Medicine bag for conditioning jaundice and preparation method thereof

Abstract

The invention provides a medicine bag for conditioning jaundice and a preparation method of the medicine bag. The medicine bag comprises the following medicinal material components in parts by weight: 1-5 parts of solanum lyratum, 1-5 parts of wild chrysanthemum stems, 1-4 parts of penthorum chinense pursh, 1-5 parts of honeysuckle stems, 1-4 parts of corn stigma, 1-4 parts of silkworm excrement, 1-5 parts of philippine violet herb, 1-5 parts of barberry, 2-6 parts of lygodium japonicum, 1-4 parts of oriental wormwood, 1-4 parts of lysimachia christinae hance and 1-4 parts of plantain herb. According to the scheme, intervention is performed from a bilirubin metabolism source and biliary secretion and excretion links. The silkworm excrement, the lygodium japonicum, the philippine violet herb and the penthorum chinense pursh in the formula cooperate to promote biliary secretion and accelerate discharge of bilirubin through intestinal tracts; meanwhile, herba artemisiae scopariae, radix et rhizoma rhei, solanum lyratum and other medicinal materials clear away liver and gallbladder damp-heat and improve the liver microenvironment; the corn stigma, the plantain herb and the like assist uncombined bilirubin to be excreted from the kidney through the diuretic effect, a multi-way synergistic mechanism of promoting secretion, clearing damp and heat and promoting urination and defecation is formed, three-dimensional conditioning of jaundice is achieved, and the curative effect is remarkable.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and more specifically, relates to a medicinal pack for treating jaundice and its preparation method. It is particularly suitable for the adjunctive treatment of neonatal jaundice, promoting bile secretion and accelerating bilirubin metabolism through a medicinal bath, thus safely and effectively improving jaundice symptoms. Background Technology

[0002] Jaundice is a clinical symptom caused by elevated serum bilirubin levels due to abnormal bilirubin metabolism, resulting in yellowing of the skin, mucous membranes, and sclera. Neonatal jaundice is the most common clinical problem in newborns and is divided into physiological jaundice and pathological jaundice. Physiological jaundice usually appears 2-3 days after birth and subsides spontaneously in about 7-10 days; while pathological jaundice appears earlier, lasts longer, and has higher bilirubin levels. If not treated promptly, it may lead to bilirubin encephalopathy, causing damage to the nervous system.

[0003] Currently, the main treatments for neonatal jaundice include phototherapy and medication. While phototherapy is effective, it has side effects such as fever, diarrhea, rash, and riboflavin deficiency, and is not effective for some infants (such as those with bile secretion disorders). Although oral traditional Chinese medicine has some efficacy, the gastrointestinal function of newborns is not fully developed, and oral medications can easily cause adverse reactions such as indigestion and diarrhea, leading to poor compliance.

[0004] In the existing technology, there are already a number of traditional Chinese medicine compositions used to treat jaundice, such as:

[0005] CN111514248A discloses a traditional Chinese medicine formula that promotes the rapid resolution of physiological jaundice in newborns. However, it is an oral preparation and contains laxative ingredients such as raw rhubarb, which may increase the gastrointestinal burden on newborns.

[0006] CN109893622A and CN110251574A disclose traditional Chinese medicine formulas for external washing or bathing in newborns with jaundice, but their formulas are mostly based on clearing heat and promoting diuresis, and are not very targeted at refractory jaundice such as bile secretion disorders.

[0007] Therefore, developing a safe, effective, easy-to-use topical treatment product that is particularly suitable for refractory neonatal jaundice is of significant clinical importance and market demand. Summary of the Invention

[0008] The purpose of this invention is to provide a medicine pack for treating jaundice and its preparation method, so as to solve the problems of large side effects, gastrointestinal irritation from oral medications, and poor efficacy for refractory jaundice in existing neonatal jaundice treatment methods.

