Composition for treating functional abdominal pain of children as well as preparation method and application of composition

Abstract

The invention discloses a composition for treating children functional abdominal pain and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions.The composition is prepared from, by weight, 400-800 parts of vinegar-processed rhizoma corydalis, 400-800 parts of angelica sinensis, 400-800 parts of radix paeoniae alba, 300-600 parts of codonopsis pilosula, 300-600 parts of radix trichosanthis, 400-800 parts of poria cocos, 200-400 parts of dark malt and 150-300 parts of honey-fried licorice roots. According to the traditional Chinese medicine composition disclosed by the invention, by controlling the variety and proportion of the medicines, the mutual synergistic effect of the components is improved, and the effect of treating the functional abdominal pain of children is improved. Compared with the prior art, the traditional Chinese medicine composition is good in medicine effect and low in cost, and more choices are provided for clinical application of functional abdominal pain of children.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions. Specifically, it relates to a composition for treating children's functional abdominal pain, its preparation method and application. Background Art

[0002] Functional abdominal pain (FAP) is one of the common diseases in clinical pediatrics, manifested as recurrent abdominal pain without obvious organic changes. At present, the pathophysiological mechanism of FAP is not fully understood, and Western pharmacy lacks specific treatment methods.

[0003] Children's functional abdominal pain belongs to the category of "abdominal pain" in traditional Chinese medicine, characterized by a long course, repeated illness, and difficulty in cure. The internal organs involved in this disease include the liver, gallbladder, stomach, large intestine, small intestine, bladder, etc. Its meridian distribution includes the three yin meridians of the foot, the foot shaoyang, the yangming meridians of the hand and foot, the chong meridian, the dai meridian, the ren meridian, etc. The pathological factors include cold coagulation, blood stasis, food retention, qi stagnation, fire pathogen, etc. Therefore, the pathogenesis of children's FAP is complex. Any factors such as exogenous six pathogenic factors, improper diet, emotional discomfort, and deficiency of qi, blood, yin, and yang can cause qi and blood stasis in the abdomen or malnutrition of the internal organs and meridians, resulting in "pain due to obstruction" or "pain due to malnutrition" and presenting abdominal pain.

[0004] Fu Changhui (Observation on the Clinical Efficacy of the Traditional Chinese Medicine Prescription for Regulating the Spleen and Relieving Pain and Self - formulated "Yunpi Zhitong Fang" Based on Modern Literature Mining for Children's Functional Abdominal Pain [D], Tianjin University of Traditional Chinese Medicine, 2022) disclosed a Yunpi Zhitong Fang, with the following composition: Atractylodes lancea, Amomum villosum, Bupleurum chinense, Paeonia lactiflora, Aurantii Fructus Immaturus, Glycyrrhiza uralensis, Aucklandia lappa, Corydalis yanhusuo, Magnolia officinalis, and Endothelium corneum gigeriae galli. The four natures of this prescription are relatively warm, and the five flavors are mainly pungent, sweet, bitter, and it mainly enters the spleen and stomach meridians. It contains prescriptions such as Sini Powder, Paeoniae Glycyrrhizae Decoction, Pingwei Powder, and Chengqi Decoction. It involves multiple drug compatibilities. Among them, Atractylodes lancea and Amomum villosum regulate the spleen as the monarch drugs, Bupleurum chinense soothes the liver and Paeonia lactiflora softens the liver as the minister drugs, Aucklandia lappa, Corydalis yanhusuo, Magnolia officinalis, and Aurantii Fructus Immaturus regulate qi and relieve pain, and Endothelium corneum gigeriae galli promotes digestion and resolves stagnation, all serving as assistant drugs, and the sweet drug relieves spasm and pain and harmonizes various drugs as the guiding drug. The whole prescription jointly exerts the effects of regulating the spleen and soothe the liver, regulating qi and relieving pain.

[0005] CN111759901A disclosed a traditional Chinese medicine composition for treating children's functional abdominal pain, which is made from the following raw materials: Atractylodes macrocephala, Aurantii Fructus Immaturus, Magnolia officinalis, Paeonia lactiflora, Aucklandia lappa, Corydalis yanhusuo, and Glycyrrhiza uralensis. According to the physiological and pathological characteristics of children, as well as the main pathogenesis of children's abdominal pain with abnormal spleen and stomach function and unsmooth qi movement, the clinical treatment principle is to invigorate the spleen and harmonize the stomach, regulate qi and relieve pain. It can not only effectively relieve the symptoms of children's abdominal pain, but also improve appetite and prevent recurrence.

