CN106606541B - Novel feeding method of Keteling capsules - Google Patents

Novel feeding method of Keteling capsules Download PDF

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CN106606541B
CN106606541B CN201710016801.0A CN201710016801A CN106606541B CN 106606541 B CN106606541 B CN 106606541B CN 201710016801 A CN201710016801 A CN 201710016801A CN 106606541 B CN106606541 B CN 106606541B
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extract
content
isovitexin
vitexin
moisture
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王美慧
姜文月
魏晓雨
边雨
徐杰
周立梅
苏婷
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Jilin Modern Chinese Medicine Engineering Research Center Co Ltd
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    • A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Abstract

The KETELING Capsule comprises Ficus microcarpa dry extract and chlorphenamine maleate. The invention discloses a novel feeding method of cough curing capsules, which takes water, extract and content measurement items of ficus microcarpa dry extract as the feeding homogenization indexes, checks the weight of a detection item in raw material quality standards, formulates the raw material feeding homogenization standards through formulating a calculation formula and industrial verification, achieves the purpose of uniform and stable finished product quality, and conforms to the new GMP requirement concept. The obtained KETELING Capsule has effects of relieving cough and asthma, eliminating inflammation and eliminating phlegm, and can be used for treating cough and asthma and chronic bronchitis.

Description

Novel feeding method of Keteling capsules
Technical Field
The invention relates to a new feeding method of Keteling capsules, belonging to the technical field of feeding processes in medicine production.
Background
The Keteling capsule is a compound preparation of Chinese and Western medicines collected in the section of the 2015 edition of Chinese pharmacopoeia, and mainly comprises ficus microcarpa dry extract and chlorphenamine maleate. Folium fici microcarpae has antibacterial, analgesic, antiinflammatory and cough and asthma relieving effects, mainly contains triterpene, flavone, acidic resin, tannin, etc., and can be used for treating cough, asthma, bronchitis, etc. The preparation method of the ficus microcarpa dry extract comprises the following steps: drying leaves of Ficus microcarpa, decocting in water twice, mixing decoctions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.10-1.20(80 deg.C), cooling, adding ethanol to make ethanol content reach 60%, standing for more than 12 hr, filtering, recovering ethanol from the filtrate, concentrating to obtain soft extract with relative density of 1.30(50 deg.C), drying below 80 deg.C, and pulverizing into fine powder.
The content difference of the extract obtained from the ficus microcarpa leaves among different batches is large for one reason: the content difference of the ficus microcarpa leaf medicinal materials of different batches in the same producing area is large, and the reason is that the content difference is large: the content difference of the prepared ficus microcarpa dry extract is large due to the difference of the extraction conditions, and although the moisture, extract, vitexin and isovitexin of the ficus microcarpa dry extract obtained by the difference extraction meet the requirements of pharmacopeia, the batch difference of the prepared finished product of the tuteling capsule is large due to the large batch difference.
In order to solve the problem of large content difference among single-batch extract batches, a pharmaceutical factory can mix and feed different batches of raw materials in the actual production process, but most of the manufacturers do not have theoretical basis for mixed feeding, only mix materials according to the difference of a single content measurement item, and do not consider the measurement result of mixed other indexes, so that the difference of other indexes except for content measurement after mixing is large, the aim of uniform feeding still cannot be fulfilled, and the problem to be solved urgently in the actual production process of a production workshop is solved.
Disclosure of Invention
The invention provides a new method for feeding a Chinese and western medicine compound preparation keteling capsule.
The invention provides a cough treating capsule which is composed of ficus microcarpa dry extract and chlorphenamine maleate, and the formula comprises 50-90% of ficus microcarpa dry extract and 0.20-0.35% of chlorphenamine maleate according to weight percentage.
The contribution of the invention lies in: the method and the device for establishing batch mixing feeding by using multiple indexes are provided for the first time, the problem that no theoretical basis exists in batch mixing feeding in the actual production process of the Keteling capsule is solved, and the technical defect that a single content determination item is used as a mixing index is overcome. After the method is applied to industrialization, theoretical basis is provided for batch mixing and feeding, the uniformity of products is obviously improved, the result stability of each index of finished products is improved, the qualification rate of the finished products is greatly improved, obvious positive effect and industrial value are generated, and the method has obvious innovation and technical progress.
