CN102078332A - In-vitro cultured calculus bovis containing preparation for treating common cold in children and preparation method thereof - Google Patents
In-vitro cultured calculus bovis containing preparation for treating common cold in children and preparation method thereof Download PDFInfo
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- CN102078332A CN102078332A CN2009102321129A CN200910232112A CN102078332A CN 102078332 A CN102078332 A CN 102078332A CN 2009102321129 A CN2009102321129 A CN 2009102321129A CN 200910232112 A CN200910232112 A CN 200910232112A CN 102078332 A CN102078332 A CN 102078332A
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Abstract
The invention provides an in-vitro cultured calculus bovis containing preparation for treating common cold in children. The preparation is particles prepared from 4 to 8 parts of in vitro cultured calculus bovis, 70 to 80parts of acetaminophen, 1 to 2 parts of chlorphenamine maleate, 20 to 25 parts of amantadine hydrochloride, and proper sucrose and essence. The in vitro cultured calculus bovis is used to replace calculus bovis artifactus, side effects of emesis and jaundice caused by excessive free bilirubin contained in the calculus bovis artifactus can be reduced; and the in-vitro cultured calculus bovis containing preparation is ground and stirred by using an equivalent increasing method so that the medicament components can be effectively dispersed to reduce the side effect caused by nonuniform degree of dispersion of the chlorphenamine maleate and the amantadine hydrochloride.
Description
Technical field
The present invention relates to a kind of preparation and preparation method that contains the treatment infantile common cold of In vitro cultured Calculus Bovis, belong to the technical field that medicine is made.
Background technology
Child's common cold and influenza are modal children diseases, can cause symptoms such as heating, headache, extremities aching pain, sneeze, rhinorrhea, nasal obstruction, pharyngalgia.A kind of preparation of being made by artificial Calculus Bovis, acetaminophen, amantadine hydrochloride and chlorphenamine maleate (common name: be that the numerous doctors and the patient head of a family are selected the golden yellow quick granule of ammonia) is arranged; but this product exists two problems not have fine solution, and quality is unstable and cause this product side reaction to take place often.The one, use the artificial Calculus Bovis in the prescription, limit owing to the oxious component unconjugated bilirubin is not carried out content in the working standard, the untoward reaction report is a lot; The 2nd, the amount of prescription Chinese medicine is much smaller than the amount of adjuvant, and common mixed method the uniformity often occurs and can not finely solve, and causes untoward reaction such as the infant appearance is drowsiness, dry pharynx laryngalgia, lethargy.
One; the golden yellow quick granule of ammonia that present infant is taken contains the artificial Calculus Bovis; in artificial Calculus Bovis's the quality standard not the content to unconjugated bilirubin limit; unconjugated bilirubin content wherein is than natural Calculus Bovis; many (free bilirubinic content must not surpass 0.7% in natural Calculus Bovis and the In vitro cultured Calculus Bovis) that the content of In vitro cultured Calculus Bovis is high; it can enter axoneure by blood brain barrier and causes jaundice when unconjugated bilirubin surpassed finite concentration; take the present golden yellow granule of the ammonia that contains the artificial Calculus Bovis less than 3 years old child for the age, often have child vomiting to occur; anorexia; the untoward reaction of jaundice.
