Infantile Ganning granular medicine and preparation process thereof

Abstract

The invention discloses a Ganning granule medicine for children and a preparation process thereof. The Ganning granule medicine for children is prepared from the following raw materials: 160g of fructus forsythiae, 200g of chimonanthus nitens leaves, 160g of radix saposhnikoviae, 80g of radix astragali, 80g of rhizoma atractylodis macrocephalae, 160g of folium eriobotryae, 40g of medicated leaven, 40g of malt, 2-4g of acetaminophen and 4-6g of taurine. The traditional Chinese medicine can quickly and effectively dispel wind and heat, clear heat and relieve cough, and can be used for treating infantile common cold and fever in spring, autumn and winter.

Description

[0001] This invention is a divisional application based on the application filed on November 20, 2023, with application number 202311541821.1 and invention title "A preparation process for a children's cold granule medicine". Technical Field

[0002] This invention relates to a preparation process for granular drugs, and more particularly to a preparation process for pediatric cold granules. Background Technology

[0003] The common cold in children, also known as acute upper respiratory tract infection, refers to an acute infection of the nasopharynx and upper respiratory tract above the larynx. It is primarily caused by viruses, but mycoplasma or bacterial infections may also occur. It is most common in early childhood, and symptoms typically include a runny nose with clear discharge, sneezing, nasal congestion, and coughing, often accompanied by fever, which can reach 39℃-40℃. Some children may also experience convulsions due to fever, or diarrhea, abdominal pain, and vomiting. Currently, the treatment of the common cold in children mainly involves Western medicine and traditional Chinese medicine. Western medicine generally uses antibiotics, hormones, and non-steroidal anti-inflammatory drugs (NSAIDs), which, while fast-acting, have significant side effects, seriously affecting the child's physical and mental health. On the other hand, most commercially available traditional Chinese medicine preparations for treating the common cold in children have relatively simple and crude extraction and preparation processes, resulting in slow onset of action, unsatisfactory treatment effects, and poor patient compliance, making it difficult to meet clinical needs.

[0004] In view of this, the present invention selects ten kinds of Chinese medicinal materials, including Forsythia suspensa, wintersweet leaves, Saposhnikovia divaricata, Astragalus membranaceus, Atractylodes macrocephala, Eriobotrya japonica leaves, Shenqu (medicated leaven), malt, acetaminophen, and taurine, as raw materials, and produces children's cold granules through modern extraction and preparation processes. These granules can quickly and effectively dispel wind-heat, clear heat and relieve cough, and can be used for children's colds and fevers in spring, autumn and winter, as well as symptoms such as insufficiency of sweating, nasal congestion and runny nose, cough and sore throat. Summary of the Invention

[0005] The purpose of this invention is to solve the technical problems existing in the prior art and to provide a preparation process for pediatric cold granules.

[0006] To achieve the above objectives, the technical solution provided by the present invention is: a children's cold relief granule medicine, which is made from the following raw materials: 160g of Forsythia suspensa, 200g of Waxberry leaves, 160g of Saposhnikovia divaricata, 80g of Astragalus membranaceus, 80g of Atractylodes macrocephala, 160g of Eriobotrya japonica leaves, 40g of Shenqu (medicated leaven), 40g of malt, 2-4g of acetaminophen, 4-6g of taurine, preferably 3g of acetaminophen and preferably 5g of taurine.

[0007] The specific manufacturing process of this children's cold granules includes the following steps: Step (1): Forsythia, wintersweet leaves, Saposhnikovia divaricata, Astragalus membranaceus, Atractylodes macrocephala, loquat leaves, Shenqu (medicated leaven), and malt are mixed and decocted with water. The decoction is then filtered and compressed into an extract. Step (2): Spray dry the extract obtained in step (1) to obtain a dry extract powder; Step (3): Then, by adding excipients, acetaminophen, and taurine to the dry ointment powder, 1000 grams of granules are made together. Step (4): Make 1000 grams of granules into 400 bags, each bag containing 2.5 grams.

[0008] Preferably, the decoction in step (1) includes two decoctions: the first decoction lasts for 2.5-3 hours and the second decoction lasts for 1.5-2 hours. The decoctions from the two decoctions are combined to obtain the refined decoction.

