CN108888669B - Preparation method of oral liquid for clearing heat and relieving cough of children - Google Patents
Preparation method of oral liquid for clearing heat and relieving cough of children Download PDFInfo
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- A61K35/56—Materials from animals other than mammals
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- A61K35/644—Beeswax; Propolis; Royal jelly; Honey
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- A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
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- 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
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- 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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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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Abstract
The invention belongs to the technical field of traditional Chinese medicine pharmacy, and particularly relates to a preparation method of an oral liquid for clearing heat and relieving cough for children. The preparation method of the oral liquid for clearing heat and relieving cough for children provided by the invention comprises the steps of carrying out water extraction on seven medicinal materials of ephedra herb, gypsum, fried bitter apricot seed, asiatic moonseed rhizome, indigowoad root, baical skullcap root and liquoric root, extracting a liquid medicine, concentrating, and adding a flocculating agent into the concentrated liquid to precipitate impurities, thus obtaining the oral liquid. The preparation method of the oral liquid for clearing heat and relieving cough for children provided by the invention has the advantages that the impurity removal effect is good, the effective components in the oral liquid can be well reserved, and the product stability is better; meanwhile, the method also has the advantages of simple operation process, short production period and low production cost, and is suitable for large-scale industrial production.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicine pharmacy, and particularly relates to a preparation method of an oral liquid for clearing heat and relieving cough for children.
Background
An oral liquid for treating infantile cough and fever is prepared from ephedra, gypsum, parched bitter apricot kernel, asiatic moonseed rhizome, isatis root, baikal skullcap root and licorice root, and has the functions of clearing heat, ventilating lung, relieving asthma and relieving sore throat. Can be used for treating common cold caused by infantile wind heat, with symptoms of fever, aversion to cold, cough, yellow phlegm, short breath, asthma, dry mouth, hoarseness, and sore throat.
The extract of the pediatric heat-clearing cough-relieving oral liquid is complex in components, wherein the extract contains colloid components such as tannin, protein, resin, wax and the like, the clarity of the oral liquid is poor, and a large amount of protein in syrup is easy to mildew. In order to overcome the problem, in the production process of the traditional Chinese medicine preparation, the extract of the medicine needs to be purified to remove impurities and retain the active ingredients in the medicinal materials. The main methods for separating and purifying traditional Chinese medicines include water extraction and alcohol precipitation, ultrafiltration, high-speed centrifugation and the like.
The water extraction and alcohol precipitation method easily causes the loss of effective components, thereby affecting the curative effect of the medicine. In addition, the water extraction and alcohol precipitation method needs a large amount of alcohol, and special equipment is purchased, so that the fixed investment is greatly increased, the energy consumption is high, the production period is long, and the labor intensity is high. The ultrafiltration method has the characteristics of high separation efficiency, no phase change in the separation process, low energy consumption and the like, and is particularly suitable for separating heat-sensitive substances, but because the screen holes on the ultrafiltration membrane are extremely small, substances deposited on the membrane surface are easy to form a layer of high-concentration gel layer, so that the throughput and the interception performance of the membrane are greatly influenced, corresponding measures are required to be taken, and pretreatment is carried out before ultrafiltration. When the purification is difficult or the effect on the active ingredient is large, a high-speed centrifugal separation method can be used. The method can well solve the problem of solid-liquid separation, but the method has certain limitation, and the high-speed centrifuge has high energy consumption, so that the cost is increased. Meanwhile, some traditional Chinese medicine impurities cannot be completely separated through centrifugal precipitation. Therefore, when preparing the oral liquid for clearing heat and relieving cough for children, a method for effectively reducing impurity precipitation of the traditional Chinese medicine oral liquid is required.
Patent document CN108175788A discloses an oral liquid for clearing heat and relieving cough for children and a preparation method thereof, wherein the preparation method comprises the steps of boiling and extracting ephedra herb, bitter apricot seed, gypsum, scutellaria baicalensis, isatis root, asiatic moonseed rhizome and liquorice for multiple times, and filtering and removing impurities by adopting the processes of heat treatment, resin adsorption, centrifugation, refrigeration and the like, so that the clarity of liquid medicine is ensured. The preparation method has the advantages of thorough adsorption and centrifugal impurity removal, and better purity of the liquid medicine by adopting equipment such as a centrifugal machine and a resin column to more accurately remove impurities in the liquid medicine. However, the macroporous adsorption resin method has the problems of resin pollution and regeneration, the cost is high, and when the macromolecular substances such as polysaccharide, protein and the like in the compound or single traditional Chinese medicine need to be reserved, the compound or single traditional Chinese medicine needs to be additionally treated.
