CN1724040A - Chinese patent drug for treating infantile cold and repeated cold, and its prepn. method - Google Patents

Abstract

A Chinese medicine for treating infantile cold and repeated cold is prepared from 10 Chinese-medicinal materials including wild chrysanthemum flower, American ginseng, astragalus root, liquorice root through distilling wild chrysanthemum flower, reflux extraction of another three in alcohol, and decocting others.

Description

Chinese patent medicine for treating cold and recurrent cold in children and preparation method thereof

technical field

The invention belongs to the field of traditional Chinese medicines, and is a medicine for treating children's colds, especially recurrent children's colds and a preparation method thereof.

Background technique

In recent years, due to abnormal global climate change, air pollution, pathogen variation and other factors, the incidence of colds, especially children's colds, has been high, and children's repeated colds are increasing day by day. Children are weak and sickly, prone to colds, and easily aggravated and repeated. Modern medical research shows that the etiology of children's colds is more complicated. From the point of view of traditional Chinese medicine: children are in the body of immature yang, the yin qi is not strong, the yang qi is weak, the body is not full, the muscles are thin, and the external defense function is not solid; Evil, solid and recurrent disease, and the disease is easy to be full and easy to be empty, easy to cold and easy to heat. In short, the understanding of children with recurrent colds in traditional Chinese medicine and modern medicine is in the same vein. There are many Chinese and Western medicines for the treatment of children's colds at present, which are basically anti-inflammatory (detoxification), antipyretic (heat-clearing) and cough-relieving medicines, which play a role in relieving symptoms. As far as the current traditional Chinese medicine is concerned, the specificity of Chinese patent medicines for treating colds in children is relatively single. For example, "Ergan Tuirening Oral Liquid" on the market is mainly used for children with exogenous fever, headache, and cough, and "Xiaoer Kechuanling" is mainly used for children with upper respiratory tract infections. Respiratory tract infection, bronchitis, pneumonia. The treatment range of these medicines is generally narrower, especially to the disease of children's recurrent colds, there is no more ideal medicine at present.

Contents of the invention

The problem to be solved by the present invention is to provide a kind of medicine that is suitable for children with qi deficiency and frequent colds and the resulting fever, cough, asthma, and sore throat, that is, to provide a Chinese patent medicine for treating children with colds and recurrent colds and a preparation method thereof.

The applicant thinks that children's bodies are not full, their muscles are sparse and interstitial, their external defense functions are not solid, and they have not been able to adapt well to changes in the external climate, so they are particularly vulnerable to invasion by wind and evil. The treatment principles proposed by the applicant are: nourishing qi and dredging the exterior, clearing away heat and detoxification, relieving cough and relieving asthma, taking into account both strengthening the body and eliminating pathogenic factors.

Based on the above principles, the Chinese patent medicine for treating infantile colds and recurrent colds provided by the present invention is mainly made of the following raw materials in parts by weight:

5-15 parts of ghost needle grass, 5-15 parts of wild chrysanthemum, 1-4 parts of American ginseng, 20-40 parts of astragalus, 15-20 parts of isatidis root, 4-8 parts of peucedanum, 3-8 parts of Fritillaria, 1.5-4 parts of ephedra 4 parts, 4-8 parts of licorice, 9.5-12.5 parts of shiitake mushrooms.

All raw materials have good curative effect within the above range, and have been proved by clinical trials.

Among the above-mentioned medicines, Guizhengcao (see pages 219-220 of "Standards of Traditional Chinese Medicinal Materials in Hunan Province" published by Hunan Provincial Department of Health in 1993) and wild chrysanthemum are the king medicines. Ghost needle grass has the functions of sweating and relieving heat, clearing heat and detoxification, dispelling blood stasis and reducing swelling; wild chrysanthemum has the functions of dispelling wind and clearing heat, reducing swelling and detoxifying, the combination of the two medicines can strengthen each other to evacuate wind-heat, clear heat and detoxify, relieve throat pain, clear lung and relieve cough role;

American ginseng and astragalus are ministerial medicines. American ginseng is similar to ginseng in invigorating qi, but it is cool in nature, sweet in taste, and slightly bitter. Polydipsia. Therefore, the choice of American ginseng not only borrows its function of strengthening the body, but also because of its cool nature, it can strengthen the effect of clearing away heat and relieving cough. Astragalus can tonify deficiency and damage. Because of its light taste, it is specialized in expressing Qi, so it can nourish Yuanyang and replenish interstitial organs. It is especially suitable for colds due to physical deficiency. What needs to be explained here is: Regarding Astragalus, some people once thought that although Astragalus is good for health, it should not be used for fever caused by exogenous factors. In fact, it is not the case. Astragalus can stop spontaneous sweating for external deficiency, and at the same time it can relieve external evils without sweating, and it can also stimulate body fluid to help sweat. Therefore, American ginseng and astragalus are selected, one is mainly to nourish the inside, and the other is mainly to nourish the outside.

