CN108524632B - Preparation process of concentrated oral liquid for treating infantile cough and asthma - Google Patents
Preparation process of concentrated oral liquid for treating infantile cough and asthma Download PDFInfo
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- A61K36/17—Gnetophyta, e.g. Ephedraceae (Mormon-tea family)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/19—Acanthaceae (Acanthus family)
- A61K36/195—Strobilanthes
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- A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
- A61K36/315—Isatis, e.g. Dyer's woad
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/35—Caprifoliaceae (Honeysuckle family)
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- 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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- A61K2236/30—Extraction of the material
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention relates to the technical field of preparation processes of Kechuanling oral liquid, in particular to a preparation process of a concentrated children Kechuanling oral liquid with an innovative specification. The preparation process of the innovative-specification concentrated oral liquid for treating infantile cough and asthma is simple, the specific flocculating agent is adopted to precipitate the solution, the subsequent filtering step is omitted, the production cost is saved, the quality of the oral liquid preparation is improved, and the loss of a large amount of effective components is avoided.
Description
Technical Field
The invention relates to the technical field of preparation processes of Kechuanling oral liquid, in particular to a preparation process of a concentrated children Kechuanling oral liquid with an innovative specification.
Background
The infantile cough and asthma belongs to a chronic airway inflammation disease, is an immunological inflammation, and is characterized in that the airway is reversibly narrowed and causes dyspnea, and the clinical manifestations of the cough and asthma are that the asthma is acute, cough, expectoration, dyspnea and audible wheeze in the lung, and particularly the wheeze is more obvious when the breath is exhaled.
The oral liquid for treating infantile cough and asthma is derived from the traditional famous prescription named 'Maxingshigan decoction', has the effects of dispersing lung qi, clearing heat, relieving cough, eliminating phlegm and relieving asthma, and is used for treating upper respiratory infection, tracheitis, pneumonia, cough and other symptoms of children. The prescription is composed of 7 traditional Chinese medicines of ephedra, honeysuckle, bitter apricot seed, isatis root, gypsum, liquorice, snakegourd fruit and the like, and the current production technology mainly adopts a water extraction and alcohol precipitation method. The technical extract of the oral liquid for treating infantile cough and asthma contains impurities such as tannin, protein and the like, wherein the tannin contains phenolic hydroxyl, is very easy to oxidize and is a strong reducing agent, and is easy to form hydrogen bonds with protein molecules, alkaloid and polysaccharide to generate water-insoluble precipitates, so that the medicinal liquid is turbid, and the quality stability of the oral liquid preparation is influenced; protein is also liable to cause the liquid medicine to go bad or precipitate, thereby affecting the quality and appearance of the liquid medicine.
The existing impurity removal technologists remove partial impurities such as protein and the like by an alcohol precipitation method, but have poor tannin removal effect. The method removes impurities and a large amount of high molecular compounds, so that a natural colloid stabilizing system of the water extract is damaged, the liquid medicine is easy to be turbid after being placed for a long time, and simultaneously, a large amount of loss of active ingredients, such as chlorogenic acid and polysaccharide, is caused.
For example, the preparation process of the oral liquid for treating cough and asthma of children disclosed in chinese patent CN101406543 adopts a water extraction method to extract a raw liquid medicine, and then the raw liquid medicine is filtered by a filter membrane to obtain the oral liquid.
Chinese patent CN104491059 discloses a concentrated oral liquid for treating infantile cough and asthma, which is prepared by extracting with water, precipitating with ethanol, and filtering with filter membrane.
The two methods can remove partial protein and other impurities, but can not effectively remove tannin, and meanwhile, a large amount of high molecular compounds are filtered by adopting a filtering membrane, so that a natural colloid stable system of the water extract is damaged, turbidity is easy to appear after long-term standing, and a large amount of loss of effective components is caused.
In addition, the existing oral liquid for treating infantile cough and asthma generally has the problems of low effective content, large dosage and unsatisfactory administration effect, and when children and old people with dysphagia take the oral liquid for treating infantile cough and asthma, a large amount of oral liquid for treating infantile cough and asthma is required to be taken.
Disclosure of Invention
The invention provides a preparation process of a concentrated infantile cough and asthma oral liquid with an innovative specification, which aims to solve the problems of low effective content, large dose and unsatisfactory administration effect of the infantile cough and asthma oral liquid in the prior art and the problem that a large amount of the infantile cough and asthma oral liquid needs to be administered to achieve curative effect when infants and old people with dysphagia take the infantile cough and asthma oral liquid. The oral liquid for treating infantile cough and asthma prepared by the preparation process can better exert the effects of freeing lung and clearing heat, relieving cough, eliminating phlegm and relieving asthma, is lower in dosage for taking with the same curative effect, and is suitable for infants and old people to take.