Patent document CN102319308A discloses a preparation method of an oral liquid for clearing heat and relieving cough for children, which adopts a diaphragm filter-pressing circulating extraction and separation integrated technology to replace the existing decocting method to extract effective components of medicinal materials in a prescription, thereby simplifying the process flow, greatly shortening the production period, saving the energy consumption, being beneficial to environmental protection and waste residue utilization, and greatly improving the recovery rate of the effective components; in the preparation step, an ultrafiltration membrane is adopted for direct filtration instead of standing for 24 hours and then filtration, so that the quality problem that the finished product is easy to generate precipitates which are not scattered and do not meet the relevant regulation of a mixture can be thoroughly solved, and the production period is further shortened. However, because the mesh size of the ultrafiltration membrane is very small, substances deposited on the membrane surface easily form a layer of high-concentration gel layer, so that the throughput and the interception performance of the membrane are greatly influenced, corresponding measures need to be taken, pretreatment is carried out before ultrafiltration, and large-scale production is not facilitated.
Disclosure of Invention
Aiming at overcoming the defects of the impurity removal process of the heat-clearing cough-relieving oral liquid for children in the prior art. The invention aims to provide a preparation method of an oral liquid for clearing heat and relieving cough of children, which aims to solve the defects.
The invention provides a preparation method of an oral liquid for clearing heat and relieving cough for children, which comprises the following components in parts by weight: 45 parts of ephedra, 60 parts of fried bitter almond, 135 parts of gypsum, 45 parts of liquorice, 90 parts of scutellaria baicalensis, 90 parts of isatis root, 45 parts of asiatic moonseed rhizome, 100 parts of honey and 1.5 parts of sodium benzoate;
the preparation method of the oral liquid for clearing heat and relieving cough for children comprises the following steps:
s1 adding herba Ephedrae and Gypsum Fibrosum into purified water, boiling and extracting for 25-35 min, wherein the addition amount of the purified water is 6-10 times of the total weight of herba Ephedrae and Gypsum Fibrosum, adding rhizoma Menispermi, radix Isatidis, Scutellariae radix, Glycyrrhrizae radix, and parched semen Armeniacae amarum, boiling and extracting for 100-150 min, filtering, collecting filtrate to obtain filtrate I, and filtering residue for use;
s2, adding purified water into the filter residue filtered in the step S1, boiling and extracting for 50-80 min, wherein the adding amount of the purified water is 6-10 times of the total weight of the filter residue, filtering, taking filtrate to obtain filtrate II, combining the filtrate I and the filtrate II obtained in the step S1, and concentrating to obtain concentrated solution;
s3, stirring the concentrated solution obtained in the step S2 at the stirring speed of 45-55 r/min, adding a flocculating agent, stirring, standing for 24 hours, and filtering to obtain a filtrate III;
s4 adding honey and sodium benzoate into the filtrate III obtained in the step S3, stirring and dissolving, fixing the volume, filling and sterilizing to obtain the traditional Chinese medicine.
Further, in the step S1, the ephedra herb and the gypsum are put into purified water with the temperature of 65-70 ℃ and extracted for 25-35 min under the pressure of 0.8-1.0 MPa, the addition amount of the purified water is 6-10 times of the total weight of the ephedra herb and the gypsum, then the asiatic moonseed rhizome, the isatis root, the baical skullcap root, the licorice root and the fried bitter apricot seed are added, the purified water with the temperature of 65-70 ℃ and the pressure of 0.8-1.0 MPa are extracted for 100-150 min, and the filtrate is filtered to obtain the filtrate I.
Further, in the step S2, the filter residue filtered in the step S1 is put into purified water at a temperature of 65-70 ℃, extracted under a pressure of 0.8-1.0 MPa for 50-80 min, the addition amount of the purified water is 6-10 times of the total weight of the filter residue, filtered, filtrate is taken to obtain filtrate II, the filtrate I and the filtrate II obtained in the step S1 are combined, and concentrated to obtain concentrated solution.
Further, in the step S3, the addition amount of the flocculating agent is 5-15% of the volume of the concentrated solution, and the treatment time is 10-30 min.
Further, the flocculating agent in the step S3 is one or a combination of more than two of chitosan 1% acetic acid solution, 101 fruit juice clarifying agent and ZTC1+1 natural clarifying agent; the chitosan 1% acetic acid solution is a uniform colloidal solution prepared by preparing chitosan into 2% (W/W) with 1% (W/W) acetic acid; the 101 fruit juice clarifying agent is an aqueous solution which is prepared into 5% (W/W) by deionized water; the component A in the ZTC1+1 natural clarifying agent is prepared into a 1% (W/W) gel solution by using deionized water, and the component B is prepared into a 1% (W/W) gel solution by using 1% (W/W) acetic acid. The addition amounts of the component A and the component B in the ZTC1+1 natural clarifying agent are added according to a conventional mode, and the addition volume amount of the component B is 2 times of the addition amount of the component A.
Further, the flocculant in the step S3 is a chitosan 1% acetic acid solution.
