CN101455729B - Kangfulingshuan medicine production technique - Google Patents
Kangfulingshuan medicine production technique Download PDFInfo
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- CN101455729B CN101455729B CN2009103001772A CN200910300177A CN101455729B CN 101455729 B CN101455729 B CN 101455729B CN 2009103001772 A CN2009103001772 A CN 2009103001772A CN 200910300177 A CN200910300177 A CN 200910300177A CN 101455729 B CN101455729 B CN 101455729B
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Abstract
The invention relates to a preparation method of a Chinese traditional medical preparation, namely a preparation technique for producing Kangfuling suppositories, comprising the following steps of crushing 19.2g of borneol and 27.4g of catechu for later use; adding 95% of ethanol to extract 674g of crude powder of rhubarb under reflux for two times, 1.5 hours each time, recycling the ethanol, concentrating under vacuum, drying under vacuum, and crushing for later use; soaking 274g of redroot gromwell with 657.5ml of balm for 72 hours, filtering out the redroot gromwell, adding balm to 493.2mlwhen the balm is less than 493.2ml after being heated, adding 330g of paraffin and 110g of beeswax, stirring to synthesize into sorbitan fatty acid ester, heating to 45 DEG C, stirring, adding fine powder of borneol and catechu and rhubarb powdered extract, uniformly stirring, encapsulating, 2.5g each, preparing into 1,000 suppositories. The technique is environment-friendly and meets requirements of GMP standard; the suppositories have reliable curative effect and are more conveniently used.
Description
Technical field
The present invention relates to a kind of preparation method of Chinese medicine preparation, i.e. production rehabilitation spirit bolt medicament preparation technology.
Background technology
In prior art, rehabilitation spirit bolt is to be developed by the Jilin Province academy of traditional Chinese medicine the early 1990s, records in " Ministry of Health of the People's Republic of China's Chinese traditional patent formulation preparation " the 8th.This medicine has the history in 16 years till now from the approval listing.Owing on production technology and ratio of adjuvant, have significant deficiency, cause this medicine almost can't produce, can't sell.Former process stipulation: " get Radix Et Rhizoma Rhei give as one thinks fit cataclasm, fried withered with Oleum sesami 650ml with putting in the pot, remove slag; add Radix Arnebiae (Radix Lithospermi) again and soaked 72 hours, the elimination Radix Arnebiae (Radix Lithospermi) is as residue Oleum sesami quantity not sufficient 365ml; the Oleum sesami after the available heating is supplied and is 365ml, adds semi-synthetic fatty acid ester, and stirring is dissolved; put coldly slightly, adds Borneolum Syntheticum, catechu fine powder, mixing; pour mould molding into; take out, make 365, promptly." there are four: one with fried its defective of Radix Et Rhizoma Rhei of Oleum sesami, do not meet the GMP requirement, producing the clean area fried Radix Et Rhizoma Rhei of pot, Oleum sesami seriously volatilizees, and the GMP standard is unallowed; The 2nd, to use instead by the fried Radix Et Rhizoma Rhei of Steam Heating interlayer extraction pot, oil smoke is discharged outdoor by pipeline, though GMP compatible, temperature reaches as high as 100 ℃, does not reach frying temperature, does not meet the requirement of " fried withered " of standard code; The 3rd, reach the requirement of " fried withered " Radix Et Rhizoma Rhei, temperature is more than at least 200 ℃, and many medicinal components are destroyed; The 4th, go to soak Radix Arnebiae (Radix Lithospermi) with the Oleum sesami that exploded Radix Et Rhizoma Rhei, even the elimination Radix Arnebiae (Radix Lithospermi), but the Radix Arnebiae (Radix Lithospermi) of elimination will speckle with a large amount of Oleum sesami undoubtedly, comprises the Radix Et Rhizoma Rhei active ingredient that contains in the Oleum sesami, and drug effect can be subjected to very big influence.
Adjuvant only uses the defective of semi-synthetic fatty acid ester to have two: one, and the pharmaceutical production molding is very difficult.According to standard-required, 365ml Oleum sesami is made 365 suppositorys, promptly will contain 1ml Oleum sesami in every suppository.The heavy 2.5g of grain, catechu that deduction should add and Borneolum Syntheticum, Oleum sesami and semi-synthetic fatty acid ester almost are 1: 1 ratios.Substrate with 1g is difficult to the Oleum sesami of 1ml is solidified into suppository.Both made and exempted from strong molding, the medicine body also is soft.The 2nd, medicine almost can't use.Because the medicine body is softening, not only is bonded on hand during medication, also is difficult to put into vagina, slightly firmly once having pushed up modification, especially when temperature surpassed more than 16 ℃, suppository was not only softening, but has become liquid.The Oleum sesami ratio is excessive, and domestic and international suppository never runs into.