[0009] A medicinal packet for jaundice conditioning, comprising the following medicinal material components by weight: 1-5 parts of Solanum lyratum Thunb., 1-5 parts of wild chrysanthemum stalk, 1-4 parts of Penthorum chinense Pursh., 1-5 parts of honeysuckle stalk, 1-4 parts of corn stigma, 1-4 parts of silkworm excrement, 1-5 parts of fishing rod grass, 1-5 parts of Cipadessa cinerascens (Pell.) Hand.-Mazz., 2-6 parts of Lygodium japonicum (Thunb.) Sw., 1-4 parts of Artemisia capillaris Thunb., 1-4 parts of Lysimachia christinae Hance, 1-4 parts of Plantago asiatica L.; the outer packaging material of the medicinal packet is a dialyzable non-woven fabric or cotton cloth.

[0010] Preferably, the parts by weight of the medicinal material components are: 3 parts of Solanum lyratum Thunb., 3 parts of wild chrysanthemum stalk, 2 parts of Penthorum chinense Pursh., 3 parts of honeysuckle stalk, 2 parts of corn stigma, 2 parts of silkworm excrement, 3 parts of fishing rod grass, 3 parts of Cipadessa cinerascens (Pell.) Hand.-Mazz., 4 parts of Lygodium japonicum (Thunb.) Sw., 2 parts of Artemisia capillaris Thunb., 2 parts of Lysimachia christinae Hance, 2 parts of Plantago asiatica L.

[0011] The wild chrysanthemum stalk, honeysuckle stalk and Cipadessa cinerascens (Pell.) Hand.-Mazz. are the stem parts of plants; the Lygodium japonicum (Thunb.) Sw. is the vine leaves harvested during the spore maturity period from August to September, and its spores are retained.

[0012] The core of the medicinal packet for jaundice conditioning provided by the present invention lies in following the compatibility principles of "syndrome differentiation and treatment" and "sovereign, ministerial, assistant and courier" in traditional Chinese medicine. Through the synergistic effect of multiple Chinese medicines, aiming at the pathogenesis of neonatal jaundice (especially the type of damp-heat in the liver and gallbladder and unsmooth bile excretion), comprehensive conditioning of "promoting bile secretion and reducing jaundice, clearing heat and promoting diuresis, and promoting defecation and urination" is achieved. The effects of each Chinese medicine raw material will be elaborated in detail below, and their compatibility relationship, mechanism of action and compatibility principles will be systematically expounded.

[0013] I. Detailed description of the effects of each Chinese medicine raw material

[0014] Solanum lyratum Thunb., effect: promoting diuresis and reducing jaundice, clearing heat and detoxifying, dispelling wind and relieving joint pain. It is mainly used for treating damp-heat jaundice, edema, rheumatic arthralgia, etc. Modern research shows that it has liver protection and anti-inflammatory effects, can improve liver function and promote bilirubin metabolism.

[0015] Wild chrysanthemum stalk, effect: clearing the liver and improving eyesight, purging fire and detoxifying, promoting diuresis and reducing swelling. In this scheme, its "stalk" part is innovatively used instead of the flower bud. The stalk part is rich in flavonoid components, has stronger effects of purging liver fire and promoting diuresis and metabolism, and avoids the risk of pollen allergy, being suitable for external use. Its diuretic effect can assist the excretion of bilirubin from urine.

[0016] Penthorum chinense Pursh., effect: promoting bile secretion and reducing jaundice, clearing heat and detoxifying, promoting blood circulation and removing blood stasis. It is a traditional Miao medicine for protecting the liver and promoting bile secretion. Modern pharmacology confirms that it can significantly promote bile secretion and excretion, and reduce the levels of serum bilirubin and transaminase, and is one of the core medicinal materials for "promoting bile secretion" in this prescription.

[0017] Honeysuckle stalk, effect: clearing heat and detoxifying, dispersing wind-heat. Using the "stalk" part takes its effect of clearing heat and detoxifying, and is milder than the flower bud, not easily causing allergies. It can clear away damp-heat and toxic pathogens in the liver and gallbladder and improve the internal environment.

[0018] Corn silk, effects: diuretic and swelling-reducing, liver-soothing and gallbladder-promoting, blood pressure lowering. Its diuretic effect is significant, increasing urine output, promoting the excretion of damp heat and unconjugated bilirubin, and enhancing the "heat-clearing and dampness-removing" effect.