Further, the flocculating agent in the step S3 is a chitosan 1% acetic acid solution and a ZTC1+1 natural clarifying agent according to the volume ratio of (4-6) to (3-5).
Further, the flocculant in the step S3 is chitosan 1% acetic acid solution and ZTC1+1 natural clarifier in a volume ratio of 5: 4.
Further, the addition mode of the flocculant is as follows: adding a 1% acetic acid solution of chitosan, standing for 4-8 min, adding the component A in the natural clarifying agent ZTC1+1, standing for 2-4 min, adding the component B in the natural clarifying agent ZTC1+1, and standing for 4-8 min.
Further, the addition mode of the flocculant is as follows: adding chitosan 1% acetic acid solution, standing for 6min, adding component A of ZTC1+1 natural clarifier, standing for 3min, adding component B of ZTC1+1 natural clarifier, and standing for 6 min.
The invention adopts the flocculation technology to reduce the impurity precipitation, which is based on the principle that the flocculant and the colloid, protein, tannin and other particles in the traditional Chinese medicine extract generate intermolecular adsorption bridging and electric neutralization to form floccules and enable the floccules to be precipitated, and then the impurity precipitation is removed through solid-liquid separation. Compared with the traditional water extraction and alcohol precipitation method, the flocculation technology adopted by the invention for reducing the impurity precipitation of the oral liquid for clearing heat and relieving cough for children has the advantages of simple operation process, short production period, low production cost, good impurity removal effect, no influence on effective components and the like.
Furthermore, a large number of groping tests prove that the chitosan 1% acetic acid solution, the 101 fruit juice clarifying agent and the ZTC1+1 natural clarifying agent have good effects of removing impurities and precipitating when being applied to the children heat-clearing cough-relieving oral liquid, can retain effective components in the oral liquid and keep the stability of the oral liquid. However, the clarity of the oral liquid treated by the flocculant still cannot achieve the effect of clarification and brightness, and the inventor continuously researches and explores to change the addition amount of the flocculant, the treatment time and the compound use mode, but the total effect is not changed greatly.
In a groping test that a chitosan 1% acetic acid solution is mixed with a ZTC1+1 natural clarifying agent for use, the inventor firstly adds the chitosan 1% acetic acid solution, then mistakenly adds the component A of the ZTC1+1 natural clarifying agent as the component B, and finally adds the component B of the ZTC1+1 natural clarifying agent, and finds that the clarifying effect is better. The theory is presumed to be: the added chitosan 1% acetic acid solution can adsorb colloid, protein and tannin in the traditional Chinese medicine extracting solution, the added A component with opposite charges to the B component of the ZTC1+1 natural clarifying agent can promote the adsorption effect of the chitosan 1% acetic acid solution on the colloid, the protein and the tannin, meanwhile, when the B component of the ZTC1+1 natural clarifying agent is added, the removal effect of impurities in the traditional Chinese medicine extracting solution can be further improved, the added A component can better assist the adsorption effect of the B component, so that the better adsorption effect is achieved, the clarity of the oral liquid is improved, and the stability of the oral liquid can be better maintained.
In addition, the processing time of the three components has a large influence on the impurity removal effect, the chitosan 1% acetic acid solution is firstly added, standing is carried out for 4-8 min, then the component A in the natural clarifying agent ZTC1+1 is added, standing is carried out for 2-4 min, finally the component B in the natural clarifying agent ZTC1+1 is added, standing is carried out for 4-8 min, the impurity removal effect is optimal, and overlong or overlong processing time has a large influence on the impurity removal effect.
The content of starch in the plant medicinal materials is rich, the starch is easy to gelatinize at too high temperature, the impurity removal effect of the flocculating agent is influenced, the inventor further finds that the gelatinization of the starch can be effectively prevented by putting the medicinal materials into purified water at 65-70 ℃ and extracting under the pressure of 0.8-1.0 MPa, and the content of ephedrine hydrochloride effective components in the oral liquid for clearing heat and relieving cough for children can be improved, so that the drug effect of the oral liquid is improved.
Compared with the prior art, the preparation method of the oral liquid for clearing heat and relieving cough for children provided by the invention has the following advantages:
(1) the preparation method of the oral liquid for clearing heat and relieving cough for children provided by the invention has the advantages that the impurity removal effect is good, the effective components in the oral liquid can be well reserved, and the product stability is better;
(2) the preparation method of the oral liquid for clearing heat and relieving cough for children provided by the invention has the advantages of simple operation process, short production period and low production cost, and is suitable for large-scale industrial production.
The specific implementation mode is as follows:
the present invention is further described in the following description of the specific embodiments, which is not intended to limit the invention, but various modifications and improvements can be made by those skilled in the art according to the basic idea of the invention, within the scope of the invention, as long as they do not depart from the basic idea of the invention.
