CN101991723B - A kind of Shiqi exogenous Chinese medicine oral liquid - Google Patents

Abstract

The invention relates to a traditional Chinese medicine oral liquid, in particular to a traditional Chinese medicine oral liquid for treating and preventing influenza. The oral liquid is prepared by processing the following traditional Chinese medicine raw materials and a pharmaceutically acceptable carrier: 980g of roughhaired holly 245, 980g of berchemia lineata 245, 980g of syzygium jambos 245, 98-392g of clerodendrum odoratum and 980g of radix seu folium Rubiae Craifolii 245.

Description

A kind of Shiqi exogenous Chinese medicine oral liquid

technical field

The invention belongs to the field of traditional Chinese medicine and relates to a traditional Chinese medicine oral liquid, in particular to a traditional Chinese medicine oral liquid for treating and preventing influenza and a preparation method thereof.

Background technique

Both colds and influenza are caused by viral infections. Since the virus is airborne, it is the nose that bears the brunt. The virus first infects the nasal mucosa and then multiplies continuously, causing inflammation of the nasal mucosa and symptoms such as sneezing, runny nose, and nasal congestion. A common cold refers to a nasal cold, which generally affects the human body only on the respiratory system. All symptoms are related to the nose, such as runny nose, stuffy nose and sore throat, cough, and even fever. It usually heals in a few days. Influenza is caused by influenza virus. Influenza symptoms affect the whole body, including fever and chills, sweating, body aches, headache, bone pain, muscle pain, fatigue, loss of appetite, cough, nasal congestion, etc. In severe cases, it can cause pneumonia and other complications, which can be fatal. The nature of influenza viruses is that there are many types, and new virus strains appear every ten years or so.

There is no concept of virus in Chinese medicine. For flu or colds, they are collectively referred to as "exogenous evil invasion". Because the origin of the virus, whether it is the nasal mucous membrane or the respiratory tract, is outside the viscera, it is called "exogenous evil". Traditional Chinese medicine is classified according to symptoms and physical reactions, and can be roughly divided into "wind-cold cold" and "wind-heat cold". Symptoms of anemopyretic cold: sore throat, fever, loss of appetite, runny nose, thick phlegm. Symptoms of anemofrigid and cold: chills and wind, fatigue, runny nose, loss of appetite.

Shiqi external sensation tea granules, standard number: WS3-B 2672-97, prescription: Gangmei iron-wrapped golden apple peach stinky feces jasmine pandanus. Functions and indications: Dispelling wind and clearing heat, relieving summer heat and eliminating food. It is used for fever and headache caused by exogenous pathogenic factors, stagnation of food, fullness, dry throat, and prevention of influenza. Usage and dosage: Take after boiling water, 10-20g each time, 3 times a day. Specifications: 10g per bag. The inventor prepared a traditional Chinese medicine oral liquid for treating and preventing influenza by improving the prior art.

The traditional Chinese medicine raw materials of Shiqi Waigan tea granules are derived from:

Pandanus: Pandanus tectorius Sol. and its relatives;

Iron-clad gold: Iron-clad gold Berchemia lineate (Linn.) DC., Berchemia floribunda (Wall.) Brongn., Bechemia polyphylla wall.ex Laws.Var.leiocladaHand.-Mazz. and closely related species

Rose apple: Rose apple Syzygium jambos (Linn.) Alston and its relatives;

Gangmei: Ilex asprella (Hook.et Arn.) Champ.ex Benth and its relatives;

Smelly jasmine: Clerodendrum lindleyi Decne.ex Planch., Clerodendrum philippinum Schauer, Clerodendrum philippinum Schauer var.simplex Moldenke and their relatives;

Although Shiqi Waigan tea granule has been on the market for many years, patients are not satisfied with its effect. The main reasons are: its taste is not good; it is inconvenient to take, it needs to be taken with boiled water; the stability is not good, the storage time is short; the detection method is not accurate , cannot guarantee the quality of medicines. In addition, due to the complex ingredients of traditional Chinese medicine, the extraction process is relatively backward, and common problems such as moisture absorption, poor fluidity, and difficulty in disintegration are prone to occur during preparation. By adding appropriate excipients and improving the process, the quality and curative effect of traditional Chinese medicine can be improved, and production efficiency can be improved.

