CN108114015A - A kind of sponge gourd water asthma in children oral solution - Google Patents
A kind of sponge gourd water asthma in children oral solution Download PDFInfo
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- CN108114015A CN108114015A CN201711500277.0A CN201711500277A CN108114015A CN 108114015 A CN108114015 A CN 108114015A CN 201711500277 A CN201711500277 A CN 201711500277A CN 108114015 A CN108114015 A CN 108114015A
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- sponge gourd
- asthma
- water
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- oral liquid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/42—Cucurbitaceae (Cucumber family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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Abstract
The invention discloses a kind of sponge gourd water asthma in children oral solution, total saponin content is 10.089mg/ branch in the sponge gourd water asthma in children oral liquid, and finished color is white, sweet；Relative density 1.051；PH value 6.7；Gained is prepared by following steps：200ml sponge gourd concentrated liquids are taken, stevioside is added in 0.08% ratio, 0.2% ratio adds in potassium sorbate, then adds purified water to 2L, 200 is made altogether, every 10ml.The sponge gourd water asthma in children oral solution of the present invention has many advantages, such as that taking dose is small, absorbs very fast, stable quality, is easy to carry and use, easy to maintain, is especially suitable for industrialized production, has preferable therapeutic effect to asthma in children, and without side-effects.
Description
Technical field
The present invention relates to pharmaceutical arts, and in particular to a kind of sponge gourd water asthma in children oral solution.
Background technology
Sponge gourd belongs to cucurbitaceous plant, comes from《The southern regions of the Yunnan Province book on Chinese herbal medicine》, sponge gourd is called a day sponge gourd, rough melon, Trivhosantnes Kirilouii Manim, water melon etc., original
In India, the Tang Dynasty is passed to China.Sponge gourd main Types are for angular sponge gourd and without two kinds of rib sponge gourd (luffa-smooth loofah), in China north and south
Various regions are cultivated extensively, are one of the main vegetables of summer and autumn.In sponge gourd containing egg vitamin, minerals, soap be general, plant sticks
The substances such as liquid, xylane have the effect of fine to child for treatment cough and asthma.
The content of the invention
To solve the above problems, the present invention provides a kind of sponge gourd water asthma in children oral solutions, absorb soon, convenient for clothes
With.
To achieve the above object, the technical solution taken of the present invention is：
A kind of sponge gourd water asthma in children oral solution, total saponin content is in the sponge gourd water asthma in children oral liquid
10.089mg/ branch, finished color is white, sweet；Relative density 1.051；PH value 6.7；Gained is prepared by following steps：
200ml sponge gourd concentrated liquids are taken, 0.08% ratio of total volume (2L) adds in stevioside, and 0.2% ratio adds
Enter potassium sorbate, then add purified water to 2L, with oral liquid filling machine liquid filling in 10ml ampoule bottles, lid rubber plug
After prick aluminium lid, the oral liquid after embedding is placed in sterilization tank, design temperature be 121 DEG C, sterilization time for 30 minutes to gland after
Sponge gourd water asthma in children oral liquid sterilize to get.
Wherein, the sponge gourd concentrated liquid is as obtained by prepared by following steps：
Take sponge gourd water stoste 5000mL, as be concentrated on Rotary Evaporators 200mL to get
The sponge gourd water asthma in children oral solution of the present invention has that taking dose is small, absorbs very fast, stable quality, carrying
With the advantages that convenient to take, easy to maintain, it is especially suitable for industrialized production, there is preferable therapeutic effect, and nothing to asthma in children
Side effect.
Description of the drawings
Fig. 1 is the preparation technology flow chart of the embodiment of the present invention.
Specific embodiment
In order to which objects and advantages of the present invention are more clearly understood, the present invention is carried out with reference to embodiments further
It is described in detail.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, it is not used to limit this hair
It is bright.