Example 1 preparation of an oral liquid for clearing heat and relieving cough in children
The oral liquid for clearing heat and relieving cough for children comprises the following components in parts by weight: 45 parts of ephedra, 60 parts of fried bitter almond, 135 parts of gypsum, 45 parts of liquorice, 90 parts of scutellaria baicalensis, 90 parts of isatis root, 45 parts of asiatic moonseed rhizome, 100 parts of honey and 1.5 parts of sodium benzoate;
the preparation method of the oral liquid for clearing heat and relieving cough for children comprises the following steps:
s1 adding herba Ephedrae and Gypsum Fibrosum into purified water with an amount of 6 times of the total weight of herba Ephedrae and Gypsum Fibrosum, boiling and extracting for 100min, filtering to obtain filtrate I, and collecting the residue;
s2, adding purified water into the filter residue filtered in the step S1, boiling and extracting for 50min, wherein the addition amount of the purified water is 6 times of the total weight of the filter residue, filtering, taking filtrate to obtain filtrate II, combining the filtrate I and the filtrate II obtained in the step S1, and concentrating to obtain concentrated solution;
s3, stirring the concentrated solution obtained in the step S2 at the stirring speed of 45r/min, adding a ZTC1+1 natural clarifying agent, wherein the adding amount of the ZTC1+1 natural clarifying agent is 10% of the volume of the concentrated solution, the treatment time is 20min, the component A in the ZTC1+1 natural clarifying agent is prepared into a 1% (W/W) gel solution by deionized water, the component B is prepared into a 1% (W/W) gel solution by 1% (W/W) acetic acid, when the natural clarifying agent is added, the component B in the ZTC1+1 natural clarifying agent is added, the component A in the ZTC1+1 natural clarifying agent is added, stirring and standing for 24h, and filtering to obtain a filtrate III;
s4 adding honey and sodium benzoate into the filtrate III obtained in the step S3, stirring and dissolving, fixing the volume, filling and sterilizing to obtain the traditional Chinese medicine.
Example 2 preparation of an oral liquid for clearing heat and relieving cough in children
The oral liquid for clearing heat and relieving cough for children comprises the following components in parts by weight: 45 parts of ephedra, 60 parts of fried bitter almond, 135 parts of gypsum, 45 parts of liquorice, 90 parts of scutellaria baicalensis, 90 parts of isatis root, 45 parts of asiatic moonseed rhizome, 100 parts of honey and 1.5 parts of sodium benzoate;
the preparation method of the oral liquid for clearing heat and relieving cough for children comprises the following steps:
s1 adding herba Ephedrae and Gypsum Fibrosum into purified water, boiling and extracting for 30min, wherein the addition amount of the purified water is 8 times of the total weight of herba Ephedrae and Gypsum Fibrosum, adding rhizoma Menispermi, radix Isatidis, Scutellariae radix, Glycyrrhrizae radix, and parched semen Armeniacae amarum, boiling and extracting for 120min, filtering, collecting filtrate to obtain filtrate I, and filtering residue;
s2, adding purified water into the filter residue filtered in the step S1, boiling and extracting for 60min, wherein the addition amount of the purified water is 8 times of the total weight of the filter residue, filtering, taking filtrate to obtain filtrate II, combining the filtrate I and the filtrate II obtained in the step S1, and concentrating to obtain concentrated solution;
s3, stirring the concentrated solution obtained in the step S2 at the stirring speed of 50r/min, adding a 1% chitosan acetic acid solution, wherein the addition amount of the 1% chitosan acetic acid solution is 10% of the volume of the concentrated solution, the treatment time is 20min, and the 1% chitosan acetic acid solution is a uniform colloidal solution prepared by preparing chitosan into 2% (W/W) by using 1% (W/W) acetic acid; stirring, standing for 24h, and filtering to obtain filtrate III;
s4 adding honey and sodium benzoate into the filtrate III obtained in the step S3, stirring and dissolving, fixing the volume, filling and sterilizing to obtain the traditional Chinese medicine.
Example 3 preparation of an oral liquid for clearing heat and relieving cough in children
The oral liquid for clearing heat and relieving cough for children comprises the following components in parts by weight: 45 parts of ephedra, 60 parts of fried bitter almond, 135 parts of gypsum, 45 parts of liquorice, 90 parts of scutellaria baicalensis, 90 parts of isatis root, 45 parts of asiatic moonseed rhizome, 100 parts of honey and 1.5 parts of sodium benzoate;
the preparation method of the oral liquid for clearing heat and relieving cough for children comprises the following steps:
s1 adding herba Ephedrae and Gypsum Fibrosum into purified water with an amount 10 times of the total weight of herba Ephedrae and Gypsum Fibrosum, boiling and extracting for 150min, filtering to obtain filtrate I, and collecting the residue;
s2, adding the filter residue filtered in the step S1 into purified water, boiling and extracting for 80min, wherein the addition amount of the purified water is 10 times of the total weight of the filter residue, filtering, taking filtrate to obtain filtrate II, combining the filtrate I and the filtrate II obtained in the step S1, and concentrating to obtain concentrated solution;
s3, stirring the concentrated solution obtained in the step S2 at the stirring speed of 55r/min, adding 101 fruit juice clarifying agent, wherein the addition amount of the 101 fruit juice clarifying agent is 15% of the volume of the concentrated solution, the treatment time is 10min, the 101 fruit juice clarifying agent is prepared into a 5% (W/W) aqueous solution by deionized water, stirring, standing for 24h, and filtering to obtain filtrate III;
s4 adding honey and sodium benzoate into the filtrate III obtained in the step S3, stirring and dissolving, fixing the volume, filling and sterilizing to obtain the traditional Chinese medicine.