Summary of the invention
The objective of the invention is provides a kind of preparation technology more reasonably production rehabilitation spirit bolt medicament preparation technology at above-mentioned deficiency.
Technical solution of the present invention is: production rehabilitation spirit bolt medicament preparation technology, and it is characterized in that step is as follows: it is that fine powder is standby that Borneolum Syntheticum, catechu are pulverized; The Radix Et Rhizoma Rhei coarse powder adds 95% alcohol reflux 2 times, and each 1.5 hours, reclaim ethanol, vacuum concentration, vacuum drying is pulverized; Get Radix Arnebiae (Radix Lithospermi) Oleum sesami and soaked 72 hours, the elimination Radix Arnebiae (Radix Lithospermi), residue Oleum sesami deficiency is then supplied Oleum sesami, adds paraffin and Cera Flava, adds semi-synthetic fatty acid ester, is heated to 45 ℃, stirs, and adds Borneolum Syntheticum, catechu fine powder and Radix Et Rhizoma Rhei dried cream powder, stirring and evenly mixing, suppository is made in embedding.Paraffin: Cera Flava=3: 1.
In order to solve fried Radix Et Rhizoma Rhei defective, the present invention uses 95% ethanol extraction Radix Et Rhizoma Rhei instead, and ethanol extraction and the resulting medicinal component of fried extraction all are fat-soluble compositions, and difference of them is little, and will be higher than the fried composition of getting of Oleum sesami far away without its effective ingredient of high temperature.Radix Arnebiae (Radix Lithospermi) is directly soaked with Oleum sesami, because immersion is a kind of medical material, Oleum sesami is gone into dose from 1000ml, is kept to 493.2ml.So also dwindle the ratio of Oleum sesami and substrate, be convenient to the suppository molding.Through test, Oleum sesami and substrate is by 1: 1 ratio, is 1: 4 ratio because of reducing the Oleum sesami quantitative change, though remollescent problem has become liquid again slightly by force when temperature reaches 20 ℃ of left and right sides.The present invention groped the time for 5 years, with tens kinds of adjuvants and substrate, done test nearly 100 times, determine paraffin at last, two kinds of substrate of Cera Flava, and at certain proportion curable medicine body, neither react with original medicine, do not influence again and melt the change time limit, meet the touchstone under the suppository item fully.When temperature below 33 ℃ the time, the medicine body is softening, just slowly liquefaction when reaching 36 ℃ makes things convenient for medicine to store and patient's use fully.Before Changchun University of Traditional Chinese Medicine is to process reform and the spirit of the rehabilitation after changing bolt carried out pharmacodynamics test, the result shows that drug effect is more excellent.
Advantage of the present invention is: 1, Radix Et Rhizoma Rhei extracts without Oleum sesami is fried and gets, and uses 95% ethanol extraction instead, and the technology environmental protection meets the GMP code requirement, and drug effect is reliable.2, soak Radix Arnebiae (Radix Lithospermi) Oleum sesami and go into dose, be reduced to 493.2ml by 1000ml.3, increase paraffin, Cera Flava in the adjuvant, overcome the remollescent deficiency of medicine body, use convenient.
Below in conjunction with embodiment embodiments of the present invention are described in further detail.
The specific embodiment
Embodiment 1
Production rehabilitation spirit bolt medicament preparation processing step: it is that fine powder is standby that Borneolum Syntheticum 19.2g, catechu 27.4g are pulverized; Radix Et Rhizoma Rhei 674g coarse powder adds 95% alcohol reflux 2 times, and each 1.5 hours, reclaim ethanol, vacuum concentration, vacuum drying is pulverized standby; Get Radix Arnebiae (Radix Lithospermi) 274g, soaked 72 hours the elimination Radix Arnebiae (Radix Lithospermi) with Oleum sesami 657.5ml, during residue Oleum sesami is not enough 493.2ml with heating afterwards Oleum sesami supply and be 493.2ml, add paraffin 330g, Cera Flava 110g, add semi-synthetic fatty acid ester, be heated to 45 ℃, stir, add Borneolum Syntheticum, catechu fine powder and Radix Et Rhizoma Rhei dried cream powder, stirring and evenly mixing, embedding, every 2.5g makes 1000 suppositorys.
Embodiment 2
Production rehabilitation spirit bolt medicament preparation processing step: with Borneolum Syntheticum 384g, catechu 548g powder is a fine powder, gets Radix Et Rhizoma Rhei 13480g coarse powder, adds 95% alcohol reflux 2 times, each 1.5 hours, reclaims ethanol, vacuum concentration, vacuum drying, pulverizing.Get Radix Arnebiae (Radix Lithospermi) 5480g, in 13150ml Oleum sesami, soaked 72 hours the elimination Radix Arnebiae (Radix Lithospermi), as remaining the not enough 9864ml of Oleum sesami, the Oleum sesami after the available heating is supplied and is 9864ml, adds paraffin 6600g, Cera Flava 2200g adds semi-synthetic fatty acid ester, is heated to 45 ℃, stir, add cool sheet, catechu fine powder and Radix Et Rhizoma Rhei dried cream powder, stirring and evenly mixing, embedding, every 2.5g makes 20,000 suppositorys.