According to the existing indexes of pharmacopoeia, the internal control quality standard is formulated by combining the indexes of the ficus microcarpa dry extract powder and chlorphenamine maleate which are actually produced and fed. The batches with higher content need to be mixed with the batches with lower content for feeding, and all indexes after mixing meet the standard requirements, so that the aim of uniform and stable quality of finished products is fulfilled, and the high-quality tuteling capsules meeting the GMP requirements are prepared.
In the novel method for feeding the cough curing capsule, the moisture, extract, content determination items and the like of the ficus microcarpa dry extract are taken as indexes for homogenizing feeding, and each detection item
And (4) checking and determining the weight, and formulating a calculation formula to obtain the raw material feeding homogenization standard.
TABLE 1 Ficus microcarpa dry extract feed homogenization index selection
Figure BDA0001206160830000031
Method for calculating dosage of ficus microcarpa dry extract
TABLE 2 Ficus microcarpa dry extract feeding homogenization calculation
Figure BDA0001206160830000032
Taking a prescription amount as an example, the formula for calculating the feeding amount X by using the moisture is as follows:
Figure BDA0001206160830000033
X1＝Xamount of prescription(PRequired moisture content-PMoisture 2)/(PMoisture content 1-PMoisture 2)
X2＝XAmount of prescription(PRequired moisture content-PMoisture content 1)/(PMoisture 2-PMoisture content 1)
Similarly, the contents of the extract, the vitexin and the isovitexin are taken as indexes, after the feeding amount of each detection index is calculated, the feeding amount of the A batch of extract and the B batch of extract is calculated according to assigned values as follows:
batch A, material feeding amount of the extract:
Xa batch size＝(FMoisture content×X1+FExtract of plant×X3+FVitexin and isovitexin×X5)/10
Batch B of extract feeding amount:
Xb batch size＝(FMoisture content×X2+FExtract of plant×X4+FVitexin and isovitexin×X6)/10
Therefore, the dosage of the ficus microcarpa extract is XDosage of ficus microcarpa extract＝XA batch size+XB batch size
Detailed Description
Example of the implementation
Feeding calculation method of ficus microcarpa dry extract
TABLE 3 Ficus microcarpa dry extract feeding homogenization calculation
Figure BDA0001206160830000041
Taking a prescription amount as an example, the formula for calculating the feeding amount X by using the moisture is as follows:
Figure BDA0001206160830000042
X1＝Xamount of prescription(PRequired moisture content-PMoisture 2)/(PMoisture content 1-PMoisture 2)＝360*(5.0-7.7)/(3.5-7.7)＝231.42g
X2＝XAmount of prescription(PRequired moisture content-PMoisture content 1)/(PMoisture 2-PMoisture content 1)＝360*(5.0-3.5)/(7.7-3.5)＝128.58g
The formula for calculating the feed X by using the extract is as follows:
Figure BDA0001206160830000043
X3＝Xamount of prescription(PRequiring extract-PExtract 2)/(PExtract 1-PExtract 2)＝360*(60.0-69.0)/(58.0-69.0)＝294.54g
X4＝XAmount of prescription(PRequiring extract-PExtract 1)/(PExtract 2-PExtract 1) The formula of the material amount X calculated by content measurement is 360 (60.0-58.0)/(69.0-58.0) 65.46g as follows:
Figure BDA0001206160830000044
X5＝Xamount of prescription(PRequired content measurement-PContent measurement 2)/(PContent measurement 1-PContent measurement 2)＝360*(1.3-1.0)/(1.4-1.0)＝270g
X6＝XAmount of prescription(PRequired content measurement-PContent measurement 1)/(PContent measurement 2-PContent measurement 1)＝360*(1.3-1.4)/(1.0-1.4)＝90g
After the feeding amount of each detection index is calculated, the feeding amount of the A batch of extract and the B batch of extract is calculated according to the assigned value as follows:
batch A, material feeding amount of the extract:
Xa batch size＝(FMoisture content×X1+FExtract of plant×X3+FVitexin and isovitexin×X5)/10＝(1*231.42g+2*294.54g+7*270g)/10＝271.05g
Batch B of extract feeding amount:
Xb batch size＝(FMoisture content×X2+FExtract of plant×X4+FVitexin and isovitexin×X6)/10＝(1*128.58g+2*65.46g+7*90g)/10＝88.95g
Therefore, the feeding amount of the ficus microcarpa extract is as follows: 271.05g of the extract of batch A and 88.95g of the extract of batch B.
The combined actual assay results were as follows:
TABLE 4 analysis chart comparing the predicted results and actual measured results of the original feeding method and the new feeding method
Analysis and discussion of experimental results: according to the original feeding method, the moisture content of the ficus microcarpa extract fed is respectively 3.5% and 7.7%, the extract is respectively 58.0% and 69.0%, the content of vitexin and isovitexin is respectively 1.40mg/g and 1.00mg/g, and the difference between the batches of raw materials fed is large. The predicted value of the water content of the batch mixing according to the new feeding method is 5.0 percent, the predicted value of the extract is 60.0 percent, the predicted content of the vitexin and the isovitexin is 1.30mg/g, the actual measured value of the water content of the sample after the batch mixing according to the calculation method of the invention is 4.71 percent (the error between the predicted value and the water content is 6.20 percent), the actual measured result of the extract is 61.25 percent (the error between the predicted value and the water content is 2.08 percent), and the actual measured result of the content of the vitexin and the isovitexin is 1.31mg/g (the error between the predicted value and the water content is 0.77 percent). The results of the experimental data are analyzed to obtain: after the new feeding method is applied, the expected measured values of all indexes of raw material batch mixing are controllable, and a reliable theoretical basis is provided for the stable quality of finished products.

