Traditional Chinese medicine essential oil and hydrolat combined liquid medicine capable of killing helicobacter pylori and suitable for sterilization and negative conversion treatment of helicobacter pylori infection of children

Abstract

The invention discloses a traditional Chinese medicine essential oil and hydrolat combined liquid medicine which has a killing effect on helicobacter pylori and is suitable for sterilization and negative conversion treatment of helicobacter pylori infection of children. The melaleuca alternifolia water-soluble essential oil and hydrolat is prepared from the following water-soluble essential oil and hydrolat: melaleuca alternifolia water-soluble essential oil, melaleuca alternifolia hydrolat, rose water-soluble essential oil, lemon water-soluble essential oil, clove water-soluble essential oil, mint water-soluble essential oil and stevioside. The sterilization rate gt of the composition on helicobacter pylori is gt; and the bactericidal composition is a powerful bactericidal preparation. Helicobacter pylori in the oral cavity, the throat and the stomach can be killed, and therefore the negative turning treatment effect on helicobacter pylori infection is achieved. The composition is suitable for sterilization and negative conversion treatment of helicobacter pylori infected children under 14 years old. The traditional Chinese medicine preparation is a pure traditional Chinese medicine preparation, is safe to use, aims at the dilemma of helicobacter pylori infection sterilization and negative conversion treatment of children under 14 years old, and fills the blank of the medicine technology in China. The method can be widely applied to the fields of medicines, functional foods, health foods and the like.

Description

Technical Field

[0001] The Chinese herbal essential oil hydrosol combination liquid has a sterilization rate of more than 99.97% against Helicobacter pylori and is an edible, potent sterilization preparation.

[0002] In response to the problem of Helicobacter pylori infection in children under 14 years old, we have developed a Chinese herbal essential oil hydrosol solution that has a killing effect on Helicobacter pylori and is suitable for the sterilization and negative treatment of Helicobacter pylori infection in children.

[0003] The current dilemma in the treatment of Helicobacter pylori infection in children under 14 years old is based on the side effects of multi-therapy with Western medicine, which is not suitable for children, and there are currently no Western medicines suitable for children.

[0004] For the treatment of Helicobacter pylori infection in children under 14 years old, there is a drug with high killing effect. As long as the drug is used in the form of oral spray and the child swallows it with a slight natural reaction, the therapeutic effect of killing bacteria and turning the infection negative can be achieved within a few days.

[0005] The technical advantage of the present invention is that it can effectively solve the dilemma of sterilization and negative conversion treatment of Helicobacter pylori infection in children under 14 years old.

[0006] The present invention can be widely used in the fields of medicine, functional food, health food, etc. Background Art

[0007] Helicobacter pylori infection is primarily transmitted through oral-oral transmission, with family gatherings and shared meals being the primary route of infection for children. Helicobacter pylori can grow and multiply in the mouth, throat, stomach, and nasal cavity of the upper respiratory tract (where it can cause rosacea). Children are susceptible to Helicobacter pylori infection, and most adults develop Helicobacter pylori infection during childhood. The diseases associated with Helicobacter pylori infection in children are similar to those in adults, and some children with Helicobacter pylori infection are asymptomatic.

[0008] While multi-therapy with antibiotics and acid suppressants has demonstrated significant efficacy in modern medical practice, it is intended for adults with H. pylori infection, and some of these medications have significant side effects, making them unsuitable for children. This is why some experts in the medical community recommend that asymptomatic children with H. pylori infection do not require treatment. However, these children also become a source of H. pylori infection. They may spread infection to family members, friends, and classmates, leading to a risk of recurrence for those requiring H. pylori eradication treatment. Repeated infection and treatment can lead to drug resistance, which can also lead to the development of drug-resistant strains. This is a common cause of familial gastric cancer.

[0009] Regarding the treatment of Helicobacter pylori infection in children under 14, the current medical community lacks appropriate treatments for children, nor are there specific medications for children. Furthermore, children generally rarely take their medication daily, whether Western or traditional Chinese medicine.

