CN110917323A - Compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm and production process thereof - Google Patents
Compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm and production process thereof Download PDFInfo
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Abstract
The invention relates to a compound Chinese medicinal oral liquid for clearing heat and eliminating phlegm and its preparation method, on the basis of existing prescription and process, adjuvants choose DL-malic acid, gallic acid as chelating agent, tyrosine is regarded as solubilizer and stabilizer, the process adopts the way of heating up and adding DL-malic acid ethanol solution in stages, make the bioavailability of the product high, improve the curative effect; and after the product passes through a high-temperature accelerated test, the properties and the color are unchanged, and the effective components cannot volatilize.
Description
Technical Field
The invention relates to a compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm and a production process thereof, belonging to the field of traditional Chinese medicine preparations.
Background
A compound Chinese medicinal oral liquid for clearing heat and eliminating phlegm, Compound XIANZHU liquid, is prepared from succus Bambusae, herba Houttuyniae, rhizoma Pinelliae, rhizoma Zingiberis recens, folium Eriobotryae, radix Platycodi, and peppermint oil.
The preparation method comprises the following steps: squeezing rhizoma Zingiberis recens to obtain juice, adding ethanol to make ethanol content reach 65%, stirring, standing for 24 hr, collecting supernatant, filtering, and recovering ethanol from filtrate; distilling herba Houttuyniae with water, and collecting distillate 150 ml; decocting the residues of rhizoma Zingiberis recens and herba Houttuyniae, rhizoma Pinelliae, folium Eriobotryae, and radix Platycodi in water twice, 1.5 hr for the first time and 1 hr for the second time, mixing decoctions, filtering, concentrating the filtrate to about 420ml, cooling, adding ethanol to make ethanol content reach 65%, stirring, standing for 24 hr, collecting supernatant, filtering, recovering ethanol from the filtrate until no ethanol smell exists, adding succus Bambusae and sucrose 150g, heating and boiling for 20min, hot filtering, cooling the filtrate, adding rhizoma Zingiberis recens juice, herba Houttuyniae distillate, peppermint oil and sodium benzoate 3g, stirring, adding water to 1000ml, and mixing.
The volatile oil component contained in the prescription is difficult to dissolve in other formulas, and the volatile oil component is easy to volatilize under the high-temperature condition of the prepared finished product, so that the curative effect of the product is influenced.
Disclosure of Invention
The invention aims to provide a compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm and a production process thereof, on the basis of the existing prescription and process, DL-malic acid and gallic acid are selected as chelating agents as auxiliary materials, tyrosine is used as a solubilizer and a stabilizer, and the process adopts a mode of staged temperature rise and DL-malic acid ethanol solution, so that the bioavailability of the product is high, and the curative effect is improved; and after the product passes through a high-temperature accelerated test, the properties and the color are unchanged, and the effective components cannot volatilize.
A compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm comprises the following components: 500ml of fresh bamboo juice, 200g of houttuynia cordata, 20-30g of unprocessed pinellia tuber, 20-30g of ginger, 200g of loquat leaf, 50-100g of platycodon grandiflorum and 0.1-2ml of peppermint oil.
The compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm also comprises the following components in formula: DL-malic acid, gallic acid, tyrosine, sucrose, and sodium benzoate.
The DL-malic acid is used after being prepared into DL-malic acid solution.
The compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm has the specific production process steps:
s1, squeezing ginger to obtain juice, adding absolute ethyl alcohol to enable the alcohol content to be 65%, stirring, standing for 24 hours, taking supernate, filtering, and recovering ethanol from the filtrate until no alcohol smell exists for later use;
s2, adding 1-2L of water into the houttuynia cordata, distilling, and collecting 150ml of distillate for later use;
s3, decocting the residues of rhizoma Zingiberis recens and herba Houttuyniae, rhizoma Pinelliae, folium Eriobotryae, and radix Platycodi in 800ml water twice (80-100 min for the first time and 50-70min for the second time), mixing decoctions, and filtering;
s4, concentrating the filtrate obtained in the step S3 to 440ml, cooling to room temperature, adding DL-malic acid solution, continuing adding absolute ethyl alcohol to enable the alcohol content to be 65%, stirring, standing for 24 hours, taking supernatant, filtering and collecting the filtrate;
s5, recovering ethanol from the filtrate S4 until no ethanol smell exists, adding succus Bambusae, sucrose, and gallic acid, heating under stirring, boiling for 10-20min, filtering, and collecting filtrate
S6, cooling the filtrate collected in S5 to room temperature, adding the ginger extract obtained in the step S1, the houttuynia cordata distillate collected in S2, the dementholized peppermint oil, sodium benzoate and tyrosine, carrying out ultrasonic treatment, adding water to 1000ml, and mixing uniformly to obtain the traditional Chinese medicine.
Preferably, the preparation method of the DL-malic acid solution comprises the following steps: dissolving 7-9 gDL-malic acid in 200ml 95% ethanol, stirring, heating to 40 deg.C, and dissolving.
Preferably, in the step S5, the amount of sucrose is 140-160g, and the mixture is heated to 70-80 ℃ and stirred for 50-70 min.
Preferably, the amount of gallic acid is 4-6 g.
Preferably, tyrosine is used in an amount of 1-2 g.
Preferably, in step S6, the amount of sodium benzoate is 2.5-3.5g, and the time of ultrasonic treatment is 20-40 min.
Preferably, in the step S6, the mixture is heated to 50-60 ℃ while being mixed.
The invention has the beneficial effects that:
(1) on the basis of the existing formula, auxiliary materials of DL-malic acid and gallic acid are added to serve as a compound chelating agent and a stabilizer, and meanwhile, the DL-malic acid is added in the form of an ethanol solution, so that various polymer extracts in a medicine prescription are effectively and uniformly mixed, and the bioavailability of the product is improved.
(2) Tyrosine is added as a solubilizer and a stabilizer, the solubility of effective components such as volatile oil in the formula in water is improved, and the tyrosine and auxiliary materials DL-malic acid and gallic acid have combined action, so that after a high-temperature accelerated test of the product, not only the properties and the color are unchanged, but also the effective components cannot volatilize.
(3) The invention adopts stage heating treatment on the basis of the original process, and improves the bioavailability of the product and increases the curative effect of the medicine by adding DL-malic acid ethanol solution, gallic acid and tyrosine.
Detailed Description
Example 1
A compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm comprises the following components: 300ml of fresh bamboo juice, 100g of houttuynia cordata, 20g of raw pinellia ternate, 20g of ginger, 100g of loquat leaf, 50g of platycodon grandiflorum, 0.1ml of peppermint oil, 7g of DL-malic acid, 4g of gallic acid and 1g of tyrosine.
The production process comprises the following specific steps:
s1, squeezing ginger to obtain juice, adding absolute ethyl alcohol to enable the alcohol content to be 65%, stirring, standing for 24 hours, taking supernate, filtering, and recovering ethanol from the filtrate until no alcohol smell exists for later use;
s2, adding 1L of water into the houttuynia cordata, distilling, and collecting 150ml of distillate for later use;
s3 decocting the residues of rhizoma Zingiberis recens and herba Houttuyniae, rhizoma Pinelliae, folium Eriobotryae, and radix Platycodi in 800ml water twice (80 min for the first time and 50min for the second time), mixing decoctions, and filtering;
s4, concentrating the filtrate obtained in the step S3 to 400ml, cooling to room temperature, adding DL-malic acid solution, adding absolute ethyl alcohol continuously until the alcohol content is 65%, stirring, standing for 24 hours, taking supernatant, filtering, and collecting filtrate;
s5, recovering ethanol from the filtrate of S4 until no alcohol smell exists, adding fresh succus Bambusae, sucrose 140g and gallic acid, heating to 70 deg.C, stirring for 50min, heating to boil for 10min, filtering, and collecting filtrate;
s6, cooling the filtrate collected in S5 to room temperature, adding the ginger extract obtained in the step S1, the houttuynia cordata distillate collected in S2, the peppermint oil, 2.5g of sodium benzoate and tyrosine, carrying out ultrasonic treatment for 20min, adding water to 1000ml, uniformly mixing, and heating to 50 ℃ to obtain the ginger extract.