[0006] At present, the treatment cost of children's FAP in traditional Chinese medicine is relatively high, and there is still room for improvement in the efficacy.

[0007] In view of the problems existing in the prior art, it is very necessary to find a composition for treating children's functional abdominal pain with better drug efficacy and lower cost. Summary of the Invention

[0008] In order to solve the above technical problems, the present invention provides a composition for treating children's functional abdominal pain, its preparation method and application. This composition has good drug efficacy and low cost, providing more choices for the clinical application of children's functional abdominal pain.

[0009] In order to achieve the above object, the present invention adopts the following technical solutions:

[0010] In the first aspect, the present invention provides a composition for treating children's functional abdominal pain, comprising the following raw materials in parts by weight: Corydalis Rhizoma Preparata 400 - 800 parts, Angelica Sinensis Radix 400 - 800 parts, Paeonia Lactiflora Radix 400 - 800 parts, Codonopsis Pilosula Radix 300 - 600 parts, Trichosanthis Radix 300 - 600 parts, Poria 400 - 800 parts, Germinated Barley 200 - 400 parts, and Honey-Fried Licorice Root 150 - 300 parts.

[0011] This invention is modified from Danggui Shaoyao Powder in Synopsis of the Golden Chamber by Zhang Zhongjing in the Eastern Han Dynasty. The original formula is used to treat abdominal pain during pregnancy with deficiency of both the liver and spleen and concurrent blood stasis and damp obstruction. The original formula is made by pounding 3 liang of Angelica Sinensis Radix, 1 jin of Paeonia Lactiflora Radix, 4 liang of Poria, 4 liang of Atractylodes Macrocephala Rhizoma, 8 liang of Alisma Orientalis Rhizoma, and 8 liang of Ligusticum Chuanxiong Rhizoma into powder. Based on the classic formula, the composition of this invention is modified according to the pathogenesis characteristics and mechanisms of children's functional abdominal pain.

[0012] Paeonia Lactiflora Radix tastes sour, bitter and is slightly cold in nature. It enters the liver and spleen meridians, nourishes the liver blood, soothes the liver and relieves pain, and at the same time has the effect of promoting urination. "Shennong Ben Cao Jing" states that it "maintains pathogenic qi and abdominal pain, removes blood stasis... relieves pain and promotes urination". Qi is the commander of blood. The addition of Corydalis Rhizoma Preparata mainly soothes the liver and promotes qi movement, and can also mainly treat qi stagnation in the gastrointestinal tract, especially suitable for abdominal pain due to qi stagnation and blood stasis in children. The two together are the monarch drugs.

[0013] Angelica Sinensis Radix is pungent, sweet and warm in nature, mainly entering the liver meridian, and is an important drug for tonifying blood; Codonopsis Pilosula Radix tonifies the middle qi and, combined with Angelica Sinensis Radix, the two drugs nourish blood and harmonize blood together as the minister drugs.

[0014] Poria tastes sweet and light, is neutral in nature, and belongs to the heart, lung, spleen and kidney meridians. It has the effects of promoting diuresis to eliminate dampness, strengthening the spleen, and calming the mind. "Lei Gong's Treatise on the Nature and Properties of Medicinal Herbs" mentions that Poria "tastes light, and is a product for promoting diuresis in the taiyang meridian. Slightly sweet, it is the taste of the central spleen earth, so it enters both. The spleen hates dampness the most, and when urination is smooth, dampness will be removed by itself, so it strengthens the spleen." Poria promotes the function of the spleen and overcomes dampness, promotes the excess water qi, and together with Angelica Sinensis Radix and Paeonia Lactiflora Radix, not only dredges the stagnant blood but also scatters the accumulated water, achieving the effect of strengthening the spleen, removing stasis and relieving pain.