Example 4 preparation of an oral liquid for clearing heat and relieving cough in children
The difference from example 2 is that: the flocculant in the step S3 is composed of a chitosan 1% acetic acid solution and a ZTC1+1 natural clarifying agent according to the volume ratio of 1:1, the B component in the chitosan 1% acetic acid solution and the ZTC1+1 natural clarifying agent is added firstly, the A component in the ZTC1+1 natural clarifying agent is added subsequently, and the rest steps are as in example 2.
Example 5 preparation of an oral liquid for clearing heat and relieving cough in children
The difference from example 2 is that: the flocculant in step S3 was a 1% acetic acid solution of chitosan and 101 juice clarifier at a volume ratio of 1:1, and the rest of the procedure was as in example 2.
Example 6 preparation of an oral liquid for clearing heat and relieving cough in children
The oral liquid for clearing heat and relieving cough for children comprises the following components in parts by weight: 45 parts of ephedra, 60 parts of fried bitter almond, 135 parts of gypsum, 45 parts of liquorice, 90 parts of scutellaria baicalensis, 90 parts of isatis root, 45 parts of asiatic moonseed rhizome, 100 parts of honey and 1.5 parts of sodium benzoate;
the preparation method of the oral liquid for clearing heat and relieving cough for children comprises the following steps:
s1 extracting herba Ephedrae and Gypsum Fibrosum with purified water at 68 deg.C under 0.9MPa for 30min, wherein the amount of the purified water is 8 times of the total weight of herba Ephedrae and Gypsum Fibrosum, adding purified water at 68 deg.C under 0.9MPa, extracting for 120min, filtering, and collecting filtrate I;
s2, putting the filter residue filtered in the step S1 into purified water at the temperature of 68 ℃, extracting for 60min under the pressure of 0.9MPa, wherein the addition amount of the purified water is 8 times of the total weight of the filter residue, filtering, taking filtrate to obtain filtrate II, combining the filtrate I and the filtrate II obtained in the step S1, and concentrating to obtain concentrated solution;
s3, stirring the concentrated solution obtained in the step S2 at the stirring speed of 50r/min, adding a 1% chitosan acetic acid solution, wherein the addition amount of the 1% chitosan acetic acid solution is 10% of the volume of the concentrated solution, the treatment time is 20min, and the 1% chitosan acetic acid solution is a uniform colloidal solution prepared by preparing chitosan into 2% (W/W) by using 1% (W/W) acetic acid; stirring, standing for 24h, and filtering to obtain filtrate III;
s4 adding honey and sodium benzoate into the filtrate III obtained in the step S3, stirring and dissolving, fixing the volume, filling and sterilizing to obtain the traditional Chinese medicine.
Example 7 preparation of an oral liquid for clearing heat and relieving cough in children
The difference from example 6 is that: the flocculating agent in the step S3 is composed of a chitosan 1% acetic acid solution and a ZTC1+1 natural clarifying agent according to the volume ratio of 4:5, the chitosan 1% acetic acid solution is added firstly, the mixture is kept stand for 4min, then the component A in the ZTC1+1 natural clarifying agent is added, the mixture is kept stand for 2min, finally the component B in the ZTC1+1 natural clarifying agent is added, the mixture is kept stand for 4min, and the rest steps are as in the example 6.
Example 8 preparation of an oral liquid for clearing away heat and relieving cough in children
The difference from example 6 is that: the flocculating agent in the step S3 is composed of a chitosan 1% acetic acid solution and a ZTC1+1 natural clarifying agent according to the volume ratio of 5:4, the chitosan 1% acetic acid solution is added firstly, the mixture is kept stand for 6min, then the component A in the ZTC1+1 natural clarifying agent is added, the mixture is kept stand for 3min, finally the component B in the ZTC1+1 natural clarifying agent is added, the mixture is kept stand for 6min, and the rest steps are as in the example 6.
