New application of arnebiaceae cynoglossum plant and extract thereof

Abstract

The invention belongs to the technical field of medicines, relates to a shikonaceae cynoglossum plant and a new application of an extract of the shikonaceae cynoglossum plant, and in particular relates to an application of the shikonaceae cynoglossum plant and / or the extract of the shikonaceae cynoglossum plant in preparing a medicine for treating allergic diseases. Wherein the allergic diseases comprise various allergic diseases such as allergic rhinitis or syndrome, allergic asthma, allergic tracheitis, allergic skin diseases (eczema, urticaria and dermatitis) and the like. The preparation prepared by taking the shikonaceae cynoglossum plant and the extract thereof as active ingredients has a remarkable curative effect on the allergic diseases, can radically cure the allergic diseases, and is safe and free of side effects. The traditional Chinese medicine belongs to natural medicinal materials and is wide in source, so that a new choice is provided for clinically treating the disease.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medicine, and particularly relates to a new use of a plant of the genus Lysimachia in the family of Lamiaceae and an extract thereof. BACKGROUND

[0002] Allergic diseases, also known as allergic diseases, are non-infectious inflammatory diseases caused by abnormal immune response of the body to allergens and mediated by mast cells / basophils. Allergic diseases are common and frequently-occurring diseases. The epidemiological survey released by the World Health Organization (WHO) shows that the prevalence of allergic diseases has increased dramatically in the global population, and now has affected 30%-40% of the world population. The 2022 China Allergic Disease Epidemiology Survey Report shows that the incidence in China is more than 30%, with 300-400 million patients nationwide. Allergic diseases have been listed as the sixth chronic disease in the world and as one of the three major diseases to be researched and prevented in the 21st century by the World Health Organization. Allergic diseases can affect the whole body, causing harm to multiple systems and organs, and affecting an individual's daily life, including sleep, work, social interaction, etc. In addition, allergic diseases also bring heavy social and economic burden. For example, allergic asthma in Beijing, China, causes social and economic losses of nearly 3.5 billion yuan per year.

[0003] Allergic diseases mainly include allergic rhinitis, allergic asthma, allergic bronchitis, allergic skin diseases (eczema, urticaria, dermatitis), etc.

[0004] At present, the treatment of allergic diseases includes:

[0005] (1) Traditional therapy (or called conventional therapy): This is the treatment method for treating allergic diseases that has been used for many years. Commonly used treatment drugs include glucocorticoids, antihistamines, leukotriene receptor antagonists, anticholinergic drugs, traditional Chinese medicines, etc. This therapy can only relieve symptoms, has poor compliance, has serious side effects, and cannot be cured, so patients need to take it for life.

[0006] (2) Anti-IgE therapy: Anti-IgE therapy is a new therapy for treating moderate-to-severe allergic asthma, allergic rhinitis, and allergic skin diseases, etc. in recent years. The drug used is omalizumab produced by Novartis, Switzerland. According to the 2022 China Expert Consensus on Omalizumab Treatment of Allergic Asthma, the treatment of allergic diseases by omalizumab requires:

[0007] 1. Course of treatment: Omalizumab treatment is divided into efficacy evaluation period and continuous treatment period.

[0008] (1) Efficacy evaluation period: The efficacy is comprehensively evaluated after 16 weeks of initial treatment, but it is not recommended to stop the medication within 1 year; if there is still no significant improvement, then use should be discontinued. (2) Continuous treatment period: If the symptoms improve after the efficacy evaluation period, then treatment should continue for more than 12 months, and it is generally recommended to treat for 12-18 months.

[0009] 2. Administration, Dosage, and Cost: Serum total IgE is measured before treatment begins. The dosage and frequency are calculated based on the patient's weight. Each dose is 75-600 mg, administered subcutaneously in 1-4 divided doses as needed, once every 2 or 4 weeks. Generally, patients aged 6-12 years receive 1-2 vials per month, while those over 12 years and adults receive 4 vials per month. Omalizumab (150 mg / vial) costs approximately 1500 yuan per vial on average, resulting in approximately 6000 yuan per month for adults, totaling over 70,000 yuan per year.