[0015] Trichosanthes root is slightly cold in nature, sweet and slightly bitter in taste, and belongs to the lung and stomach meridians. It has the effects of clearing heat and purging fire, promoting the production of body fluid to quench thirst, and expelling pus and reducing swelling. Modern pharmacological research confirms that Trichosanthes root mainly contains four components: protein, polysaccharide, saponin, and aminophenol. Among them, trichosanthin can bidirectionally regulate cellular immunity and humoral immune responses and adjust the body's immune capacity. Malt is sweet and neutral in nature, and belongs to the spleen and stomach meridians, with the effects of promoting qi circulation to promote digestion and strengthening the spleen and stomach. At the same time, the rich glutamine protein and hemicellulose fiber in malt can inhibit the signal transduction of IL-6 and mucous membranes and reduce the damage of intestinal mucosa. The two work together to improve the immunity of intestinal mucosa and reduce intestinal damage.

[0016] Prepared Licorice Root is sweet in taste and warm in nature, strengthening the spleen and regulating the middle energizer. When combined with White Peony Root, it relieves pain by the sour and sweet method, and coordinates various medicinal herbs, serving as the adjuvant drug.

[0017] In some embodiments, the weight ratio of the prepared Corydalis Rhizoma, Chinese Angelica Root, White Peony Root, and Trichosanthes Root is 3-4:2-4:3-4:2-3; preferably 4:2:3:3.

[0018] In some embodiments, the composition comprises the following raw materials in parts by weight: 600-800 parts of prepared Corydalis Rhizoma, 400-600 parts of Chinese Angelica Root, 600-800 parts of White Peony Root, 300-500 parts of Codonopsis Pilosula Root, 400-600 parts of Trichosanthes Root, 400-600 parts of Poria Cocos, 300-400 parts of stir-fried malt, and 200-300 parts of prepared Licorice Root.

[0019] In some embodiments, the composition comprises the following raw materials in parts by weight: 800 parts of prepared Corydalis Rhizoma, 400 parts of Chinese Angelica Root, 600 parts of White Peony Root, 400 parts of Codonopsis Pilosula Root, 600 parts of Trichosanthes Root, 400 parts of Poria Cocos, 400 parts of stir-fried malt, and 300 parts of prepared Licorice Root.

[0020] In a second aspect, the present invention provides a preparation method of the above composition, comprising the following steps:

[0021] Decoct the prepared Corydalis Rhizoma, Chinese Angelica Root, White Peony Root, Codonopsis Pilosula Root, Trichosanthes Root, Poria Cocos, stir-fried malt, and prepared Licorice Root in an amount according to the formula with water, separate the solid and liquid, and concentrate and dry to obtain the product.

[0022] In some embodiments, the number of decoction times is 1-3 times, and each time is 0.5-2 h; preferably, decoct 2 times, each time for 1 h.

[0023] In some embodiments, the amount of water used in the decoction is 8-14 times the total weight of the prepared Corydalis Rhizoma, Chinese Angelica Root, White Peony Root, Codonopsis Pilosula Root, Trichosanthes Root, Poria Cocos, stir-fried malt, and Licorice Root; preferably 9-12 times.

[0024] In some embodiments, the solid-liquid separation is a conventional technical means for separating solid and liquid in the art, such as filtration, centrifugation, or pressure filtration.

[0025] In some embodiments, the drying is to dry to a water content of less than 10%. Preferably, the drying is spray drying, vacuum drying or freeze drying.

[0026] In a third aspect, the present invention provides the use of the above composition or the composition prepared by the preparation method in the preparation of a medicament for treating functional abdominal pain in children.

[0027] In a fourth aspect, the present invention further provides a pharmaceutical preparation for treating functional abdominal pain in children, comprising the aforementioned composition or the composition prepared by the aforementioned preparation method.

[0028] In some embodiments, the composition of the present invention can also be used as a raw material and mixed with pharmaceutically acceptable excipients to prepare corresponding pharmaceutical preparations.

[0029] Preferably, the dosage form of the pharmaceutical preparation is tablets, granules, pills, powders, syrups or mixtures.

[0030] In some embodiments, the present invention provides a granule for treating functional abdominal pain in children, comprising the aforementioned composition or the composition prepared by the aforementioned preparation method and pharmaceutically acceptable excipients.

[0031] Preferably, the excipients are at least one of starch, dextrin, sucrose, milk powder, sweetening agent, mannitol, lactose, cellulose and its derivatives, calcium carbonate, phospholipid materials, magnesium stearate, talcum powder and essence.

[0032] The beneficial effects of the present invention are as follows:

[0033] (1) By controlling the types and ratios of the drugs, the present invention improves the synergistic effect among the components and enhances the therapeutic effect on functional abdominal pain in children.