Experimental example
For checking whether rationally feasible behind the process reform, the present invention by Changchun University of Traditional Chinese Medicine to process reform before and change after rehabilitation spirit bolt carried out pharmacodynamics test.
Method and result
One, the antibacterial parasite killing of two kinds of rehabilitation spirit bolts relatively
1, cup-plate method:
Two kinds of rehabilitation spirit bolt difference water proofs are in 80 ℃ of sterilization 2h, with bacterial classification inoculation in suitable culture base (meat soup blood meida, chocolate blood meida, broth agar culture medium, blood agar culture-medium, sabouraud culture medium, liver-peptone-sugar culture-medium), being diluted to bacteria containing amount respectively is 900,000/ml, Candida albicans is diluted to 50,000/ml, in the pipe dish of each strain culturing ware, add 0.25g rehabilitation spirit bolt, behind 37 ℃ of cultivation 18h, survey inhibition zone, the result shows that two kinds of rehabilitation spirit bolt fungistatic effects have significance difference (P＜0.05) detailed results to see Table 1.
The external fungistatic effect of two kinds of rehabilitation spirits of table 1 bolt relatively
P＜0.05
2, test tube method:
Get 10 in 10ml sterilization test tube, each pipe adds quantitative culture medium, two kinds of each 50 on rehabilitation spirit bolts add water 100ml, heating and melting, jolting 10 minutes, divide the water intaking layer, simmer down to contains the rehabilitation spirit treatment fluid of crude drug 1g/ml, in 80 ℃ of water proof sterilizations 2 hours, does doubling dilution then, concentration was respectively 1: 2,1: 4,1: 8,1: 16,1: 32, each experiment tube adds the 0.1ml experimental bacteria, establishes negative control pipe (not adding bacterium liquid) and positive control (do not add medicinal liquid and only add bacterium liquid) simultaneously, cultivates 24 hours for 37 ℃, observe the minimum inhibitory concentration of medicinal liquid, the results are shown in Table 2 each experimental bacteria.
Table 2, change before and after the technology the outer bacteriostasis of rehabilitation spirit key relatively
Multiple clever diluted concentration (the 1g crude drug/ml)
Annotate :+for bacteria growing is arranged ,-be asepsis growth, () is for changing bacteriostasis after the technology
3, two kinds of rehabilitation spirit keys kill trichomonas vaginitis outward relatively
Separate trichomonas vaginitis from the female patient vaginal secretions, be inoculated in the liver-peptone-sugar culture-medium that contains penicillin and streptomycin, per four days transferred speciess are once inoculated counting 4 times repeatedly, make in the culture fluid infusorian number reach 10,000/ml and use for experiment.Negative control (adding the equal-volume normal saline), positive control (5% metronidazole) are established in experiment, rehabilitation spirit treatment fluid (seeing test tube method) carries out doubling dilution with culture medium, add 0.1ml (the trichomonas vaginitis culture fluid that contains 10,000 of infusorian/ml) in every pipe culture medium, in 37 ℃ of following continuous culture 3 days (examine under a microscope every day), observation in the 3rd day is also write down activity and the death condition of infusorian in each pipe, the results are shown in Table 3
Rehabilitation spirit key killed the infusorian effect outward relatively before and after table 3 changed technology
Annotate: the motion of "+" trichomonas vaginitis is active, and cell is glossy, and quantity increases
"-" trichomonas vaginitis is in heaven, and polypide becomes circle, flagellum, undulating membrane stop motion, cell tarnish, part polypide
Break.