Example 9 preparation of an oral liquid for clearing away heat and relieving cough in children
The difference from example 6 is that: the flocculating agent in the step S3 is composed of a chitosan 1% acetic acid solution and a ZTC1+1 natural clarifying agent according to the volume ratio of 6:3, the chitosan 1% acetic acid solution is added firstly, the mixture is kept stand for 8min, then the component A in the ZTC1+1 natural clarifying agent is added, the mixture is kept stand for 4min, finally the component B in the ZTC1+1 natural clarifying agent is added, the mixture is kept stand for 8min, and the rest steps are as in the example 6.
Comparative example 1 preparation of an oral liquid for clearing heat and relieving cough in children
The difference from example 1 is that: the flocculant in step S3 was gelatin, and the rest of the procedure was as in example 1.
Comparative example 2 preparation of an oral liquid for clearing heat and relieving cough in children
The difference from example 1 is that: and (3) adding the flocculant ZTC1+1 natural clarifying agent in the step S3 into the component A in the ZTC1+1 natural clarifying agent, then adding the component B in the ZTC1+1 natural clarifying agent, stirring, standing for 24 hours, and filtering to obtain filtrate III, wherein the rest steps are as in example 1.
Comparative example 3 preparation of an oral liquid for clearing heat and relieving cough in children
The difference from example 8 is that: the flocculating agent in the step S3 is formed by a flocculating agent of chitosan 1% acetic acid solution and ZTC1+1 natural clarifying agent according to the volume ratio of 1:1, the chitosan 1% acetic acid solution is firstly added, the mixture is kept stand for 6min, then the component A in the ZTC1+1 natural clarifying agent is added, the mixture is kept stand for 3min, finally the component B in the ZTC1+1 natural clarifying agent is added, the mixture is kept stand for 6min, and the rest steps are as in the example 8.
Comparative example 4 preparation of an oral liquid for clearing heat and relieving cough in children
The difference from example 8 is that: the flocculating agent in the step S3 is composed of a chitosan 1% acetic acid solution and a ZTC1+1 natural clarifying agent according to the volume ratio of 5:4, the chitosan 1% acetic acid solution is added firstly, the mixture is kept stand for 6min, then the component A in the ZTC1+1 natural clarifying agent is added, the mixture is kept stand for 6min, finally the component B in the ZTC1+1 natural clarifying agent is added, the mixture is kept stand for 6min, and the rest steps are as in the example 8.
Comparative example 5 preparation of an oral liquid for clearing heat and relieving cough in children
The difference from example 8 is that: the flocculating agent in the step S3 is composed of chitosan 1% acetic acid solution and ZTC1+1 natural clarifying agent according to the volume ratio of 5:4, the component A in the ZTC1+1 natural clarifying agent is firstly added, the mixture is kept stand for 3min, the component B in the ZTC1+1 natural clarifying agent is then added, the mixture is kept stand for 6min, finally, the chitosan 1% acetic acid solution is added, the mixture is kept stand for 6min, and the rest steps are as in the example 8.
Comparative example 6 preparation of an oral liquid for clearing heat and relieving cough in children
The difference from example 8 is that: the flocculating agent in the step S3 is composed of chitosan 1% acetic acid solution and ZTC1+1 natural clarifying agent according to the volume ratio of 5:4, the component B in the ZTC1+1 natural clarifying agent is firstly added, the mixture is kept stand for 6min, the component A in the ZTC1+1 natural clarifying agent is then added, the mixture is kept stand for 3min, finally, the chitosan 1% acetic acid solution is added, the mixture is kept stand for 6min, and the rest steps are as in the example 8.
Test example I, quality detection test of oral liquid for clearing heat and relieving cough in children
1. Test materials:
the oral liquid for clearing away heat and relieving cough for children prepared in example 1, example 2, example 3, example 4, example 5, example 6, example 7, example 8, example 9, comparative example 1, comparative example 2, comparative example 3, comparative example 4, comparative example 5 and comparative example 6.
2. The test method comprises the following steps:
the oral liquid for clearing away heat and relieving cough for children prepared in example 1, example 2, example 3, example 4, example 5, example 6, example 7, example 8, example 9, comparative example 1, comparative example 2, comparative example 3, comparative example 4, comparative example 5 and comparative example 6 is subjected to clarity and ephedrine hydrochloride content measurement. Wherein:
2.1, the clarity is measured by a turbidimeter.
2.2, the determination method of the ephedrine hydrochloride content comprises the following steps:
precisely measuring 5mL of the product, adding 10mL of water and 0.5mL of concentrated ammonia water, shaking and extracting with diethyl ether for 5 times (30mL, 30mL, 20mL, 20mL and 20mL), combining the diethyl ether solution, adding 2mL of hydrochloric acid ethanol solution (1-20), mixing, recovering solvent at low temperature until the solution is dry, dissolving the residue with 5mL of ethanol, transferring to a 25mL measuring flask, adding 0.1mol/L of hydrochloric acid solution to scale, and shaking up to obtain the product. Taking a proper amount of ephedrine hydrochloride reference substance, precisely weighing, and adding 0.1mol/L hydrochloric acid solution to obtain 45 μ g/ml reference substance solution. Precisely sucking 10 μ l of each of the reference solution and the sample solution, injecting into a liquid chromatograph, and using octadecylsilane chemically bonded silica as filler; the measurement was carried out using acetonitrile-water-phosphoric acid (4.5:95:0.5) as a mobile phase.
