CN1408371A - Novel preparation of oyster calcium - Google Patents
Novel preparation of oyster calcium Download PDFInfo
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- CN1408371A CN1408371A CN02130693A CN02130693A CN1408371A CN 1408371 A CN1408371 A CN 1408371A CN 02130693 A CN02130693 A CN 02130693A CN 02130693 A CN02130693 A CN 02130693A CN 1408371 A CN1408371 A CN 1408371A
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Abstract
The present invention provides a new calcium replenishing technology scheme to prepare calcium replenishing preparation with medicinal material conforming with the standard WS-275(X-206)-98.
Description
Invention field the present invention develops the new folk prescription and the Concha Ostreae calcium medicine and the health food of compound recipe with the Concha Ostreae calcium raw material drug, is used for the field of replenishing the calcium of human body.
The technical background Concha Ostreae is traditional Chinese crude drug, with Concha Ostreae treatment calcium deficiency disease long history is arranged in China's traditional medicine.Record in " herbal classic ": " Concha Ostreae, salty in the mouth, flat, obey the bone strengthening joint for a long time "; Record in " herbal argument record ": " the frightened gas of being enraged of Concha Ostreae master is arrested slow "; Illustrate Concha Ostreae calmness, go frightened gentle firm effect and the modern medicine that nourish blood to have palpitation because of calcium deficiency, it is consistent to twitch.Abroad, the preparation that Concha Ostreae is made as replenishing the calcium crude drug behind micronization also goes on the market already, the medicine made from micronized Concha Ostreae of replenishing the calcium that is referred to as the Margarita calcium tablet in the big pharmaceutical factory of for example Canadian Shi Danli has entered China market as far back as 94 years, the import authentication code is X940336.Yet regrettably in China with Concha Ostreae as the replenish the calcium research of medicine and the use one section detour of having passed by, pulverize again after many researcheres are at high temperature calcined Concha Ostreae and make so-called " activated calcium ", this activated calcium comes down to calcium oxide, take back chance water and become calcium hydroxide, produce very high alkalescence under one's belt, very big to the stimulation of stomach.The calcium preparation investigation group that was set up by China sanitation Ministry tissue in 1992 has proposed criticism to Concha Ostreae is become calcium oxide be used to the to replenish the calcium phenomenon of medicine after high temperature is cremated after through medicine investigation that whole nation listing is replenished the calcium.Just in this case, the new drug research person of China to have carried out be the new drug development of the medicine of replenishing the calcium of raw material with the Concha Ostreae.And obtaining Concha Ostreae calcium raw material drug New Drug Certificate and oyster calcium tablet New Drug Certificate on November 20th, 1998, its New Drug Certificate number is respectively: traditional Chinese medicines card words (1998) X-368 number and traditional Chinese medicines card words (1998) X-369 number.This kind transfers Harbin Liu Chang production.The protection period of this new drug is 3 years, expires November 20 calendar year 2001.The inventor participates in and has led the research and the new drug declaration work of Concha Ostreae calcium and oyster calcium tablet.
But up to the present, is that the calcium-supplementing preparation of raw material only has oyster calcium tablet agent (common plain sheet) a kind of in China with Concha Ostreae calcium, and other replenish the calcium crude drug such as calcium carbonate, calcium gluconate, Citric acid calcium etc. all have the situation of multiple folk prescription such as tablet, capsule, chewable tablet, granule, dry suspension, effervescent tablet, oral liquid and compound preparation listing to compare, and the replenish the calcium independent conventional tablet of crude drug of this good All Pure Nature of Concha Ostreae calcium is the needs that can not satisfy the market of replenishing the calcium.
Goal of the invention is a preparation raw material with the Concha Ostreae calcium raw material drug, and folk prescription and compound preparations such as exploitation chewable tablet, dry suspension, effervescent tablet, granule satisfy the needs in market.