The invention aims to provide a preparation process of a concentrated infantile cough and asthma oral liquid with an innovative specification, which is characterized by comprising the following steps: the formula of the oral liquid for treating infantile cough and asthma is as follows: 25g of ephedra, 250g of honeysuckle, 125g of bitter apricot seed, 250g of isatis root, 375g of gypsum, 125g of liquorice and 125g of snakegourd fruit or a formula with the same proportion, and the preparation process comprises the following steps:
1) decocting semen Armeniacae amarum, Gypsum Fibrosum, radix Isatidis, Glycyrrhrizae radix, and fructus Trichosanthis with water, filtering to obtain residue, decocting the residue with herba Ephedrae and flos Lonicerae with water, filtering, and mixing filtrates;
2) standing the filtrate, taking supernatant, filtering with a ceramic membrane, adding a flocculating agent, stirring, standing until layering, collecting supernatant, and concentrating the supernatant into a fluid extract;
3) adding ethanol into the fluid extract, stirring, standing, refrigerating, collecting supernatant, filtering, recovering ethanol, concentrating to appropriate amount, adding stevioside and sodium benzoate, stirring, and filtering to obtain filtrate;
4) adding water into the filtrate, stirring, refrigerating, adding water, refrigerating, and collecting supernatant;
5) and 4) carrying out centrifugal separation on the supernatant obtained in the step 4) to obtain a clear solution, sterilizing, adding water, adding an alkaline solution to adjust the pH value, heating, and cooling to obtain the product.
Further, the filtering pressure in the step 2) is controlled to be 0.3-0.4MPa, and the temperature is controlled to be 30-35 ℃.
Further, the flocculant in the step 2) is chitosan.
Further, the addition amount of the chitosan is 0.5-0.65 g/L.
Further, the flocculating agent in the step 2) is L-aspartic acid and cationic starch.
Further, the cationic starch is starch tertiary amino alkyl ether.
Further, the total amount of the L-aspartic acid and the cationic starch is 0.3-0.4 g/L.
Further, the mass ratio of the L-aspartic acid to the cationic starch is 0.3-0.7: 1.
Furthermore, the adding sequence of the L-aspartic acid and the cationic starch is that the cationic starch is added first, and then the L-aspartic acid is added.
Further, the membrane aperture of the ceramic membrane in the step 2) is 180-220 nm.
Further, the amount of the water added twice in the step 4) is 0.1 time of the total weight of the raw material medicaments.
Further, the alkaline solution in the step 5) is one or two of a sodium hydroxide solution and a potassium hydroxide solution.
Further, the heating temperature in the step 5) is 60-70 ℃.
The inventive concentrated oral liquid for treating infantile cough and asthma is 1.25ml, 2.5ml, 3.75ml or 5ml per unit, and the sum of the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride is more than 2 times of the common specification; is brown liquid, has sweet taste and numb feeling; can be used for dispersing lung qi, clearing heat away, relieving cough, and eliminating phlegm, and can be used for treating cough caused by upper respiratory infection.
In the invention, amino and carboxyl of L-aspartic acid are easy to form small flocs with alkaline impurities and the like, can enhance flocculation of cationic starch, enhances bridging and net capturing among molecules, and shows good synergistic effect. Meanwhile, the adding proportion and the adding sequence of the L-aspartic acid and the cationic starch have important influence on the removal of impurities in the liquid medicine. In the research process, the inventor finds that good impurity removal effect can be achieved only when the mass ratio of the L-aspartic acid to the cationic starch is 0.3-0.7:1, and meanwhile, the impurity removal effect is reduced by changing the adding sequence of the L-aspartic acid and the cationic starch.
In the invention, the inventor adopts a method of adding water with the same amount twice in the step 4) and respectively refrigerating for treatment, so that related impurities can be further removed, and the clarity of the liquid medicine is improved.
The invention has the beneficial effects that:
1. compared with the existing concentrated oral liquid for treating infantile cough and asthma, the oral liquid for treating infantile cough and asthma provided by the invention has the advantages that the content of active ingredients is greatly improved, raw materials are saved, the cost is reduced, the dosage for achieving the same curative effect is reduced, the dosage is small, the oral liquid is easy to carry, and the oral liquid is suitable for old people and children who have difficulty in swallowing.
