research and development again; " as mentioned above, China's tablet manufacturing exists the backwardness that dosage form is few, specification is few, is badly in need of product structure is progressively adjusted.
1. controlled release preparation (summary).
2. dispersible tablet: use homemade adjuvant, 6-8 dispersible tablet that is particularly useful for old age, children of exploitation strives for that 5-6 is pushed to production as early as possible.Quality problems by exploitation novel form solution old product exist the dissolution problem as Co-trimoxazole Tablet, make dispersible tablet shortened disintegration, and dissolution improves thereupon.
3. new drug preparation (summary).
4. compound preparation (summary).
But the patent of dispersible tablet that has gone on the market at present or " dispersible tablet " applied for is only paid attention to the quality standard that said preparation reaches dispersible tablet, shortens the disintegration of tablet and the dissolution of raising medicine, has ignored the mouthfeel of children.Present gone on the market the U.S. general strong " panadol ", " paracetamol " of Xi'an Yang Sen of China market children, chewable tablet by name, in fact reached the standard of dispersible tablet following disintegration in the dispersible tablet rated condition, but mouthfeel has still kept the bitterness of acetaminophen.Not necessarily become the medicine of the most popular first-selected dosage form of child patient.
The right stimulation of child's taste bud is responsive especially, so there is the minority child to form monophagia disease, Most of children is accepted the bad food refusal of mouthfeel.For this reason, the maximum child's medicine of consumption will be counted granule (dry syrup granule, dry syrup suspensoid) and oral liquid on the China market, and these two kinds of dosage forms are fragrant and sweet good to eat liquid or suspension when being oral, have adapted to child's characteristics and demand.Release " medicine (containing health product) dried molassed granule (slurry) dispersible tablet " as us, it not only can solve the quality problems of conventional tablet, and can keep the fragrant and sweet impression of dry syrup granule, oral liquid good mouthfeel, and also can have a kind ofly as the new good taste of Candy for food, have novelty.After prediction is put on market, will inevitably be subjected to the child patient and the head of a family's welcome, become child's medicine salable on a kind of market.
This novel form application inventor, it is as follows once to carry out literature search before " DST is applied to the standard using method of " dispersible tablet " medicine series (containing health product) " of the application number 96 1 01776.7 that proposes on March 11st, 96 write articles:
With " dispersible tablet ", " super carboxymethyl starch sodium ", " low substituted carboxymethyl starch sodium ", " carboxymethyl starch sodium " word combination search, one piece of paper and report do not retrieve (1983-1995) by CD.There is March in this year " medication economics newspaper " one piece of article once to mention dispersible tablet (day in March, 1,996 edition) about the exploitation of tablet.
Arrive 13 pieces of English data by CD with " Dispersible tsbets ", " Sodium Starch Glycolate " two word combination searches once more, and the translation Chinese of asking someone, do not find to mention that with saccharide or the similar saccharide adjuvant of mouthfeel be main component, develop when oral such as confection, under the dispersible tablet rated condition, be dispersed into the documents and materials and the report of the tablet of syrup formula suspension in the water.
" national pharmaceutical preparation new product development guide " recommends seven " dispersible tablets " of exploitation, and it is main component like the saccharide adjuvant that its prescription does not all adopt saccharide or mouthfeel, just can not make medicine dried molassed granule (slurry) dispersible tablet.
At present, on Chinese market, also find no medicine and the health product that the present invention proposes distinctive dried molassed granule (slurry) dispersible tablet.
The special performance of " dispersible tablet ":
In 19-21 ℃ water disintegration less than 3 minutes;
2. forming after the disintegrate can be by the suspension in 710um hole sizer footpath.
" dried molassed granule (slurry) dispersible tablet " not only has the above particular performances of dispersible tablet, and also has the characteristics on the following mouthfeel:
1. chewing, contain mouthfeel when sucking is main confection like sweet (perfume (or spice)) flavor of saccharide;
2. forming sweet (perfume (or spice)) flavor after the disintegrate is the suspension of main syrup formula.
Characteristics according to " dispersible tablet ", " national pharmaceutical preparation new product development guide " designs " dispersible tablet " prescription and points out, " the main component of writing out a prescription is medicine and at least a disintegrating agent and meets water and form compatibility such as full-bodied swelling adjuvant and form that the key factor one of control of quality is to select proper auxiliary materials; The 2nd, the granularity of control medicine and adjuvant ".
" medicine dried molassed granule (slurry) dispersible tablet " when taking mouthfeel be to be main confection or to disperse the back to form the suspension of syrup formula like sweet (perfume (or spice)) flavor, the main component of prescription also should increase saccharide or pass through preparation back mouthfeel such as one or more adjuvants of saccharide, could guarantee that " medicine dried molassed granule (slurry) dispersible tablet " have any different in the characteristics of " dispersible tablet ", adapt to the psychological requirement of child patient, open up the market of the field that reopens after a cessation of business.