The combination of the above-mentioned monarch and minister medicines has formed the basic pattern of strengthening the body and eliminating the evil, eliminating the evil without hurting the body, strengthening the body without retaining the evil, this combination is just suitable for children with fever caused by exogenous factors that are not yet full of immature yang and immature yin. disease.

Banlangen, Peucedanum, Fritillaria, Ephedra, Licorice, and Mushrooms are used as adjuvant medicines. Among them, Qianhu can disperse wind-heat, and ephedra also has pungent and antipyretic effects. The two drugs are compatible with the monarch drug Guizhencao, antipyretic and sweating, and the effect of dispersing wind-heat is doubled; Compatibility can strengthen the heat-clearing and detoxifying effect; the compatibility of the four herbs of Fritillaria, Ephedra, Peucedanum, and Licorice can relieve cough, relieve asthma, and eliminate phlegm. Licorice and licorice are mainly used to relieve cough; shiitake mushrooms (see pages 181-182 of the second volume of "Guangxi Traditional Chinese Medicinal Materials Standards" 1996 edition of the Health Department of Guangxi Zhuang Autonomous Region) have the functions of nourishing stomach qi, reducing phlegm and regulating qi, and vitamin supplements. American ginseng and astragalus are used together to benefit lung qi and invigorate the spleen and stomach; licorice is also used medicinally, mainly to relieve cough, and can also adjust the flavor and reconcile various medicines.

There are many qi-enhancing medicines in this medicine combination, but the selected qi-invigorating medicines are warm but not dry, and the main qi-invigorating ingredient—American ginseng is also cool in nature, which has the effect of clearing lung heat and relieving cough, not only does not affect ghost needle grass, Radix Isatidis and wild chrysanthemum are both clear on the outside and inside, which will actually increase their effects. It can be seen that the above-mentioned combination makes the efficacy of each drug produce a synergistic effect, and a large number of clinical trials have also proved that its curative effect is very significant.

The American ginseng, astragalus root and shiitake mushroom selected in the present invention can also improve the ability of the human body to resist pathogenic factors, that is, it has the effect of enhancing the immunity of the human body.

The Fritillaria in the above-mentioned medicines is best to choose Fritillaria Fritillaria, because Fritillaria Fritillaria is more bitter and cold, has a strong excretory power, and has a stronger effect of clearing away fire and dissipating stagnation.

10-30 parts by weight of honey can also be added to the above-mentioned medicine as a flavoring agent. The honey itself also has the pharmacological effects of benefiting qi and invigorating the spleen, moistening the lung and relieving cough, and the medicine tastes better after being added. Of course, sucrose can also be used as a flavoring agent.

The preferred dosage range of the present invention is: 10-15 parts of ghost needle grass, 6-10 parts of wild chrysanthemum, 1.5-3 parts of American ginseng, 25-35 parts of astragalus, 15-20 parts of Radix Radix, 5-7 parts of Radix Peucedanum, Fritillaria fritillaria 3 to 5 parts, 1.5 to 2.5 parts of ephedra, 5 to 7 parts of licorice, and 9.5 to 11 parts of shiitake mushrooms.

The preferred dosage form of the present invention is oral liquid, and other oral dosage forms, such as syrup, granules, capsules, tablets, pills, etc. also belong to the category of the present invention.

Preferred dosage form of the present invention---the preparation method of oral liquid is:

1) Raw material preparation: Weigh ghost needle grass, wild chrysanthemum, American ginseng, astragalus, isatis root, peucedanum, fritillaria, ephedra, licorice, and shiitake mushrooms according to the weight ratio;

2) Extract volatile matter: take wild chrysanthemum, steam distill for 1.5 to 3 hours, collect the obtained volatile oil and distillate according to the volume ratio of 1:1, then add solubilizing agent, mix well and store in another device for later use; the solubilizing agent can preferably be polymerized Sorbitol -80.