According to the theory of traditional Chinese medicine, the inventor of the present invention screened the formula and preparation method through continuous scientific experiments, and effectively solved the above-mentioned problems.

Contents of the invention

The object of the present invention is to provide a kind of traditional Chinese medicine oral liquid for treating and preventing influenza.

Chinese medicine oral liquid of the present invention is processed by following Chinese medicine raw material and pharmaceutically acceptable carrier:

Gangmei 245-980g Iron clad gold 245-980g Rose apple 245-980g

Smelly jasmine 98-392g Pandanus 245-980g

In the above composition, the weight of the medicine is calculated based on the crude drug, and the weight is used as the proportion, which can be increased or decreased according to the proportion during production. For example, the unit of kilogram or ton can be used for large-scale production, and the unit of small-scale production can also be The unit can be gram or milligram, and the weight can be increased or decreased, but the weight ratio of the raw medicinal materials among the components remains unchanged.

The proportion of the above weight ratio is obtained through scientific screening. For special patients, such as severe or mild, obese or thin patients, the proportion of the composition can be adjusted accordingly, and the increase or decrease does not exceed 100%. Change.

The above composition can be made into 1000ml of oral liquid of the present invention.

Preferably, the traditional Chinese medicine oral liquid of the present invention is processed from the following traditional Chinese medicine raw materials and pharmaceutically acceptable carriers:

Gangmei 245-980g Iron clad gold 245-980g Rose apple 245-980g

Smelly jasmine 98-392g Pandanus 245-980g Flavoring agent 2-100g

Bacteriostat 1-4g Thickener 1.5-6g Distilled water 10-1000ml

Wherein, the bacteriostatic agent includes but not limited to potassium sorbate, phenol, chitosan, 101 fruit juice clarifier, ZTC1+1, ethanol and the like.

Wherein, the flavoring agent includes but not limited to sucrose, mannitol, xylitol, steviol glycoside, lactose, fructose, sucrose, protein sugar, maltitol, glycyrrhizin, sodium cyclamate, gelatin, Spartame, banana flavor, pineapple flavor, vanillin, orange flavor, orange flavor, mint flavor, ginseng flavor, citric acid, citric acid, etc. can be used alone or in combination.

Wherein, the thickener includes but not limited to potassium alginate, starch, pectin, agar, gelatin, algae fat, carrageenan, dextrin, tragacanth gum, and polysaccharide derivatives.

Further preferably, the oral liquid of the present invention is processed from the following traditional Chinese medicine raw materials and pharmaceutically acceptable carriers:

Gangmei 245-980g Iron clad gold 245-980g Rose apple 245-980g

Smelly jasmine 98-392g Pandanus 245-980g Sucrose 2-100g

Potassium sorbate 1-4g Potassium alginate 1.5-6g Distilled water 10-1000ml.

More preferably, the oral liquid of the present invention is processed from the following traditional Chinese medicine raw materials and pharmaceutically acceptable carriers:

Gangmei 490g Iron clad gold 490g Rose apple 490g

Stinking jasmine 196g Pandanus 490g Sucrose 50g

Potassium sorbate 2g Potassium alginate 3g Distilled water to 1000ml.

Other preferred formulations of the present invention are included in the examples.

Another object of the present invention is to provide the preparation method of the oral liquid of the present invention.

The preparation method of oral liquid of the present invention comprises the following steps:

The traditional Chinese medicine preparation of the present invention is obtained by extracting or processing the raw materials of traditional Chinese medicine composed of the above formula, taking 490g of Shanggangmei, 490g of iron-clad gold, 490g of rose apple, 196g of jasmine, and 490g of pandanus, and decocting them with water. The second time, 2 hours each time, the amount of water added each time is 6 times the amount of medicinal materials, the extracts are combined, filtered, the filtrate is concentrated into a thick paste, the above-mentioned auxiliary materials are added, and mixed to make 1000ml.