[0034] (2) The present invention decocts drugs such as Angelica sinensis and Paeonia lactiflora with water to prepare a traditional Chinese medicine composition, which has a simple process, high drug bioavailability, clear components and good therapeutic effects.

[0035] (3) Compared with the prior art, the composition of the present invention has better effects on preventing and treating functional abdominal pain in children, less dosage and lower cost. Specific Embodiments

[0036] The following specific examples illustrate the embodiments of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0037] Before further describing the specific embodiments of the present invention, it should be understood that the protection scope of the present invention is not limited to the specific embodiments described below; it should also be understood that the terms used in the embodiments of the present invention are for describing specific embodiments and not for limiting the protection scope of the present invention.

[0038] When an embodiment gives a numerical range, it should be understood that unless otherwise specified in the present invention, both endpoints of each numerical range and any value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which the present invention belongs.

[0039] The "pharmaceutical preparation" described in the present invention includes a composition and a pharmaceutically acceptable excipient. In a specific embodiment, the composition set forth in the present invention is provided in the pharmaceutical preparation in an effective amount (e.g., a therapeutically effective amount).

[0040] The "acceptable" ingredients in the present invention are substances that are suitable for humans and / or animals without excessive adverse side effects (such as toxicity, irritation, and allergic reactions), that is, substances with a reasonable benefit / risk ratio. The "pharmaceutically acceptable excipients" include inert diluents, dispersants and / or granulating agents, surfactants and / or emulsifying agents, disintegrants, binders, preservatives, buffering agents, lubricants and / or oils. Excipients (such as cocoa butter and suppository wax), colorants, coating agents, sweeteners, and flavoring agents may also be present in the composition.

[0041] The "pharmaceutical preparation" described in the present invention can be prepared by any method known in pharmacy. Generally, these preparation methods include associating the composition (hereinafter referred to as the active ingredient) with a carrier or excipient and / or one or more other auxiliary ingredients, and then, if necessary and / or desired, shaping and / or packaging the product into a desired single-dose or multi-dose unit.

[0042] The pharmaceutical preparation of the present invention can be prepared according to known methods, such as the methods described in the general rules of the Chinese Pharmacopoeia 2020 Edition, the 16th Edition of the Japanese Pharmacopoeia, the United States Pharmacopoeia, and the 9th Edition of the European Pharmacopoeia. The specific preparation method depends on the dosage form.

[0043] The active ingredient and pharmaceutically acceptable excipient in the "pharmaceutical preparation" described in the present invention will vary according to the identity, body size, and / or condition of the subject to be treated and further according to the administration route of the active ingredient. The pharmaceutical preparation may contain an active ingredient between 0.1% and 100% (w / w).

[0044] As used in the present invention, the term "treatment", unless otherwise indicated, means reversing, alleviating the disorder or disease to which the term applies or one or more symptoms of such a disorder or disease, inhibiting the progression of the disorder or disease or one or more of its symptoms, or preventing the disorder or disease or one or more of its symptoms. The term "treatment" as used in the invention refers to a treatment act as "treatment" was just defined above.

[0045] The "effective amount" as used in the present invention refers to the amount sufficient to elicit the desired biological response. The effective amount of the active ingredient of the present invention may vary depending on factors such as the desired biological endpoint, the pharmacokinetics of the compound, the disorder being treated, the mode of administration, and the age and health status of the subject. In certain embodiments, the effective amount is a therapeutically effective amount. The effective amount is the amount of the sole active ingredient described in the present invention in a single dose. In certain embodiments, the effective amount is the combined amount of the sole active ingredient described in the present invention in multiple doses.

[0046] The "therapeutically effective amount" as used in the present invention is the amount sufficient to provide a therapeutic benefit in the treatment of a disorder or sufficient to delay or minimize one or more symptoms associated with the disorder. The therapeutically effective amount of the active ingredient means the amount of the therapeutic agent alone or in combination with other therapies that provides a therapeutic benefit in the treatment of the disorder. The term "therapeutically effective amount" may encompass an amount that improves the overall therapy, reduces or avoids the symptoms, signs or causes of the disorder, and / or enhances the therapeutic efficacy of another therapeutic agent. In certain embodiments, the therapeutically effective amount is the amount sufficient to treat any disease or disorder described.