[0009] Preferably, the spray drying conditions in step (2) are: inlet air temperature of 90-100℃, outlet air temperature of 70-80℃, atomization pressure of 0.1-0.3Mpa, and spray speed of 5-10ml / s.

[0010] Preferably, the excipients in step (3) are one or more of sucrose, dextrin, starch, stevioside, microcrystalline cellulose, and magnesium stearate.

[0011] Beneficial effects of this invention: This invention relates to pediatric cold relief granules made from ten Chinese medicinal herbs, including forsythia, wintersweet leaves, saposhnikovia root, astragalus root, atractylodes rhizome, loquat leaves, medicated leaven, malt, acetaminophen, and taurine. These granules can quickly and effectively dispel wind-heat, clear heat and relieve cough, and can be used for children's colds and fevers in spring, autumn, and winter. Detailed Implementation

[0012] This section will describe in detail specific embodiments of the present invention, enabling people to intuitively and vividly understand each technical feature and overall technical solution of the present invention, but it should not be construed as a limitation on the scope of protection of the present invention.

[0013] This invention discloses a preparation process for a children's cold granule, which is made from the following raw materials: 160g of Forsythia suspensa, 200g of Waxberry leaves, 160g of Saposhnikovia divaricata, 80g of Astragalus membranaceus, 80g of Atractylodes macrocephala, 160g of Eriobotrya japonica leaves, 40g of Shenqu (medicated leaven), 40g of malt, 2-4g of acetaminophen, and 4-6g of taurine; preferably 3g of acetaminophen and 5g of taurine.

[0014] Forsythia, also known as: Luoqiao, Huanghuatiao, Huangliantiaohua; Properties: slightly cold in nature, bitter in taste; Functions: clearing heat and detoxifying, reducing swelling and dissipating nodules.

[0015] Mountain wax plum leaves, also known as: bright-leaf wax plum, hairy mountain tea, rock mulberry, fragrant wind tea, mountain wax plum, stinky wax plum, iron chopsticks, small dam king, autumn wax plum, wild wax plum, snow flower, chicken egg fruit (National Compendium of Chinese Herbal Medicines); taste: pungent, slightly bitter, warm in nature; effects: dispel wind and release the exterior, aromatically resolve dampness.

[0016] Fangfeng, also known as Tongyun, Huiyun, Huicao, Baizhi, and Baizhong; taste: pungent and sweet, slightly warm; effects: dispels wind and releases the exterior, eliminates dampness and relieves pain, and stops spasms.

[0017] Astragalus, also known as: Mianqi, Huangshen, Xueshen; taste: sweet, slightly warm; functions: strengthens the spleen and replenishes the middle jiao, raises yang and lifts prolapse, benefits the defensive qi and consolidates the exterior, promotes diuresis, and promotes tissue regeneration and detoxification.

[0018] Atractylodes macrocephala, also known as: Yushu, Dongshu, Zheshu, Zhongshu, Shanji, Yangbaoji, Shu, Shanjie, Tianji, Shanjiang, Qilijia, Shanjing, Shanlian, Dongbaizhu, Yangfuji, Shu; Properties and effects: bitter, sweet, warm; tonifies the spleen, benefits the stomach, dries dampness, harmonizes the middle jiao, and calms the fetus.

[0019] Loquat leaf, also known as: Ba leaf, Luju leaf; taste: bitter, slightly pungent, slightly cold; effects: clears the lungs and relieves cough, harmonizes the stomach and relieves nausea, quenches thirst.

[0020] Liu Shenqu, also known as Shenqu or Liuqu; Properties: Stale smell, slightly bitter taste; Functions: Strengthens the spleen and stomach, promotes digestion and regulates the middle jiao.

[0021] Malt, also known as barley sprout, barley malt; taste: sweet, neutral; effects: promotes digestion, strengthens the spleen and stomach, reduces lactation and relieves bloating.

[0022] Acetaminophen, also known as N-acetyl-p-aminophen or 4-acetaminophen; Properties: white crystals or crystalline powder, odorless; Efficacy: antipyretic and analgesic effects.

[0023] Taurine, also known as taurine or taurine; properties: white or off-white crystals or crystalline powder, odorless; efficacy: used to relieve fever in the early stages of a cold.