Invention summary the present invention in fact mainly is the research technical scheme that has proposed new calcium-supplementing preparation to the research of Concha Ostreae calcium novel formulation, and the core of this technical scheme just is to use the Concha Ostreae calcium medicinal raw material that meets the described technical standard of Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98 to prepare new calcium-supplementing preparation.All having a common feature according to the prepared calcium-supplementing preparation of a tree name the technical program, is exactly that these preparations all contain the Concha Ostreae calcium medicinal raw material that meets Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98 and this standard described technical standard of standard of becoming a full member in the future.
The basic point of the technical scheme that detailed Description Of The Invention is proposed by the invention is: use Concha Ostreae calcium (the New Drug Certificate numbering: traditional Chinese medicines card words (1998) X-368 number) be preparation raw material, prepare new Concha Ostreae transformation of the way agent of on November 20th, 1998 by National Drug Administration's approval.Prepare knowledge according to general medicament, after the delivery mode of mouthfeel, medicine, clinical factors such as demand were analyzed, the single preparations of ephedrine that can prepare Concha Ostreae calcium as required had: the Concha Ostreae Biocal; The Concha Ostreae calcium dried suspension; Concha Ostreae calcium effervescence tablet etc.; The compound preparation of Concha Ostreae calcium has: the compound preparation of Concha Ostreae calcium and vitamin D; The compound preparation of Concha Ostreae calcium and lysine; The compound preparation of Concha Ostreae calcium and folic acid etc.; And the trace element replenisher of forming as calcium constituent and other trace element with Concha Ostreae calcium etc.The calcium-supplementing preparation that uses the technical program and prepare is: Concha Ostreae Biocal, Concha Ostreae calcium dried suspension, Concha Ostreae calcium effervescence tablet; The compound preparation of Concha Ostreae calcium has: the compound recipe chewable tablet of Concha Ostreae calcium and vitamin D, dry suspension; The compound recipe chewable tablet of Concha Ostreae calcium and lysine, dry suspension; Sandwich of the compound recipe of Concha Ostreae calcium and folic acid; And the trace element replenisher of forming as calcium constituent and other trace element with Concha Ostreae calcium etc.These preparations all have the composition characteristics that contains the Concha Ostreae calcium medicinal raw material that meets the described technical standard of Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98.The Concha Ostreae calcium medicinal raw material that meets the described technical standard of Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98 has surpassed the time in 3 years so far through the approval of China pharmaceutical control and administration department as new drug.Though the administrative protection phase of this new drug expires, up to the present nobody uses the new Concha Ostreae calcium preparation of this new drug development of raw materials.Though with the calcium-supplementing preparation that Concha Ostreae prepares many kinds are arranged in China, but compare with the new Concha Ostreae calcium preparation that the technical scheme of preparation Concha Ostreae calcium novel formulation proposed by the invention is prepared, these preparations all do not have strict control at aspects such as heavy metal, acid insoluble matter, magnesium salt and alkali metal salt, arsenic salt, barium salt, iron salt, microgranule, nitrogen contents, and the control of these indexs is all played crucial effect to aspects such as the absorption of Concha Ostreae calcium preparation, long-term prescription safety.Because the Concha Ostreae calcium medicinal raw material that meets the described technical standard of Ministry of Health of the People's Republic of China's ministerial standard (try) WS-275 (X-206)-98 has carried out strict control to this, so use the prepared new Concha Ostreae calcium preparation of this raw material also just to have basic different with the prepared calcium-supplementing preparation of other Concha Ostreae calcium of use.Because the inventor is the organizer and the main research participant of the new drug development work of new drug Concha Ostreae calcium raw material drug and its common plain sheet (oyster calcium tablet), fail the further exploitation that obtains continuing at these outstanding calcium-enriching products of Concha Ostreae calcium medicinal raw material of seeing China's approved after 3 years in exploitation, feel regret! For making this outstanding kind can be vast calcium deficiency patient's service better, the inventor has proposed the further technical scheme of other the Concha Ostreae calcium preparation of exploitation except that the common plain sheet of Concha Ostreae calcium of this Concha Ostreae calcium medicinal raw material medicine of above-mentioned use, according to this technical scheme, can develop a series of outstanding calcium-supplementing preparations, these preparations can be declared by functional food and produce and listing, also can declare and produce and listing, thereby fill a hole in the market by the medicine of replenishing the calcium.