2. The preparation process of the innovative-specification concentrated oral liquid for treating infantile cough and asthma is simple, the specific flocculating agent is adopted to precipitate the solution, the subsequent filtering step is omitted, the production cost is saved, the quality of the oral liquid preparation is improved, and the loss of a large amount of effective components is avoided.
3. The method can effectively improve the removal rate of protein and tannin and improve the clarity of the liquid medicine. The ultrafiltration membrane adopted in the prior art removes a large amount of macromolecular compounds, destroys the natural colloid stable system of the water extract, is easy to generate turbidity after being placed for a long time, and simultaneously causes a large amount of loss of effective components. The invention does not destroy the natural colloid stable system of the water extract, does not generate turbidity after long-term storage, and has longer shelf life.
Detailed Description
Example 1
The formula of the oral liquid for treating infantile cough and asthma is as follows: 25g of ephedra, 250g of honeysuckle, 125g of bitter apricot seed, 250g of isatis root, 375g of gypsum, 125g of liquorice and 125g of snakegourd fruit, and the preparation process comprises the following steps:
decocting semen Armeniacae amarum, Gypsum Fibrosum, radix Isatidis, Glycyrrhrizae radix, and fructus Trichosanthis in water for 1 hr, and filtering; decocting the residue, herba Ephedrae and flos Lonicerae in water for 1 hr, filtering, and mixing filtrates; standing, collecting supernatant, filtering with ceramic membrane with membrane pore diameter of 180nm, controlling filtering pressure at 0.3-0.4MPa and temperature at 30-35 deg.C, adding chitosan according to concentration of 0.6g/L, stirring, standing for layering, collecting supernatant, and concentrating the supernatant into fluid extract; adding ethanol to make the ethanol account for 65% of the mass of the fluid extract ethanol solution, stirring, standing and refrigerating; taking the supernatant, filtering, recovering ethanol, concentrating to appropriate amount, adding stevioside 2g and sodium benzoate 3g, stirring well, and filtering to obtain filtrate; adding water 0.1 times the total weight of the raw materials into the filtrate, stirring, refrigerating for 24 hr, adding water 0.1 times the total weight of the raw materials, refrigerating for 24 hr, and collecting supernatant; and (3) carrying out centrifugal separation on the supernatant obtained in the step to obtain a clear solution, sterilizing, adding water to 1000ml, adding a sodium hydroxide solution with the mass fraction of 5% to adjust the pH value to 4.5, heating to 60 ℃, and cooling to obtain the traditional Chinese medicine.
Example 2
The formula of the oral liquid for treating infantile cough and asthma is as follows: 25g of ephedra, 250g of honeysuckle, 125g of bitter apricot seed, 250g of isatis root, 375g of gypsum, 125g of liquorice and 125g of snakegourd fruit, and the preparation process comprises the following steps:
decocting semen Armeniacae amarum, Gypsum Fibrosum, radix Isatidis, Glycyrrhrizae radix, and fructus Trichosanthis in water for 1 hr, and filtering; decocting the residue, herba Ephedrae and flos Lonicerae in water for 1 hr, filtering, and mixing filtrates; standing, collecting supernatant, filtering with ceramic membrane with membrane pore diameter of 220nm, controlling filtering pressure at 0.3-0.4MPa and temperature at 30-35 deg.C, adding L-aspartic acid and cationic starch (mass ratio of L-aspartic acid to cationic starch is 0.3: 1) according to concentration of 0.4g/L, adding cationic starch, stirring for 15 min, adding L-aspartic acid, stirring, standing for layering, collecting supernatant, and concentrating into fluid extract; adding ethanol to make the ethanol account for 65% of the mass of the fluid extract ethanol solution, stirring, standing and refrigerating; taking the supernatant, filtering, recovering ethanol, concentrating to appropriate amount, adding stevioside 2g and sodium benzoate 3g, stirring well, and filtering to obtain filtrate; adding water 0.1 times the total weight of the raw materials into the filtrate, stirring, refrigerating for 24 hr, adding water 0.1 times the total weight of the raw materials, refrigerating for 24 hr, and collecting supernatant; and (3) carrying out centrifugal separation on the supernatant obtained in the step to obtain a clear solution, sterilizing, adding water to 1000ml, adding a sodium hydroxide solution with the mass fraction of 5% to adjust the pH value to 4.5, heating to 70 ℃, and cooling to obtain the traditional Chinese medicine.