[0019] Silkworm excrement, its effects include dispelling wind and dampness, harmonizing the stomach and resolving turbidity, and promoting blood circulation and unblocking the meridians. Modern research has found that silkworm excrement can stimulate liver cells to secrete bile and promote gallbladder contraction. It is the key ingredient in this formula for "promoting bile secretion" and directly acts on the metabolic source of jaundice.

[0020] Fishing Rod Grass (also known as Abdominal Water Grass), with the following effects: diuretic and swelling-reducing, heat-clearing and detoxifying, blood-stasis-dispersing and pain-relieving. In folk medicine, it is used to treat jaundice due to weakness, as it promotes bile secretion and excretion, and works synergistically with Yellow-Reducing Grass to enhance its choleretic and jaundice-reducing effects.

[0021] Spiny yellow (also known as white thorn yellow), its effects include clearing heat and purging fire, detoxifying and drying dampness, and promoting diuresis to reduce jaundice. It is mainly used to treat damp-heat jaundice, dysentery, etc. Its bitter and cold properties clear excess heat from the liver and gallbladder, and dry damp-heat in the middle and lower jiao, making it an essential medicine for reducing jaundice.

[0022] Lygodium japonicum, its effects include: promoting urination and relieving strangury, clearing damp-heat, and promoting bile secretion and reducing jaundice. Its spores, when used medicinally, can promote bile excretion and accelerate bile secretion by liver cells, making it one of the most abundant and potent choleretic ingredients in this formula.

[0023] Artemisia capillaris, with the effects of clearing damp-heat, promoting bile secretion, and reducing jaundice, is a key medicine for treating jaundice and is known as a "jaundice-specific medicine." It can promote bile secretion and excretion, reduce serum bilirubin concentration, and is effective for various types of jaundice.

[0024] Lysimachia christinae, with the following effects: promotes diuresis and relieves jaundice, detoxifies and reduces swelling. It can promote bile secretion, relax the bile duct sphincter, and facilitate the excretion of bilirubin. It is often used for liver, gallbladder, and urinary tract stones, and damp-heat jaundice.

[0025] Plantain, its effects include clearing heat and promoting diuresis, eliminating dampness and relieving strangury, improving eyesight and resolving phlegm. Its diuretic effect can help eliminate damp heat and bilirubin from the body, and it works synergistically with corn silk to enhance the effect of "clearing the lower burner".

[0026] II. Compatibility and Mechanism of Action

[0027] This formula is based on the general principle of "promoting bile secretion and relieving jaundice, clearing heat and promoting diuresis". Through the synergistic effect of multiple drugs, it forms a three-dimensional network of action that "promotes secretion, clears damp heat, and promotes urination and defecation".

[0028] The core mechanism of this treatment lies in promoting bile secretion and excretion. Its innovation lies in strengthening the "choleretic" aspect. Six herbs—Gynostemma pentaphyllum, silkworm excrement, Artemisia capillaris, Lygodium japonicum, Artemisia capillaris, and Lysimachia christinae—are used in combination to form a powerful "choleretic matrix." Lygodium japonicum is the principal herb, used in the largest dose, primarily responsible for promoting bile secretion and reducing jaundice; Gynostemma pentaphyllum and silkworm excrement are assistant herbs, assisting the principal herb in enhancing bile secretion; Artemisia capillaris, Artemisia capillaris, and Lysimachia christinae are adjuvant herbs, further clearing the bile ducts and promoting bile excretion. This combination directly intervenes at the source of bilirubin metabolism, resulting in a profound therapeutic effect.

[0029] Secondly, the stems of Aralia elata, Solanum lyratum, and Lonicera japonica clear damp-heat from the liver, gallbladder, and lower burner; the stems of Chrysanthemum indicum clear the liver, improve eyesight, and purge liver fire. These three herbs, in combination with choleretic drugs, eliminate the "damp-heat" cause of bile stasis, creating conditions for normal bile secretion.

[0030] Corn silk and plantain enhance diuresis, promoting the excretion of bilirubin through urine; while choleretic drugs themselves promote the excretion of bilirubin through the intestines. Together, they form a dual-channel excretion pattern of "liver-intestinal-kidney-urine," significantly accelerating the clearance of bilirubin from the body.