What need specially explanation is: the Concha Ostreae calcium of indication of the present invention is meant the Concha Ostreae calcium medicinal raw material that meets the described technical standard of Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98.Why this patent limits to some extent to Concha Ostreae calcium, be because at present more with the similar products of so-called Concha Ostreae calcium using names, but it is a kind of that the Concha Ostreae calcium that meets the described technical standard of Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98 only has in China, is unique.The inventor is the organizer and the participant of this seed oyster calcium of research.This Concha Ostreae calcium not only impurity as: insoluble matter, barium salt, magnesium salt and alkali metal, iron salt, heavy metal, arsenic salt in the acid, system and strict specification requirement are arranged, and microgranule, the nitrogen content of Concha Ostreae are also had index request.These technical specifications are not only the unique characteristics and the sign of this seed oyster calcium, the safety of clinical administration that simultaneously more main is for calcium-supplementing preparation, effectively play crucial effect.Before Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98 standard mesh is the tentative standard of Concha Ostreae calcium medicinal raw material, this standard will be become a full member with the new drug of Concha Ostreae calcium medicinal raw material and be carried out standard and become a full member, this standard might be made amendment in the process of becoming a full member, therefore the feature of the Concha Ostreae calcium of indication of the present invention also will change with the variation of standard, but with the concordance of this standard be unalterable.Inventor's microgranule average diameter to Concha Ostreae calcium when the Concha Ostreae crude drug is studied requires to reach about 1 μ m.Though formulate Ministry of Health of the People's Republic of China's ministerial standard (try) WS-275 (X-206)-98 o'clock with grain through being loosened to below the 20 μ m, this is owing to the preciseness of medicinal standard and the air-flow size reduction machinery factor to the omission of larger particles causes.That is to say that if the standard of pulverizing is controlled at below the 20 μ m substantially utterly then the grain of in fact pulverizing out with jet mill at that time is through on average about 1 μ m.This is a situation at that time, at present the technology of jet mill is enhanced, so the inventor also thinks the stricter requirement of granularity proposition of Chinese Pharmacopoeia Commission's reply Concha Ostreae calcium to the becoming a full member of Ministry of Health of the People's Republic of China's ministerial standard (try) WS-275 (X-206)-98 time.The present invention specially proposes and emphasizes for this reason: the Concha Ostreae calcium of indication is meant that the Concha Ostreae calcium medicinal raw material that meets the described technical standard of Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98 also contained generally the Concha Ostreae calcium medicinal raw material of the described technical standard of revised standard that meets Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98 in the future among the present invention.
Below inventive embodiments to be used to further specify and verify proposed by the invention be the technical scheme that raw material is made new calcium-supplementing preparation with Concha Ostreae calcium, but do not think concrete prescription and concrete preparation technology and specific product described in the invention for example that the technical scheme that proposes of the present invention only limits to enumerate below.The preparation of inventive embodiments 1 Concha Ostreae calcium folk prescription and compound recipe chewable tablet
1, the preparation prescription of Concha Ostreae Biocal: Concha Ostreae calcium 250g
Mannitol 150g
Defatted milk powder 150g
Cocoa powder 15g
Maltodextrin 20g
Magnesium stearate is an amount of
Cream flavour (or other flavouring agent) is an amount of
Acesulfame potassium (or other sweeting agent) is an amount of
Make 1000
Method for making: other is former except that cream flavour, maltodextrin, magnesium stearate, adjuvant is by the prescription amount of getting, and supplementary material is crossed 100 mesh sieves or 200 mesh sieves, mixes.With conventional milk cooking process maltodextrin is made 20% maltodextrin slurry, and join in mix former, the adjuvant, make soft.Granulate with 60 mesh sieves, 60 ℃ of forced air dryings made particulate moisture Control between 0.5～3% about 2 hours.Granulate is behind fine powder and the magnesium stearate mixing, again with the granule mixing.After evenly spraying cream flavour, airtight depositing 24 hours in hermetic container, the content of calcium is selected suitable mould tabletting according to content, promptly in the mensuration granule.