[0010] Although Helicobacter pylori infection can damage the gastric mucosa, children have sufficient yang energy and a strong ability to heal their gastric mucosa. As long as the Helicobacter pylori is eliminated and the disease is cleared, most children's stomachs can heal naturally, with little need for medication to assist recovery. Therefore, developing a swallowable drug with a strong, disinfecting effect against Helicobacter pylori could effectively solve the dilemma of sterilizing and clearing Helicobacter pylori in children.

[0011] The invention title (application number 2025105139517) previously applied by our company is: "A Chinese medicine composition with a strong antibacterial effect on Helicobacter pylori and a therapeutic effect on Helicobacter pylori-infected gastritis". This invention (application number 2025105139517) is an invention that can treat both Helicobacter pylori infection and gastritis at the same time. The present invention application "A Chinese medicine essential oil hydrosol combination liquid with a killing effect on Helicobacter pylori, suitable for the sterilization and negative treatment of Helicobacter pylori infection in children" is an invention of a simple bactericidal agent that can only kill Helicobacter pylori. It is also a new achievement developed by our company for the professional sterilization and negative treatment of Helicobacter pylori-infected children. Summary of the Invention

[0012] In response to the problem of Helicobacter pylori infection in children, a Chinese herbal essential oil hydrosol combination liquid has been developed, which has a killing effect on Helicobacter pylori and is suitable for the sterilization and negative treatment of Helicobacter pylori infection in children. The Chinese herbal essential oil hydrosol combination liquid is prepared from water-soluble essential oils and floral dew containing the following weight proportions: 8-50 parts of Melaleuca alternifolia water-soluble essential oil, 1000-5000 parts of Melaleuca alternifolia hydrosol, 4.3-27 parts of rose water-soluble essential oil, 7-40 parts of lemon water-soluble essential oil, 5-30 parts of clove water-soluble essential oil, 4.5-60 parts of peppermint water-soluble essential oil, and 6.5-30 parts of stevioside.

[0013] Furthermore, the Chinese medicine essential oil hydrosol combination liquid is prepared from water-soluble essential oil hydrosols containing the following weight proportions: 8 parts of Melaleuca alternifolia water-soluble essential oil, 1000 parts of Melaleuca alternifolia hydrosol, 4.3 parts of rose water-soluble essential oil, 7 parts of lemon water-soluble essential oil, 5 parts of clove water-soluble essential oil, 4.5 parts of peppermint water-soluble essential oil, and 6.5 parts of stevioside.

[0014] Furthermore, it is a preparation prepared by adding the traditional Chinese medicine essential oil pure dew combined medicinal liquid to auxiliary materials or auxiliary ingredients acceptable to medicines or foods.

[0015] Furthermore, the preparation can be in the form of an oral spray, a gargle, a jelly, a paste, a tablet, a granule, a pill, a soft candy, or a liquid.

[0016] The present invention also provides a use of the aforementioned traditional Chinese medicine essential oil hydrosol composition liquid in the preparation of a medicine for treating Helicobacter pylori infection.

[0017] The present invention also provides a use of the aforementioned Chinese herbal essential oil hydrosol combination liquid in the preparation of functional foods, medical foods, and health foods against Helicobacter pylori infection.

[0018] The invention discloses a swallowable Chinese medicinal essential oil hydrosol combination liquid with a bactericidal effect on Helicobacter pylori, which has a strong and fragrant smell and is suitable for the bactericidal and negative-conversion treatment of Helicobacter pylori infection in children.

[0019] Traditional Chinese medicine essential oils are a class of volatile compounds with distinctive aromas and natural bioactive properties. They are not only safe, biocompatible, and rapidly effective, but also possess analgesic, antibacterial, bactericidal, antifungal, anti-inflammatory, antioxidant, antimutagenic, free radical scavenging, immune system-boosting, and multidrug resistance modulating properties. Their unique aroma can penetrate capillaries and nerve endings.

[0020] The invention is formulated by utilizing the pharmacological properties of traditional Chinese medicine essential oils.