The preparation method of the DL-malic acid solution comprises the following steps: DL-malic acid is dissolved in 200ml of 95% ethanol, stirred and heated to 40 ℃ to dissolve uniformly.
Example 2
A compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm comprises the following components: 400ml of fresh bamboo juice, 150g of houttuynia cordata, 25g of raw pinellia ternate, 25g of ginger, 150g of loquat leaf, 75g of platycodon grandiflorum, 1ml of peppermint oil, 8g of DL-malic acid, 5g of gallic acid and 1.5g of tyrosine.
The production process comprises the following specific steps:
s1, squeezing ginger to obtain juice, adding absolute ethyl alcohol to enable the alcohol content to be 65%, stirring, standing for 24 hours, taking supernate, filtering, and recovering ethanol from the filtrate until no alcohol smell exists for later use;
s2, adding 1.5L water into houttuynia cordata, distilling, and collecting 150ml of distillate for later use;
s3, decocting the residues of rhizoma Zingiberis recens and herba Houttuyniae, rhizoma Pinelliae, folium Eriobotryae, and radix Platycodi in 800ml water twice for 90min and 60min, mixing decoctions, and filtering;
s4, concentrating the filtrate obtained in the step S3 to 420ml, cooling to room temperature, adding DL-malic acid solution, adding absolute ethyl alcohol continuously until the alcohol content is 65%, stirring, standing for 24 hours, taking supernatant, filtering, and collecting filtrate;
s5, recovering ethanol from the filtrate of S4 until no alcohol smell exists, adding fresh succus Bambusae, sucrose 150g and gallic acid, heating to 75 deg.C, stirring for 60min, heating to boil for 15min, filtering, and collecting filtrate;
s6, cooling the filtrate collected in S5 to room temperature, adding the ginger extract obtained in the step S1, the houttuynia cordata distillate collected in S2, the peppermint oil, 3g of sodium benzoate and tyrosine, carrying out ultrasonic treatment for 30min, adding water to 1000ml, uniformly mixing, and heating to 55 ℃ to obtain the ginger tea.
The preparation method of the DL-malic acid solution comprises the following steps: DL-malic acid is dissolved in 200ml of 95% ethanol, stirred and heated to 40 ℃ to dissolve uniformly.
Example 3
A compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm comprises the following components: 500ml of fresh bamboo juice, 200g of houttuynia cordata, 30g of raw pinellia ternate, 30g of ginger, 200g of loquat leaf, 100g of platycodon grandiflorum, 2ml of peppermint oil, 9g of DL-malic acid, 6g of gallic acid and 2g of tyrosine.
The production process comprises the following specific steps:
s1, squeezing ginger to obtain juice, adding absolute ethyl alcohol to enable the alcohol content to be 65%, stirring, standing for 24 hours, taking supernate, filtering, and recovering ethanol from the filtrate until no alcohol smell exists for later use;
s2, adding 2L of water into the houttuynia cordata, distilling, and collecting 150ml of distillate for later use;
s3, decocting the residues of rhizoma Zingiberis recens and herba Houttuyniae, rhizoma Pinelliae, folium Eriobotryae, and radix Platycodi in 800ml water twice (100 min for the first time and 70min for the second time), mixing decoctions, and filtering;
s4, concentrating the filtrate obtained in the step S3 to 440ml, cooling to room temperature, adding DL-malic acid solution, adding absolute ethyl alcohol continuously until the alcohol content is 65%, stirring, standing for 24 hours, taking supernatant, filtering, and collecting filtrate;
s5, recovering ethanol from the filtrate of S4 until no alcohol smell exists, adding fresh succus Bambusae, sucrose 160g and gallic acid, heating to 80 deg.C, stirring for 70min, heating to boil for 20min, filtering, and collecting filtrate;
s6, cooling the filtrate collected in S5 to room temperature, adding the ginger extract obtained in the step S1, the houttuynia cordata distillate collected in S2, the peppermint oil, 3.5g of sodium benzoate and tyrosine, carrying out ultrasonic treatment for 40min, adding water to 1000ml, uniformly mixing, and heating to 60 ℃ to obtain the ginger tea.