[0010] 3. Combination with other drugs: During the use of omalizumab, the dosage of hormones and antihistamines can be reduced, but they cannot be completely discontinued.

[0011] 4. Efficacy of Omalizumab: Omalizumab can significantly improve symptoms, reduce the frequency of acute attacks, reduce the dosage of glucocorticoids and other drugs, improve quality of life, and has a modulatory effect on antiviral immunity.

[0012] As the level of omalizumab in the body gradually decreases or even disappears, the patient's allergic disease will still relapse, so it cannot be cured, nor can the use of glucocorticoids and other drugs be stopped. Moreover, the cost is expensive, with the annual treatment cost for adults exceeding 70,000 yuan.

[0013] (III) Immunotherapy: Immunotherapy is a first-line treatment for allergic diseases and is clinically recommended. It is a causal treatment targeting allergic diseases. Immunotherapy involves extracting, weakening, and attenuating the patient's allergen (such as mites) to create a vaccine. This vaccine is administered subcutaneously or sublingually over 2-3 years to gradually stimulate the body's immune tolerance, ultimately achieving desensitization to the allergen and curing the disease. The main problems with this therapy are: 1. The treatment course is too long. It requires continuous treatment for 2-3 years, which many patients find difficult to adhere to. 2. Many scholars claim that this is the only treatment that can cure allergic diseases. However, in reality, after 2-3 years of treatment, symptoms are only maintained for 8-10 years, or the symptoms are mild. After 8-10 years, treatment must continue, so it cannot be considered a cure. Moreover, most patients often have more than one allergen, making a complete cure extremely difficult. 3. The treatment cost is high. Injectable immunotherapy costs more than 10,000 yuan per year.

[0014] The aforementioned main clinical treatments cannot cure allergic diseases, and they are lengthy and expensive. Zhang Luo, president of Beijing Tongren Hospital, chairman of the Chinese Medical Association's Allergy Branch, and a leading expert in allergy science in my country, stated that allergic diseases are "incurable." This is also a consensus in the global medical community.

[0015] Plants belonging to the genus *Cynoglossum* (also known as the genus *Cynoglossum*, but all with the Latin name *Cynoglossum*) in the Boraginaceae family, according to the *Flora of China* and other sources, comprise about 28 species worldwide, with more than ten found in my country. Plants in the genus *Cynoglossum* have similar morphology and medicinal properties. Among them, the most widely distributed and representative plants are *Cynoglossum zeylanicum*, *Cynoglossum var. zeylanicum*, and *Cynoglossum var. zeylanicum*. According to the *National Compendium of Traditional Chinese Medicine*, *Cynoglossum zeylanicum* (Vahl) Thunb. ex Lehm. is an annual herb, commonly known in folk medicine as *Tiegu San*, *Lanlu Hu*, *Nian Nian Cao*, *Nian Niang Niang*, *Zhu Weiba*, and *Da Liuli Cao*. *Cynoglossum zeylanicum* is slightly bitter and cold in nature; it clears heat and dampness, invigorates blood, and regulates menstruation. It is mainly used to treat hepatitis, irregular menstruation, leukorrhea, and edema. Externally, it is often used to treat boils, carbuncles, snake bites, traumatic injuries, and fractures. *Cynoglossum lanceolatum* Forsk., the whole plant and root are used medicinally. It clears heat and detoxifies, promotes diuresis and reduces swelling, and invigorates blood circulation. It is mainly used to treat acute nephritis and irregular menstruation; externally, it is used to treat carbuncles, boils, and snake bites. *Cynoglossum amabile* Stapfet Drumm., a perennial herb, is commonly known by various folk names such as Blue Skirt, Dog Shit Flower, Dog Shit Radish, Dog Shit Blue Flower, Bone-Stick Powder, Big Fat Root, Roadblock Tiger, Chicken Claw Ginseng, One Handful, Green Flower Leaf, Green Flower Heart, Seven Star Arrow [Chongqing], Blue Flower Ginseng [Yunnan Honghe], etc. *Cynoglossum amabile* is sweet, bitter, and cool in nature, clearing heat and promoting diuresis, dispersing blood stasis and stopping bleeding, and relieving cough. It is used for malaria, hepatitis, dysentery, dysuria, leukorrhea, and cough due to pulmonary tuberculosis; externally, it is used to treat traumatic bleeding, fractures, and joint dislocations.