[0021] There are two types of products in the Chinese herbal plant essential oil market: one is pure essential oil, which is insoluble in water; the other is water-soluble essential oil, which is soluble in water.

[0022] Water-soluble essential oils are essential oil products made by adding pharmaceutically or food-acceptable additives to pure essential oils (such as using Tween 80 solubilization technology or PEG-60 hydrogenated castor oil solubilization technology) to make the essential oils water-soluble.

[0023] The essential oil raw materials used in this invention are all conventional commercial products produced by domestic steam distillation and comply with relevant national standards. Therefore, the present invention does not limit the source of the raw materials. However, the main component content of water-soluble essential oils and hydrosols must meet the following standards:

[0024] The main components of Melaleuca alternifolia essential oil are: r-terpinene ≥ 17%, 4-terpineol ≥ 30%, and total volatile essential oil ≥ 80%.

[0025] The main components of rose water-soluble essential oil are: citronellol ≥32%, geraniol ≥8%, nerol ≥1.6%, and total volatile essential oil ≥80%.

[0026] The main components of lemon water-soluble essential oil are: limonene ≥42%, citral ≥2.7%, and total volatile essential oil ≥50%.

[0027] The main components of clove water-soluble essential oil: eugenol ≥ 64%, total volatile essential oil ≥ 80%.

[0028] The main components of peppermint water-soluble essential oil are: menthol ≥38%, total volatile essential oil ≥80%.

[0029] Melaleuca alternifolia hydrosol: total volatile essential oil ≥0.15%.

[0030] Melaleuca alternifolia, lemon, clove, mint, and rose in the Chinese medicine essential oil combination liquid of the present invention all have antibacterial, anti-inflammatory, and antiviral effects in terms of the pharmacological effects of traditional Chinese medicine. These effects are all due to the fact that these medicinal materials contain certain aromatic volatile oils, i.e., essential oils.

[0031] Although the stevioside in the Chinese herbal essential oil hydrosol combination liquid of the present invention is used as a sweetener in the present invention, it has the pharmacological effect of inhibiting pathogens. Moreover, while inhibiting pathogens, it is also a "prebiotic" ingredient that promotes the growth and reproduction of probiotics, thereby achieving a protective effect on probiotics.

[0032] The Melaleuca alternifolia hydrosol in the traditional Chinese medicine essential oil hydrosol combination liquid of the present invention is used as a base solution in the present invention, and its efficacy is similar to that of the Melaleuca alternifolia essential oil.

[0033] The Chinese herbal essential oil hydrosol combination liquid is formulated based on the pharmacological properties of Chinese herbal essential oils, leveraging their antibacterial properties. It boasts a strong aroma, high volatility, and strong penetrating power, making it a direct-contact bactericide with a strong bactericidal effect. When packaged as an oral spray, it can achieve full coverage of the oral cavity, throat, and stomach.

[0034] It is obvious to those skilled in the art that the Melaleuca alternifolia hydrosol in the Chinese herbal essential oil hydrosol combination liquid serves as the base solution, stevioside serves as the sweetener, and the conversion between the essential oil and the hydrosol of the present invention can be made without departing from the above-mentioned basic technical ideas of the present invention, and various other forms of changes, replacements, and modifications can be made, which still fall within the scope of protection of the present invention.

[0035] Compared with the prior art, the present invention has the following advantages:

[0036] The sterilization rate of the traditional Chinese medicine essential oil hydrosol combination liquid against Helicobacter pylori is greater than 99.97%;

[0037] The raw materials of the Chinese herbal essential oil hydrosol combined medicinal liquid of the present invention are derived from Chinese herbal medicines and Chinese herbal medicine food and medicine excipients of the same origin as medicine and food, thus ensuring the safety of the medicine;

[0038] The technical advantage of the present invention is that it can effectively solve the dilemma of sterilization and negative treatment of Helicobacter pylori infection in children under 14 years old, filling the gap in my country's medical technology in this regard. DETAILED DESCRIPTION