Embodiment
As described in Figure 1, prepared by sponge gourd water asthma in children oral liquid of the invention prepares gained especially by following steps：
200ml sponge gourd concentrated liquids are taken, stevioside, 0.2% ratio are added according to 0.08% ratio of total volume (2L)
Example adds in potassium sorbate, and then plus purified water 800ml, dissolving and mixing filter, the purified water after addition filtering to 2L,
It is uniformly mixed, it is with oral liquid filling machine that liquid is filling in 10ml ampoule bottles, aluminium lid is pricked after lid rubber plug, the oral liquid after embedding
Be placed in sterilization tank, design temperature be 121 DEG C, sterilization time for 30 minutes to the sponge gourd water asthma in children oral liquid after gland into
Row sterilizing 1 time to get.
The selection of additives
The selection of preservative
Sponge gourd water asthma in children oral liquid is made by sponge gourd concentrated liquid, belongs to organic substance, during preparation
Sanitary cleaning cleanliness is also very high, in order to ensure the quality of oral liquid, prevents the growth and breeding of microorganism, the preservative added in right amount
Ensure the quality of oral liquid.The common sodium benzoate of this experimental selection, potassium sorbate.It determines to select potassium sorbate as preservative
This experiment has also carried out dosage of the selection State Food and Drug Administration to preservative to the additive amount of potassium sorbate afterwards
It being provided, the maximum adding quantity of potassium sorbate must not exceed 0.3%, therefore this experiment is prepared for 0.1%, 0.2% respectively,
0.3% using potassium sorbate as the oral liquid of preservative, the room temperature lower holding time be 6 months after, detect preservative anti-corrosion effect
Fruit
The selection of corrigent
This experiment screening corrigent stevioside, honey element carry out flavoring as the corrigent of oral liquid, and dosage refers to flavoring
The usual amounts of agent, ask 20 have certain distinguishing ability Faculty and Students carry out subjective appreciations, eventually by comprehensive grading into
Row determines.Leak detection
Medicine is placed on inspection frame, checks whether on a small quantity, whether sealed bottle loosens, and the finished product checked is not with conforming to ocular estimate
Lattice product are stored respectively.
Sterilizing
Vertical steam sterilizer (YXQ-LS-50S) design temperature is 121, and sterilization time is for 30 minutes to the silk after gland
Melon water asthma in children oral liquid sterilizes.
The quality standard of sponge gourd water asthma in children oral liquid and detection
The relevant document material of oral liquid quality standard is searched, it is each to determine that sponge gourd water asthma in children oral liquid needs detect
Item quality index mainly includes character discriminating, pH value detection, relative density detection, discrimination test, content detection, microorganism limit
Degree checks.And quality testing is carried out to the oral liquid of 6 lot numbers according to indices, compare testing result, finally formulate sponge gourd
Water asthma in children oral liquid quality standard.
Character differentiates
Sponge gourd water asthma in children oral liquid finished color is observed, mouth tastes sponge gourd water oral liquid taste.
Relative density inspection
The specific gravity bottle of clean, dry and accurately weighed weight is taken, after filling test sample (temperature should be less than 20 DEG C), in insertion
The heart has the bottle stopper of pore, dries the liquid overflowed from bottle stopper with filter paper, puts in 20 DEG C of waters bath with thermostatic control, place several minutes,
With the rising of test solution temperature, excessive liquid will constantly be overflowed from mouth, at any time be dried bottle stopper top with filter paper
Only, treat that liquid is no longer flowed out by consent, news take out specific gravity bottle from water-bath.It will be dried again with filter paper outside specific gravity bottle,
It is accurately weighed, the weight of specific gravity bottle is subtracted, after the weight for acquiring test sample, test sample is inclined, cleans specific gravity bottle, is filled new
The cold water boiled, then when measuring same temperature according to upper method water weight.
PH value
This product is taken, is operated in accordance with the law by (2015 editions annex VIIG of Chinese Pharmacopoeia).
Content
Total saponin content in oral liquid is measured using ultraviolet spectrophotometer method.
The preparation of reference substance solution：Precision is weighed puts 100mL measuring bottles in 105 DEG C of dry oleanolic acid 15mg to constant weight
In, it is dissolved in water, and scale is diluted to, it shakes up to get (containing 30 μ g oleanolic acids per 1mL).
Measure the selection of wavelength：Reference substance oleanolic acid solution is taken to carry out the survey of trap in 500-600nm wave-length coverages
Fixed, solution has maximum absorption band in 560nm, therefore selects 560nm as Detection wavelength.