[0024] The pediatric cold relief granules made from ten Chinese medicinal herbs, including forsythia, wintersweet leaves, saposhnikovia root, astragalus root, atractylodes rhizome, loquat leaves, medicated leaven, malt, acetaminophen, and taurine, can quickly and effectively dispel wind-heat, clear heat and relieve cough. They can be used for children's colds and fevers in spring, autumn, and winter.

[0025] Example 1 A preparation process for a children's cold granule, the granules being made from the following raw materials: 160g Forsythia suspensa, 200g Winter Jasmine leaves, 160g Saposhnikovia divaricata, 80g Astragalus membranaceus, 80g Atractylodes macrocephala, 160g Eriobotrya japonica leaves, 40g Shenqu (medicated leaven), 40g Malt, 3g Acetaminophen, and 5g Taurine. The specific preparation process includes the following steps: Step (1): Forsythia, wintersweet leaves, Saposhnikovia divaricata, Astragalus membranaceus, Atractylodes macrocephala, Eriobotrya japonica leaves, Shenqu (medicated leaven), and malt are mixed and decocted with water. The decoction is then filtered and compressed into an extract. The decoction includes two decoctions: the first decoction lasts 2.5-3 hours and the second decoction lasts 1.5-2 hours. The two decoctions are combined to obtain the refined decoction. Step (2): The extract obtained in step (1) is spray-dried to obtain dry extract powder; the spray drying conditions are: inlet air temperature of 90-100℃, outlet air temperature of 70-80℃, atomization pressure of 0.1-0.3Mpa, and spray speed of 5-10ml / s; Step (3): Then, the dry powder is mixed with excipients, 3 grams of acetaminophen, and 5 grams of taurine to make 1000 grams of granules; the excipients are one or more of sucrose, dextrin, starch, stevioside, microcrystalline cellulose, and magnesium stearate.

[0026] Step (4): Make 1000 grams of granules into 400 bags, each bag containing 2.5 grams.

[0027] Example 2 A preparation process for a children's cold granule, the granules being made from the following raw materials: 160g Forsythia suspensa, 200g Winter Jasmine leaves, 160g Saposhnikovia divaricata, 80g Astragalus membranaceus, 80g Atractylodes macrocephala, 160g Eriobotrya japonica leaves, 40g Shenqu (medicated leaven), 40g Malt, 2g Acetaminophen, and 4g Taurine. The specific preparation process includes the following steps: Step (1): Forsythia, wintersweet leaves, Saposhnikovia divaricata, Astragalus membranaceus, Atractylodes macrocephala, Eriobotrya japonica leaves, Shenqu (medicated leaven), and malt are mixed and decocted with water. The decoction is then filtered and compressed into an extract. The decoction includes two decoctions: the first decoction lasts 2.5-3 hours and the second decoction lasts 1.5-2 hours. The two decoctions are combined to obtain the refined decoction. Step (2): The extract obtained in step (1) is spray-dried to obtain dry extract powder; the spray drying conditions are: inlet air temperature of 90-100℃, outlet air temperature of 70-80℃, atomization pressure of 0.1-0.3Mpa, and spray speed of 5-10ml / s; Step (3): Then, the dry powder is mixed with excipients, 3 grams of acetaminophen, and 5 grams of taurine to make 1000 grams of granules; the excipients are one or more of sucrose, dextrin, starch, stevioside, microcrystalline cellulose, and magnesium stearate.

[0028] Step (4): Make 1000 grams of granules into 400 bags, each bag containing 2.5 grams.

[0029] Example 3 A preparation process for a children's cold granule, the granules being made from the following raw materials: 160g Forsythia suspensa, 200g Winter Jasmine leaves, 160g Saposhnikovia divaricata, 80g Astragalus membranaceus, 80g Atractylodes macrocephala, 160g Eriobotrya japonica leaves, 40g Shenqu (medicated leaven), 40g Malt, 3g Acetaminophen, and 5g Taurine. The specific preparation process includes the following steps: Step (1): Forsythia, wintersweet leaves, Saposhnikovia divaricata, Astragalus membranaceus, Atractylodes macrocephala, Eriobotrya japonica leaves, Shenqu (medicated leaven), and malt are mixed and decocted with water. The decoction is then filtered and compressed into an extract. The decoction includes two decoctions: the first decoction lasts 2.5-3 hours and the second decoction lasts 1.5-2 hours. The two decoctions are combined to obtain the refined decoction. Step (2): The extract obtained in step (1) is spray-dried to obtain dry extract powder; the spray drying conditions are: inlet air temperature of 90-100℃, outlet air temperature of 70-80℃, atomization pressure of 0.1-0.3Mpa, and spray speed of 5-10ml / s; Step (3): Then, add excipients, 4 grams of acetaminophen, and 6 grams of taurine to the dry ointment powder to make 1000 grams of granules; the excipients are one or more of sucrose, dextrin, starch, stevioside, microcrystalline cellulose, and magnesium stearate.

