A Qiaoqi compound preparation, its preparation method and uses

Abstract

The present invention discloses a Qiaoqi compound preparation, its preparation method and uses. The components of the traditional Chinese medicine formula are composed of raw materials or raw material extracts in the following parts by mass: 9-11 parts of honeysuckle, 9-11 parts of forsythia suspensa, 9-11 parts of scutellaria baicalensis, 9-11 parts of artemisia annua, 9-11 parts of astragalus membranaceus, 9-11 parts of stir-fried atractylodes macrocephala, 9-11 parts of pogostemon cablin, 5-7 parts of ledebouriella seseloides, 9-11 parts of ophiopogon japonicus, and 5-7 parts of licorice. It can be made into oral liquid, granules, infusion, tablets. The present invention also discloses the application of the Qiaoqi compound preparation in the preparation of drugs for preventing and / or treating viral influenza diseases. Through the composition of the drug formula, the present invention produces a strong combined antiviral effect of drugs, and at the same time enhances the immune function of the human body, achieving a good integrated and synergistic antiviral effect.

Description

Technical Field

[0001] The present invention relates to a Qiaogi compound preparation, its preparation method and use, belonging to the field of pharmaceutical technology. Background Art

[0002] Influenza (abbreviated as flu) is mainly a respiratory infection caused by influenza virus, which is highly contagious and spreads rapidly. Typical clinical symptoms are: fever, headache, limb soreness, sneezing, dry throat, sore throat, cough, and fatigue.

[0003] At present, there is no specific medicine for the treatment of influenza clinically. The prevalence of influenza endangers social public health safety and people's health. Therefore, the research and development of new drugs for viral influenza is a major demand of today's society and also a major demand for people's livelihood and health. Summary of the Invention

[0004] Objective: To solve the deficiencies of the prior art, the present invention provides a Qiaogi compound preparation, its preparation method and use.

[0005] Technical Solution: To solve the above technical problems, the technical solution adopted by the present invention is as follows:

[0006] In the first aspect, a Qiaogi compound preparation is provided, including a traditional Chinese medicine formula component, and the traditional Chinese medicine formula component is composed of the following raw materials or raw material extracts in parts by mass: 9-11 parts of honeysuckle, 9-11 parts of forsythia, 9-11 parts of scutellaria baicalensis, 9-11 parts of artemisia annua, 9-11 parts of astragalus membranaceus, 9-11 parts of stir-fried atractylodes macrocephala, 9-11 parts of agastache rugosa, 5-7 parts of ledebouriella seseloides, 9-11 parts of ophiopogon japonicus, 5-7 parts of licorice.

[0007] As a preferred embodiment, for the Qiaogi compound preparation, the traditional Chinese medicine formula component is composed of the following components in parts by mass: 10 parts of honeysuckle, 10 parts of forsythia, 10 parts of scutellaria baicalensis, 10 parts of artemisia annua, 10 parts of astragalus membranaceus, 10 parts of stir-fried atractylodes macrocephala, 10 parts of agastache rugosa, 6 parts of ledebouriella seseloides, 10 parts of ophiopogon japonicus, 6 parts of licorice.

[0008] In some embodiments, the Qiaogi compound preparation includes an effective dose of the traditional Chinese medicine formula component and pharmaceutically acceptable excipients.

[0009] In some embodiments, the dosage forms of the Qiaogi compound preparation include oral liquid, granule, infusion, and tablet.

[0010] In the second aspect, a preparation method of Qiaogi oral liquid is provided, including:

[0011] (1) Prepare raw materials according to the formula ratio: 10 parts of honeysuckle, 10 parts of forsythia, 10 parts of scutellaria baicalensis, 10 parts of artemisia annua, 10 parts of astragalus membranaceus, 10 parts of stir-fried atractylodes macrocephala, 10 parts of agastache rugosa, 6 parts of ledebouriella seseloides, 10 parts of ophiopogon japonicus, 6 parts of licorice; rinse the medicinal materials with water to remove impurities;

[0012] (2) Soak in deionized water at 25°C for 120 minutes;

[0013] (3) Extract with water at 100°C for 20 minutes;

[0014] (4) Take the decoction, let it stand at 4°C for 12 hours, filter, concentrate, and add benzoic acid or sodium benzoate;

[0015] (5) Seal and sterilize to obtain the product.