[0039] The invention discloses a traditional Chinese medicine essential oil and floral dew combination liquid which has a killing effect on Helicobacter pylori and is suitable for sterilizing and turning Helicobacter pylori infection in children negative. The liquid is prepared from water-soluble essential oils and floral dew in the following proportions by weight: 8-50 parts of Melaleuca alternifolia water-soluble essential oil, 1000-5000 parts of Melaleuca alternifolia hydrosol, 4.3-27 parts of rose water-soluble essential oil, 7-40 parts of lemon water-soluble essential oil, 5-30 parts of clove water-soluble essential oil, 4.5-60 parts of peppermint water-soluble essential oil, and 6.5-30 parts of stevioside.

[0040] The water-soluble essential oil of Melaleuca alternifolia includes, but is not limited to, any one of 8 parts to 50 parts by weight or any range between the two parts.

[0041] Among them, the Melaleuca alternifolia hydrosol includes but is not limited to any point value between 1000 parts and 5000 parts by weight or any range value between the two.

[0042] The water-soluble essential oil of rose is calculated by weight in parts but not limited to any one of 4.3 parts to 27 parts or any range between the two.

[0043] The lemon water-soluble essential oil includes, but is not limited to, any one of 7 parts to 40 parts by weight or any range between the two parts.

[0044] The clove water-soluble essential oil includes, but is not limited to, any one of 5 parts to 30 parts by weight or any range between the two parts.

[0045] The water-soluble peppermint essential oil includes, but is not limited to, any one of 4.5 parts to 60 parts by weight or any range between the two.

[0046] Wherein, the steviol glycoside includes but is not limited to any one of 6.5 parts to 30 parts by weight or any range between the two.

[0047] Example 1: Preparation of the Traditional Chinese Medicine Essential Oil Hydrosol Combination Liquid of the Present Invention

[0048] Formula: 8 parts of Melaleuca alternifolia water-soluble essence, 1000 parts of Melaleuca alternifolia hydrosol, 4.3 parts of rose water-soluble essential oil, 7 parts of lemon water-soluble essential oil, 5 parts of clove water-soluble essential oil, 4.5 parts of peppermint water-soluble essential oil, and 6.5 parts of steviol glycosides.

[0049] Preparation method:

[0050] ① Weigh the above essential oil hydrosol according to weight ratio;

[0051] ②Put it into a sealed container at room temperature and mix it evenly;

[0052] ③Packaged into mouth spray packaging according to the dissolution volume of 20ml per bottle;

[0053] ④ Take 500ml of the drug solution and seal it as the original solution sample of the test group.

[0054] Example 2: Preparation of the Traditional Chinese Medicine Essential Oil Hydrosol Combination Liquid of the Present Invention

[0055] Formula: 9 parts of Melaleuca alternifolia water-soluble essence, 1000 parts of Melaleuca alternifolia hydrosol, 4.3 parts of rose water-soluble essential oil, 8.4 parts of lemon water-soluble essential oil, 5.6 parts of clove water-soluble essential oil, 4.8 parts of peppermint water-soluble essential oil, and 6.5 parts of steviol glycosides.

[0056] Preparation method:

[0057] ① Weigh the above essential oil hydrosol according to weight ratio;

[0058] ②Put it into a sealed container at room temperature and mix it evenly;

[0059] ③Packaged into mouth spray packaging according to the dissolution volume of 20ml per bottle;

[0060] ④ Take 500ml of the drug solution and seal it as the original solution sample of the test group.

[0061] Example 3: Preparation of the Traditional Chinese Medicine Essential Oil Hydrosol Combination Liquid of the Present Invention

[0062] Formula: 9.5 parts of Melaleuca alternifolia water-soluble essential oil, 1000 parts of Melaleuca alternifolia hydrosol, 4.8 parts of rose water-soluble essential oil, 9.4 parts of lemon water-soluble essential oil, 6.2 parts of clove water-soluble essential oil, 5.2 parts of peppermint water-soluble essential oil, and 6.5 parts of steviol glycosides.