The preparation method of the DL-malic acid solution comprises the following steps: DL-malic acid is dissolved in 200ml of 95% ethanol, stirred and heated to 40 ℃ to dissolve uniformly.
Example 4
A compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm comprises the following components: 300ml of fresh bamboo juice, 150g of houttuynia cordata, 30g of raw pinellia ternate, 20g of ginger, 150g of loquat leaf, 100g of platycodon grandiflorum, 0.1ml of peppermint oil, 8g of DL-malic acid, 6g of gallic acid and 1g of tyrosine.
The production process comprises the following specific steps:
s1, squeezing ginger to obtain juice, adding absolute ethyl alcohol to enable the alcohol content to be 65%, stirring, standing for 24 hours, taking supernate, filtering, and recovering ethanol from the filtrate until no alcohol smell exists for later use;
s2, adding 1.5L water into houttuynia cordata, distilling, and collecting 150ml of distillate for later use;
s3, decocting the residues of rhizoma Zingiberis recens and herba Houttuyniae, rhizoma Pinelliae, folium Eriobotryae, and radix Platycodi in 800ml water twice (100 min for the first time and 50min for the second time), mixing decoctions, and filtering;
s4, concentrating the filtrate obtained in the step S3 to 420ml, cooling to room temperature, adding DL-malic acid solution, adding absolute ethyl alcohol continuously until the alcohol content is 65%, stirring, standing for 24 hours, taking supernatant, filtering, and collecting filtrate;
s5, recovering ethanol from the filtrate of S4 until no alcohol smell exists, adding fresh succus Bambusae, sucrose 160g and gallic acid, heating to 70 deg.C, stirring for 60min, heating to boil for 20min, filtering, and collecting filtrate;
s6, cooling the filtrate collected in S5 to room temperature, adding the ginger extract obtained in the step S1, the houttuynia cordata distillate collected in S2, the peppermint oil, 2.5g of sodium benzoate and tyrosine, carrying out ultrasonic treatment for 30min, adding water to 1000ml, uniformly mixing, and heating to 60 ℃ to obtain the ginger tea.
The preparation method of the DL-malic acid solution comprises the following steps: DL-malic acid is dissolved in 200ml of 95% ethanol, stirred and heated to 40 ℃ to dissolve uniformly.
Example 5
A compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm comprises the following components: 400ml of fresh bamboo juice, 200g of houttuynia cordata, 20g of raw pinellia ternate, 25g of ginger, 200g of loquat leaf, 50g of platycodon grandiflorum, 1ml of peppermint oil, 9g of DL-malic acid, 4g of gallic acid and 1.5g of tyrosine.
The production process comprises the following specific steps:
s1, squeezing ginger to obtain juice, adding absolute ethyl alcohol to enable the alcohol content to be 65%, stirring, standing for 24 hours, taking supernate, filtering, and recovering ethanol from the filtrate until no alcohol smell exists for later use;
s2, adding 2L of water into the houttuynia cordata, distilling, and collecting 150ml of distillate for later use;
s3, decocting the residues of rhizoma Zingiberis recens and herba Houttuyniae, rhizoma Pinelliae, folium Eriobotryae, and radix Platycodi in 800ml water twice (80 min for the first time and 60min for the second time), mixing decoctions, and filtering;
s4, concentrating the filtrate obtained in the step S3 to 440ml, cooling to room temperature, adding DL-malic acid solution, adding absolute ethyl alcohol continuously until the alcohol content is 65%, stirring, standing for 24 hours, taking supernatant, filtering, and collecting filtrate;
s5, recovering ethanol from the filtrate of S4 until no alcohol smell exists, adding fresh succus Bambusae, sucrose 140g and gallic acid, heating to 75 deg.C, stirring for 70min, heating to boil for 10min, filtering, and collecting filtrate;
s6, cooling the filtrate collected in S5 to room temperature, adding the ginger extract obtained in the step S1, the houttuynia cordata distillate collected in S2, the peppermint oil, 3g of sodium benzoate and tyrosine, carrying out ultrasonic treatment for 40min, adding water to 1000ml, uniformly mixing, and heating to 50 ℃ to obtain the ginger tea.