The In vitro cultured Calculus Bovis that the present invention uses is the crude drug that obtains State Food and Drug Administration's approval registration, has perfect quality standard.In vitro cultured Calculus Bovis is the lithogenous biochemical process of mock bull body inner bag; the Calculus Bovis of in external Fel Bovis seu Bubali, developing; its character, surface structure, microstructure, composition, content are all consistent with the high-quality natural Calculus Bovis; steady quality, controlled; do not contain Hyodeoxycholic Acid; can carry out suitability for industrialized production, just in time remedy the deficiency of natural Calculus Bovis.The one-tenth stone process of In vitro cultured Calculus Bovis is Biochemical processes, is the process that various effective ingredient, effective group make up naturally.1997, In vitro cultured Calculus Bovis obtained national Chinese medicine one kind new medicine certificate, and 2002, the research achievement obtained national technological invention second prize.Expert through Chinese Pharmacopoeia Commission's tissue repeatedly proves: the shape of In vitro cultured Calculus Bovis, structure, composition, content are all similar to natural Calculus Bovis; pharmacodynamics, toxicologic study result prove safety; clinical efficacy is consistent with natural Calculus Bovis; and being higher than natural Calculus Bovis for some sick curative effect of planting, is the ideal substitute of natural Calculus Bovis.The quality standard of In vitro cultured Calculus Bovis is by " Chinese pharmacopoeia version in 2005 is recorded.
State Food and Drug Administration successively holds expert discussion on Wuhan, Beijing and other places, and whether alternative natural Calculus Bovis has carried out discussing again and again with Calculus Bovis cultivating to In vitro cultured Calculus Bovis.Detection to the multiple one-tenth such as content of bilirubin of In vitro cultured Calculus Bovis shows; In vitro cultured Calculus Bovis can substitute natural Calculus Bovis fully; State Food and Drug Administration is according to expert's conclusion, and decision can use 41 kinds of emergency and severe disease medications such as cow-bezoar bolus for resurrections In vitro cultured Calculus Bovis, Calculus Bovis cultivating to substitute.To solve this problem of Calculus Bovis insufficient raw material.The cultivation success of In vitro cultured Calculus Bovis will make more common people can benefit from the medicinal efficacy of Calculus Bovis.
On January 31st, 2004, State Food and Drug Administration sends " about the notice of Calculus Bovis and succedaneum use problem thereof ": for the new drug that contains Calculus Bovis of clinical anxious severe disease disease medicine variety that contains Calculus Bovis in the national drug standards prescription and the approval of national drug supervisory and management department, Calculus Bovis in the prescription can be substituted uses that feed intake of Calculus Bovis equivalent with Calculus Bovis cultivating, In vitro cultured Calculus Bovis, but it is alternative not to be able to the artificial Calculus Bovis; Other kinds that contain Calculus Bovis can substitute the use that feeds intake of Calculus Bovis equivalent with Calculus Bovis cultivating, In vitro cultured Calculus Bovis or artificial Calculus Bovis with the Calculus Bovis in the prescription.The scope of application to the artificial Calculus Bovis of this document limits, and can be equal to use with natural Calculus Bovis to In vitro cultured Calculus Bovis, also is the affirming of quality, drug effect, clinical efficacy to In vitro cultured Calculus Bovis.
The present invention uses the artificial Calculus Bovis in the golden yellow granule of In vitro cultured Calculus Bovis replacement ammonia, has scientific basis and policy support.With regard to active ingredient, in existing statutory standards, the bilirubin that the artificial Calculus Bovis is contained (active ingredient) must not be less than 0.63%, bilirubinicly must not be less than 35.0% and In vitro cultured Calculus Bovis and natural Calculus Bovis contain.The two mass discrepancy is seen some from this.
Two; the golden yellow quick granule of existing ammonia is by the artificial Calculus Bovis; acetaminophen; amantadine hydrochloride and chlorphenamine maleate are made; because medicine and adjuvant use amount difference are big; often cause the uniformity of medicine undesirable; amantadine hydrochloride and chlorphenamine maleate are because drug action is strong; content is low again; use conventional mixing to stir; the method that extruding is granulated is difficult to make the uniformity to meet the requirements; after often having the child to take the golden yellow quick granule of ammonia more serious symptom appears: as stupor; bradykinesia; xerostomia pharyngalgia etc. are thought because the uniformity of medicine does not have fine solution to cause now than significant side effects.Mixed method and process technology scheme that the present invention uses can finely address this problem.
Summary of the invention
The present invention has provided a kind of preparation and preparation method that contains the treatment infantile common cold of In vitro cultured Calculus Bovis.