[0047] Unless otherwise specified, the raw materials used are ordinary commercially available products, so their sources are not specifically defined. Unless otherwise specified, all operations are carried out at room temperature, where room temperature is 20 - 25 °C.

[0048] Citation of prior art:

[0049] [1] Lai Biyu, Hong Mengying, Li Xing, et al. Preparation of a rat model of diarrhea-predominant irritable bowel syndrome with liver depression and spleen deficiency by acetic acid enema combined with restraint tail clamping stress [J]. Acta Laboratorium Animalis Scientia Sinica, 2024, 32(3): 317 - 328.

[0050] [2] Yu Jiaying, Zhang Huiyong, Wang Feng, et al. Research progress and review on modeling methods of nine animal models of blood stasis syndrome [J]. World Science and Technology - Modernization of Traditional Chinese Medicine, 2022, 24(12): 4855 - 4864.

[0051] [3] Liao Li, Zhao Xingtao, Wang Cheng, et al. Research progress on blood stasis syndrome models [J]. China Journal of Traditional Chinese Medicine and Pharmacy, 2021, 36(12): 7256 - 7260.

[0052] [4] Zhang Yonglong, Ma Weigang, Qian Xingyu, et al. Review on the construction and evaluation methods of experimental animal models of spleen deficiency syndrome [J]. Acta Laboratorium Animalis Scientia Sinica, 2024, 32(3): 385-396.

[0053] Example 1 A composition for treating children's functional abdominal pain

[0054] The raw materials are as follows by weight: 800 parts of Corydalis Rhizoma Vinegar-processed, 400 parts of Angelica Sinensis Radix, 600 parts of Paeonia Lactiflora Radix Alba, 400 parts of Codonopsis Pilosula Radix, 600 parts of Trichosanthis Radix, 400 parts of Poria Cocos Sclerotium, 400 parts of Fructus Hordei Germinatus Praeparatus, and 300 parts of Glycyrrhiza Glabra Radix Preparata.

[0055] The preparation method is as follows:

[0056] Decoct the formula amounts of Corydalis Rhizoma Vinegar-processed, Angelica Sinensis Radix, Paeonia Lactiflora Radix Alba, Codonopsis Pilosula Radix, Trichosanthis Radix, Poria Cocos Sclerotium, Fructus Hordei Germinatus Praeparatus, and Glycyrrhiza Glabra Radix Preparata with water twice, each time for 1 h. The amount of water added for the first decoction is 9 times the total weight of Corydalis Rhizoma Vinegar-processed, Angelica Sinensis Radix, Paeonia Lactiflora Radix Alba, Codonopsis Pilosula Radix, Trichosanthis Radix, Poria Cocos Sclerotium, Fructus Hordei Germinatus Praeparatus, and Glycyrrhiza Glabra Radix Preparata; the amount of water added for the second decoction is 12 times the total weight of Corydalis Rhizoma Vinegar-processed, Angelica Sinensis Radix, Paeonia Lactiflora Radix Alba, Codonopsis Pilosula Radix, Trichosanthis Radix, Poria Cocos Sclerotium, Fructus Hordei Germinatus Praeparatus, and Glycyrrhiza Glabra Radix Preparata; filter, combine the filtrates, and concentrate and dry at 70 °C.

[0057] Example 2 A composition for treating children's functional abdominal pain

[0058] The raw materials are as follows by weight: 800 parts of Corydalis Rhizoma Vinegar-processed, 800 parts of Angelica Sinensis Radix, 800 parts of Paeonia Lactiflora Radix Alba, 300 parts of Codonopsis Pilosula Radix, 600 parts of Trichosanthis Radix, 400 parts of Poria Cocos Sclerotium, 400 parts of Fructus Hordei Germinatus Praeparatus, and 300 parts of Glycyrrhiza Glabra Radix Preparata.

[0059] The preparation method is the same as that in Example 1.

[0060] Example 3 A composition for treating children's functional abdominal pain

[0061] The raw materials are as follows by weight: 600 parts of Corydalis Rhizoma Vinegar-processed, 400 parts of Angelica Sinensis Radix, 600 parts of Paeonia Lactiflora Radix Alba, 500 parts of Codonopsis Pilosula Radix, 400 parts of Trichosanthis Radix, 600 parts of Poria Cocos Sclerotium, 200 parts of Fructus Hordei Germinatus Praeparatus, and 150 parts of Glycyrrhiza Glabra Radix Preparata.