Example 3
The formula of the oral liquid for treating infantile cough and asthma is as follows: 25g of ephedra, 250g of honeysuckle, 125g of bitter apricot seed, 250g of isatis root, 375g of gypsum, 125g of liquorice and 125g of snakegourd fruit, and the preparation process comprises the following steps:
decocting semen Armeniacae amarum, Gypsum Fibrosum, radix Isatidis, Glycyrrhrizae radix, and fructus Trichosanthis in water for 1 hr, and filtering; decocting the residue, herba Ephedrae and flos Lonicerae in water for 1 hr, filtering, and mixing filtrates; standing, collecting supernatant, filtering with ceramic membrane with membrane pore diameter of 200nm, controlling filtering pressure at 0.3-0.4MPa and temperature at 30-35 deg.C, adding L-aspartic acid and cationic starch (mass ratio of L-aspartic acid to cationic starch is 0.6: 1) according to concentration of 0.3g/L, adding cationic starch, stirring for 15 min, adding L-aspartic acid, stirring, standing for layering, collecting supernatant, and concentrating into fluid extract; adding ethanol to make the ethanol account for 65% of the mass of the fluid extract ethanol solution, stirring, standing and refrigerating; taking the supernatant, filtering, recovering ethanol, concentrating to appropriate amount, adding stevioside 2g and sodium benzoate 3g, stirring well, and filtering to obtain filtrate; adding water 0.1 times the total weight of the raw materials into the filtrate, stirring, refrigerating for 24 hr, adding water 0.1 times the total weight of the raw materials, refrigerating for 24 hr, and collecting supernatant; and (3) carrying out centrifugal separation on the supernatant obtained in the step to obtain a clear solution, sterilizing, adding water to 1000ml, adding a sodium hydroxide solution with the mass fraction of 5% to adjust the pH value to 4.5, heating to 65 ℃, and cooling to obtain the traditional Chinese medicine.
Comparative example 1
The formula of the oral liquid for treating infantile cough and asthma is as follows: 25g of ephedra, 250g of honeysuckle, 125g of bitter apricot seed, 250g of isatis root, 375g of gypsum, 125g of liquorice and 125g of snakegourd fruit, and the preparation process comprises the following steps:
decocting semen Armeniacae amarum, Gypsum Fibrosum, radix Isatidis, Glycyrrhrizae radix, and fructus Trichosanthis in water for 1 hr, and filtering; decocting the residue, herba Ephedrae and flos Lonicerae in water for 1 hr, filtering, and mixing filtrates; standing, collecting supernatant, filtering with ceramic membrane with membrane pore diameter of 200nm, filtering under 0.3-0.4MPa and 30-35 deg.C, adding L-aspartic acid at concentration of 0.3g/L, stirring, standing for layering, collecting supernatant, and concentrating to obtain fluid extract; adding ethanol to make the ethanol account for 65% of the mass of the fluid extract ethanol solution, stirring, standing and refrigerating; taking the supernatant, filtering, recovering ethanol, concentrating to appropriate amount, adding stevioside 2g and sodium benzoate 3g, stirring well, and filtering to obtain filtrate; adding water 0.1 times the total weight of the raw materials into the filtrate, stirring, refrigerating for 24 hr, adding water 0.1 times the total weight of the raw materials, refrigerating for 24 hr, and collecting supernatant; and (3) carrying out centrifugal separation on the supernatant obtained in the step to obtain a clear solution, sterilizing, adding water to 1000ml, adding a sodium hydroxide solution with the mass fraction of 5% to adjust the pH value to 4.5, heating to 65 ℃, and cooling to obtain the traditional Chinese medicine.
Comparative example 2
The formula of the oral liquid for treating infantile cough and asthma is as follows: 25g of ephedra, 250g of honeysuckle, 125g of bitter apricot seed, 250g of isatis root, 375g of gypsum, 125g of liquorice and 125g of snakegourd fruit, and the preparation process comprises the following steps:
decocting semen Armeniacae amarum, Gypsum Fibrosum, radix Isatidis, Glycyrrhrizae radix, and fructus Trichosanthis in water for 1 hr, and filtering; decocting the residue, herba Ephedrae and flos Lonicerae in water for 1 hr, filtering, and mixing filtrates; standing, collecting supernatant, filtering with ceramic membrane with membrane pore diameter of 200nm, controlling filtering pressure at 0.3-0.4MPa and temperature at 30-35 deg.C, adding cationic starch according to concentration of 0.3g/L, stirring, standing for layering, collecting supernatant, and concentrating into fluid extract; adding ethanol to make the ethanol account for 65% of the mass of the fluid extract ethanol solution, stirring, standing and refrigerating; taking the supernatant, filtering, recovering ethanol, concentrating to appropriate amount, adding stevioside 2g and sodium benzoate 3g, stirring well, and filtering to obtain filtrate; adding water 0.1 times the total weight of the raw materials into the filtrate, stirring, refrigerating for 24 hr, adding water 0.1 times the total weight of the raw materials, refrigerating for 24 hr, and collecting supernatant; and (3) carrying out centrifugal separation on the supernatant obtained in the step to obtain a clear solution, sterilizing, adding water to 1000ml, adding a sodium hydroxide solution with the mass fraction of 5% to adjust the pH value to 4.5, heating to 65 ℃, and cooling to obtain the traditional Chinese medicine.