For this reason, " medicine dried molassed granule (slurry) dispersible tablet " removes and should increase saccharide or one or more adjuvants by preparing back mouthfeel such as saccharide are main component on the prescription design basis of dispersible tablet, and saccharide or like the saccharide supplementary product consumption, add according to its amount that can change " dispersible tablet " eating mouth feel such as confection requirement, all the other prescription designs and preparation technology are same as conventional " dispersible tablet "; Can make plain sheet, also can make coated tablet according to the physicochemical property particular requirement of medicine.
1. " medicine dried molassed granule (slurry) dispersible tablet " increased saccharide or one or more adjuvants by preparing back mouthfeel such as saccharide are main component in prescription design.Therefore, chewing or contain mouthfeel when sucking is main confection like sweet (perfume (or spice)) flavor of saccharide; Disperseing the back mouthfeel in the water is main suspension like sweet (perfume (or spice)) flavor of syrup formula then.The mouthfeel characteristic that obviously is different from routine " medicine dispersible tablet " is arranged.
2. finding no this type of " medicine dried molassed granule (slurry) dispersible tablet " in the market appears on the market.
3. from present our patent of retrieving documents and materials and report and having found, all not saccharide or the kind by preparation back mouthfeel such as saccharide one or several adjuvant main component for the prescription design.The mouthfeel characteristics that " medicine dried molassed granule (slurry) dispersible tablet " therefore, can not be arranged by the dispersible tablet of the document of above-mentioned dispersible tablet, report and Patent data preparation.
" medicine dried molassed granule (slurry) dispersible tablet " obviously is different from routine " medicine dispersible tablet ", introduced the particular requirement of the prescription design of medicine dry syrup suspensoid in prescription design, promptly be convenient to the child and chew, contain the mode of sucking and take; Kept the characteristic of the mouthfeel of medicine dry syrup suspensoid again, changed the specific peculiar smell of medicine that conventional dispersible tablet has, adapted to the psychological characteristics of child patient based on sweet (perfume (or spice)) flavor.Therefore, " medicine (containing health product) dried molassed granule (slurry) dispersible tablet " has originality and practicality.
The prescription design of " medicine (containing health product) dried molassed grain (slurry) dispersible tablet " meets the particular requirement of conventional " medicine dispersible tablet " and " agent of medicine dry syrup mix suspension grain ", and saccharide or like the saccharide supplementary product consumption, adding according to its amount that can change " dispersible tablet " eating mouth feel such as confection requirement, is " medicine dispersible tablet " branch's dosage form.Its preparation had both kept to be convenient to swallow, to chew, to contain and suck, the characteristics of taking after disperseing in the water; No matter introduced again that the mouthfeel of which kind of instructions of taking is that confection sweet (perfume (or spice)) flavor is main characteristic, having changed the drug flavor that conventional " dispersible tablet " had is main mouthfeel, has novelty, has adapted to the psychological characteristics of child patient.Having huge market potential, is a kind of new formulation that is worthy to be popularized.
The preparation technology of " medicine (containing health product) dried molassed granule (slurry) dispersible tablet " is same as conventional " medicine dispersible tablet ", can be general in, small enterprise accepts, and has practicality; It is suitable for Western medicine, Chinese medicine (containing extract), in the manufacturing of medicine of (containing extract) Western medicine compound recipe.Be specially adapted to the child and use Tri-Biocin, the new product development of " medicine dried molassed granule (slurry) dispersible tablet " of respiratory medicine, digestive system medication, antipyretic-antalgic medication (containing Coritab) also has versatility.
" medicine (containing health product) dried molassed granule (slurry) dispersible tablet " not only has the advantage of good mouthfeel; And the disintegration of shortening conventional tablet, the dissolution and the bioavailability of raising medicine; Also can reduce the destruction of some drugs to GI irritation effect stomach function regulating intestinal microbial balance.
For this reason, the following Patent right requirement of special proposition:
1. every production " medicine (health product) dried molassed granule (slurry) dispersible tablet " novel form product (containing plain sheet, coated tablet) is considered as infringement, and the request "Patent Law" provides protection.
2. untenable as the dosage form patent of " medicine (health product) dried molassed granule (slurry) dispersible tablet "; then Patent right requirement changes to: supplementary notes are listed dried molassed granule (slurry) dispersible tablet (containing plain sheet, coated tablet) of medicine or medicaments compound in every production this patent claims; be considered as infringement, the request "Patent Law" provides protection.