[0016] Plants of the genus *Hylocereus* in the Boraginaceae family are morphologically very similar, and it is generally difficult to distinguish them without careful examination or by non-professionals, especially when purchasing dried products. In fact, when purchasing medicinal materials from the public, whether it's *Hylocereus* var. *glabra*, *Hylocereus simonii*, or *Hylocereus invertedus*, they are basically mixtures of plants of the genus *Hylocereus*, primarily *Hylocereus*, *Hylocereus simonii*, or *Hylocereus invertedus*. This invention refers to plants of the genus *Hylocereus*, or mixtures thereof, primarily composed of *Hylocereus*, *Hylocereus simonii*, or *Hylocereus invertedus*, as collectively referred to as plants of the genus *Hylocereus* in the Boraginaceae family. In terms of efficacy, plants of the genus *Hylocereus* in the Boraginaceae family are very similar, all possessing the effects of clearing heat and dampness, reducing inflammation and relieving pain, and promoting blood circulation and removing blood stasis. However, there are currently no reports on the use of plants of the genus *Hylocereus* or their extracts as raw materials, or on the application of drug compositions containing plants of the genus *Hylocereus* or their extracts in the treatment of allergic diseases. Summary of the Invention

[0017] There is no report about using plants of Boraginaceae genus Lysimachia and extracts thereof as raw materials alone, and using pharmaceutical compositions containing plants of Boraginaceae genus Lysimachia and extracts thereof to treat allergic diseases.

[0018] The present application provides use of plants of Boraginaceae genus Lysimachia and / or extracts thereof in preparation of drugs for treating allergic diseases.

[0019] The allergic diseases include at least one of allergic rhinitis or syndrome, allergic asthma, allergic bronchitis, and allergic dermatosis.

[0020] Preferably, the allergic dermatosis includes at least one of eczema, urticaria, and dermatitis.

[0021] The plants of Boraginaceae genus Lysimachia are roots or whole plants of at least one of Lysimachia clethroides, Lysimachia paridiformis, Lysimachia christinae, or other plants of Lysimachia genus. Native medicinal materials, processed products, or extracts thereof can be used.

[0022] The extract is a water or organic solvent extract, or an extract prepared by carbon dioxide extraction method.

[0023] Preferably, the organic solvent is a solvent with different polarity, including at least one of ethanol and methanol.

[0024] The extract is a multi-component chemical constituent extract or a single chemical constituent extract of plants of Boraginaceae genus Lysimachia.

[0025] Another technical problem solved by the present application is to provide a pharmaceutical composition for treating allergic diseases.

[0026] The pharmaceutical composition of the present application is a medicament prepared by adding pharmaceutically acceptable excipients or auxiliary ingredients to an effective dose of native medicinal materials, processed products, and / or extracts of plants of Boraginaceae genus Lysimachia as active ingredients.

[0027] The pharmaceutical composition of the present application is a compound preparation prepared by adding other Chinese medicines or chemical drugs acceptable in pharmacy to an effective dose of native medicinal materials, processed products, and / or extracts of plants of Boraginaceae genus Lysimachia as active ingredients.

[0028] The medicament or compound preparation contains 2-50 grams of native medicinal materials of plants of Boraginaceae genus Lysimachia and 0.1-10 grams of extracts per unit of preparation.

[0029] The medicament or compound preparation is an oral preparation, an external preparation, or an injection preparation.

[0030] Preferably, the oral preparation is a decoction, powder, tea, tablet, tincture, pill, extract, oral liquid, capsule or granule; the external preparation is a nasal cream, drop, patch or spray.

[0031] Beneficial effects: The medicament or compound preparation prepared by taking the plants of Boraginaceae and Cynoglossum and extracts thereof as active ingredients to treat allergic diseases has significant curative effect on allergic diseases, can radically cure the diseases, is safe and has no side effects. Since the plants are natural medicinal materials and have wide sources, the application provides a new choice for clinical treatment of such diseases. DETAILED DESCRIPTION

[0032] The application provides use of plants of Boraginaceae and Cynoglossum and / or extracts thereof in preparation of a medicament for treating allergic diseases.