The preparation method of the DL-malic acid solution comprises the following steps: DL-malic acid is dissolved in 200ml of 95% ethanol, stirred and heated to 40 ℃ to dissolve uniformly.
Example 6
A compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm comprises the following components: 500ml of fresh bamboo juice, 100g of houttuynia cordata, 25g of raw pinellia ternate, 30g of ginger, 100g of loquat leaf, 75g of platycodon grandiflorum, 2ml of peppermint oil, 7g of DL-malic acid, 5g of gallic acid and 2g of tyrosine.
The production process comprises the following specific steps:
s1, squeezing ginger to obtain juice, adding absolute ethyl alcohol to enable the alcohol content to be 65%, stirring, standing for 24 hours, taking supernate, filtering, and recovering ethanol from the filtrate until no alcohol smell exists for later use;
s2, adding 1L of water into the houttuynia cordata, distilling, and collecting 150ml of distillate for later use;
s3, decocting the residues of rhizoma Zingiberis recens and herba Houttuyniae, rhizoma Pinelliae, folium Eriobotryae, and radix Platycodi in 800ml water twice for 90min and 70min, mixing decoctions, and filtering;
s4, concentrating the filtrate obtained in the step S3 to 400ml, cooling to room temperature, adding DL-malic acid solution, adding absolute ethyl alcohol continuously until the alcohol content is 65%, stirring, standing for 24 hours, taking supernatant, filtering, and collecting filtrate;
s5, recovering ethanol from the filtrate of S4 until no alcohol smell exists, adding fresh succus Bambusae, sucrose 150g and gallic acid, heating to 80 deg.C, stirring for 50min, heating to boil for 15min, filtering, and collecting filtrate;
s6, cooling the filtrate collected in S5 to room temperature, adding the ginger extract obtained in the step S1, the houttuynia cordata distillate collected in S2, the peppermint oil, 3.5g of sodium benzoate and tyrosine, carrying out ultrasonic treatment for 20min, adding water to 1000ml, uniformly mixing, and heating to 55 ℃ to obtain the ginger tea.
The preparation method of the DL-malic acid solution comprises the following steps: DL-malic acid is dissolved in 200ml of 95% ethanol, stirred and heated to 40 ℃ to dissolve uniformly.
Comparative example 1
A specific example 1 of Chinese patent ZL 201310594805.9 preparation method of compound fresh bamboo juice.
Comparative example 2
Example 1 differs in that:
DL-malic acid was added directly to S4, but not as a DL-malic acid solution.
Comparative example 3
The difference from example 2 is that:
and replacing the auxiliary material DL-malic acid with the auxiliary material edetate disodium to prepare the edetate disodium water solution.
The preparation method of the edetate disodium aqueous solution comprises the following steps: dissolving edetate disodium in 200ml water, stirring and heating to 40 deg.C, and dissolving uniformly.
Comparative example 4
The difference from example 3 is that:
substituting glycine for tyrosine.
Comparative example 5
The difference from example 4 is that:
s5, recovering ethanol from the filtrate of S4 until no alcohol smell exists, adding fresh succus Bambusae, sucrose 160g and gallic acid, stirring for 60min, heating to boil for 20min, filtering, and collecting filtrate;
the present invention is not limited to the above-described embodiments, and various changes may be made by those skilled in the art, and any changes equivalent or similar to the present invention are intended to be included within the scope of the claims.