3) Alcohol extraction:

3.1) Grind American ginseng, heat and reflux twice with 60% to 80% ethanol for 1.5 to 3 hours each time, combine the extracts, filter, recover the ethanol from the filtrate until it has no alcohol smell, and use the concentrated solution for later use;

3.2) Take ephedra and Fritillaria, heat and reflux twice with 70% to 85% ethanol, each time for 1 to 2 hours, combine the extracts, filter, recover the ethanol from the filtrate until it has no alcohol smell, and use the concentrated solution for later use;

4) Water extraction: take the remaining ghost needles, astragalus, isatidis, peucedanum, licorice, and shiitake mushrooms, mix them with the dregs of the above steps, add water to decoct twice, each time for 1.5 to 3 hours, combine the decoctions, and filter , concentrating the filtrate, ethanol precipitation, standing still, filtering the supernatant, recovering ethanol from the filtrate until it has no alcohol smell, and using the concentrated solution for later use;

5) Mix the above-mentioned standby medicinal liquids and concentrated liquids, adjust the pH value to 4.0-6.5 with sodium hydroxide solution, add water to the specified amount, and sterilize to obtain the oral liquid of the present invention.

When the flavoring agent needs to be added, the flavoring agent is added in the above-mentioned step 5), that is, the flavoring agent is added after each standby medicinal liquid and concentrated solution are mixed.

All the process parameters involved in the above preparation method are obtained after a large number of comparative tests. According to this method, the active ingredients in the medicine can be extracted to the greatest extent, and the quality of the obtained medicine is stable.

The oral liquid is a pure traditional Chinese medicine preparation, which has fast absorption, rapid drug effect, high active ingredient content, less dosage, good taste, safety, no side effects, and convenient administration, especially suitable for children.

The preparation steps 1), 2), 3) and 4) of the syrup of the present invention are the same as the steps 1), 2), 3) and 4) of the above-mentioned oral liquid preparation method, except that the correction agent added in step 5) The flavoring agent is 4.5-6.5 parts by weight of sucrose, which is boiled, dissolved, and concentrated into syrup, then mixed with each standby medicinal liquid and concentrated solution, adjusted to pH 4.0-6.5 with sodium hydroxide solution, and then added with water to The prescribed amount is sterilized to obtain the syrup of the present invention.

It is the same as steps 1), 2), 3) and 4) of the oral liquid preparation method, and step 5) is: mix the spare concentrated solution obtained in the above steps 3), 4) with the commonly used auxiliary materials for granules, and make soft material, granulated, dried, and then the volatile oil obtained in the above step 2) is dissolved in ethanol and sprayed on the aforementioned dried granules, mixed evenly, and packaged to obtain the granules of the present invention.

The standby volatile oil and concentrated solution obtained by above-mentioned steps 2), 3), and 4) can also be made into oral dosage forms such as tablets and pills of the present invention by adopting conventional methods. In the preparation of tablets and pills of the present invention, American ginseng and Fritillaria can also be ground into powder, and then mixed with other medicinal material extracts and common auxiliary materials.

Detailed ways

Example 1

12 parts of ghost needle grass, 8 parts of wild chrysanthemum, 2 parts of American ginseng, 30 parts of astragalus, 20 parts of Radix Radix, 6 parts of peucedanum, 4 parts of fritillaria, 2 parts of ephedra, 6 parts of licorice, 10 parts of shiitake mushrooms, and 20 parts of honey.

The preparation method of its oral liquid is:

1) Take the wild chrysanthemum flower, steam distill it for 2 hours, collect the obtained volatile oil and distillate according to the volume ratio of 1:1, then add the solubilizing agent - polysorbate-80, mix well and store in another device for later use;

3) Take American ginseng and grind it into a coarse powder, heat and reflux twice with 70% ethanol for 2 hours each time, combine the extracts, filter, recover the ethanol from the filtrate until it has no alcohol smell, and prepare the liquid for later use;

4) Take ephedra and Fritillaria, heat and reflux twice with 80% ethanol for 1 hour each time, combine the extracts, filter, recover the ethanol and concentrate under reduced pressure until there is no alcohol smell, and the liquid medicine is set aside;

5) Take the remaining ghost needles, astragalus, isatidis, peucedanum, licorice, and shiitake mushrooms, mix them with the dregs of the above steps, add water and decoct twice for 2 hours each time, combine the decoctions, filter, and concentrate the filtrate to For the clear ointment with a relative density of 1.1-1.2 (60°C), add ethanol until the alcohol content reaches 60%, let it stand, filter, recover the ethanol from the filtrate until it has no alcohol smell, and prepare the liquid medicine for later use;

6) Mix the above-mentioned standby medicinal liquids and concentrates, then add 20 parts of honey, stir well, adjust the pH value to 6.5 with 2mol/L sodium hydroxide solution, add water to the specified amount, and sterilize to obtain the present invention. Oral solution for treating colds and recurrent colds in children.