Comparative example 3
The formula of the oral liquid for treating infantile cough and asthma is as follows: 25g of ephedra, 250g of honeysuckle, 125g of bitter apricot seed, 250g of isatis root, 375g of gypsum, 125g of liquorice and 125g of snakegourd fruit, and the preparation process comprises the following steps:
decocting semen Armeniacae amarum, Gypsum Fibrosum, radix Isatidis, Glycyrrhrizae radix, and fructus Trichosanthis in water for 1 hr, and filtering; decocting the residue, herba Ephedrae and flos Lonicerae in water for 1 hr, filtering, and mixing filtrates; standing, collecting supernatant, filtering with ceramic membrane with membrane pore diameter of 200nm, controlling filtering pressure at 0.3-0.4MPa and temperature at 30-35 deg.C, adding L-aspartic acid and cationic starch (mass ratio of L-aspartic acid to cationic starch is 2: 1) according to concentration of 0.3g/L, adding cationic starch, stirring for 15 min, adding L-aspartic acid, stirring, standing for layering, collecting supernatant, and concentrating into fluid extract; adding ethanol to make the ethanol account for 65% of the mass of the fluid extract ethanol solution, stirring, standing and refrigerating; taking the supernatant, filtering, recovering ethanol, concentrating to appropriate amount, adding stevioside 2g and sodium benzoate 3g, stirring well, and filtering to obtain filtrate; adding water 0.1 times the total weight of the raw materials into the filtrate, stirring, refrigerating for 24 hr, adding water 0.1 times the total weight of the raw materials, refrigerating for 24 hr, and collecting supernatant; and (3) carrying out centrifugal separation on the supernatant obtained in the step to obtain a clear solution, sterilizing, adding water to 1000ml, adding a sodium hydroxide solution with the mass fraction of 5% to adjust the pH value to 4.5, heating to 65 ℃, and cooling to obtain the traditional Chinese medicine.
Comparative example 4
The formula of the oral liquid for treating infantile cough and asthma is as follows: 25g of ephedra, 250g of honeysuckle, 125g of bitter apricot seed, 250g of isatis root, 375g of gypsum, 125g of liquorice and 125g of snakegourd fruit, and the preparation process comprises the following steps:
decocting semen Armeniacae amarum, Gypsum Fibrosum, radix Isatidis, Glycyrrhrizae radix, and fructus Trichosanthis in water for 1 hr, and filtering; decocting the residue, herba Ephedrae and flos Lonicerae in water for 1 hr, filtering, and mixing filtrates; standing, collecting supernatant, filtering with ceramic membrane with membrane pore diameter of 200nm, controlling filtering pressure at 0.3-0.4MPa and temperature at 30-35 deg.C, adding L-aspartic acid and cationic starch (mass ratio of L-aspartic acid to cationic starch is 0.6: 1) at 0.3g/L, adding L-aspartic acid, stirring for 15 min, adding cationic starch, stirring, standing for layering, collecting supernatant, and concentrating into fluid extract; adding ethanol to make the ethanol account for 65% of the mass of the fluid extract ethanol solution, stirring, standing and refrigerating; taking the supernatant, filtering, recovering ethanol, concentrating to appropriate amount, adding stevioside 2g and sodium benzoate 3g, stirring well, and filtering to obtain filtrate; adding water 0.1 times the total weight of the raw materials into the filtrate, stirring, refrigerating for 24 hr, adding water 0.1 times the total weight of the raw materials, refrigerating for 24 hr, and collecting supernatant; and (3) carrying out centrifugal separation on the supernatant obtained in the step to obtain a clear solution, sterilizing, adding water to 1000ml, adding a sodium hydroxide solution with the mass fraction of 5% to adjust the pH value to 4.5, heating to 65 ℃, and cooling to obtain the traditional Chinese medicine.