[0062] The preparation method is the same as that in Example 1.

[0063] Effect example: Research on the efficacy mechanism of the spleen-strengthening and stasis-removing pain-relieving formula in treating functional abdominal pain with spleen deficiency and blood stasis syndrome in mice by the disease-syndrome combination modeling method

[0064] 1. Experimental materials

[0065] 1.1. Experimental animals

[0066] 45 3-week-old male SD rats, SPF grade, were housed in the Experimental Animal Center of Beijing University of Chinese Medicine.

[0067] 1.2 Experimental drugs

[0068] The composition prepared by the classic prescription Danggui Shaoyao San and Example 1.

[0069] 2. Animal Modeling

[0070] 2.1 Grouping

[0071] Three-week-old SD rats were randomly divided into a blank control group, a model group, a Chinese medicine control group, a medium-dose combination group, and a high-dose combination group, with 9 rats in each group.

[0072] 2.2 Drug administration and modeling

[0073] The blank control group received no intervention; the model group used the disease-syndrome combination modeling method to model functional abdominal pain in children with spleen deficiency and stasis. Disease modeling: acetic acid enema + restraint stress, refer to the prior art [1]. Syndrome modeling: unhealthy diet + weighted swimming, refer to the prior art [2-3]. After the modeling, the model was evaluated by abdominal wall withdrawal experiment, and the rats with successful modeling were randomly divided into 4 groups, 9 rats in each group. The rats in the medium-dose group and the high-dose group of the composition were treated with the composition prepared in Example 1 by gavage every day, the Chinese medicine control group was gavaged with the classic prescription Danggui Shaoyao San every day, and the model group and the blank control group were gavaged with an equal amount of normal saline every day for 2 weeks.

[0074] 3. Detection indicators

[0075] 3.1 General Observations

[0076] During the modeling and drug administration period, the appearance and activities of the rats were observed every day, such as listlessness, curling up, huddling, slow reaction, dry and messy fur, dirty perianal area, reduced appetite, and weight loss.

[0077] 3.2 Food intake

[0078] The feed was weighed daily during modeling and the last week of treatment, and the average daily food intake was calculated.

[0079] 3.3 Changes in body weight and rectal temperature

[0080] The rectal temperature and body weight of the rats were measured on the last day after modeling and treatment.

[0081] 3.4 Fecal Bristol grading score and loose stool rate

[0082] On the last day of drug administration, the Bristol grading score of rat feces and the loose stool rate were determined. The total number of feces and the number of loose feces particles of rats were calculated by filter paper blotting method 6 hours after modeling and on the last day of drug administration.

[0083] The Bristol stool scale is as follows: type 1 is scattered dry pellet stools, type 2 is lumpy, type 3 is sausage-shaped with cracks, type 4 is soft sausage-shaped, type 5 is soft lumps, type 6 is pasty stools, and type 7 is watery stools, corresponding to 1 - 7 points in sequence.

[0084] The determination of loose stools is based on whether there are stains on the filter paper. Loose stool rate / % = number of loose stool grains / total number of stool grains × 100.

[0085] 3.5 Abdominal withdrawal reflex (AWR) score After the administration, the AWR scores of rats in each group were measured under colorectal distension stimulation to determine the visceral sensitivity of rats. The AWR scoring criteria are as follows: no behavioral response, scored 0; reduced head movement and body stillness, scored 1; mild abdominal muscle contraction but not lifting off the ground, scored 2; strong abdominal muscle contraction and abdomen lifting off the platform, scored 3; pelvis lifting and body arching, scored 4.

[0086] 4. Test results

[0087] 4.1 Bristol stool score and loose stool rate

[0088] The results of the Bristol stool score are shown in Table 1.

[0089] Table 1

[0090]

[0091] The results showed that after modeling, compared with the blank control group, there were no obvious abnormal changes in the stool characteristics of rats in each group, and there were no differences in the Bristol stool score and loose stool rate among groups, indicating that the modeling was in line with the clinical actual situation of children with functional abdominal pain.

[0092] 4.2 Abdominal withdrawal score (AWR)

[0093] The results of the abdominal withdrawal score are shown in Table 2.

[0094] Table 2

[0095]

[0096] Note: Compared with the model group, *P < 0.05; compared with the medium-dose group of the composition, #P < 0.05.