Example 2

Take 5 parts of ghost needle grass, 15 parts of wild chrysanthemum, 1 part of American ginseng, 40 parts of astragalus, 15 parts of Radix Isatidis, 8 parts of peucedanum, 8 parts of fritillaria, 4 parts of ephedra, 8 parts of licorice, 12.5 parts of shiitake mushrooms, and 20 parts of honey . The preparation method of its oral liquid is with example 1.

Example 3

Take 15 parts of ghost needle grass, 5 parts of wild chrysanthemum, 4 parts of American ginseng, 20 parts of astragalus, 15 parts of Radix Radix, 4 parts of peucedanum, 3 parts of fritillaria, 1.5 parts of ephedra, 4 parts of licorice, 11 parts of shiitake mushrooms, and 20 parts of honey . The preparation method of its oral liquid is with example 1.

Example 4

Take 11 parts of ghost needle grass, 11 parts of wild chrysanthemum, 3 parts of American ginseng, 35 parts of astragalus, 17 parts of Radix Isatidis, 5 parts of peucedanum, 6 parts of fritillaria, 3 parts of ephedra, 6 parts of licorice, 9.5 parts of shiitake mushrooms, and 20 parts of honey . The preparation method of its oral liquid is with example 1.

The applicant has proved through a large number of clinical trials that the above embodiments can all achieve good results.

Toxicity test

The test drug is the preparation of the present invention, and every 1ml of oral liquid contains 1g of the original medicinal material. The test animals are ICR white mice, weighing 20g±2g, male and female, 20 in total. Test unit: Institute of Clinical Pathology, Xi'an Jiaotong University. The test method is: after 12 hours of fasting, 20g/Kg (120 times of the recommended clinical dose) is given to mice orally, and then observed for 7 days, no obvious toxicity is seen. According to the dose of 10g/Kg, the mice were continuously gavaged for 3 months, and no abnormalities were found. Show that the safety of the drug is large, belonging to non-toxic level.

Clinical Trials

The subjects of the test were children diagnosed with upper respiratory tract infection; the curative effect was determined according to the "Cold and Influenza Diagnosis Key Points and Prevention and Control Effect Judgment Standard (Draft)" formulated by the National Collaborative Symposium on Prevention and Control of Cold Research; the test unit was Shaanxi Academy of Traditional Chinese Medicine Four hospitals including the Affiliated Hospital and the First Affiliated Hospital of Xi'an Jiaotong University; the experimental method adopts a parallel control design and is randomly divided into groups. Test group takes oral liquid of the present invention, and specification is 10ml/ supports. Under 1 year old, take 1/2 stick each time, 3 times a day; 1-3 years old, take 1 stick each time, 3 times a day; 3-6 years old, take 1 stick each time, 4 times a day; 6-12 years old, take 1 stick each time, 4 times a day; 1 stick each time, 5 times a day. The control group took "Qingrejiedu Oral Liquid", produced by Luoyang Minsheng Pharmaceutical Factory in Henan Province.

The clinical trial results are as follows:

1) Acute upper flu: A total of 152 cases were observed, and the results are shown in Table 1.

Table 1 group Number of cases get well markedly effective efficient invalid total effective rate test group 152 95 (62.5%) 34 (22.4%) 15 (9.9%) 8 (5.2%) 94.8%

The total effective rate of the control group was 84.4%.

2) Frequent colds in children: A total of 112 cases were observed in the test group, the results are shown in Table 2

Table 2 group Number of cases get well markedly effective efficient invalid total effective rate test group 112 43 (38.4%) 43 (38.4%) 16 (14.3%) 10 (8.9%) 91.1%

The total effective rate of the control group was 86.0%.

As can be seen from the above, the curative effect of the present invention is remarkable, especially the effective rate of treating common colds in children reaches 91.1%.