The preparation of standard curve：Precision measure reference substance oleanolic acid solution 0.1mL, 0.2mL.0.3mL, 0.4mL,
0.5mL is placed in 5mL volumetric flasks, is added water constant volume, shake up the standard solution that various concentration is made.It is pipetted respectively from each bottle
2mL standard solution adds in water saturated n-butanol 4.5mL mixings in test tube, after placing 10min, adds in 40 DEG C of water-baths
Hot 10min, then 10min is placed, using corresponding reagent as blank, absorbance is measured at 560nm, using absorbance as ordinate,
Concentration is abscissa, draws standard curve.
Sample size measures：Each lot number product about 1mL is taken, precision measures, puts in 5mL volumetric flasks, Purified Water q. s is added to make
Dissolving, scale is settled to water, then therefrom takes 2mL in test tube, and then the method identical with making standard curve measures extinction
Degree calculates concentration by equation of linear regression.
Microbial limit
This product is taken, is operated in accordance with the law by (2015 editions annex XIJ of Chinese Pharmacopoeia).
Sponge gourd water asthma in children oral liquid quality standard is formulated
According to the quality measurements of above-mentioned sponge gourd water asthma in children oral liquid, sponge gourd water asthma in children oral liquid matter is determined
Amount standard.
As a result
The selection of preservative species
The comparative test result of 1 preservative of table
The result shows that：The use of the two to the appearance character indifference of oral liquid, but in view of security, selects sorb
Sour potassium is preservative.
The screening of preservative dosage
The experimental result of 2 preservative additive amount of table
The result shows that：The addition of potassium sorbate preservative is 0.2%, meanwhile, the addition of preservative is in state food
In the claimed range of Drug Administration.
The selection of corrigent
The selection result of 3 corrigent of table
The result shows that：When adding in corrigent stevioside 0.08%, think that the number of good mouthfeel is more, so corrigent selects
It is general to select 0.08% stevia rebaudianum.
Character differentiates
The different lot number oral liquid character identification results of table 4
As shown in Table 4, the equal oral liquid character of lot number meets regulation (regulation oral liquid character is white liquid, sweet).Phase
Density inspection, pH value are differentiated
According to National Pharmacopeia, density should be in 1.03-1.06；PH value should be 6-7.
The different lot number oral liquid physical property inspection results of table 5
As a result understand, 6 batches of oral liquid identification checks and pH value testing result are qualified.
Oleanolic acid Specification Curve of Increasing
Oleanolic acid standard curve determines：The standard solution of accurate formulation 0.2mg/mL oleanolic acids, takes respectively
0.10mL, 0.15mL, 0.20mL, 0.25mL, 0.30mL, 0.35mL are evaporated in 6 10mL colorimetric cylinders in 70 DEG C of water-baths,
Add 5% vanillic aldehyde-glacial acetic acid 0.20mL of Fresh and perchloric acid 1.00mL, shake up, protected in 60 DEG C of water-baths
Warm 25min, takes out immediately
Flowing water cools down 5min, and vinegar 5mL on the rocks shakes up, and measure absorbance at 560nm in 90min represents olive with x
Acid amount (mg), y represent absorbance, obtain standard curve and calculate regression equation：
Y=7.846x-0.0403, r2=0.9993
Microbial limit
6 limit test of microbe of table
Chinese Pharmacopoeia 2015 editions, per 1mL test samples in except bacterial population must not cross 100, yeast and mold number must not
10 are crossed, escherichia coli must not be detected.
It it is 121 DEG C in temperature, sterilization time is to sterilize under the conditions of 30 minutes, and sterilization effect is good from table 1-6
Good, the microorganism checking of 6 batches of products meets regulation.
Sponge gourd water asthma in children oral liquid assay
Sponge gourd water asthma in children oral liquid quality standard is formulated
In conclusion finally formulate sponge gourd water asthma in children oral liquid quality standard.The discriminating of finished product character requires the color to be
White clear, it is sweet；It is 1.051 that relative density is measured in experiment, meets national Specification；PH value 6.7；Experiment measures mouth
It is 10.089mg/ branch to take total saponin content in liquid；Microbial limit requirement meets national standard.