Test example 1: high temperature accelerated test
The oral liquid is prepared according to the method of the embodiment and the comparative example, and is placed in a 40 ℃ incubator for 9 months, the product characters are observed, and the content of the volatile oil of the product is detected. The results are shown in tables 1 to 3.
The volatile oil content detection method comprises the following steps: the oral liquid is prepared by the method of the embodiment and the comparative example, the volatile oil amount (ml) is measured according to a method A for measuring the volatile oil in four parts of the 2015 version in Chinese pharmacopoeia, and the volatile oil content (ml/L) is calculated.
TABLE 1 examination result of high temperature accelerated test properties of the oral liquid of the present invention
| Group of | 0 month | 3 months old | 6 months old | 9 months old |
| Example 1 | Yellowish brown liquid | Yellowish brown liquid | Yellowish brown liquid | Yellowish brown liquid |
| Example 2 | Yellowish brown liquid | Yellowish brown liquid | Yellowish brown liquid | Yellowish brown liquid |
| Example 3 | Yellowish brown liquid | Yellowish brown liquid | Yellowish brown liquid | Yellowish brown liquid |
| Example 4 | Yellowish brown liquid | Yellowish brown liquid | Yellowish brown liquid | Yellowish brown liquid |
| Example 5 | Yellowish brown liquid | Yellowish brown liquid | Yellowish brown liquid | Yellowish brown liquid |
| Example 6 | Yellowish brown liquid | Yellowish brown liquid | Yellowish brown liquid | Yellowish brown liquid |
| Comparative example 1 | Yellowish brown liquid | Yellowish brown liquid | Brown liquid | Dark brown liquid |
| Comparative example 2 | Yellowish brown liquid | Yellowish brown liquid | Brown liquid | Dark brown liquid |
| Comparative example 3 | Yellowish brown liquid | Brown liquid | Dark brown liquid | Black liquid |
| Comparative example 4 | Yellowish brown liquid | Brown liquid | Dark brown liquid | Black liquid |
| Comparative example 5 | Yellowish brown liquid | Brown liquid | Dark brown liquid | Dark brown liquid |
TABLE 2 clarity test results of the high temperature accelerated test of the oral liquid of the present invention
| Group of | 0 month | 3 months old | 6 months old | 9 months old |
| Example 1 | Clarification | Clarification | Clarification | Clarification |
| Example 2 | Clarification | Clarification | Clarification | Clarification |
| Example 3 | Clarification | Clarification | Clarification | Clarification |
| Example 4 | Clarification | Clarification | Clarification | Clarification |
| Example 5 | Clarification | Clarification | Clarification | Clarification |
| Example 6 | Clarification | Clarification | Clarification | Clarification |
| Comparative example 1 | Clarification | Clarification | Clarification | Slight cloudiness |
| Comparative example 2 | Clarification | Clarification | Slight cloudiness | Slight cloudiness |
| Comparative example 3 | Clarification | Slight cloudiness | Turbidity | Turbidity |
| Comparative example 4 | Clarification | Slight cloudiness | Turbidity | Turbidity |
| Comparative example 5 | Clarification | Slight cloudiness | Slight cloudiness | Turbidity |
TABLE 1 examination result (ml/L) of volatile oil content in high temperature accelerated test of oral liquid of the present invention
| Group of | 0 month | 3 months old | 6 months old | 9 months old |
| Example 1 | 0.71 | 0.71 | 0.71 | 0.69 |
| Example 2 | 0.78 | 0.78 | 0.78 | 0.77 |
| Example 3 | 0.75 | 0.75 | 0.75 | 0.74 |
| Example 4 | 0.76 | 0.76 | 0.76 | 0.74 |
| Example 5 | 0.75 | 0.75 | 0.75 | 0.73 |
| Example 6 | 0.72 | 0.72 | 0.72 | 0.71 |
| Comparative example 1 | 0.19 | 0.15 | 0.12 | 0.07 |
| Comparative example 2 | 0.53 | 0.53 | 0.50 | 0.48 |
| Comparative example 3 | 0.34 | 0.30 | 0.27 | 0.23 |
| Comparative example 4 | 0.30 | 0.25 | 0.22 | 0.20 |
| Comparative example 5 | 0.41 | 0.40 | 0.38 | 0.35 |