[0033] The allergic diseases include at least one of allergic rhinitis or syndrome, allergic asthma, allergic bronchitis, and allergic skin diseases, wherein the allergic skin diseases include at least one of eczema, urticaria and dermatitis.

[0034] The plants of Boraginaceae and Cynoglossum used are roots or whole plants of the plants, such as roots or whole plants of Cynoglossum zeylanicum (Vahl) Thunb. ex Lehm., Cynoglossum lanceolatum Forsk., Cynoglossum amabile Stapf et Drumm., or other plants of Boraginaceae and Cynoglossum, which can be one of the plants of Cynoglossum or any mixture of the plants.

[0035] In order to facilitate patients to take the medicament, the plants of Boraginaceae and Cynoglossum are used as active ingredients, pharmaceutically acceptable excipients or auxiliary ingredients are added, and the medicament is prepared.

[0036] The medicament or compound preparation is an oral preparation, an external preparation or an injection preparation.

[0037] The oral preparation is a decoction, powder, tea, tablet, tincture, pill, extract, oral liquid, capsule or granule; the external preparation is a nasal cream, drop, patch or spray.

[0038] The medicine or compound preparation contains 2-50 grams of the original medicinal material of Boraginaceae genus Pulmonaria per unit of preparation; and 0.1-10 grams of extract. The unit of preparation refers to the unit dosage, such as a tablet, a capsule, 10 ml of oral liquid, etc. The unit of preparation is a direct reflection of the dosage for a human.

[0039] The above-mentioned various dosage forms of the medicine can be prepared according to the conventional methods in the field of pharmacy. The present application provides the preparation methods of the above-mentioned dosage forms, including but not limited to:

[0040] Method one: the Boraginaceae genus Pulmonaria is crushed into fine powder, and mixed to become a powder; or

[0041] Method two: the Boraginaceae genus Pulmonaria is crushed into fine powder, and packed into a capsule to become a capsule; or

[0042] Method three: the Boraginaceae genus Pulmonaria is crushed into fine powder, and pressed into a tablet to become a tablet; or

[0043] Method four: the Boraginaceae genus Pulmonaria is extracted with water, and then a pharmaceutically acceptable traditional Chinese medicine is added, and a water decoction is obtained by filtration; or

[0044] Method five: the Boraginaceae genus Pulmonaria is crushed and sieved, and then packed into a bag to become a tea bag; or

[0045] Method six: the Boraginaceae genus Pulmonaria is extracted with water, and then the extract is concentrated to become a thick paste, and conventional excipients such as dextrin are added, and dried, crushed and granulated to become a granule; or

[0046] Method seven: the Boraginaceae genus Pulmonaria is extracted with water, and then the extract is concentrated to become a thick paste, and conventional excipients such as soluble starch dextrin, crude drug powder and magnesium stearate are added, and mixed and pressed to become a tablet; or

[0047] Method eight: the Boraginaceae genus Pulmonaria is extracted with water, and then the extract is concentrated to become a thick paste, and conventional excipients such as dextrin and crude drug powder are added, and dried, crushed and granulated to pack into a capsule to become a capsule; or

[0048] Method nine: the Boraginaceae genus Pulmonaria is extracted with water, and then the extract is concentrated, and a pharmaceutically acceptable traditional Chinese medicine or a chemical medicine is added or not added, and a preservative and a flavoring agent are added, and sterilized to become an oral liquid, a syrup or a paste; or

[0049] Method ten: the Boraginaceae genus Pulmonaria is extracted with water, and then the extract is concentrated, and corresponding excipients or auxiliary ingredients are added to become a nasal cream, a drop, a patch or a spray.

[0050] Method eleven: the Boraginaceae genus Pulmonaria plant is extracted with water, the extract is concentrated, and a pharmaceutically acceptable traditional Chinese medicine or chemical medicine is added to prepare a compound preparation.

[0051] Method twelve: the Boraginaceae genus Pulmonaria plant is extracted with water, the extract is concentrated, and water and / or an organic solvent, such as ethanol or benzyl alcohol, is added to the extract, and the mixture is repeatedly dissolved, precipitated, and filtered to be clear, and sterilized to prepare an injection. In addition, activated carbon can be added for auxiliary filtration.