Claims (1)

1. A new feeding method of Keteling capsules is characterized in that: taking water, extract and content measurement items of the ficus microcarpa dry extract as feeding homogenization indexes, checking the weight of each detection item, and formulating a calculation formula to obtain a raw material feeding homogenization standard; the method comprises the following specific steps:
(1) selecting the uniformity index of the banyan dry extract:
A. the detection standard of the charging homogenization index of the ficus microcarpa dry extract in the Chinese pharmacopoeia 2015 edition is that the inspection of water content is not more than 9.0%, the extract is not less than 50.0%, and the total amount of vitexin and isovitexin in each 1g is not less than 0.9 mg;
B. the detection standard of the feeding homogenization index of the ficus microcarpa dry extract with the internal control quality standard is that the inspection of water content is 3.0-7.0%, the extract is 55.0-70.0%, and the total amount of vitexin and isovitexin in each 1g is not less than 1.1-1.5 mg;
C. the Ficus microcarpa dry extract has the required indexes of 5.0% of water content, 60.0% of extract, and 1.3mg of total vitexin and isovitexin in each 1 g;
giving out assigned value of 10 points for measuring items of water, extract and content affecting the ficus microcarpa dry extract, wherein the water is FMoisture content1, extract FExtract of plantThe other two of the glycoside and isovitexin are FVitexin and isovitexin＝7，
(2) Calculation method of dosage of ficus microcarpa dry extract
The representation modes of the moisture, extract, vitexin and isovitexin of A, B batches of ficus microcarpa dry extract are as follows:
the water content of A batch of extractum is the feed amount X1Content P ofMoisture content 1The feed amount of the extract is X3Content P ofExtract 3Vitexin and isovitexin are the feed amount X5Content P ofVitexin and isovitexin 5；
The water content of B batch of extractum is the feed amount X2Content P ofMoisture 2The feed amount of the extract is X4Content P ofExtract 4Vitexin and isovitexin are the feed amount X6Content P ofVitexin and isovitexin 6；
The formula for calculating the feeding amount X by using the moisture is as follows:
Figure FDA0002323566270000011
the following formula is obtained
X1＝XAmount of prescription(PRequired moisture content－PMoisture 2)/(PMoisture content 1－PMoisture 2)
X2＝XAmount of prescription(PRequired moisture content－PMoisture content 1)/(PMoisture 2－PMoisture content 1)
Extract and Vitex negundo L.in the same wayCalculating X by using the content of glycoside and isovitexin as index3、X4、X5、X6And calculating the respective feeding amounts of the A batch of extract and the B batch of extract according to the assigned values as follows
Batch A, material feeding amount of the extract:
Xa batch size＝(FMoisture content×X1+FExtract of plant×X3+FVitexin and isovitexin×X5)/10
XB batch size＝(FMoisture content×X2+FExtract of plant×X4+FVitexin and isovitexin×X6)/10
Therefore, the dosage of the ficus microcarpa dry extract is XDosage of ficus microcarpa dry extract＝XA batch size+XB batch size: the cough treating capsule consists of ficus microcarpa dry extract and chlorphenamine maleate, and the formula comprises 50-90% of ficus microcarpa dry extract and 0.20-0.35% of chlorphenamine maleate according to weight percentage; taking Ficus microcarpa dry extract, adding chlorphenamine maleate and appropriate amount of adjuvants, mixing, granulating, and making into capsule.
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CN102342977A (en) * 2011-07-15 2012-02-08 吉林敖东集团大连药业股份有限公司 Keteling capsule and preparation method thereof

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CN102342977A (en) * 2011-07-15 2012-02-08 吉林敖东集团大连药业股份有限公司 Keteling capsule and preparation method thereof

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