[0031] III. Principles of Matching (Emperor, Minister, Assistant, and Envoy)

[0032] This formula strictly follows the traditional Chinese medicine principle of "principal, assistant, adjuvant, and guide" in its formulation:

[0033] The principal herb (the herb that treats the main ailment): Lygodium japonicum. It is used in the largest quantity and has the strongest effect, primarily responsible for "promoting bile secretion and reducing jaundice." It is the core of the entire formula and governs all the other herbs.

[0034] Assistant herbs (herbs that assist the principal herb): *Gynostemma pentaphyllum* and silkworm excrement. These herbs assist the principal herb in enhancing its choleretic and bile-promoting effects, thereby strengthening the main efficacy.

[0035] Adjuvant herbs (assistant, moderating, and counteracting herbs): Assistant herbs: Artemisia capillaris, Artemisia capillaris, Lysimachia christinae, further enhance the effect of promoting bile secretion and reducing jaundice; Moderating herbs: Scutellaria baicalensis, Solanum lyratum, clear heat and dry dampness, eliminate the cause of damp-heat, and prevent damp-heat from obstructing the bile duct; Counteracting herbs: Chrysanthemum indicum stem, Lonicera japonica stem, clear liver fire, and prevent bitter and cold herbs from damaging the stomach.

[0036] Guide herbs (medicines that guide the flow of qi and harmonize the body): corn silk and plantain. These herbs guide the medicine downwards, promote urination, and expel damp-heat pathogens through urination. They also harmonize the effects of other herbs and guide them to the affected area.

[0037] In summary, this treatment plan, through scientific formulation, constructs a complete system of prescriptions with Lygodium japonicum as the principal ingredient, Eclipta prostrata and silkworm excrement as secondary ingredients, multiple herbs as adjuvants, and corn silk and Plantago asiatica as guiding ingredients. Its mechanism of action goes beyond the traditional "clearing heat and promoting diuresis," innovatively strengthening the key link of "promoting bile secretion and excretion," thus deepening the approach from "symptomatic treatment" to "causal regulation." The various herbs work synergistically, complementing each other to achieve the effects of promoting bile secretion and relieving jaundice, clearing heat and promoting diuresis, and facilitating urination and defecation. This embodies the essence of traditional Chinese medicine's holistic concept and syndrome differentiation and treatment, demonstrating significant clinical value and innovation.

[0038] A method for preparing a medicine pack for treating jaundice includes the following steps:

[0039] (1) Weigh each Chinese medicinal material according to the stated weight proportions, wherein wild chrysanthemum stems, honeysuckle stems, thorny rhizome, and sea lychnophora are harvested according to specific requirements and chopped into 1–3 cm sections;

[0040] (2) After washing and drying all Chinese medicinal materials, mix them evenly to obtain the core of the medicine;

[0041] (3) The drug core is placed into a dialysis-compatible non-woven fabric or cotton bag and sealed to obtain the drug pack.

[0042] Preferably, in step (1), the sea chrysanthemum is air-dried, while the wild chrysanthemum stems, honeysuckle stems, and thorny yellow are sun-dried.

[0043] A method for treating jaundice using a medicated pack includes the following steps:

[0044] a) Soak the medicine packet in water for 2–3 hours;

[0045] b) Boil the soaked herb packet together with the water until boiling, then simmer over low heat for 0.5 hours to obtain the medicinal liquid;

[0046] c) Pour the medicinal liquid into warm water, adjust the water temperature to 38–40℃, and give the person who needs treatment a full-body constant temperature bath for 10 minutes each time.

[0047] Furthermore, the patient requiring treatment is a newborn, and the jaundice is neonatal physiological jaundice, breast milk jaundice, or refractory jaundice that does not respond well to blue light therapy.

[0048] Compared with the prior art, the present invention has the following beneficial effects:

[0049] (1) This treatment plan intervenes at the source of bilirubin metabolism, namely the bile secretion and excretion process. The silkworm excrement, lygodium japonicum, scutellaria barbata, and scutellaria barbata in the formula work together to promote bile secretion and accelerate the excretion of conjugated bilirubin through the intestines. At the same time, herbs such as Artemisia capillaris, scutellaria barbata, and Solanum lyratum clear damp-heat in the liver and gallbladder and improve the liver microenvironment. Corn silk and plantain, through their diuretic effect, assist unconjugated bilirubin in being excreted from the kidneys, forming a multi-pathway synergistic mechanism of "promoting secretion + clearing damp-heat + promoting urination and defecation", achieving a three-dimensional treatment of jaundice with significant efficacy.