[0052] The drug prepared from the Boraginaceae genus Pulmonaria plant and the extract thereof as active ingredients is used for treating allergic diseases and has a definite curative effect. The drug prepared from the Boraginaceae genus Pulmonaria plant and the extract thereof as active ingredients is used for treating allergic diseases, and according to different conditions, the drug is generally used for 1-6 months. The drug has a remarkable curative effect on allergic diseases, can effectively relieve and eliminate symptoms, and control the development of the disease. The symptoms of most patients are eliminated, and the disease is cured.

[0053] The scheme of the present application will be explained in combination with examples. Those skilled in the art will understand that the examples below are only used to illustrate the present application and should not be regarded as limiting the scope of the present application. If the specific technology or condition is not specified in the examples, the conventional technology or condition in the art or according to the specification is used. If the manufacturer of the reagent or instrument is not specified, it is a conventional product that can be obtained from the market.

[0054] The fresh or dried product of the Boraginaceae genus Pulmonaria plant is used in the examples of the present application, and is referred to as the Boraginaceae genus Pulmonaria plant.

[0055] Example 1 Preparation of the tablet of the present application

[0056] Take 500 grams of the Boraginaceae genus Pulmonaria plant, soak in water at 10-20 times the amount of the drug for 1 hour, put in a decoction pot and boil for 1 hour, filter out the medicinal liquid, add 10 times the amount of water and decoct for 1 hour, filter out the medicinal liquid, combine the two medicinal liquids, and dehydrate and concentrate to a thick paste. Add 20% soluble starch dextrin (or add the same amount of 200-mesh raw material powder), mix well, vacuum dry at 60-80°C, crush, add 1% magnesium stearate and other auxiliary materials, mix well, sieve through a 20-mesh sieve, and press into tablets with a tablet weight of 0.5 grams. The method of taking the medicine is as follows: 3-4 tablets each time, three times a day.

[0057] Example 2 Preparation of the tea of the present application

[0058] Take 1 kg of the Boraginaceae genus Pulmonaria plant, crush, and sieve through a 60-mesh sieve. Pack the tea in a tea bag with a filter paper on a tea bag packing machine at 4 grams per bag. The method of taking the medicine is as follows: 3-4 bags each time, three times a day. Put the medicine bag in a thermos cup, soak with hot water for 2 hours or so, and then drink. The tea is sweet and tasty, and can be drunk all year round.

[0059] Example 3 Preparation of granules of the present application

[0060] Take 500 grams of Boraginaceae genus Lithospermum plant, soak in 10 times the amount of water for 1 hour, place in a decoction pot and simmer for 1 hour, filter out the medicinal liquid, add 10 times the amount of water and decoct for 1 hour, filter out the medicinal liquid, combine the two medicinal liquids, dehydrate and concentrate to a thick paste, add dextrin and other auxiliary materials, vacuum dry at 60-80°C, pulverize, granulate, and make into granules with 6 grams of medicinal material per bag. Method of administration: 2-3 times per day, 1-2 bags each time.

[0061] Example 4 Preparation of water decoction of the present application

[0062] Take 30-60 grams of Boraginaceae genus Lithospermum plant, add pharmaceutically acceptable traditional Chinese medicine, soak in 10 times the amount of water for 1 hour, place in a decoction pot, and when the water boils, decoct for 30 minutes, pour out the medicinal liquid, add 10 times the amount of water, decoct for 30 minutes, combine the two decoctions, and take in the morning, afternoon, and evening.

[0063] Example 5 Preparation of capsules of the present application

[0064] Take 500 grams of Boraginaceae genus Lithospermum plant, soak in 10 times the amount of water for 1 hour, place in a decoction pot and simmer for 1 hour, filter out the medicinal liquid, add 10 times the amount of water and decoct for 1 hour, filter out the medicinal liquid, combine the two medicinal liquids, dehydrate and concentrate to a thick paste, add 20% 200-mesh raw medicinal powder and other auxiliary materials, vacuum dry at 60-80°C, pulverize, and make into capsules with 0.3 grams of medicinal material per capsule. Method of administration: 3-4 capsules each time, three times per day.