3. And (3) test results:
the test results are shown in table 1.
TABLE 1 quality test results of oral liquid for clearing heat and relieving cough for children
| Clarity (NTU) | Ephedrine hydrochloride content (mg/ml) | |
| Example 1 | 30.8 | 0.22 |
| Example 2 | 20.2 | 0.27 |
| Example 3 | 25.5 | 0.26 |
| Example 4 | 19.4 | 0.28 |
| Example 5 | 17.5 | 0.30 |
| Example 6 | 18.2 | 0.29 |
| Example 7 | 5.0 | 0.32 |
| Example 8 | 3.4 | 0.36 |
| Example 9 | 5.4 | 0.30 |
| Comparative example 1 | ＞100 | 0.10 |
| Comparative example 2 | 40.3 | 0.20 |
| Comparative example 3 | 9.8 | 0.29 |
| Comparative example 4 | 8.6 | 0.31 |
| Comparative example 5 | 16.4 | 0.30 |
| Comparative example 6 | 10.7 | 0.31 |
As can be seen from table 1, the oral liquid for clearing heat and relieving cough for children prepared by the preparation method of the oral liquid for clearing heat and relieving cough provided by the invention has high clarity, can reach the clarity and transparency degree, is less than 30.8NTU, and has high ephedrine hydrochloride content, which indicates that the oral liquid for clearing heat and relieving cough for children treated by the flocculant provided by the invention can better retain the effective components in the oral liquid for clearing heat and relieving cough for children, so that the oral liquid for clearing heat and relieving cough for children has better stability, can also shorten the production process, and reduce the production cost, and is a more ideal preparation method of the oral liquid for clearing heat and relieving cough for children.
Test example two, stability test of heat-clearing cough-relieving oral liquid for children
1. Test materials:
the pediatric oral solutions for clearing heat and relieving cough prepared in example 1, example 2, example 4 and example 8.
2. The test method comprises the following steps:
referring to the test method of appendix XIXC of the second part of the year 2015 edition, the oral liquid for clearing away heat and relieving cough for children prepared in example 1, example 2, example 4 and example 8 is tested for a long time at the temperature of 25 ℃ +/-2 ℃ and the relative humidity of 60% +/-10%, and the clarity and ephedrine hydrochloride content of the oral liquid are determined.
Wherein:
2.1, the clarity is measured by a turbidimeter.
2.2, the determination method of the ephedrine hydrochloride content comprises the following steps:
precisely measuring 5mL of the product, adding 10mL of water and 0.5mL of concentrated ammonia water, shaking and extracting with diethyl ether for 5 times (30mL, 30mL, 20mL, 20mL and 20mL), combining the diethyl ether solution, adding 2mL of hydrochloric acid ethanol solution (1-20), mixing, recovering solvent at low temperature until the solution is dry, dissolving the residue with 5mL of ethanol, transferring to a 25mL measuring flask, adding 0.1mol/L of hydrochloric acid solution to scale, and shaking up to obtain the product. Taking a proper amount of ephedrine hydrochloride reference substance, precisely weighing, and adding 0.1mol/L hydrochloric acid solution to obtain 45 μ g/ml reference substance solution. Precisely sucking 10 μ l of each of the reference solution and the sample solution, injecting into a liquid chromatograph, and using octadecylsilane chemically bonded silica as filler; the measurement was carried out using acetonitrile-water-phosphoric acid (4.5:95:0.5) as a mobile phase.
3. And (3) test results:
the test results are shown in table 2.
TABLE 2 stability test of oral liquid for clearing away heat and relieving cough for children
As can be seen from table 2, the clarity and ephedrine hydrochloride content of the oral liquid for clearing heat and relieving cough of children prepared by the method for preparing the oral liquid for clearing heat and relieving cough of children provided by the invention are not changed greatly under the conditions of the temperature of 25 ℃ ± 2 ℃ and the relative humidity of 60% ± 10%, which indicates that the oral liquid for clearing heat and relieving cough of children prepared by the invention has higher stability within 12 months, while the oral liquid for clearing heat and relieving cough of children prepared by the best embodiment 8 can keep the clarity and ephedrine hydrochloride content of the oral liquid unchanged basically within 18 months, and can effectively prolong the shelf life of the oral liquid.