[0016] Thirdly, a method for preparing Qiaoqi granules is provided, including:

[0017] (1) Prepare raw materials according to the formula ratio: 10 parts of honeysuckle, 10 parts of forsythia, 10 parts of scutellaria baicalensis, 10 parts of artemisia annua, 10 parts of astragalus membranaceus, 10 parts of stir-fried atractylodes macrocephala, 10 parts of pogostemon cablin, 6 parts of ledebouriella seseloides, 10 parts of ophiopogon japonicus, 6 parts of licorice; Rinse the medicinal materials with water to remove impurities;

[0018] (2) Soak in deionized water at 25°C for 120 minutes;

[0019] (3) Extract with water at 100°C for 20 minutes;

[0020] (4) Take the decoction, let it stand at 4°C for 12 hours, filter, concentrate, and add benzoic acid or sodium benzoate;

[0021] (5) Dry, granulate, package, and sterilize to obtain the product.

[0022] Fourthly, the application of the described Qiaoqi compound preparation in the preparation of drugs for preventing and / or treating viral influenza diseases is provided.

[0023] The monarch drugs of this formula: honeysuckle, forsythia, scutellaria baicalensis, artemisia annua; minister drugs: astragalus membranaceus, stir-fried atractylodes macrocephala, pogostemon cablin; assistant drugs: ledebouriella seseloides, ophiopogon japonicus; envoy drug, licorice.

[0024] The functions of this formula are: clearing heat and detoxifying, inhibiting virus activity, nourishing yin and relieving cough, tonifying the lung and spleen, strengthening the healthy qi and clearing away pathogenic factors of pestilence. It is applicable to influenza, fever, headache, limb soreness, sore throat, cough, and fatigue.

[0025] Beneficial effects: The compound preparation of Qiaoqi provided by the present invention and its preparation method and use are compared with the existing Chinese medicines such as Zhengchaihuyin Granules, Banlangen Granules, Lianhua Qingwen Capsules, Shuanghuanglian Oral Liquid, etc.: 1. The drug composition of this prescription is different from the existing related Chinese medicines, and the drug formula composition is unique and novel; 2. The innovative point of the drug efficacy of this prescription is that through the drug formula composition, a stronger drug combined antiviral effect is produced, while the human immune function is enhanced to achieve a better integrated synergistic antiviral effect. For example, honeysuckle, forsythia, and scutellaria have antiviral effects. This prescription uses three Chinese medicines in combination to enhance the antiviral effect of the drug. At the same time, the astragalus and licorice in this prescription can play a better integrated synergistic antiviral effect by regulating the human immune function, and effectively inhibit the activity of the virus to relieve the patient's symptoms and achieve the effect of strengthening the body and eliminating evil; 3. The theory of dialectical treatment of influenza in this prescription is unique and innovative. Its innovative point is to propose "nourishing yin and relieving cough, benefiting the lungs and spleen, and strengthening the body and clearing away the plague" on the basis of traditional heat-clearing and detoxification. For example, honeysuckle, forsythia, scutellaria, and artemisia annua enter the lung, stomach, liver, gallbladder, and large intestine meridians, and have the effects of clearing away heat and detoxifying, clearing the lungs and relieving cough; astragalus, stir-fried atractylodes, and patchouli have the effects of tonifying qi and benefiting the spleen, and enhance the body's resistance; Saposhnikovia divaricata is combined with astragalus and atractylodes, namely Yupingfeng Powder, which has the effects of tonifying qi, strengthening the exterior, and enhancing the body's immune function, and plays a role in strengthening the body; artemisia annua reduces fever, while patchouli has an aromatic effect that clears turbidity, clears the lungs and relieves cough; Ophiopogon japonicus nourishes yin and produces body fluid, moistens the lungs and relieves cough; licorice tonifies the spleen and benefits qi, clears heat and detoxifies, harmonizes all the medicines, and exerts a synergistic effect. DETAILED DESCRIPTION