[0065] Example 6 Preparation of oral liquid of the present application

[0066] Take 500 grams of Boraginaceae genus Lithospermum plant, soak in 10 times the amount of water for 1 hour, place in a decoction pot and simmer for 1 hour, filter out the medicinal liquid, add 10 times the amount of water and decoct for 1 hour, filter out the medicinal liquid, combine the two medicinal liquids, dehydrate and concentrate to a thick paste, add appropriate preservatives and flavorings and other auxiliary materials, and divide into 10-ml glass bottles, seal, and sterilize with steam. Method of administration: oral, 1-3 bottles each time, three times per day.

[0067] Example 7 Preparation of injection of the present application

[0068] Take 2 kg of Boraginaceae species of the genus Echium, add 10 times the amount of distilled water, and boil for 1 hour. Filter the mixture, and add another 10 times the amount of water to the residue and boil for 1 hour. Filter the mixture, combine the filtrates, and concentrate to a thick paste. Add 96% ethanol to the paste to achieve an alcohol content of 80%, and let the mixture stand for 24 hours. Then, filter the mixture, recover the ethanol, and repeat the precipitation process twice. Add distilled water to the filtrate to achieve a total volume of 800 mL. Add 1% activated carbon to the mixture, filter the mixture, and add distilled water to the filtrate to achieve a total volume of 1000 mL. Heat the mixture to 80°C, add 2% benzyl alcohol, and filter the mixture until it is clear. Fill 2 mL ampoules with the mixture, and sterilize the ampoules by steam for 30 minutes. The resulting product is ready for use. The product can be administered intramuscularly, twice a day, with 4 mL per administration.

[0069] Example 8. Preparation of external preparations of the present application

[0070] According to the common technical knowledge and practices in the field, the extract of Boraginaceae species of the genus Echium is added to appropriate excipients or auxiliary ingredients to prepare a nasal cream, drops, patch, or spray.

[0071] Example 9. Preparation of compound preparations of the present application

[0072] The Boraginaceae species of the genus Echium is used as the main ingredient in the preparation of various compound preparations by adding pharmaceutically acceptable traditional Chinese medicines or chemical drugs to meet the different treatment needs for the above-mentioned diseases.

[0073] The Boraginaceae species of the genus Echium is used as the main ingredient in the preparation of various compound preparations by adding pharmaceutically acceptable traditional Chinese medicines or chemical drugs to meet the different treatment needs for the above-mentioned diseases.

[0074] Clinical cases:

[0075] I. Qian Xifeng, male, 44 years old, lives in Xichang City.

[0076] He has suffered from allergic rhinitis for 23 years, and the allergen is pollen. The symptoms include nasal congestion, clear rhinorrhea, sneezing, headache, difficulty falling asleep at night, and sore throat. The symptoms are most severe in spring, so he has to wear a mask for two to three months every spring. He has sought medical treatment from experts in local, Chengdu, and Beijing hospitals, but his condition has not improved.

[0077] He started taking Echium granules (prepared according to Example 3) in July 2017, and recovered after more than two months of treatment. He has not had a relapse for nearly 6 years, and has not worn a mask in spring since 2018.

[0078] II. Qin Gang, male, 59 years old, lives in Changping, Beijing.

[0079] The patient had suffered from allergic asthma for over ten years. Despite being in Beijing, a city teeming with large hospitals and specialists, their condition showed no improvement. They carried an inhaler with them daily, relying on frequent use to control and alleviate their symptoms. In May 2016, a friend introduced them to *Ligusticum striatum* granules (prepared in Example 3). After using them for over two months, they were completely cured. A recent follow-up, more than seven years later, showed no recurrence of asthma.

[0080] 3. Deng ×, female, 6 and a half years old, lives in Wuhan City.

[0081] At the age of 3, the child developed allergic rhinitis syndrome, experiencing nasal congestion, runny nose, sneezing, and allergic asthma. The child had difficulty breathing, cried constantly, and couldn't sleep, suffering greatly, much to the distress of the adults. The mother, a hospital nurse, would take the child to the hospital for intravenous hormone therapy each time the condition improved, only to return home shortly after. The symptoms would then recur, requiring further hospitalization, and the frequency of attacks increased. In March 2016, a decoction of *Hedyotis diffusa* (prepared in Example 4) was used, and the child recovered in less than two weeks. A phone follow-up in April 2023 revealed that the child had not relapsed for over seven years and was very healthy.