[0050] (2) The external medicated bath method completely avoids the stimulation of the newborn's delicate gastrointestinal system caused by oral administration, and will not cause diarrhea or indigestion. The medicinal materials are packaged in a permeable non-woven fabric or cotton bag, so that the active ingredients can dissolve and the residue does not come into contact with the skin, reducing the risk of allergies and irritation. The selected medicinal materials are all commonly used Chinese medicines with mild properties and no toxic ingredients. The water temperature is controlled at 38-40℃ to ensure physical safety. It is a truly suitable "green therapy" for newborns. Detailed Implementation

[0051] The embodiments of the present invention will be described in further detail below with reference to examples. These examples are for illustrative purposes only and should not be construed as limiting the scope of the invention.

[0052] Example 1:

[0053] Formula composition (by weight): Solanum lyratum: 1 part, Chrysanthemum indicum stem: 1 part, *Gnaphalium affine*: 1 part, Lonicera japonica stem: 1 part, Corn silk: 1 part, Silkworm excrement: 1 part, *Gnaphalium affine*: 1 part, *Gnaphalium affine*: 1 part, *Lygodium japonicum*: 2 parts, *Artemisia capillaris*: 1 part, *Lysimachia christinae*: 1 part, *Plantago asiatica*: 1 part

[0054] Preparation method: Weigh the Chinese medicinal materials according to the above proportions, with a total of 14 parts. Taking 10g of Solanum nigrum as an example, the dosage of each medicinal material is as follows: 10g of Solanum nigrum, 10g of Chrysanthemum indicum stem, 10g of Gynostemma pentaphyllum, 10g of Lonicera japonica stem, 10g of Corn silk, 10g of Silkworm excrement, 10g of Artemisia argyi, 10g of Spirodela polyrhiza, 20g of Lygodium japonicum, 10g of Artemisia capillaris, 10g of Lysimachia christinae, and 10g of Plantago asiatica, totaling 130g.

[0055] Harvesting and Processing of Medicinal Herbs: Wild chrysanthemum stems (harvest stems at the beginning of flowering), honeysuckle stems (harvest after flowering), *Scutellaria barbata* (harvest non-fruiting plants in July-August), and *Lygodium japonicum* (harvest mature vines and leaves with spores in August-September, retaining the spores) are all processed according to requirements. Other medicinal herbs are processed conventionally. All herbs are washed, dried, and chopped into 1-3cm segments, then mixed thoroughly. The mixture is then placed into 10cm × 15cm non-woven bags, heat-sealed, and the contents are obtained as low-value formula medicine packets.

[0056] Example 2:

[0057] Formula composition (by weight): Solanum lyratum: 3 parts, Chrysanthemum indicum stem: 3 parts, Gynostemma pentaphyllum: 2 parts, Lonicera japonica stem: 3 parts, Corn silk: 2 parts, Silkworm excrement: 2 parts, Fishing rod grass: 3 parts, Spiny yellow: 3 parts, Lygodium japonicum: 4 parts, Artemisia capillaris: 2 parts, Lysimachia christinae: 2 parts, Plantago asiatica: 2 parts.

[0058] Preparation method: Weigh the Chinese medicinal materials according to the above proportions, with a total of 30 portions. Taking 30g of Solanum nigrum as an example, the dosage of each medicinal material is as follows: 30g of Solanum nigrum, 30g of Chrysanthemum indicum stem, 20g of Gynostemma pentaphyllum, 30g of Lonicera japonica stem, 20g of Corn silk, 20g of Silkworm excrement, 30g of Artemisia argyi, 30g of Aralia elata, 40g of Lygodium japonicum, 20g of Artemisia capillaris, 20g of Lysimachia christinae, and 20g of Plantago asiatica, totaling 310g.

[0059] Harvesting and processing of medicinal materials: Same as in Example 1, ensuring that key medicinal materials (wild chrysanthemum stems, honeysuckle stems, aralia elata, and lygodium japonicum) are processed according to specific requirements. After washing and drying all medicinal materials, chop them into 1–3 cm segments and mix them evenly. Pack them into 15 cm × 20 cm non-woven bags, heat-seal the opening, and you will get the medium-value formula medicine pack.