[0026] The present invention is specifically described below in conjunction with embodiments:

[0027] Example 1: Preparation of Qiaoqi Oral Liquid

[0028] The original ingredients are as follows: 100 parts of honeysuckle, 100 parts of forsythia, 100 parts of scutellaria, 100 parts of artemisia annua, 100 parts of raw astragalus, 100 parts of stir-fried atractylodes, 100 parts of patchouli, 60 parts of siler, 100 parts of ophiopogon, and 60 parts of licorice.

[0029] Preparation method and steps:

[0030] (1) Rinse the medicinal materials with water to remove impurities;

[0031] (2) Prepare 1000 parts by volume and soak in deionized water at 25°C for 120 minutes;

[0032] (3) Water extraction, 100°C, decocting for 20 minutes;

[0033] (4) Take the decoction, let it stand at 4°C for 12 hours, filter, concentrate, and add benzoic acid or sodium benzoate;

[0034] (5) Filling and sterilization.

[0035] Example 2: Preparation of Qiaoqi Granules

[0036] The original formula ingredients are as follows: 100 parts of honeysuckle, 100 parts of forsythia, 100 parts of scutellaria baicalensis, 100 parts of artemisia annua, 100 parts of astragalus membranaceus, 100 parts of stir-fried atractylodes macrocephala, 100 parts of agastache rugosa, 60 parts of ledebouriella seseloides, 100 parts of ophiopogon japonicus, 60 parts of licorice.

[0037] Preparation method and steps:

[0038] (1) Rinse the medicinal materials with water to remove impurities;

[0039] (2) Prepare 1000 volume parts, soak with deionized water at 25 °C for 120 minutes;

[0040] (3) Extract with water at 100 °C and decoct for 20 minutes;

[0041] (4) Take the decoction, let it stand at 4 °C for 12 hours, filter, concentrate, and add benzoic acid or sodium benzoate;

[0042] (5) Dry, granulate, package, and sterilize to obtain the product.

[0043] Example 3: Effect of Qiaoqi Granules on Lung Lesions in Mice Infected with Influenza Virus

[0044] Materials: Qiaoqi Granules are prepared into stock solution (15.6 g of crude drug / kg); ribavirin (positive control drug, 0.075 g / kg); chicken embryos, influenza A virus FM1 strain, ICR mice.

[0045] Method: Randomly divide the mice into 4 groups, with 6 mice in each group, namely the normal group, the model group, the ribavirin group, and the Qiaogi Granules group. Administer the drug by gavage twice a day, 0.3 ml each time. The normal group is given the same dose of double-distilled water for 5 consecutive days. Infect by dripping the virus allantoic fluid into the nasal cavity, with an attack dose of 15 LD50 for each mouse. On the 6th day, decapitate the mice to death, fix them with 10% formaldehyde solution, take samples routinely, dehydrate, embed in paraffin, stain with HE, and read the slides under a light microscope. According to the different degrees of mild, moderate, and severe lesions, assign values of 0, 1, 2, 3, and 4 respectively, calculate the lesion score and perform statistical analysis. Use the rank sum test, and the statistical software SPSS13.0 is used.

[0046] Results:

[0047] Table Effect of Qiaogi Granules on the Degree of Lung Lesions in Mice Infected with Influenza Virus (n = 6)

[0048]

[0049]

[0050] Note: (1) In different tissue lesions, there were statistically significant differences between the model group, ribavirin group, Qiaoqi Granule group and the normal group (P < 0.05). (2) There was no statistically significant difference between the ribavirin group and the Qiaqi Granule group (P > 0.05).