[0082] Fourth, Deng X, male, 11 years old, residing in Wuhan City.

[0083] Case 3: The little girl's brother had suffered from urticaria for many years. After his sister recovered, he also tried taking a decoction of borage. He recovered after taking it for more than ten days and has not had a recurrence for more than seven years.

[0084] 5. Wang Xilian, female, 74 years old, retired doctor, residing in Shanghai.

[0085] In November 2019, she contacted us through a friend's introduction. During our conversation, her voice was hoarse, and she coughed incessantly after speaking for only a minute or two. She stated that she had been diagnosed with allergic rhinitis and cough-variant asthma (allergic bronchitis) at Shanghai Pulmonary Hospital for over ten years. Based on her complaints and symptoms, we formulated a traditional Chinese medicine preparation for her, primarily using *Ligusticum striatum* granules (prepared in Example 3). She began taking the medication on November 13, 2019, and after two months of continuous use, she was completely cured and has remained free of recurrence for over three years.

[0086] Below is her WeChat message describing her treatment process:

[0087] Traditional Chinese medicine cured my chronic illness of many years

[0088] My surname is Wang, I am a 74-year-old woman, and I currently live in Shanghai. Ten years ago, due to renovations to my new house, I developed a dry throat, a feeling of something stuck in my throat, hoarseness, and recurring, severe dry cough, especially at night, accompanied by nasal congestion, sneezing, and a runny nose. I went to the Shanghai Pulmonary Hospital for treatment, and after various examinations, I was diagnosed with "cough-variant asthma with allergic rhinitis." I was treated with hormones, anti-allergy medications, and cough suppressants, but my condition fluctuated and never fully resolved. Over the years, besides the hoarseness and persistent nighttime cough that made it difficult to sleep, what bothered me most was that whenever I spoke to someone, I would start coughing incessantly after two or three minutes, causing me great distress and embarrassment. Furthermore, my nasal congestion, sneezing, and constant runny nose were also persistent and difficult to cure. Having undergone treatment at so many top-tier hospitals for so many years without improvement, I lost faith in treatment and stopped persisting with it. I only bought some anti-allergy and cough suppressants from the pharmacy to relieve the symptoms when they were more severe.

[0089] In November 2019, through a friend's introduction, I contacted Mr. Zhao via WeChat and asked them for help with treatment. I was given a powder made from concentrated and dried traditional Chinese medicine. I started taking it on November 13, 2019, and after more than two months, the symptoms of my cough-variant asthma disappeared. My chronic illness of over ten years was completely cured. I stopped taking the medication for almost a month and there was no recurrence. In addition to treating this illness, it also cured my allergic rhinitis and my chronic constipation that had plagued me for over ten years.

[0090] VI. Yang X. Lu, male, 38 years old, resident of Chuanxing Town, Xichang City.

[0091] Suffering from allergic rhinitis for more than 3 years and having sought treatment from various sources without success, the patient came to my clinic on November 19, 2019. The doctor prescribed a week's worth of borage decoction (prepared in Example 4) for the patient. After taking the decoction, the patient's condition was quickly relieved, and after continuing to take it for another 3 weeks, the patient was cured.

[0092] We originally planned to have him take the medication for another month to consolidate the therapeutic effect, and he agreed. However, after seeing that he had fully recovered, he gave up the medication. When we called to inquire recently, his condition remained stable without any relapse.

[0093] 7. Yi X, male, 69 years old, residing in Qingyang District, Chengdu, sought medical treatment on May 16, 2023.

[0094] Chief complaint: Suffering from allergic rhinitis for over ten years. Besides nasal congestion and sneezing, the most bothersome symptom is a constant runny nose; it involuntarily flows while eating or talking, causing great embarrassment. Doctor's diagnosis: Allergic rhinitis.