Mannitol can replace with sorbitol in this prescription, and the amount of cocoa powder, defatted milk powder can be regulated according to mouthfeel.The also available stomach dissolution type coating material of this product carries out colored coating.
2, Concha Ostreae calcium and vitamin D
3The preparation of chewable tablet
Vitamin D
3The preparation of-Benexate Hydrochloride: get alpha-hydroxy vitamin D
3(about 30mg) is dissolved in the acetone (about 1.2ml), adds to contain 0.43g beta-schardinger dextrin-solution (about 24ml), and mixed liquor at room temperature stirred 3 hours, filters taking precipitate, and be dry with the ether washing, promptly.Vitamin D
3Alpha-hydroxy vitamin D in the-Benexate Hydrochloride
3Content is about 17.44% (w/w).
Concha Ostreae calcium and vitamin D
3The preparation of chewable tablet: specification: every calcic 100mg, vitamin D
30.445 iu.Prescription: Concha Ostreae calcium 250g
Vitamin D
3-Benexate Hydrochloride 0.239mg
Mannitol 150g
Defatted milk powder 150g
Cocoa powder 15g
Maltodextrin 20g
Magnesium stearate is an amount of
Cream flavour (or other flavouring agent) is an amount of
Acesulfame potassium (or other sweeting agent) is an amount of
Make 1000
Method for making: other is former except that cream flavour, maltodextrin, magnesium stearate, adjuvant is by the prescription amount of getting, and supplementary material is crossed 100 mesh sieves or 200 mesh sieves, mixes.With conventional milk cooking process maltodextrin is made 20% maltodextrin slurry, and join in mix former, the adjuvant, make soft.Granulate with 60 mesh sieves, 60 ℃ of forced air dryings made particulate moisture Control between 0.5～3% about 2 hours.Granulate.Behind fine powder and the magnesium stearate mixing, again with the granule mixing.After evenly spraying cream flavour, airtight depositing 24 hours in hermetic container measured calcium and vitamin D in the granule
3Content, select suitable mould tabletting according to content, promptly.
Mannitol can replace with sorbitol in this prescription, and the amount of cocoa powder, defatted milk powder can be regulated according to mouthfeel.The also available stomach dissolution type coating material of this product carries out colored coating.
3, the preparation of oyster calcium and folic acid double-layer tablet
Decompose easily because folic acid is met Concha Ostreae calcium, so this product is made the enteric chip with folic acid, Concha Ostreae calcium is made the tablet skin.Concha Ostreae calcium dissociates under the effect of gastric juice, generates calcium particle and carbon dioxide and water, and calcium particle is absorbed in the harmonization of the stomach intestinal gradually; After the folic acid chip is transported to intestinal portion, discharge folic acid after enteric coating is dissolved, folic acid is absorbed at jejunum.Enteric coating plays the buffer action of folic acid and Concha Ostreae calcium in this product.
The prescription of folic acid chip: folic acid 2.5g
The fine little plain 20g of crystallite
For hydroxypropyl cellulose 10g
6% starch slurry is an amount of
Magnesium stearate is an amount of
Make 1000
Method for making: except that magnesium stearate, adjuvant is crossed 100 mesh sieves or 200 mesh sieves by the prescription amount of getting with supplementary material, mixes.Make soft ability with 6% starch slurry.Granulate with 26 mesh sieves, 60 ℃ of forced air dryings made particulate moisture Control between 0.5～3% about 2 hours.Granulate.Behind fine powder and the magnesium stearate mixing, again with the granule mixing.Measure the content of folic acid in the granule, select suitable mould tabletting, promptly get the plain sheet chip of folic acid according to content.