[0051] The results showed that Qiaqi Granule had the effect of alleviating lung lesions in mice caused by influenza virus.

[0052] Example 4:

[0053] General information: From September 2019 to February 2020, for clinical influenza patients who met the following symptoms (fever, headache, limb soreness, dry throat, sore throat, cough), they were enrolled and treated with oral administration of Qiaqi Granule. There were 30 patients, aged 19 - 60 years old. One dose of traditional Chinese medicine was taken every day, orally twice in the morning and evening, and taken continuously for 3 - 5 days. There were 30 patients in the control group, and an open parallel and conventional treatment control was set up.

[0054] Clinical efficacy criteria: Within 3 days of continuous medication, the body temperature returned to normal, the symptoms of headache, limb soreness, dry throat, sore throat, and cough were significantly relieved, the blood picture was normal, and the chest X-ray image was normal. The markedly effective and relieved cases were combined as effective, and the effective rate reached 87%.

[0055] The present invention has been disclosed in the above preferred embodiments, but it is not intended to limit the present invention. Any technical solutions obtained by using equivalent substitutions or equivalent transformations fall within the protection scope of the present invention.

Claims

1. A Qiaogi compound preparation, characterized in that, The traditional Chinese medicine formula components are composed of raw materials or raw material extracts in the following parts by mass: 10 parts of honeysuckle, 10 parts of forsythia, 10 parts of scutellaria baicalensis, 10 parts of artemisia annua, 10 parts of astragalus membranaceus, 10 parts of stir-fried atractylodes macrocephala, 10 parts of pogostemon cablin, 6 parts of ledebouriella seseloides, 10 parts of ophiopogon japonicus, and 6 parts of licorice.

2. The Qiaogi compound preparation according to claim 1, wherein It includes the above-mentioned traditional Chinese medicine formula components and pharmaceutically acceptable excipients.

3. The Qiaogi compound preparation according to claim 2, wherein The dosage form of the forsythia and astragalus compound preparation is oral liquid, granule, infusion, or tablet.

4. A preparation method of Qiaoqi Oral Liquid, characterized in that, It includes: (1) Prepare raw materials according to the formula ratio: 10 parts of honeysuckle, 10 parts of forsythia, 10 parts of scutellaria baicalensis, 10 parts of artemisia annua, 10 parts of astragalus membranaceus, 10 parts of stir-fried atractylodes macrocephala, 10 parts of pogostemon cablin, 6 parts of ledebouriella seseloides, 10 parts of ophiopogon japonicus, and 6 parts of licorice; rinse the medicinal materials with water to remove impurities. (2) Soak with deionized water at 25°C for 120 minutes. (3) Perform water extraction at 100°C and decoct for 20 minutes. (4) Take the decoction, let it stand at 4°C for 12 hours, filter, concentrate, and add benzoic acid or sodium benzoate. (5) Seal and sterilize to obtain the product.

5. A preparation method of Qiaoqi granules, characterized in that, It includes: (1) Prepare raw materials according to the formula ratio: 10 parts of honeysuckle, 10 parts of forsythia, 10 parts of scutellaria baicalensis, 10 parts of artemisia annua, 10 parts of astragalus membranaceus, 10 parts of stir-fried atractylodes macrocephala, 10 parts of pogostemon cablin, 6 parts of ledebouriella seseloides, 10 parts of ophiopogon japonicus, and 6 parts of licorice; rinse the medicinal materials with water to remove impurities. (2) Soak with deionized water at 25°C for 120 minutes. (3) Perform water extraction at 100°C and decoct for 20 minutes. (4) Take the decoction, let it stand at 4°C for 12 hours, filter, concentrate, and add benzoic acid or sodium benzoate. (5) Dry, granulate, package, and sterilize to obtain the product.

6. Use of the forsythia and astragalus compound preparation according to any one of claims 1 - 3 in the preparation of a drug for preventing and / or treating viral influenza.

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