[0095] The doctor prepared a four-day decoction of borage (prepared in Example 4) for the patient. On the 21st, the patient returned for a follow-up visit, stating that the runny nose had stopped on the second day of medication, and the patient felt much better. The doctor then prescribed another eight days of the borage decoction, instructing the patient to complete the treatment for at least one month. However, the patient did not return for further prescriptions. A follow-up phone call on May 23rd confirmed that the runny nose had completely stopped and the rhinitis was cured.

[0096] 8. Wang Xijia, male, 10 years old, resident of Qingyang District, Chengdu. He sought medical treatment on June 3, 2023.

[0097] The mother said that her child had suffered from allergic rhinitis for eight years and had been to several large hospitals in Chengdu, but it had not gotten better. The main problem now was severe nasal congestion, which had been affecting his sleep for a long time; he could not fall asleep until after midnight.

[0098] When the child was seen, he was in relatively good spirits, but had a stuffy nose, difficulty breathing, and hyperactivity.

[0099] The doctor diagnosed allergic rhinitis complicated by sleep disorder syndrome. The doctor prescribed a compound decoction of *Lonicera japonica* (prepared in Example 4) for seven days. On June 10th, the child returned for a follow-up visit, stating that after 2-3 days of medication, nasal congestion had eased and sleep time had moved to around 10 PM. The doctor prescribed another seven days' worth of medication. By June 24th, the child had been taking the medication for four weeks, symptoms had largely disappeared, sleep was stable, and hyperactivity had significantly improved. The doctor prescribed another week's worth of the compound decoction, instructing the parents to assess the condition after one week and decide whether to continue medication. Later, the parents stated the child was cured and discontinued the medication.

[0100] The aforementioned clinical cases directly demonstrate that preparations made from plants of the Boraginaceae family and their extracts, as active ingredients, have significant therapeutic effects on allergic diseases, offering a potential cure, and are safe with no side effects. Furthermore, due to their status as natural medicinal materials and their wide availability, they provide a new option for the clinical treatment of this disease.

[0101] It should be noted that the specific features, structures, materials, or characteristics described in this specification can be replicated or implemented in any suitable manner in one or more embodiments. Furthermore, those skilled in the art can combine and integrate the different embodiments described in this specification and the features of those embodiments without contradiction.

Claims

1. Use of plants of the genus Boraginaceae (Bororhizon family) and / or their extracts in the preparation of medicaments for the treatment of allergic diseases.

2. The use according to claim 1, characterized in that: The allergic diseases include at least one of allergic rhinitis or syndrome, allergic asthma, allergic bronchitis, or allergic dermatitis.

3. The use according to claim 1, characterized in that: The plants of the Boraginaceae family and the Boraginaceae genus include the root or whole plant of at least one of Boraginaceae, Boraginaceae var. variegata, Boraginaceae var. variegata, or other Boraginaceae plants.

4. The use according to claim 1, characterized in that: The extract is an aqueous or organic solvent extract, or an extract prepared by carbon dioxide extraction.

5. The use according to claim 1, characterized in that: The extract is a multi-component chemical component extract or a single chemical component extract from plants of the Boraginaceae family, Boraginaceae genus Boraginaceae.

6. A pharmaceutical composition for treating allergic diseases, characterized in that: The composition is a pharmaceutical preparation made by adding pharmaceutical excipients or auxiliary ingredients to an effective dose of the original medicinal material, processed product and / or extract of Boraginaceae ...

7. A pharmaceutical composition for treating allergic diseases, characterized in that: The pharmaceutical composition is a compound preparation made by adding other pharmaceutically acceptable traditional Chinese medicines or chemical drugs to an effective dose of the original medicinal material, processed product and / or extract of Boraginaceae ...

8. The composition according to claim 6 or 7, characterized in that: Each unit of the medicine or compound preparation contains 2-50 grams of raw medicinal material from the Boraginaceae family, Boraginaceae genus Boraginaceae, and 0.1-10 grams of extract.

9. The composition according to claim 6 or 7, characterized in that: The medicine or compound preparation is an oral preparation, a topical preparation, or an injectable preparation.

10. The composition according to claim 9, characterized in that: The oral preparations are decoctions, powders, teas, tablets, tinctures, pills, extracts, oral liquids, capsules, or granules; the external preparations are nasal creams, drops, patches, or sprays.