[0097] The results showed that: compared with the model group, the abdominal wall withdrawal scores of rats in each group were significantly increased (P < 0.05), indicating that after drug intervention, the visceral sensitivity of rats in each group was reduced and the pain threshold was increased. Among them, the curative effects of the medium-dose group and the high-dose group of the composition were equivalent, and there was no significant difference between the two (P > 0.05). Compared with the traditional Chinese medicine control group, the abdominal wall withdrawal scores of rats in the medium-dose group of the composition were significantly increased (P < 0.05), indicating that the composition prepared by the present invention has better curative effect than the classical prescription Danggui Shaoyao San.

[0098] The above is a further description of the present invention in combination with specific embodiments, but these embodiments are merely exemplary and do not constitute any limitation to the scope of the present invention. Those skilled in the art should understand that the details and forms of the technical solutions of the present invention can be modified or replaced without departing from the spirit and scope of the present invention, but these modifications and replacements all fall within the protection scope of the present invention.

Claims

1. A composition for treating functional abdominal pain in children, characterized in that, It comprises the following raw materials in parts by weight: 400 - 800 parts of Corydalis Rhizoma processed with vinegar, 400 - 800 parts of Angelica Sinensis, 400 - 800 parts of Paeonia Lactiflora Pall., 300 - 600 parts of Codonopsis Pilosula, 300 - 600 parts of Trichosanthes Root, 400 - 800 parts of Poria, 200 - 400 parts of Germinated Barley, and 150 - 300 parts of Honey - fried Licorice Root.

2. The composition according to claim 1, characterized in that, The weight ratio of Corydalis Rhizoma processed with vinegar, Angelica Sinensis, Paeonia Lactiflora Pall., and Trichosanthes Root is 3 - 4:2 - 4:3 - 4:2 - 3.

3. The composition according to claim 1, characterized in that, It comprises the following raw materials in parts by weight: 600 - 800 parts of Corydalis Rhizoma processed with vinegar, 400 - 600 parts of Angelica Sinensis, 600 - 800 parts of Paeonia Lactiflora Pall., 300 - 500 parts of Codonopsis Pilosula, 400 - 600 parts of Trichosanthes Root, 400 - 600 parts of Poria, 300 - 400 parts of Germinated Barley, and 200 - 300 parts of Honey - fried Licorice Root.

4. The composition according to claim 1, characterized in that, The weight ratio of Corydalis Rhizoma, Angelica Sinensis, Paeonia Lactiflora Pall., and Trichosanthes Root is 4:2:3:

3.

5. The composition according to claim 1, wherein It comprises the following raw materials in parts by weight: 800 parts of Corydalis Rhizoma processed with vinegar, 400 parts of Angelica Sinensis, 600 parts of Paeonia Lactiflora Pall., 400 parts of Codonopsis Pilosula, 600 parts of Trichosanthes Root, 400 parts of Poria, 400 parts of Germinated Barley, and 300 parts of Honey - fried Licorice Root.

6. A method for preparing the composition according to any one of claims 1-5, characterized in that, It comprises the following steps: adding water to decoct the Corydalis Rhizoma processed with vinegar, Angelica Sinensis, Paeonia Lactiflora Pall., Codonopsis Pilosula, Trichosanthes Root, Poria, Germinated Barley, and Honey - fried Licorice Root in the formula amount, performing solid - liquid separation, and concentrating and drying.

7. The preparation method according to claim 6, characterized in that, The number of decocting times is 1 - 3 times, and each time is 0.5 - 2 h; and / or the amount of water used for decocting is 8 - 14 times the total weight of Corydalis Rhizoma processed with vinegar, Angelica Sinensis, Paeonia Lactiflora Pall., Codonopsis Pilosula, Trichosanthes Root, Poria, Germinated Barley, and Honey - fried Licorice Root.

8. Use of the composition according to any one of claims 1 - 5 or the composition prepared by the preparation method according to any one of claims 6 - 7 in the preparation of a drug for treating children's functional abdominal pain.

9. A pharmaceutical preparation, characterized in that, It comprises the composition according to any one of claims 1 - 5 or the composition prepared by the preparation method according to any one of claims 6 - 7.

10. The pharmaceutical preparation according to claim 9, characterized in that, The dosage form of the pharmaceutical preparation is tablet, granule, pill, powder, syrup or mixture.

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