As can be seen from the results in tables 1 to 3, the oral liquids prepared in examples 1 to 6 of the present invention, after being subjected to the high temperature accelerated test, have the same properties and clarity, and the volatile oil content is slightly reduced until 9 months, which is better than the results of comparative example 1 (published prior patent), comparative example 2: (direct addition of DL-malic acid, not added as a DL-malic acid solution), comparative example 3: (disodium edetate in place of DL-malic acid), comparative example 4 (glycine in place of tyrosine), comparative example 5 (step S5 different process). Therefore, the auxiliary materials DL-malic acid and gallic acid are added as chelating agents, tyrosine is used as a solubilizer and a stabilizer on the basis of the existing prescription and process, the process adopts the mode of stage temperature rise and addition of DL-malic acid ethanol solution, so that the product has unchanged properties, color and clarity after passing the high-temperature acceleration test, the effective components such as volatile oil in the product are improved, and the effective components such as the volatile oil are not easy to volatilize.
Test example 2: test of therapeutic effects
1. Diagnostic criteria
Refer to the published 1984 edition of Shanghai science and technology of Chinese medicine internal science, which is a teaching material of higher medical colleges and universities.
(1) Wind-heat affecting the lung
Frequent cough, coarse qi or coarse cough, dry throat and sore throat, uncomfortable expectoration, sticky or thick yellow sputum, sweating during cough, yellow nasal discharge, thirst, headache, limb pain, aversion to wind, fever and other exterior syndromes, thin and yellow tongue coating, floating and rapid pulse or slippery pulse.
(2) Phlegm-dampness accumulating in the lung
Cough with recurrent episodes, heavy and turbid cough with excessive phlegm, cough with phlegm, even and sticky sputum or thick sputum into lumps, white or grayish sputum, cough with excessive phlegm in the morning or after eating every day, aggravation by eating sweet and greasy food, chest distress, epigastric fullness, nausea, poor appetite, tiredness, loose stool, white and greasy tongue coating, and soft and smooth pulse.
(3) Phlegm-heat obstructing the lung
Cough with rapid and coarse smell, phlegm in the throat, profuse sputum, sticky and thick or yellow, uncomfortable cough and vomiting, or hot and fishy smell, or hematemesis, fullness in chest and hypochondrium, pain in cough, flushed face, or fever, dry mouth and desire to drink, thin, yellow and greasy coating on the tongue, red in texture, and smooth and rapid pulse.
2. Basic condition of case
Is selected from 200 patients with the above symptoms in TCM college, 20-70 years old, 93 men and 67 women, and is divided into 3 groups.
3. Administration method and treatment course
Treatment group 80 persons: the medicine prepared in the embodiment 2 of the invention is orally taken, 20ml is taken once, three times a day, and three days are a course of treatment.
Control group 60 persons: the drug prepared in comparative example 1 was orally administered at a dose of 20ml three times a day, and three days was one treatment course.
Control group 60 persons: the compound fresh bamboo juice (2015 pharmacopoeia process) is orally taken, 20ml is taken once, three times a day, and three days are a treatment course.
4. Criteria for therapeutic effect
The effect is shown: cough and various accompanying symptoms disappear, and the body temperature returns to normal.
The method has the following advantages: the cough is relieved, the sputum volume is reduced, the body temperature is reduced and various accompanied symptoms are improved.
And (4) invalidation: cough, body temperature and various accompanying symptoms are not improved.
5. Therapeutic results
The treatment results are shown in table 4 based on the therapeutic effect judgment criteria.