[0063] Preparation method:

[0064] ① Weigh the above essential oil hydrosol according to weight ratio;

[0065] ②Put it into a sealed container at room temperature and mix it evenly;

[0066] ③Packaged into mouth spray packaging according to the dissolution volume of 20ml per bottle;

[0067] ④ Take 500ml of the drug solution and seal it as the original solution sample of the test group.

[0068] The preparations prepared in the examples are uniformly named: Youlusha

[0069] The stock solution samples of the pharmaceutical preparations prepared in Example 1, Example 2, and Example 3 were extracted for laboratory analysis and testing, and the preparation samples prepared in the examples were used as the stock solution of the test group.

[0070] A 500 ml packaged stock solution sample of the preparation of Example 1 was taken as test group 1;

[0071] A 500 ml packaged stock solution sample of the preparation of Example 2 was taken as test group 2;

[0072] A 500 ml packaged stock solution sample of the preparation of Example 3 was taken as test group 3.

[0073] The testing is based on the health industry standard issued by the National Health Commission of the People's Republic of China: "WS / T650-2019 Evaluation Method for Antibacterial and Antibacterial Effects", and the testing unit is the Guangdong Institute of Microbiology / Guangdong Provincial Microbiological Analysis and Testing Center, a national P3-level microbiology laboratory.

[0074] Test basis and method: WS / T 650-2019 (5.2.1)

[0075] Test item: Suspension quantitative bactericidal test.

[0076] Test report number (Report N o ):2021ZD00717R01

[0077] Test result query verification code: 42397081

[0078] Evaluation of the test results: The sterilization rate of the Chinese herbal essential oil hydrosol combination liquid of the present invention against Helicobacter pylori is >99.97%, see Table 1 for details.

[0079] Table 1 Helicobacter pylori bactericidal analysis test results Report No.: o) 2021ZD01295R01 Verification Code: 42397081

[0080]

[0081]

[0082] Observation on the clinical application effect of the Chinese medicine essential oil hydrosol combination liquid of the present invention

[0083] The preparation Youlusa prepared in Example 1 is a medicine for sterilizing and converting Helicobacter pylori to negative in children, and the dosage form is an oral spray.

[0084] From August 2021 to June 2022, the company cooperated with the tertiary hospitals in the province to recruit 40 children aged 8-14 who were infected with Helicobacter pylori. After the consent of their parents, these 40 children infected with Helicobacter pylori served as volunteers for clinical effect observation of cases. Inclusion criteria: The diagnosis of Helicobacter pylori infection in children shall be based on the diagnosis of the tertiary hospitals, and there shall be no other digestive tract diseases such as gastric ulcers and gastric erosions; at least one of the parents must also be infected with Helicobacter pylori; they are required to persist in taking the medicine for 9 days and meet the conditions for being interviewed. Each of the 40 child volunteers will be provided by the company with 4 bottles of Youlusa, a total of 9 days' supply, which is an oral spray for killing Helicobacter pylori and turning negative for treatment. The company will also give each child's family an additional 3 bottles of Youlusa for their parents to use (their family parents are using the hospital's Western medicine multi-therapy, so their parents are not in the clinical effect observation case).

[0085] Instructions for use: One course of treatment is 9 days; spray into the mouth on an empty stomach in the morning, noon and before bedtime and swallow, 2 to 3 ml each time; do not eat anything within 30 minutes after oral spray.

[0086] 40 volunteers, including 24 males and 16 females with an average age of (11,4±2.7) years, were enrolled in the study. They were treated with the drug for 9 days and then discontinued for 1 month before being re-examined.

[0087] During the observation period, all volunteers had no adverse reactions.

[0088] Clinical observation results: The effect of Helicobacter pylori infection in children after being sterilized and turned negative by Yulusa is significant. See Table 2 for details.