Prescription provided by the invention and preparation are verified through clinical experiment: in treatment infantile common cold symptom, can reduce the probability that untoward reaction such as vomiting, anorexia, jaundice, stupor, bradykinesia, xerostomia pharyngalgia take place.
A kind of preparation that contains the treatment infantile common cold of In vitro cultured Calculus Bovis; it is characterized in that: calculate according to composition by weight; be by 4～8 parts of In vitro cultured Calculus Boviss, 70～80 parts of acetaminophen, 1～2 part of chlorphenamine maleate, 20～25 parts of amantadine hydrochlorides, add suitable amount of sucrose and essence is made.
According to calculation, select for use the concrete numerical value ratio of above-mentioned raw materials to be according to composition by weight: 5 parts of In vitro cultured Calculus Boviss, 75 parts of acetaminophen, 1 part of chlorphenamine maleate, 25 parts of amantadine hydrochlorides add that suitable amount of sucrose and essence makes.
Technical scheme of the present invention is:
The first step: get In vitro cultured Calculus Bovis earlier and be ground into impalpable powder, standby;
Second step: get the method that chlorphenamine maleate increases progressively with equivalent and join in the amantadine hydrochloride, grind well, cross 120 mesh sieves, standby;
The 3rd step: get the method that mixed powder that second step obtained increases progressively with equivalent and join in the powder of acetaminophen, grind well, cross 120 mesh sieves, standby;
The 4th step: get method that mixed powder that the first step obtains increases progressively with equivalent and joined for the 3rd step and obtain to grind well in the medicated powder, cross 120 mesh sieves, standby;
The 5th step: the powder of getting the acquisition of the 4th step mixes with adjuvant sucrose powder and essence, stirs 30 minutes, does binding agent with 85～90% ethanol, method according to granule prepares granule with squeezing and pressing method, 12 mesh sieves are crossed in oven dry (water content is less than 5%), obtain the finished particle agent.
The innovative point of the present invention on prescription is: select for use In vitro cultured Calculus Bovis to replace the artificial Calculus Bovis.The artificial Calculus Bovis crosses the very rare succedaneum of seeking down of Calculus Bovis resource at me; be directly allotment after the Fel Bovis seu Bubali drying to be formed; because unconjugated bilirubin content is higher; the content of conjugated bilirubin is on the low side; the clinical report side reaction is a lot; the artificial Calculus Bovis can not substitute natural Calculus Bovis and use, and In vitro cultured Calculus Bovis be State Food and Drug Administration's approval can be by the Calculus Bovis succedaneum that uses with the natural Calculus Bovis Isodose.
The innovative point of the present invention on preparation technology is: will measure little, big to curative effect contribution composition processing in advance earlier, and mix according to the mixed method of grinding that equivalent increases progressively, and can avoid medicine to disperse uneven phenomenon.Because chlorphenamine maleate and amantadine hydrochloride content are very low in the prescription, but the side reaction report is a lot, if disperse inhomogeneously, infant is had a lot of adverse effects.Utilization equivalent increases progressively and mixes the method for grinding by different level, and good dispersion effect can be arranged.
The specific embodiment
Get In vitro cultured Calculus Bovis 10 grams, acetaminophen 150 grams, amantadine hydrochloride 50 grams, chlorphenamine maleate 2 grams, adjuvant is: 1780 gram sucrose, sweet Fructus Citri tangerinae essence 8 grams are made 1000 bags, every bag 2 gram.Concrete preparation method is as follows:
The first step: get In vitro cultured Calculus Bovis earlier and be ground into impalpable powder, standby;
Second step: get the method that chlorphenamine maleate increases progressively with equivalent and join in the amantadine hydrochloride, grind well, cross 120 mesh sieves, standby;
The 3rd step: get the method that mixed powder that second step obtained increases progressively with equivalent and join in the powder of acetaminophen, grind well, cross 120 mesh sieves, standby;
The 4th step: get method that mixed powder that the first step obtains increases progressively with equivalent and joined for the 3rd step and obtain to grind well in the medicated powder, cross 120 mesh sieves, standby;
The 5th step: the powder of getting the acquisition of the 4th step mixes with adjuvant sucrose powder and essence, stirred 30 minutes, and did binding agent, prepare granule with squeezing and pressing method according to the method for granule with 85～90% ethanol, oven dry (water content is less than 5%), cross 12 mesh sieves, obtain the finished particle agent, seal 24 hours, obtain the finished particle agent, packing, every bag of 2g, totally 1000 bags.