The special feature of the present invention is that the existing preparation process has been improved, and water boiling is changed to water boiling and alcohol precipitation. The process steps are: take the above five-flavored plum, iron-coated gold, rose peach, stinky jasmine and pandanus , add water and decoct twice, each time for 2 hours, the amount of water added each time is 6 times the amount of medicinal materials, the combined extracts are concentrated to a relative density of 1.10 to 1.15 (50 to 60 ° C), and 95% medicinal ethanol is added for use. The solution has an alcohol content of 60-70%, standing for 12-24 hours, filtering, concentrating the filtrate, drying, pulverizing into fine powder, adding auxiliary materials, and mixing to make 1000ml.

There are many non-medicinal ingredients proposed by the water extraction process, the content of the water extraction process is highly variable and hygroscopic; it will interfere with the detection of drug quality standards, the quality of the drug cannot be accurately controlled, and the process is unstable; the samples of the water extraction and alcohol precipitation process All identification items can be detected, the content of active ingredients is high, and the difference in content is small, indicating that the process stability after alcohol precipitation is good.

Another preferred improvement of the present invention is to change boiling to wine extraction, and the preparation method includes the following steps:

Take the above five-flavored plum, iron-coated gold, rose apple, stinky jasmine and pandanus, add 95% ethanol for reflux extraction twice, combine the extracts, filter, and concentrate the filtrate until it has no alcohol smell, and obtain a thick paste product. Add auxiliary materials and mix to make 1000ml.

The oral liquid of the invention can effectively improve the bad taste and increase the patient's medication compliance. Due to the excellent taste of the preparation prescription, which improves the intrinsic value of the product, this preparation will occupy a certain advantage in the competition of similar products. The oral liquid of the present invention is suitable for use by people of all ages, especially when it is used in pediatrics, the taste is easy for children. Accepted, increase the scope of clinical use. In addition, the invention also effectively improves the clarity of the oral liquid, and solves the problem that the traditional Chinese medicine oral liquid is prone to precipitation after being placed for a period of time.

Compared with the prior art, the oral liquid of the present invention also has the advantages of good therapeutic effect, few side effects, quick effect, good taste, long drug shelf life, good stability, low cost, simpler preparation process, and saves time for preparing drugs, etc. Many advantages.

Detailed ways

The present invention will be further illustrated by the following specific examples, but not as a limitation of the present invention.

Embodiment 1, oral liquid

Gangmei 490g Iron clad gold 490g Rose apple 490g

Stinking jasmine 196g Pandanus 490g Sucrose 50g

Potassium sorbate 2g Potassium alginate 3g Distilled water to 1000ml.

Take the above five-flavored plum, iron-coated gold, rose peach, stinky jasmine and pandanus, add water to decoct twice, 24 hours each time, add 6 times the amount of medicinal materials each time, combine the extracts, concentrate, add The 95% medicinal ethanol is that the solution contains 70% alcohol, put it aside for 24 hours, filter, concentrate the filtrate, dry, pulverize into fine powder, add auxiliary materials, and mix to make 1000ml.

Embodiment 2, oral liquid

Gangmei 490g Iron clad gold 490g Rose apple 490g

Stinking jasmine 196g Pandanus 490g Sucrose 50g

Potassium sorbate 2g Potassium alginate 3g Distilled water to 1000ml.

Take the above five-flavored plum, iron-coated gold, rose peach, stinky jasmine and pandanus, and use 95% ethanol to reflux extract twice, add 10 times the amount for the first time, reflux extraction for 2 hours, filter, and dregs for the second time Add 8 times the amount, reflux extraction for 1 hour, filter, combine the filtrates, recover ethanol under reduced pressure until there is no alcohol smell, combine the extracts, filter, and concentrate the filtrate to a thick paste with a density of 1.15-1.20 (60°C thermal measurement), add The auxiliary materials are mixed to make 1000ml.