TABLE 4 therapeutic Effect of the groups
As can be seen from the results in table 4, the oral liquid prepared by the present invention has high treatment effect and total effective rate, which are significantly higher than those of the comparative example 1 (the published prior patent) and the process of the chinese pharmacopoeia in 2015, so that the present invention adds the auxiliary materials DL-malic acid and gallic acid as the chelating agent, tyrosine as the solubilizer and the stabilizer on the basis of the prior prescription and process, and the process adopts the way of staged temperature rise and addition of DL-malic acid ethanol solution, such that the product bioavailability is high, and the curative effect is greatly improved.
Claims (10)
1. A compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm is characterized in that: the formula comprises the following components: 500ml of fresh bamboo juice, 200g of houttuynia cordata, 20-30g of unprocessed pinellia tuber, 20-30g of ginger, 200g of loquat leaf, 50-100g of platycodon grandiflorum and 0.1-2ml of peppermint oil.
2. The compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm as claimed in claim 1, is characterized in that: the formula also comprises: DL-malic acid, gallic acid, tyrosine, sucrose, and sodium benzoate.
3. The compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm as claimed in claim 2, wherein the DL-malic acid is used after being prepared into DL-malic acid solution.
4. The compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm as claimed in claim 2, the production process comprises the following steps:
s1, squeezing ginger to obtain juice, adding absolute ethyl alcohol to enable the alcohol content to be 65%, stirring, standing for 24 hours, taking supernate, filtering, and recovering ethanol from the filtrate until no alcohol smell exists for later use;
s2, adding 1-2L of water into the houttuynia cordata, distilling, and collecting 150ml of distillate for later use;
s3, decocting the residues of rhizoma Zingiberis recens and herba Houttuyniae, rhizoma Pinelliae, folium Eriobotryae, and radix Platycodi in 800ml water twice (80-100 min for the first time and 50-70min for the second time), mixing decoctions, and filtering;
s4, concentrating the filtrate obtained in the step S3 to 440ml, cooling to room temperature, adding DL-malic acid solution, continuing adding absolute ethyl alcohol to enable the alcohol content to be 65%, stirring, standing for 24 hours, taking supernatant, filtering and collecting the filtrate;
s5, recovering ethanol from the filtrate of S4 until no alcohol smell exists, adding fresh succus Bambusae, sucrose and gallic acid, heating and stirring, continuously heating to boil for 10-20min, filtering, and collecting filtrate;
s6, cooling the filtrate collected in S5 to room temperature, adding the ginger extract obtained in the step S1, the houttuynia cordata distillate collected in S2, the dementholized peppermint oil, sodium benzoate and tyrosine, carrying out ultrasonic treatment, adding water to 1000ml, and mixing uniformly to obtain the traditional Chinese medicine.
5. The compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm as claimed in claim 3 or 4, the preparation method of DL-malic acid solution is: dissolving 7-9 gDL-malic acid in 200ml 95% ethanol, stirring, heating to 40 deg.C, and dissolving.
6. The compound Chinese medicinal oral liquid for clearing heat and eliminating phlegm as claimed in claim 4, wherein in step S5, the amount of sucrose is 140-160g, heated to 70-80 deg.C and stirred for 50-70 min.
7. The compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm as claimed in claim 2 or 4, the dosage of gallic acid is 4-6 g.
8. The compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm as claimed in claim 2 or 4, wherein the dosage of tyrosine is 1-2 g.
9. The compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm as claimed in claim 4, wherein in the step S6, the amount of sodium benzoate is 2.5-3.5g, and the time of ultrasonic treatment is 20-40 min.
10. The compound traditional Chinese medicine oral liquid for clearing heat and eliminating phlegm as claimed in claim 4, wherein in the step S6, the mixture is heated to 50-60 ℃ while being mixed uniformly.
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| CN115381905A (en) * | 2022-09-28 | 2022-11-25 | 江西李氏烤鲜竹沥药业有限公司 | Bamboo juice ointment for clearing heat and reducing phlegm and preparation method thereof |
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