Comparative example 5
The formula of the oral liquid for treating infantile cough and asthma is as follows: 25g of ephedra, 250g of honeysuckle, 125g of bitter apricot seed, 250g of isatis root, 375g of gypsum, 125g of liquorice and 125g of snakegourd fruit, and the preparation process comprises the following steps:
decocting semen Armeniacae amarum, Gypsum Fibrosum, radix Isatidis, Glycyrrhrizae radix, and fructus Trichosanthis in water for 1 hr, and filtering; decocting the residue, herba Ephedrae and flos Lonicerae in water for 1 hr, filtering, and mixing filtrates; standing, collecting supernatant, filtering with ceramic membrane with membrane pore diameter of 200nm, controlling filtering pressure at 0.3-0.4MPa and temperature at 30-35 deg.C, adding L-aspartic acid and cationic starch (mass ratio of L-aspartic acid to cationic starch is 0.6: 1) according to concentration of 0.3g/L, adding cationic starch, stirring for 15 min, adding L-aspartic acid, stirring, standing for layering, collecting supernatant, and concentrating into fluid extract; adding ethanol to make the ethanol account for 65% of the mass of the fluid extract ethanol solution, stirring, standing and refrigerating; taking the supernatant, filtering, recovering ethanol, concentrating to appropriate amount, adding stevioside 2g and sodium benzoate 3g, stirring well, and filtering to obtain filtrate; adding water 0.2 times the total weight of the raw materials into the filtrate, stirring, refrigerating for 48 hr, and collecting supernatant; and (3) carrying out centrifugal separation on the supernatant obtained in the step to obtain a clear solution, sterilizing, adding water to 1000ml, adding a sodium hydroxide solution with the mass fraction of 5% to adjust the pH value to 4.5, heating to 65 ℃, and cooling to obtain the traditional Chinese medicine.
Compared with the common oral liquid for treating infantile cough and asthma, the invention has the following characteristics:
TABLE 1
| Common oral liquid for children cough and asthma | The invention relates to a cough and asthma oral liquid for children | |
| Traits | Brown yellow liquid, sweet taste and numb feeling | Brown liquid, sweet taste and numb feeling |
| Of ephedrine hydrochloride and pseudoephedrine hydrochloride Sum of contents | About 2 times or more of the common type | |
| Specification of | Each 10ml, each box contains 10 pieces | Each 1.25ml, 2.5ml, 3.75ml or 5ml, each box has 10 pieces |
| Using and using amount | Orally administered once within 2 years old by 5ml, once within 3-4 years old by 7.5ml, and once within 5-7 years old by 5-7 years old 10ml, 3-4 times a day | Orally administered at a dose of 2.5ml for 2 years, 3.75ml for 3-4 years, 5-7 years 5ml each time, 3-4 times a day |
Major pharmacodynamic studies
Test drug
Common oral liquid for cough and asthma of children: prepared according to the method carried in volume 4 of the Chinese medicinal Standard Chinese medicinal prescription preparation of Ministry of public health of the people's republic of China.
Concentrated oral liquid for cough and asthma of children 1: the preparation was carried out according to the method described in CN 104491059A.
Concentrated oral liquid for cough and asthma of children 2: prepared according to the method of the invention example 3.
Experimental methods and results:
1. cough-relieving experiment: 48 Kunming mice are selected, male and female are half of each other, and are randomly divided into 4 groups, namely a control group, a common infantile cough and asthma oral liquid group, a concentrated infantile cough and asthma oral liquid group 1 group and a concentrated infantile cough and asthma oral liquid group 2 group, wherein each group comprises 12 mice. Each administration group was administered with 20ml/kg by intragastric administration, and the control group was administered with an equal volume of distilled water 1 time per day for 3 consecutive days. 1h after the last dose, the mice were placed in a spray device to begin receiving spray, the cough latency of the mice was recorded, and the cough rate was calculated: cough rate% = (cough reaction time in administration group/cough reaction time in control group) × 100%
As a result, compared with the conventional oral liquid for treating infantile cough and asthma and the concentrated oral liquid for treating infantile cough and asthma 1, the cough incubation period of mice in the concentrated oral liquid for treating infantile cough and asthma 2 is significantly longer, and the cough rate is also significantly increased, and compared with the control group, the conventional oral liquid for treating infantile cough and asthma and the concentrated oral liquid for treating infantile cough and asthma 1, P in the concentrated oral liquid for treating infantile cough and asthma 2 is less than 0.01. The results are shown in Table 2.