The preparation of enteric coating: the prescription of enteric coating:
Hydroxypropylmethyl cellulose phthalate 10.0g
Diethyl phthalate 1.0g
Pulvis Talci 10.0g
The compound method of acetone (4: 6) liquid 200ml enteric coating liquid:
Correctly take by weighing the hydroxypropylmethyl cellulose phthalate of recipe quantity, add acetone liquid 200ml dissolving, add the dissolving of diethyl phthalate mixing, add Pulvis Talci again and stir promptly.Folic acid enteric chip art for coating:
Get the plain sheet chip of folic acid and put in the coating pan, the rolling coating pan, limit spray enteric coating liquid, the limit blowing hot-air wraps to sheet and heavily increases to about 10%, takes out and puts 60 ℃ of dryings of baking oven 1 hour.Take out, the release of checking this product in the 0.1M hydrochloric acid solution 2 hours burst size should be less than 10%, in phosphate buffer (PH6.8) 0.5 hour burst size should be greater than 70% (detection method be with reference to the second method inspection of two appendix XD of Chinese Pharmacopoeia version in 2000 drug release determination method).The outer particulate prescription preparation of Concha Ostreae calcium:
Prescription Concha Ostreae calcium 250g
The fine little plain 20g of crystallite
Carboxymethyl starch sodium 4.2g
6% starch slurry is an amount of
Magnesium stearate is an amount of
Be equivalent to 1000 outer granule
Granulate: except that magnesium stearate, adjuvant is crossed 100 mesh sieves or 200 mesh sieves by the prescription amount of getting with supplementary material, mixes.Make soft ability with 6% starch slurry.Granulate with 26 mesh sieves, 60 ℃ of forced air dryings made particulate moisture Control between 0.5～3% about 2 hours.Granulate.Behind fine powder and the magnesium stearate mixing, again with the granule mixing.Measure the content of calcium in the granule, standby.
The compacting of Concha Ostreae calcium and folic acid double-layer tablet:
With the double tablet machine above-mentioned folic acid enteric chip that has prepared and the outer granule of Concha Ostreae calcium are pressed into double-layer tablet.
This method also is applicable to preparation calcium carbonate and folic acid double-layer tablet.
Above-mentioned double-layer tablet also available stomach dissolution type coating material after in flakes carries out colored coating.The preparation of embodiment 2 Concha Ostreae calcium folk prescriptions and compound dried suspension
1, the preparation of Concha Ostreae calcium dried suspension
(1) prescription: Concha Ostreae calcium 1250g
Non-dairy creamer 18000g
Defatted milk powder 2000g
Ethyl Fructus Hordei Germinatus 20g
Xanthan gum 100g
Sodium carboxymethyl cellulose 250g
Acesulfame potassium (or other sweeting agent) is an amount of
Make 1000 bag (2) technologies: (environmental requirement: this product should in that to purify rank be to produce in the dust proof workshop more than ten thousand grades)
The processing of supplementary material and processing: all supplementary materials are crossed 200 mesh sieves respectively on request through after the assay was approved.Take by weighing Concha Ostreae calcium raw material drug, non-dairy creamer, defatted milk powder, ethyl maltol, xanthan gum, sodium carboxymethyl cellulose by recipe quantity.Getting xanthan gum, sodium carboxymethyl cellulose, ethyl maltol, Concha Ostreae calcium raw material drug earlier, to carry out ground and mixed even, gets an amount of (being suitable for good with the mouthfeel sugariness) mixing of acesulfame potassium then, adds non-dairy creamer, defatted milk powder mix homogeneously at last again.With the calcium content in the above-mentioned sample of EDTA complexometric titration, then by every bag of calcic 500mg packing.Is qualified products 5% with in the content of moisture content in the non-aqueous titration measuring samples.