Embodiment 3, comprehensive curative effect evaluation:

Test group: the oral liquid of embodiment 1 and 2 of the present invention;

Existing granule control group: Shiqi Waigan Granules, produced by Zhongshan Hengsheng Pharmaceutical Co., Ltd., Z44020184. Specifications: 10g per bag, batch number: 20071201,

METHODS: Random blind method and positive drug parallel control were adopted.

Course of treatment: 3 days.

Dosing regimen: (1) Test group: 1 bottle (10ml/bottle) each time, 3 times a day; (2) Control group: 2 bags each time, 3 times a day.

The test results are as follows:

Comprehensive curative effect evaluation standard

Recovery: within 3 days of treatment, the body temperature returned to normal, and the symptoms and signs of colds decreased by ≥90%;

Significantly effective: within 3 days of treatment, the body temperature is normal, and the symptoms and signs of colds are reduced by ≥70%, <90%;

Effective: within 3 days of treatment, the body temperature is lower than before, and the score of cold symptoms and signs is reduced by ≥30%, <70%;

Ineffective: The body temperature did not drop or rise within 3 days of treatment, and the symptoms and signs of colds were less than 30%.

Comprehensive curative effect evaluation of TCM syndrome of cold and wind-heat: the effective rate of the test group (Example 1 of the present invention) is 90.17%; (Example 2 of the present invention) effective rate is 87.96%;

Comprehensive curative effect evaluation of TCM syndrome of common cold and heat-dampness: the effective rate of the test group (Example 1 of the present invention) is 91.45%; the effective rate of (Example 2 of the present invention) is 89.27%; the effective rate of the existing granule control group is 83.17%.

Criteria for judging curative effect of TCM syndromes

The formula for calculating curative effect index is (n)=(total score before treatment-total score after treatment)/total score before treatment×100% (nimodipine method)

Clinical recovery: curative effect index (integral value reduction) ≥ 95%;

Markedly effective: 70% ≤ curative effect index (integral value reduction) < 95%;

Effective: 30% ≤ curative effect index (integral value reduction) < 70%;

Ineffective: curative effect index (decrease in integral value) <30%.

Evaluation of the curative effect of traditional Chinese medicine cold and wind-heat syndrome: the effective rate of the test group (the embodiment 1 of the present invention) is 89.45%; the effective rate of (the embodiment 2 of the present invention) is 89.66%;

Evaluation of the curative effect of TCM cold and heat-dampness syndrome: the effective rate of the test group (Example 1 of the present invention) is 93.27%; (Example 2 of the present invention) effective rate is 89.22%; the effective rate of the existing granule control group is 88.07%.

Criteria for Judgment of Antipyretic Efficacy

Recovery: within 24 hours of treatment, the body temperature returned to normal without recurrence;

Significantly effective: within 24 hours of treatment, the body temperature drops ≥ 1.0°C, but not to normal;

Effective: Within 24 hours of treatment, the body temperature decreased by >0.5<1.0°C, but not to normal;

Ineffective: within 24 hours of treatment, the temperature drop is less than 0.5°C.

Comparison of antipyretic efficacy (24 hours) and antipyretic onset time

Anemopyretic cold comparison: test group (the embodiment of the present invention 1) antipyretic curative effect (24 hours) effective rate 83.78%; (the present invention 2) effective rate 78.28%; Existing granule control group effective rate 75.27%.

Shushi cold comparison: test group (embodiment 1 of the present invention) antipyretic curative effect (24 hours) effective rate 81.25%; (embodiment 2 of the present invention) effective rate 80.52%, existing granule control group effective rate 76.85%.

Efficacy evaluation of individual symptoms:

Headache: the effective rate of the test group (Example 1 of the present invention) is 90.24%; the effective rate of (Example 2 of the present invention) is 88.56%, and the effective rate of the existing granule control group is 86.10%.

Nausea: the effective rate of the test group (Example 1 of the present invention) is 96.25%; the effective rate of (Example 2 of the present invention) is 80.87%, and the effective rate of the existing granule control group is 89.38%.