TABLE 2
| Group of | Dosage g/crude drug/kg | Cough latency s | The cough relieving rate is% |
| Control group | - | 18.76±4.68 | - |
| Oral liquid for treating infantile cough and asthma | 5.6 | 35.76±15.12 | 192.54 |
| Concentrated oral liquid 1 for treating infantile cough and asthma | 5.6 | 42.45±16.52 | 230.01 |
| Concentrated oral liquid for treating infantile cough and asthma 2 groups | 5.6 | 54.24±14.76 | 256.43 |
2. Phlegm reduction experiment: a capillary glass tube method comprises dividing WISTER rat into 4 groups, including control group, common oral liquid for treating infantile cough and asthma, concentrated oral liquid for treating infantile cough and asthma 1 group, and concentrated oral liquid for treating infantile cough and asthma 2 groups. Before each group of experiments, the patient is fasted for 12 hours, lidocaine is anesthetized by intraperitoneal injection of 1g/kg, the patient is fixed in a supine position, the skin in the middle of the neck is cut, the air outlet pipe is separated, a small hole is pricked between two cartilages in the middle of the lower edge of the thyroid cartilage through a sharp injection needle, and then a glass capillary tube with the inner diameter of 0.8cm is inserted, so that the capillary tube just contacts the surface of the bottom of the trachea to absorb sputum at the rear part of the trachea, and the length of the sputum absorbed by the capillary tube is used as the phlegm. After recording the normal secretion amount 1h before administration, each administration group was gavaged with 10ml/kg according to the dose, the control group was given distilled water of the same volume, and the sputum secretion amount of each group of rats administered 1h was recorded. The results are shown in Table 3.
TABLE 3
| Group of | Dosage g/crude drug/kg | Normal secretion of sputum cm | Secretion of sputum after administration is cm |
| Control group | - | 2.14±0.87 | 2.43±0.21 |
| Oral liquid for treating infantile cough and asthma | 5.6 | 2.16±0.23 | 3.31±0.15 |
| Concentrated oral liquid 1 for treating infantile cough and asthma | 5.6 | 2.16±0.31 | 3.85±0.18 |
| Concentrated oral liquid for treating infantile cough and asthma 2 groups | 5.6 | 2.15±0.24 | 4.68±0.23 |
3. Asthma test: a spray-induced asthma method comprises selecting 40 guinea pigs, half male and half female, and randomly dividing into 4 groups, which are control group, common oral liquid for treating infantile cough and asthma, concentrated oral liquid for treating infantile cough and asthma 1 group, and concentrated oral liquid for treating infantile cough and asthma 2 group. Each administration group was administered with 10ml/kg of the drug according to the dose and the control group was administered with distilled water of the same volume 1 time a day for 3 consecutive days. 1h after the last administration, the guinea pigs were placed in the apparatus box one by one, the WH-96 ultrasonic atomizer was started, histamine phosphate of 1mg/ml was sprayed, and at the same time, timing was started, the time from the start of spraying to the twitch of the guinea pigs was recorded as the asthma latency, and the asthma suppression rate was calculated. Compared with the control group, the results of the concentrated oral liquid for treating infantile cough and asthma are obviously prolonged in 2 groups, wherein P is less than 0.05 and P is less than 0.01. Compared with the concentrated oral liquid 1 group, the concentrated oral liquid for treating infantile cough and asthma is also obviously prolonged, and P is less than 0.05. The results are shown in the following table.
TABLE 4
| Group of | Dosage g/crude drug/kg | Latent phase s of asthma | The inhibition rate of asthma% |
| Control group | - | 2.15±0.43 | - |
| Oral liquid for treating infantile cough and asthma | 5.4 | 2.54±0.34 | 121.35 |
| Concentrated oral liquid 1 for treating infantile cough and asthma | 5.4 | 3.11±0.78 | 143.57 |
| Concentrated oral liquid for treating infantile cough and asthma 2 groups | 5.4 | 5.34±0.21 | 159.20 |
And (3) immune experiment: the method comprises randomly dividing 48 NIH mice into 4 groups, including control group, common oral liquid for treating infantile cough and asthma, concentrated oral liquid for treating infantile cough and asthma 1 group, and concentrated oral liquid for treating infantile cough and asthma 2 groups. Each administration group was administered with 20ml/kg by intragastric administration, and the control group was administered with an equal volume of distilled water 1 time per day for 7 consecutive days. 1h after the last administration, the mice were sacrificed by cervical dislocation, thymus and spleen of each group of mice were picked up, weighed by BA61 type electron, and mouse thymus index and spleen index were calculated. The results are shown in the following table:
TABLE 5
| Group of | Dosage g/crude drug/kg | Thymus index mg/g | Spleen index mg/g |
| Control group | - | 1.254±0.361 | 3.187±0.245 |
| Oral liquid for treating infantile cough and asthma | 5.4 | 1.913±0.34 | 4.401±1.245 |
| Concentrated oral liquid 1 for treating infantile cough and asthma | 5.4 | 1.991±0.78 | 4.807±1.431 |
| Concentrated oral liquid for treating infantile cough and asthma 2 groups | 5.4 | 2.001±0.21 | 4.917±1.245 |
As a result, the thymus index and spleen index of the concentrated Xiao ' er Kechuanling oral liquid 2 group are obviously higher than those of the common Xiao ' er Kechuanling oral liquid, and are slightly higher than those of the concentrated Xiao ' er Kechuanling oral liquid 1 group. Compared with the control group, the thymus index P is less than 0.01, and the spleen index P is less than 0.05.