4, two kinds of comparisons that rehabilitation spirit bolt infects the caused by Staphylococcus aureus mouse skin:
With mouse back both sides skin tears, infect staphylococcus aureus, the success of modeling type
30 of mices, be divided at random 3 groups (the penicillin group, change before rehabilitation spirit bolt group, change back rehabilitation spirit bolt group), left side medication beyond the region of objective existence is coated with, the right side is coated with outward with water for injection, once-a-day, does own control and observes wound healing time, statistical procedures the results are shown in Table 4:
Table 4 changes the therapeutical effect that rehabilitation spirit bolt infects the caused by Staphylococcus aureus mouse skin before and after the technology (X ± s)
From above result as can be known, the clever bolt of rehabilitation infects the caused by Staphylococcus aureus mouse skin and has significant therapeutic effect, and compares before changing with after changing, there were significant differences (
* *P＜0.005)
5, two kinds of rehabilitations spirit bolt is to the comparison of rabbit reproductive tract fungal infection
Get 10 of rabbit reproductive tract Candida albicans infection models, divide 2 groups at random, every group 5, be respectively rehabilitation spirit and nystatin group, the administration group is filled in the rabbit reproductive tract with the rehabilitation spirit of 0.2g/kg, pastes vaginal orifice with medical proof fabric, face upward the position and fix 4 hours, matched group is with 5% nystatin suspension 0.5ml, and successive administration 14 days is respectively at making rabbit genital secretion smear after the last administration in 6 hours, 3 days, 7 days.Criterion of therapeutical effect: continuous 3 secretions smear funguses (-), vaginal secretions sepage flowing water (-) is for curing; Smear has 1 fungus (+) secretions smear for 3 times, and vagina still has secretions to ooze out, and flowing water is obviously supported to effectively; Continuous 3 secretions smear funguses (+), vaginal secretions sepage flowing water do not have support or increase to invalid.The results are shown in following table:
Table 5 changes the influence of rehabilitation spirit bolt in technology front and back to rabbit reproductive tract fungal infection
The The above results prompting, rehabilitation spirit bolt has the obvious treatment effect to rabbit reproductive tract fungal infection, rehabilitation spirit bolt before changing, curative effect is a little less than changing back rehabilitation spirit bolt.
Claims (1)
1. a production rehabilitation spirit bolt medicament preparation technology is characterized in that step is as follows: Borneolum Syntheticum 19.2g, catechu 27.4g pulverizing is standby for fine powder; Radix Et Rhizoma Rhei 674g coarse powder adds 95% alcohol reflux 2 times, and each 1.5 hours, reclaim ethanol, vacuum concentration, vacuum drying is pulverized standby; Get Radix Arnebiae (Radix Lithospermi) 274g, soaked 72 hours the elimination Radix Arnebiae (Radix Lithospermi) with Oleum sesami 657.5ml, during residue Oleum sesami is not enough 493.2ml with heating afterwards Oleum sesami supply and be 493.2ml, add paraffin 330g, Cera Flava 110g, add semi-synthetic fatty acid ester, be heated to 45 ℃, stir, add Borneolum Syntheticum, catechu fine powder and Radix Et Rhizoma Rhei dried cream powder, stirring and evenly mixing, embedding, every 2.5g makes 1000 suppositorys.
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| CN2009103001772A CN101455729B (en) | 2009-01-14 | 2009-01-14 | Kangfulingshuan medicine production technique |
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| CN2009103001772A CN101455729B (en) | 2009-01-14 | 2009-01-14 | Kangfulingshuan medicine production technique |
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| CN101455729B true CN101455729B (en) | 2011-05-25 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101926859B (en) * | 2010-08-27 | 2011-12-14 | 北京同御康泰科技有限公司 | Chinese medicinal composition |
| CN103520295B (en) * | 2013-10-11 | 2016-01-13 | 哈尔滨欧替药业有限公司 | Health woman spirit vaginal expansion plug and preparation method thereof and detection method |
| CN110742928B (en) * | 2019-09-09 | 2023-05-26 | 通化百信药业有限公司 | Method and equipment for preparing recovery suppository |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1068500A (en) * | 1992-06-16 | 1993-02-03 | 沈阳东方制药厂 | A kind of suppository process method for the treatment of gynaecopathia |
| CN1583088A (en) * | 2004-06-08 | 2005-02-23 | 陈志成 | Vaginal effervescent tablets for woman inflammation and their preparation |
| CN1839949A (en) * | 2006-01-23 | 2006-10-04 | 贵阳新天药业股份有限公司 | Glue for treating female genital system inflammation and its preparing process |
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2009
- 2009-01-14 CN CN2009103001772A patent/CN101455729B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1068500A (en) * | 1992-06-16 | 1993-02-03 | 沈阳东方制药厂 | A kind of suppository process method for the treatment of gynaecopathia |
| CN1583088A (en) * | 2004-06-08 | 2005-02-23 | 陈志成 | Vaginal effervescent tablets for woman inflammation and their preparation |
| CN1839949A (en) * | 2006-01-23 | 2006-10-04 | 贵阳新天药业股份有限公司 | Glue for treating female genital system inflammation and its preparing process |
Non-Patent Citations (2)
| Title |
|---|
| 中华人民共和国卫生部药典委员会.康复灵栓.《中华人民共和国卫生部药品标准中药成方制剂（第八册）》.1993, * |
| 陈颖等.高效液相色谱法测定康复灵栓中大黄素和大黄酚的含量.《云南中医中药杂志》.2005,第26卷(第2期), * |
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