The above is only the preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
For member, without departing from the principle of the present invention, several improvements and modifications can also be made, these improvements and modifications
It should be regarded as protection scope of the present invention.
Claims (2)
- A kind of 1. sponge gourd water asthma in children oral solution, which is characterized in that total saposins in the sponge gourd water asthma in children oral liquid Content is 10.089mg/ branch, and gained is prepared by following steps：200ml sponge gourd concentrated liquids are taken, 0.08% ratio of total volume adds in stevioside, and 0.2% ratio adds in sorbic acid Potassium, then addition purified water to 2L, filling in 10ml ampoule bottles liquid with oral liquid filling machine, and aluminium lid is pricked after lid rubber plug, Oral liquid after embedding is placed in sterilization tank, and design temperature is 121 DEG C, and sterilization time is 30 minutes small to the sponge gourd water after gland Youngster's asthma oral liquid sterilize to get.
- A kind of 2. sponge gourd water asthma in children oral solution as described in claim 1, which is characterized in that the sponge gourd water concentration Liquid is as obtained by prepared by following steps：Take sponge gourd water stoste 5000mL, as be concentrated on Rotary Evaporators 200mL to get.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711500277.0A CN108114015A (en) | 2017-12-29 | 2017-12-29 | A kind of sponge gourd water asthma in children oral solution |
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| CN201711500277.0A CN108114015A (en) | 2017-12-29 | 2017-12-29 | A kind of sponge gourd water asthma in children oral solution |
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| CN108114015A true CN108114015A (en) | 2018-06-05 |
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| CN201711500277.0A Pending CN108114015A (en) | 2017-12-29 | 2017-12-29 | A kind of sponge gourd water asthma in children oral solution |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112335878A (en) * | 2020-10-21 | 2021-02-09 | 新晃县华森科技有限责任公司 | Trichosanthes kirilowii oral liquid and preparation method thereof |
| CN114796385A (en) * | 2022-06-15 | 2022-07-29 | 张孝忠 | Formula for treating asthma |
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|---|---|---|---|---|
| CN103656132A (en) * | 2012-09-05 | 2014-03-26 | 杨波 | Drug for treating infantile cough and preparation method thereof |
| CN103989909A (en) * | 2014-06-11 | 2014-08-20 | 任新年 | Traditional Chinese medicine oral liquid for treating asthma and preparation method thereof |
| CN104547013A (en) * | 2014-08-01 | 2015-04-29 | 陕西正晟康源生物医药有限公司 | Oral liquid for treating gastric mucosa and liver injury and preparation method of oral liquid |
| CN104686704A (en) * | 2013-12-07 | 2015-06-10 | 哈尔滨升益生物科技开发有限公司 | Formula and production method of luffa asthma rehabilitation tea |
-
2017
- 2017-12-29 CN CN201711500277.0A patent/CN108114015A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103656132A (en) * | 2012-09-05 | 2014-03-26 | 杨波 | Drug for treating infantile cough and preparation method thereof |
| CN104686704A (en) * | 2013-12-07 | 2015-06-10 | 哈尔滨升益生物科技开发有限公司 | Formula and production method of luffa asthma rehabilitation tea |
| CN103989909A (en) * | 2014-06-11 | 2014-08-20 | 任新年 | Traditional Chinese medicine oral liquid for treating asthma and preparation method thereof |
| CN104547013A (en) * | 2014-08-01 | 2015-04-29 | 陕西正晟康源生物医药有限公司 | Oral liquid for treating gastric mucosa and liver injury and preparation method of oral liquid |
Non-Patent Citations (1)
| Title |
|---|
| 不详: ""发作期小儿哮喘食疗方"", 《医学文选》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112335878A (en) * | 2020-10-21 | 2021-02-09 | 新晃县华森科技有限责任公司 | Trichosanthes kirilowii oral liquid and preparation method thereof |
| CN114796385A (en) * | 2022-06-15 | 2022-07-29 | 张孝忠 | Formula for treating asthma |
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Application publication date: 20180605 |