Third, physical and chemical detection experiment
The oral liquid for treating cough and asthma of children is prepared by the methods of the invention in the embodiment 3 and the comparative examples 1 to 5, and the tannin removal rate and the protein removal rate are respectively determined.
The tannin is measured by a method of 'Chinese pharmacopoeia' 2010 edition appendix, and a phosphomolybdotungstic acid colorimetric method which takes phosphomolybdotungstic acid as a color developing agent, casein as an adsorbent and gallic acid as a reference substance. Proteins were determined using the Bradfor assay. The removal rates of tannin and protein were calculated according to the following formulas, respectively:
tannin removal rate = 1-mass concentration of tannin in liquid medicine/mass concentration of tannin in raw material liquid after treatment
Protein removal rate = 1-mass concentration of protein in treated drug solution/mass concentration of protein in raw material solution
| Group of | Tannin removal rate% | Protein removal Rate% |
| Example 3 | 78.6 | 70.2 |
| Comparative example 1 | 39.1 | 30.5 |
| Comparative example 2 | 54.3 | 28.7 |
| Comparative example 3 | 61.6 | 56.9 |
| Comparative example 4 | 70.9 | 63.7 |
| Comparative example 5 | 71.8 | 57.5 |
From the results, it can be seen that the L-aspartic acid and the cationic starch show good synergistic effect, the addition ratio of the L-aspartic acid and the cationic starch has important influence on the tannin and the protein, and in addition, the removal rate of the tannin and the protein shows more obvious change by changing the addition sequence of the L-aspartic acid and the cationic starch.
The above-described embodiments of the present invention are only examples, but are not limited to the examples, and equivalent modifications and additions made by the present application and the prior art may be considered within the technical scope of the present invention without departing from the spirit of the present invention.
Claims (4)
1. A preparation process of concentrated oral liquid for treating infantile cough and asthma is characterized by comprising the following steps: the formula of the oral liquid for treating infantile cough and asthma is as follows: 25g of ephedra, 250g of honeysuckle, 125g of bitter apricot seed, 250g of isatis root, 375g of gypsum, 125g of liquorice and 125g of snakegourd fruit, and the preparation steps are as follows:
1) decocting semen Armeniacae amarum, Gypsum Fibrosum, radix Isatidis, Glycyrrhrizae radix, and fructus Trichosanthis with water, filtering to obtain residue, decocting the residue with herba Ephedrae and flos Lonicerae with water, filtering, and mixing filtrates;
2) standing the filtrate, taking supernatant, filtering with a ceramic membrane, adding a flocculating agent, stirring, standing until layering, collecting supernatant, and concentrating the supernatant into a fluid extract;
3) adding ethanol into the fluid extract, stirring, standing, refrigerating, collecting supernatant, filtering, recovering ethanol, concentrating to appropriate amount, adding stevioside and sodium benzoate, stirring, and filtering to obtain filtrate;
4) adding water into the filtrate, stirring, refrigerating, adding water, refrigerating, and collecting supernatant;
5) centrifuging the supernatant obtained in the step 4) to obtain a clear solution, sterilizing, adding water, adding an alkaline solution to adjust the pH value, heating, and cooling to obtain a product;
the flocculant is L-aspartic acid and cationic starch, and the adding sequence of the L-aspartic acid and the cationic starch is that the cationic starch is added firstly, and then the L-aspartic acid is added;
the total adding amount of the L-aspartic acid and the cationic starch is 0.3-0.4g/L, and the mass ratio is 0.3-0.7: 1.
2. The process according to claim 1, wherein the ceramic membrane in step 2) has a membrane pore size of 180-220 nm.
3. The preparation process of claim 1, wherein the alkaline solution in step 5) is one or two of sodium hydroxide solution and potassium hydroxide solution.
4. The process according to claim 1, wherein the heating temperature in step 5) is 60 to 70 ℃.
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