[0060] Example 3:

[0061] Formula composition (by weight): Solanum lyratum: 5 parts, Chrysanthemum indicum stem: 5 parts, Gynostemma pentaphyllum: 4 parts, Lonicera japonica stem: 5 parts, Corn silk: 4 parts, Silkworm excrement: 4 parts, Fishing rod grass: 5 parts, Spiny yellow: 5 parts, Lygodium japonicum: 6 parts, Artemisia capillaris: 4 parts, Lysimachia christinae: 4 parts, Plantago asiatica: 4 parts.

[0062] Preparation method: Weigh the Chinese medicinal materials according to the above proportions, with a total of 50 portions. Taking 50g of Solanum nigrum as an example, the dosage of each medicinal material is as follows: 50g of Solanum nigrum, 50g of Chrysanthemum indicum stem, 40g of Gynostemma pentaphyllum, 50g of Lonicera japonica stem, 40g of Corn silk, 40g of Silkworm excrement, 50g of Artemisia argyi, 50g of Prickly ash, 60g of Lygodium japonicum, 40g of Artemisia capillaris, 40g of Lysimachia christinae, and 40g of Plantago asiatica, totaling 550g.

[0063] Harvesting and processing of medicinal materials: Same as in Example 1, with key medicinal materials processed according to specific requirements. After washing and drying all medicinal materials, chop them into 1–3 cm segments and mix them evenly. Pack them into 20 cm × 25 cm non-woven bags, heat-seal the opening, and you will get the high-value formula medicine package.

[0064] The above embodiments 1 to 3 shall be used according to the following scheme:

[0065] Preparation of the decoction: Take one herb packet prepared in Examples 1-3 and place it in a stainless steel pot. Add 1500mL of cold water and soak for 2.5 hours until the water turns slightly yellow. Heat the pot and, after boiling, reduce the heat to low and continue simmering for 30 minutes. Turn off the heat and let it stand for 5 minutes. Then, pour the decoction along with the herb packet into a prepared bathtub.

[0066] Medicated bath procedure: Add an appropriate amount of warm water to the bathtub, and use a thermometer to measure the temperature, adjusting it to 39℃. Give the newborn a full-body bath, avoiding the eyes, mouth, nose, and umbilical cord. Each bath should last no more than 10 minutes. After bathing, gently dry the newborn with a soft towel and keep them warm.

[0067] Frequency of use: It is recommended to use once daily. For children with high jaundice levels or slow jaundice resolution, continuous use for 5–7 days is possible. After significant jaundice relief, use can be adjusted to once every other day until complete resolution. The medicine packet can be reused twice (i.e., one packet can be used for 3 days). The efficacy will be significantly reduced during the third use, and a new packet should be used.

[0068] The clinical application effects are observed as follows:

[0069] To verify the actual therapeutic effect of this medicine pack, five cases of neonatal jaundice with different types were selected for observation. The specific cases and effects are as follows:

[0070] (1) He Wanyi (breast milk jaundice) (Example 1)

[0071] Basic information: Female infant, 5 days after birth, weighing 2.6kg.

[0072] Symptoms: Breast milk jaundice, transcutaneous jaundice level: forehead 16 mg / dL, chest 17 mg / dL, with obvious yellowing of face, eyes, hands and feet.

[0073] Treatment: Use this medicine pack for bathing once a day.

[0074] Results: After 4 days of continuous use, the jaundice symptoms were significantly relieved; on the 7th day, a follow-up examination showed that the jaundice level had dropped to the normal range and the yellowing of the skin had completely disappeared.

[0075] (2) Yuan Zhirui (Hyperbilirubinemia) (Example 2)

[0076] Basic information: Male infant, 8 days after birth, weighing 2.9kg.

[0077] Symptoms: High jaundice levels, 23 mg / dL on the forehead and 24 mg / dL on the chest, with yellowing all over the body.

[0078] Treatment: Use this medicine pack for bathing once a day.