Claims (6)
1. The preparation method of the oral liquid for clearing heat and relieving cough for children is characterized in that the oral liquid for clearing heat and relieving cough for children is prepared from the following raw materials in parts by weight: 45 parts of ephedra, 60 parts of fried bitter almond, 135 parts of gypsum, 45 parts of liquorice, 90 parts of scutellaria baicalensis, 90 parts of isatis root, 45 parts of asiatic moonseed rhizome, 100 parts of honey and 1.5 parts of sodium benzoate;
the preparation method of the oral liquid for clearing heat and relieving cough for children comprises the following steps:
s1 adding herba Ephedrae and Gypsum Fibrosum into purified water, boiling and extracting for 25-35 min, wherein the addition amount of the purified water is 6-10 times of the total weight of herba Ephedrae and Gypsum Fibrosum, adding rhizoma Menispermi, radix Isatidis, Scutellariae radix, Glycyrrhrizae radix, and parched semen Armeniacae amarum, boiling and extracting for 100-150 min, filtering, collecting filtrate to obtain filtrate I, and filtering residue for use;
s2, adding purified water into the filter residue filtered in the step S1, boiling and extracting for 50-80 min, wherein the adding amount of the purified water is 6-10 times of the total weight of the filter residue, filtering, taking filtrate to obtain filtrate II, combining the filtrate I and the filtrate II obtained in the step S1, and concentrating to obtain concentrated solution;
s3, stirring the concentrated solution obtained in the step S2 at the stirring speed of 45-55 r/min, adding a flocculating agent, stirring, standing for 24 hours, and filtering to obtain a filtrate III;
s4, adding honey and sodium benzoate into the filtrate III obtained in the step S3, stirring and dissolving, fixing the volume, filling and sterilizing to obtain the product;
the flocculating agent in the step S3 is a chitosan 1% acetic acid solution and a ZTC1+1 natural clarifying agent; the chitosan 1% acetic acid solution is a uniform colloidal solution prepared by preparing chitosan into 2% (W/W) with 1% (W/W) acetic acid; in the ZTC1+1 natural clarifying agent, a component A is prepared into a 1% (W/W) gel solution by using deionized water, and a component B is prepared into a 1% (W/W) gel solution by using 1% (W/W) acetic acid;
the flocculating agent in the step S3 is composed of a chitosan 1% acetic acid solution and a ZTC1+1 natural clarifying agent according to the volume ratio of (4-6) to (3-5);
the addition mode of the flocculant is as follows: adding a 1% acetic acid solution of chitosan, standing for 4-8 min, adding the component A in the natural clarifying agent ZTC1+1, standing for 2-4 min, adding the component B in the natural clarifying agent ZTC1+1, and standing for 4-8 min.
2. The method for preparing an oral liquid for clearing away heat and relieving cough in children according to claim 1, wherein in step S1, the ephedra herb and the gypsum are put into purified water at a temperature of 65 to 70 ℃ and extracted under a pressure of 0.8 to 1.0MPa for 25 to 35min, the amount of the purified water is 6 to 10 times of the total weight of the ephedra herb and the gypsum, then the asiatic moonseed rhizome, the indigowoad root, the baical skullcap root, the liquoric root and the fried bitter apricot seed are added into the purified water at a temperature of 65 to 70 ℃ and extracted under a pressure of 0.8 to 1.0MPa for 100 to 150min, and the filtrate is filtered to obtain the filtrate I.
3. The method for preparing an oral liquid for clearing heat and relieving cough for children according to claim 1, wherein in step S2, the filter residue filtered in step S1 is put into purified water at 65-70 ℃ and extracted under a pressure of 0.8-1.0 MPa for 50-80 min, the addition of the purified water is 6-10 times of the total weight of the filter residue, the filter residue is filtered, a filtrate is obtained to obtain a filtrate II, and the filtrate I and the filtrate II obtained in step S1 are combined and concentrated to obtain a concentrated solution.
4. The method for preparing an oral liquid for clearing away heat and relieving cough in children according to claim 1, wherein the flocculating agent is added in an amount of 5-15% by volume of the concentrated solution in step S3, and the treatment time is 10-30 min.
5. The method for preparing oral liquid for clearing away heat and relieving cough in children according to claim 1, wherein the flocculating agent in step S3 is chitosan 1% acetic acid solution and ZTC1+1 natural clarifying agent in a volume ratio of 5: 4.
6. The preparation method of the oral liquid for clearing heat and relieving cough for children according to claim 1, wherein the flocculating agent is added in a manner that: adding chitosan 1% acetic acid solution, standing for 6min, adding component A of ZTC1+1 natural clarifier, standing for 3min, adding component B of ZTC1+1 natural clarifier, and standing for 6 min.
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| CN111803547A (en) * | 2020-06-12 | 2020-10-23 | 浙江康恩贝制药股份有限公司 | Preparation process of heat-clearing cough-relieving oral liquid for children |
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