2, Concha Ostreae calcium and vitamin D
3The preparation of dry suspension
In the prescription of the Concha Ostreae calcium dried suspension of above-mentioned preparation, add vitamin D
3-Benexate Hydrochloride 1.43mg, preparation technology is identical, is prepared into Concha Ostreae calcium and vitamin D
3Compound dried suspension, every bag of calcic 500mg contains vitamin D
3(0.25ug being equivalent to 2.667 ius).
3, the preparation of Concha Ostreae calcium and lysine dry suspension
Add lysine 1000g in the prescription of the Concha Ostreae calcium dried suspension of above-mentioned preparation, preparation technology is identical, is prepared into Concha Ostreae calcium and lysine compound dried suspension, and per generation calcic 500mg contains lysine 1000mg.
Claims (5)
1, a class contains the novel calcium-supplementing preparation that Concha Ostreae calcium is the preparation raw material preparation, and these preparations comprise: the single preparations of ephedrine of the Concha Ostreae calcium except that oyster calcium tablet has: the Concha Ostreae Biocal; The Concha Ostreae calcium dried suspension; Concha Ostreae calcium effervescence tablet etc.The compound preparation of Concha Ostreae calcium has: the compound preparation of Concha Ostreae calcium and vitamin D; The compound preparation of Concha Ostreae calcium and lysine; The compound preparation of Concha Ostreae calcium and folic acid etc.The common trait that this class calcium-supplementing preparation is had is the feature that they contain the Concha Ostreae calcium medicinal raw material that meets Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98 and this standard described technical standard of standard of becoming a full member in the future.
2, Concha Ostreae Biocal, dry suspension, the effervescent tablet for preparing according to right 1 described product feature is characterized in that this product has used the Concha Ostreae calcium medicinal raw material that meets Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98 and this standard described technical standard of standard of becoming a full member in the future.
3, compound recipe chewable tablet, the dry suspension of the Concha Ostreae calcium vitaminize D quasi drugs for preparing according to right 1 described product feature is characterized in that this product has used the Concha Ostreae calcium medicinal raw material that meets Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98 and this standard described technical standard of standard of becoming a full member in the future.
4, the Concha Ostreae calcium for preparing according to right 1 described product feature adds the compound recipe interlayer sheet of folic acid, it is characterized in that this product has used the Concha Ostreae calcium medicinal raw material that meets Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98 and this standard described technical standard of standard of becoming a full member in the future, and folic acid made the form that intestinal discharges, Concha Ostreae calcium is made the form that discharges in the stomach.
5, the Concha Ostreae calcium for preparing according to right 1 described product feature adds the compound dried suspension of lysine, it is characterized in that this product has used the Concha Ostreae calcium medicinal raw material that meets Ministry of Health of the People's Republic of China's ministerial standard (trying) WS-275 (X-206)-98 and this standard described technical standard of standard of becoming a full member in the future.
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|---|---|---|---|
| CN02130693A CN1408371A (en) | 2002-09-20 | 2002-09-20 | Novel preparation of oyster calcium |
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|---|---|---|---|
| CN02130693A CN1408371A (en) | 2002-09-20 | 2002-09-20 | Novel preparation of oyster calcium |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104523804A (en) * | 2014-12-18 | 2015-04-22 | 山东天地健生物工程有限公司 | Capsule for increasing bone density and preparation method of capsule |
-
2002
- 2002-09-20 CN CN02130693A patent/CN1408371A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104523804A (en) * | 2014-12-18 | 2015-04-22 | 山东天地健生物工程有限公司 | Capsule for increasing bone density and preparation method of capsule |
| CN104523804B (en) * | 2014-12-18 | 2018-02-16 | 山东天地健生物工程有限公司 | A kind of capsule for increasing bone density and preparation method thereof |
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