[0079] Results: Jaundice levels fluctuated slightly during the first 4 days of use, began to decrease significantly on the 6th day, dropped to 18 mg / dL in the forehead and 20 mg / dL in the chest on the 8th day, and returned to normal on the 13th day.

[0080] (3) Wang Honghong (Jaundice unresponsive to blue light therapy) (Example 3)

[0081] Basic information: Male infant, 25 days after birth, weighing 3.1 kg.

[0082] Medical history: Jaundice appeared on the 3rd day after birth, with a value of 28 mg / dL on the forehead and 29 mg / dL on the chest. After receiving phototherapy for 17 days, the jaundice level did not decrease significantly and was accompanied by bloody stools.

[0083] Symptoms: Initial jaundice levels: forehead 25 mg / dL, chest 26 mg / dL; yellowing of the entire body, yellowing of fingernails; poor appetite; restless sleep.

[0084] Treatment: Use this medicine pack for bathing once a day.

[0085] Results: Bloody stool symptoms disappeared on day 3; sleep improved on day 7; appetite improved on day 14, and weight increased to 3.3 kg; skin color improved on day 28, and jaundice levels decreased to 14 mg / dL on the forehead and 15 mg / dL on the chest; after one month of continuous use, jaundice completely subsided and all indicators returned to normal.

[0086] (4) Jiang Shiyi (jaundice rebound) (Example 2)

[0087] Basic information: Female infant, 4 days after birth, weighing 3.4kg.

[0088] Medical history: On the 4th day after birth, the jaundice level was 17 mg / dL on the forehead and 18 mg / dL on the chest. After receiving blue light therapy for 5 days, the patient was discharged from the hospital, and the jaundice level dropped to 4 mg / dL on the forehead and 5 mg / dL on the chest.

[0089] Symptoms: One week after returning home, jaundice rebounded to 18 mg / dL on the forehead and 19 mg / dL on the chest.

[0090] Treatment: Use this medicine pack for bathing once a day.

[0091] Results: After one week of bathing, the jaundice level dropped to 11 mg / dL in the forehead and 12 mg / dL in the chest; after another week, it dropped to 5 mg / dL in the forehead and 6 mg / dL in the chest, returning to normal.

[0092] (5) Hu Ziyue (bile secretion disorder) (Example 2)

[0093] Basic information: Female infant, 2 months old, weighing 2.8kg.

[0094] Medical history: Diagnosed with bile duct obstruction, high direct bilirubin, taking ursodeoxycholic acid tablets, with jaundice all over the body, poor appetite, and weight below target.

[0095] Treatment: Use this medicine pack to bathe once a day for the first half month, then change to once every other day.

[0096] Results: Appetite returned and weight began to increase after half a month; weight reached target after one month, jaundice levels returned to normal, and jaundice subsided.

[0097] As can be seen from the above embodiments, the preparation process of the medicine pack of the present invention is simple and convenient to use. It has a good conditioning effect on various types of neonatal jaundice (including physiological, breast milk, hyperbilirubinemia, blue light ineffective type and bile secretion disorder type), is safe and effective, and is suitable for family use.

[0098] Example 4: Reusability Test of Medicine Packets

[0099] Take one medicine packet from Example 1, decoct it according to the corresponding method, and record the color and smell of the liquid.

[0100] First use: The liquid is dark yellowish-brown and has a strong odor.

[0101] Second use: The liquid turns light yellow and the smell becomes fainter, but it still has a certain medicinal fragrance.

[0102] Third use: The liquid is almost colorless and has a faint odor.

[0103] Conclusion: This medicine pack can be used effectively twice. It is recommended that one pack be used within 3 days to ensure the best efficacy.

[0104] As can be seen from the above embodiments, the preparation process of the medicine pack of the present invention is simple and convenient to use. It has a good conditioning effect on various types of neonatal jaundice (including physiological, breast milk, hyperbilirubinemia, blue light ineffective type and bile secretion disorder type), is safe and effective, and is suitable for family use.

[0105] The innovative aspects of the traditional Chinese medicine composition in this scheme will be further elaborated below:

[0106] In this protocol, since newborns cannot be directly used in control trials due to ethical restrictions in reality, this protocol mainly relies on clinical observation supplemented by basic research to conduct cell or animal experiments to explain the core innovation of this protocol.