The unique properties of " medicine dispersible tablet ", thereby its taking convenience can be same as conventional tablet and equally swallow; Also can adapt to old man, child's dysphagia, obey again after in water, decomposing; Also can chew or contain and suck according to state of an illness needs and child patient food custom.And also have that disintegrate is fast, dissolution is high, bioavailability is high and advantage such as the gastrointestinal untoward reaction is little, and the latter just forms distinct contrast with the problem that China tablet quality exists the product dissolution of most factories not reach criterion of acceptability.The exploitation of " dispersible tablet " is to solve the good method that has technical barrier in China's tablet." medicine dried molassed granule (slurry) dispersible tablet " not only has " medicine dispersible tablet " above-mentioned special performance, and mouthfeel is main taste like sweet (perfume (or spice)) flavor of saccharide when taking, it has changed the drug flavor that " medicine dispersible tablet " held is main mouthfeel, adapts to the psychological characteristics of child patient more.Its exploitation not only can be and adjusts the product mix, and improves the quality of China's tablet product; Also can change the mouthfeel of routine " medicine dispersible tablet ", have novelty, adapt to the market demand of children, contend for markets, improve the market share with the product of import, the enterprise with three kinds of capital.
" medicine dispersible tablet " is the emphasis novel form that exploitation is recommended by national medical general bureau, " medicine dried molassed granule (slurry) dispersible tablet " is branch's dosage form of " medicine dispersible tablet ", and the rate of exchange of crude drug and preparation can be decided to be 1 under the existing economic condition of China: 6-7 (abroad being 1: 10).Its exploitation can be China's medicine of the national medical general bureau of realization proposition under the situation that does not increase raw material output, and the target that the tablet sales volume is doubled provides new growth engines.
" medicine dried molassed granule (slurry) dispersible tablet " is applied widely, simple for process, and the market demand of product adaptation children product is expected into the first-use drug (containing health product) of children therapy and health care.It can be medium-sized and small enterprises and accepts and pass on rapidly to turn to the productivity, and with the new medicine of this formulation development series, adjusts the product mix.All right " medicine dried molassed granule (slurry) dispersible tablet " flanker is leading, sets up intensification group company, advances carrying out smoothly of China's medication economics system reform.
Claims (13)
1. the design of the prescription of medicine (containing health product) dried molassed granule (slurry) dispersible tablet meets the conventional medicine dispersible tablet and the particular requirement of medicine dry syrup mix suspension grain agent, and saccharide or like the saccharide supplementary product consumption, add according to its amount that can change dispersible tablet eating mouth feel such as confection requirement, making medicine dried molassed granule (slurry) dispersible tablet have the characteristics of oneself, is branch's dosage form of medicine dispersible tablet.Its preparation had both kept to be convenient to swallow, to chew, to contain and suck, the characteristics of taking after disperseing in the water; No matter introduced again that the mouthfeel of which kind of instructions of taking is that confection sweet (perfume (or spice)) flavor is main characteristic, having changed the drug flavor that conventional dispersible tablet had is main mouthfeel, has novelty, has adapted to the psychological characteristics of child patient.
2. amoxicillin dried molassed granule (slurry) dispersible tablet;
3. potassium v calcium dried molassed granule (slurry) dispersible tablet;
4. cefalexin dried molassed granule (slurry) dispersible tablet;
5. cefradine dried molassed granule (slurry) dispersible tablet;
6. Roxithromycin dried molassed granule (slurry) dispersible tablet;
7. erythromycin estolate dried molassed granule (slurry) dispersible tablet;
8. amino acid (prescription of the tablet that prescription contains 95 editions pharmacopeia of China and the local pharmacopeia of each provinces is recorded various " amino acids " before 95 years, oral liquid, granule, injection) dried molassed granule (slurry) dispersible tablet;
9. taurine dried molassed granule (slurry) dispersible tablet;
10. (prescription is seen the local drug standard in Hebei province newly to imitate quick-acting cold dried molassed granule (slurry) dispersible tablet; New effect quick-acting cold sheet, children's are newly imitated the quick-acting cold sheet);
11. vitamin dried molassed granule (slurry) dispersible tablet (prescription contains 95 years version pharmacopeia of China and the local pharmacopeia of each provinces is recorded before 95 years various vitamin folk prescriptions and compound tablet);
12. Chinese medicine (containing Chinese medicine extract) dried molassed granule (slurry) dispersible tablet;
13. in (containing Chinese medicine extract), Western medicine compound recipe dried molassed granule (slurry) dispersible tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 96107983 CN1198328A (en) | 1996-06-04 | 1996-06-04 | Medicinal (health care preparation) dry sugar granular (syrup) tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 96107983 CN1198328A (en) | 1996-06-04 | 1996-06-04 | Medicinal (health care preparation) dry sugar granular (syrup) tablet |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1198328A true CN1198328A (en) | 1998-11-11 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 96107983 Pending CN1198328A (en) | 1996-06-04 | 1996-06-04 | Medicinal (health care preparation) dry sugar granular (syrup) tablet |
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| CN (1) | CN1198328A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110881555A (en) * | 2019-11-07 | 2020-03-17 | 哈尔滨梵境园生物科技有限公司 | Dispersible candy tablet with dual-effect of lowering blood pressure |
-
1996
- 1996-06-04 CN CN 96107983 patent/CN1198328A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110881555A (en) * | 2019-11-07 | 2020-03-17 | 哈尔滨梵境园生物科技有限公司 | Dispersible candy tablet with dual-effect of lowering blood pressure |
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