Safety evaluation: The drug of Example 1 of the present invention has been checked for blood, urine, stool routine, liver function, kidney function and electrocardiogram before and after treatment. According to the test results of safety indicators before and after the test, no abnormalities in newly added laboratory inspection indicators were found. Appear.

Embodiment 4, oral liquid

Gangmei 245g Iron clad gold 245g Rose apple 245g

Smelly jasmine 98g Pandanus 245g Sucrose 2g

Potassium sorbate 1g Potassium alginate 1.5g Distilled water to 1000ml.

The preparation method selects the above-mentioned alcohol extraction or water extraction.

Embodiment 5, oral liquid

Gangmei 2980g Iron clad gold 980g Rose apple 980g

Stinking jasmine 392g Pandanus 980g Sucrose 100g

Potassium sorbate 4g Potassium alginate 6g Distilled water to 1000ml.

The preparation method selects the above-mentioned alcohol extraction or water extraction.

The preparation method selects the above-mentioned alcohol extraction or water extraction.

Embodiment 12, oral liquid

Gangmei 490g Iron clad gold 490g Rose apple 490g

Stinking jasmine 196g Pandanus 490g Stevioside 2.5g

Phenol 1.5g Potassium alginate 4g Distilled water to 1000ml.

Embodiment 6, oral liquid

Gangmei 490g Iron clad gold 490g Rose apple 490g

Stinking jasmine 196g Pandanus 490g Stevioside 4g

phenol 2g agar 3g distilled water to 1000ml

The preparation method selects the above-mentioned alcohol extraction or water extraction.

Embodiment 7, oral liquid

Gangmei 490g Iron clad gold 490g Rose apple 490g

Smelly feces jasmine 196g Pandanus 490g Xylitol 4g

ZTC1+1 2g agar 3g distilled water to 1000ml.

The preparation method selects the above-mentioned alcohol extraction or water extraction.

Embodiment 8, oral liquid

Gangmei 490g Iron clad gold 490g Rose apple 490g

Smelly feces jasmine 196g Pandanus 490g Xylitol 4g

ZTC1+1 2g dextrin 3g distilled water to 1000ml.

The preparation method selects the above-mentioned alcohol extraction or water extraction.

Embodiment 9, oral liquid

Gangmei 490g Iron clad gold 490g Rose apple 490g

Stinking jasmine 196g Pandanus 490g Stevioside 2g

Chitosan 1g Potassium alginate 1.5g Distilled water to 1000ml.

The preparation method selects the above-mentioned alcohol extraction or water extraction.

Embodiment 10, oral liquid

Gangmei 490g Iron clad gold 490g Rose apple 490g

Stinking jasmine 196g Pandanus 490g Stevioside 8g

Chitosan 4g Potassium alginate 6g Distilled water to 1000ml.

The preparation method selects the above-mentioned alcohol extraction or water extraction.

Embodiment 11, oral liquid

Gangmei 490g Iron clad gold 490g Rose apple 490g

Stinking jasmine 196g Pandanus 490g Stevioside 6g

Chitosan 2g Potassium alginate 5g Distilled water to 1000ml.

Claims (1)

1. stone qi diseases caused by exogenous pathogenic factor Chinese medicine oral liquid, be processed into by following raw material of Chinese medicine medicine and pharmaceutically acceptable carrier:

Flos Ilicis Asprellae 245-980g Radix berchemiae lineatae 245-980g Jambul 245-980g

Smelly dung jasmine 98-392g Pandanus tectorius (L.) Parkins. 245-980g sucrose 2-100g

Potassium sorbate 1-4g potassium alginate 1.5-6g distilled water 10-1000ml

The method for preparing step is following:

Get above five tastes Flos Ilicis Asprellae, Radix berchemiae lineatae, Jambul, smelly dung jasmine and Pandanus tectorius (L.) Parkins. add 95% alcohol reflux secondary, and merge extractive liquid, filters, and filtrating is concentrated into does not have the alcohol flavor, obtains thick paste shape product, adds adjuvant and is mixed and made into 1000ml.