Claims (4)
1. a treatment contains the preparation of the treatment infantile common cold of In vitro cultured Calculus Bovis; it is characterized in that: calculate according to composition by weight; be by 4～8 parts of In vitro cultured Calculus Boviss, 70～80 parts of acetaminophen, 1～2 part of chlorphenamine maleate, 20～25 parts of amantadine hydrochlorides, add suitable amount of sucrose and essence is made.
2. according to the described preparation of claim 1, it is characterized in that: calculating according to composition by weight, is by 5 parts of In vitro cultured Calculus Boviss, 75 parts of acetaminophen, 1 part of chlorphenamine maleate, 25 parts of amantadine hydrochlorides, adds that suitable amount of sucrose and essence makes.
3. according to claim 1 or 2 described preparations, it is characterized in that: described preparation is a granule.
4. according to the preparation method of the arbitrary described preparation of claim 1～3, it is characterized in that:
The first step: get In vitro cultured Calculus Bovis earlier and be ground into impalpable powder, standby;
Second step: get the method that chlorphenamine maleate increases progressively with equivalent and join in the amantadine hydrochloride, grind well, cross 120 mesh sieves, standby;
The 3rd step: get the method that mixed powder that second step obtained increases progressively with equivalent and join in the powder of acetaminophen, grind well, cross 120 mesh sieves, standby;
The 4th step: get method that mixed powder that the first step obtains increases progressively with equivalent and joined for the 3rd step and obtain to grind well in the medicated powder, cross 120 mesh sieves, standby;
The 5th step: the powder of getting the acquisition of the 4th step mixes with adjuvant sucrose powder and essence, stirs 30 minutes, does binding agent with 85～90% ethanol, method according to granule prepares granule with squeezing and pressing method, 12 mesh sieves are crossed in oven dry (water content is less than 5%), obtain the finished particle agent.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103948715A (en) * | 2014-04-23 | 2014-07-30 | 通化万通药业股份有限公司 | Pediatric parace |
| CN109966263A (en) * | 2019-04-03 | 2019-07-05 | 江西普正制药有限公司 | A kind of preparation method of Zhongganling capsule |
| CN116492372A (en) * | 2023-06-19 | 2023-07-28 | 内蒙古为旭生物科技有限公司 | Formula of traditional Chinese medicine for feeding lucid ganoderma to form bezoar by cattle and application of formula |
-
2009
- 2009-12-01 CN CN2009102321129A patent/CN102078332A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103948715A (en) * | 2014-04-23 | 2014-07-30 | 通化万通药业股份有限公司 | Pediatric parace |
| CN109966263A (en) * | 2019-04-03 | 2019-07-05 | 江西普正制药有限公司 | A kind of preparation method of Zhongganling capsule |
| CN116492372A (en) * | 2023-06-19 | 2023-07-28 | 内蒙古为旭生物科技有限公司 | Formula of traditional Chinese medicine for feeding lucid ganoderma to form bezoar by cattle and application of formula |
| CN116492372B (en) * | 2023-06-19 | 2023-09-12 | 内蒙古为旭生物科技有限公司 | Formula of traditional Chinese medicine for feeding lucid ganoderma to form bezoar by cattle and application of formula |
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Application publication date: 20110601 |