The oral liquid of the present invention shows through the pharmacodynamics test that Xi'an Jiaotong University Institute of Clinical Pharmacology carries out: this oral liquid has significant antipyretic, analgesic, antitussive effect, obvious anti-inflammatory effect, and the effect of significant relaxation bronchial smooth muscle (That is, there is an antiasthmatic effect). The oral liquid has a strong broad-spectrum antiviral effect, especially a more significant effect on respiratory virus, but not obvious effect on adenovirus. Tests also show that the oral liquid has a significant effect of enhancing cellular immune function.

Claims (10)

1. A Chinese patent medicine for treating infantile colds and recurrent colds, characterized in that it is mainly made of the following raw materials in parts by weight: 5-15 parts of ghost needle grass, 5-15 parts of wild chrysanthemum, 1-4 parts of American ginseng, 20-40 parts of astragalus, 15-20 parts of isatidis root, 4-8 parts of peucedanum, 3-8 parts of Fritillaria, 1.5-4 parts of ephedra 4 parts, 4-8 parts of licorice, 9.5-12.5 parts of shiitake mushrooms. 2. The Chinese patent medicine according to claim 1, characterized in that the dosage of each raw material is: 10-15 parts of ghost needle grass, 6-10 parts of wild chrysanthemum, 1.5-3 parts of American ginseng, 25-35 parts of astragalus, Radix Radix 15-20 parts, 5-7 parts Peucedanum, 3-5 parts Fritillaria, 1.5-2.5 parts ephedra, 5-7 parts licorice, 9.5-11 parts mushrooms. 3. The Chinese patent medicine according to claim 1 or 2, characterized in that the crude drug also contains 10-30 parts by weight of honey. 4. The Chinese patent medicine according to claim 1 or 2, characterized in that the crude drug also contains 4.5-6.5 parts by weight of sucrose. 5. The Chinese patent medicine according to claim 1 or 2, characterized in that said fritillaria is fritillary fritillaria. 6. The Chinese patent medicine according to claim 3, characterized in that said fritillaria is fritillary fritillaria. 7. The Chinese patent medicine according to claim 4, characterized in that said fritillaria is fritillary fritillaria. 8. The Chinese patent medicine according to claim 6, characterized in that the dosage of each raw material is: 12 parts of ghost needle grass, 8 parts of wild chrysanthemum, 2 parts of American ginseng, 30 parts of astragalus, 20 parts of Radix Radix, 6 parts of peucedanum, 4 parts of fritillaria, 2 parts of ephedra, 6 parts of licorice, 10 parts of shiitake mushrooms, and 20 parts of honey. 9. The method for preparing oral liquid of Chinese patent medicine according to claim 1, characterized in that it comprises the following steps: 1) Raw material preparation: Weigh ghost needle grass, wild chrysanthemum, American ginseng, astragalus, isatis root, peucedanum, fritillaria, ephedra, licorice, and shiitake mushrooms according to the weight ratio; 2) Extract volatile matter: take wild chrysanthemum, steam distill for 1.5 to 3 hours, collect the obtained volatile oil and distillate according to the volume ratio of 1:1, then add solubilizer, mix well and store in another device for later use; 3) Alcohol extraction: 3.1) Grind American ginseng, heat and reflux twice with 60% to 80% ethanol for 1.5 to 3 hours each time, combine the extracts, filter, recover the ethanol from the filtrate until it has no alcohol smell, and use the concentrated solution for later use; 3.2) Take ephedra and Fritillaria, heat and reflux twice with 70% to 85% ethanol, each time for 1 to 2 hours, combine the extracts, filter, recover the ethanol from the filtrate until it has no alcohol smell, and use the concentrated solution for later use; 4) Water extraction: take the remaining ghost needles, astragalus, isatidis, peucedanum, licorice, and shiitake mushrooms, mix them with the dregs of the above steps, add water to decoct twice, each time for 1.5 to 3 hours, combine the decoctions, and filter , concentrating the filtrate, ethanol precipitation, standing still, filtering the supernatant, recovering ethanol from the filtrate until it has no alcohol smell, and using the concentrated solution for later use; 5) Mix the above-mentioned standby medicinal liquids and concentrated liquids, adjust the pH value to 4.0-6.5 with sodium hydroxide solution, add water to the specified amount, and sterilize to obtain the oral liquid of the present invention. 10. The preparation method of oral liquid according to claim 9, characterized in that in step 6), after mixing the above-mentioned spare medicinal liquids, add 10-30 parts of honey, stir well, and then adjust the pH value to 4.0-6.5 .