[0030] Step (4): Make 1000 grams of granules into 400 bags, each bag containing 2.5 grams.

[0031] Test case Fifty healthy mice of uniform weight were randomly divided into five groups, and their body temperature was measured (recorded as T1). On the second day, they were injected with 15% fresh yeast saline solution to induce fever, and their body temperature was measured in the afternoon (recorded as T2). One group was fed commercially available children's cold granules as the control group, and the other four groups were fed the children's cold granules provided in Examples 1-3 of this invention as the experimental groups. The mice were given the medicine once in the morning (8:00) and once in the afternoon (6:00) at a dose of 1g / kg for 3 consecutive days. Their body temperature was measured at 9:00 pm on the last day of medication and recorded as T3, T4, and T5, respectively. The results are expressed as average values, as shown in Table 1.

[0032] Table 1

[0033] As shown in Table 1, the body temperature (T2) of mice in all groups increased after injection of fresh yeast saline. When fed the children's cold granules provided in Examples 1-3 of this invention, the body temperature of the experimental group returned to normal on the second day of medication (T4), while the body temperature of the control group returned to normal on the third day of medication (T5). This shows that the children's cold medicine provided in the examples of this invention has a significant antipyretic effect.

[0034] The pediatric cold relief granules made from ten Chinese medicinal herbs, including forsythia, wintersweet leaves, saposhnikovia root, astragalus root, atractylodes rhizome, loquat leaves, medicated leaven, malt, acetaminophen, and taurine, can quickly and effectively dispel wind-heat, clear heat and relieve cough. They can be used for children's colds and fevers in spring, autumn, and winter.

[0035] Without causing conflict, those skilled in the art can freely combine and use the above-mentioned additional technical features.

[0036] The above description is only a preferred embodiment of the present invention. Any technical solution that achieves the purpose of the present invention by essentially the same means is within the protection scope of the present invention.

Claims

1. A pediatric Ganmaoning granule medicine, characterized in that, It is made from the following ingredients: 160g of Forsythia suspensa, 200g of Waxberry leaves, 160g of Saposhnikovia divaricata, 80g of Astragalus membranaceus, 80g of Atractylodes macrocephala, 160g of Eriobotrya japonica leaves, 40g of Shenqu (medicated leaven), 40g of malt, 2-4g of acetaminophen, and 4-6g of taurine.

2. The pediatric Ganmaoning granules of claim 1, characterized in that, It also includes excipients, which are one or more of sucrose, dextrin, starch, stevioside, microcrystalline cellulose, and magnesium stearate.

3. The process for the preparation of Xiaoer Ganrouning granules as claimed in claim 1 or 2, wherein, Includes the following steps: Step (1): Mix forsythia, wintersweet leaves, saposhnikovia root, astragalus root, atractylodes rhizome, loquat leaves, medicated leaven and malt, add water and decoct thoroughly. Filter the decoction and compress it into an extract. Step (2): Spray dry the extract obtained in step (1) to obtain a dry extract powder; Step (3): Prepare 1000g of granules by adding excipients, acetaminophen, and taurine to the dry ointment powder; Step (4): Make 1000 grams of granules into 400 bags, each bag containing 2.5 grams.

4. The process for the preparation of granules of Xiaoer Ganlongning medicine as claimed in claim 3, wherein, The decoction process described in step (1) includes two decoctions; The first decoction is 2.5-3 hours, the second decoction is 1.5-2 hours, and the decoctions from the two decoctions are combined to obtain the refined decoction.

5. The process for the preparation of granules of Xiaoer Ganlongning medicine as claimed in claim 3, wherein, The spray drying conditions described in step (2) are: inlet air temperature of 90-100℃, outlet air temperature of 70-80℃, atomization pressure of 0.1-0.3Mpa, and spray speed of 5-10ml / s.

Images