[0089] Table 2 HP values of 13C breath reexamination after 9 days of treatment and one month after stopping the drug (DOB<4.0-)(DOB>4.0+)

[0090]

[0091] Clinical observations show that the bactericidal and negative conversion rate for Helicobacter pylori infection in children reached 92.5%, a satisfactory result. However, the inefficiency rate was 7.5%, which may be related to children's poor medication use. Nine volunteers did not take medication for more than six days, indicating that nearly a quarter of the children did not take their medication seriously.

[0092] In summary, the Chinese herbal essential oil combination liquid provided by the present invention has an excellent effect of killing Helicobacter pylori, and can be suitable for the sterilization and negative conversion treatment of children infected with Helicobacter pylori; it can be widely used in the fields of medicine, functional food, health care food, ordinary food, etc.; it can effectively prevent children from becoming the source of Helicobacter pylori transmission and infection among family members and schoolmates, and has national public health and medical significance in reducing the infection rate of Helicobacter pylori in our country.

[0093] The embodiments of the present invention are described in detail above, but the present invention is not limited to the described embodiments. Based on the above content of the present invention, according to the common technical knowledge and customary means in the field, it is obvious to those skilled in the art that various other changes and modifications can be made to these embodiments without departing from the basic technical concept of the present invention, which still fall within the scope of protection of the present invention.

Claims

The invention discloses a traditional Chinese medicine essential oil hydrosol combination liquid which has a killing effect on Helicobacter pylori and is suitable for sterilizing and converting Helicobacter pylori infection in children to negative. The liquid is prepared from water-soluble essential oils and floral dew containing the following proportions by weight: 8-50 parts of Melaleuca alternifolia water-soluble essential oil, 1000-5000 parts of Melaleuca alternifolia hydrosol, 4.3-27 parts of rose water-soluble essential oil, 7-40 parts of lemon water-soluble essential oil, 5-30 parts of clove water-soluble essential oil, 4.5-60 parts of peppermint water-soluble essential oil, and 6.5-30 parts of stevioside.

2. The Chinese herbal essential oil hydrosol composition according to claim 1, wherein The invention is prepared from a water-soluble essential oil floral dew containing the following weight proportions: 8 parts of Melaleuca alternifolia water-soluble essential oil, 1000 parts of Melaleuca alternifolia hydrosol, 4.3 parts of rose water-soluble essential oil, 7 parts of lemon water-soluble essential oil, 5 parts of clove water-soluble essential oil, 4.5 parts of peppermint water-soluble essential oil and 6.5 parts of stevioside.

3. The water-soluble essential oil in the Chinese herbal essential oil hydrosol composition according to claim 1-2, characterized in that: Water-soluble essential oils are water-soluble essential oils made by adding pharmaceutical and food-acceptable excipients to pure Chinese herbal essential oils.

4. The Chinese herbal essential oil hydrosol combination liquid according to claims 1 to 3, characterized in that It is a preparation that can be used directly; further, the essential oil hydrosol combined liquid is added with excipients or auxiliary ingredients acceptable to medicines or foods to prepare a variety of preparations.

5. The Chinese herbal essential oil hydrosol combination liquid and the preparation according to claims 1 to 4, characterized in that It can be in the form of an oral spray, a gargle, a jelly, a paste, a tablet, a granule, a pill, a soft candy, or a liquid.

6. Use of the traditional Chinese medicine essential oil hydrosol combination liquid and the preparation according to any one of claims 1 to 5 in the preparation of a drug for treating Helicobacter pylori infection.

7. Use of the Chinese herbal essential oil hydrosol combination liquid and the preparation according to any one of claims 1 to 5 in the preparation of functional foods, medical foods, and health foods against Helicobacter pylori infection.

8. The Chinese herbal essential oil hydrosol combination liquid and the preparation according to any one of claims 1 to 5, characterized in that: Those skilled in the art can use the Melaleuca alternifolia hydrosol replaced by other base liquids and base oils, or replace stevioside by other sweeteners in the preparation of drugs for Helicobacter pylori infection, or in the preparation of functional foods, medical foods, and health foods for Helicobacter pylori infection.

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