[0107] I. Cellular Experiments: Effects of Silkworm Excrement and Lygodium japonicum Extracts on the Expression of Bile Acid Transporter Proteins in Hepatocytes

[0108] Experimental objective: To investigate whether water extracts of silkworm excrement and Lygodium japonicum can upregulate the expression of key bile acid transport proteins in hepatocytes, thereby promoting bile secretion.

[0109] Experimental materials

[0110] Cell line: Human hepatoblastoma cells (HepG2), which have bile metabolism functions similar to those of hepatocytes.

[0111] Drugs: Water extract of silkworm excrement and water extract of Lygodium japonicum (prepared by conventional methods and concentrated to high, medium and low concentrations).

[0112] Control groups: blank control group (containing only culture medium) and positive control group (using the known choleretic drug ursodeoxycholic acid, UDCA).

[0113] Detection indicators: mRNA and protein expression levels of BSEP (bile salt output pump), MRP2 (multidrug resistance-associated protein 2), and FXR (farnesol X receptor).

[0114] Experimental methods

[0115] HepG2 cells were seeded in 6-well plates and cultured to 80% confluence. Culture media containing different concentrations of silkworm excrement / Lygodium japonicum extract were added, and the cells were treated for 48 hours. Cells were collected, and the mRNA expression levels of BSEP, MRP2, and FXR were detected by qRT-PCR. The expression levels of these proteins were detected by Western blotting.

[0116] The experimental results are shown in the table below:

[0117] Group BSEP mRNA (relative expression level) MRP2 mRNA (relative expression level) FXR mRNA (relative expression level) Blank control 1.00 ± 0.12 1.00 ± 0.15 1.00 ± 0.10 UDCA (positive) 2.85 ± 0.31** 2.67 ± 0.28** 2.79 ± 0.33** Silkworm excrement (high concentration) 2.43 ± 0.26** 2.15 ± 0.22** 2.31 ± 0.27** High concentration of Lygodium japonicum 2.61 ± 0.29** 2.38 ± 0.25** 2.47 ± 0.30**

[0118] (** indicates p<0.01 vs. blank control)

[0119] Western blot results showed that extracts of silkworm excrement and Lygodium japonicum significantly upregulated the expression of BSEP and MRP2 proteins, consistent with the mRNA results.

[0120] In summary, the extracts of silkworm excrement and Lygodium japonicum in this treatment significantly upregulated the expression of BSEP, MRP2, and FXR in HepG2 cells. BSEP is a key transporter for bile salts from hepatocytes into bile canaliculi; MRP2 is responsible for the excretion of organic anions such as bilirubin; and FXR is a core nuclear receptor regulating bile acid synthesis and excretion. This indicates that both enhance bile acid transporter expression by activating the FXR signaling pathway, thereby promoting bile secretion and providing molecular mechanistic support for their role in jaundice management.

[0121] II. Animal Experiments: The Intervention Effects of Silkworm Excrement and Lygodium japonicum on a Newborn Rat Jaundice Model

[0122] Experimental objective: To verify the external washing intervention effects of silkworm excrement, lygodium japonicum, and their combinations in a neonatal rat model of hyperbilirubinemia.

[0123] Experimental materials

[0124] Animals: 40 SD rat pups, 7 days old, were randomly divided into 4 groups of 10 each.

[0125] Jaundice model establishment: Hyperbilirubinemia was induced by intraperitoneal injection of sulfisoxazole.

[0126] Handling method:

[0127] Group A (model control group): Wipe with warm water only.

[0128] Group B (Silkworm Excrement Group): The whole body was wiped with a decoction of silkworm excrement (concentration converted according to the equivalent adult dose) once a day.

[0129] Group C (Lygodium japonicum group): The decoction of Lygodium japonicum was used in the same way.

[0130] Group D (Silkworm Excrement + Lygodium japonicum): Use a decoction of the two in equal proportions.

[0131] Testing indicators: Blood samples were collected before treatment, on day 3 of treatment, and on day 5 of treatment to test serum total bilirubin (TBIL), direct bilirubin (DBIL), and total bile acids (TBA).

[0132] Experimental methods

[0133] After establishing the jaundice model, intervention was initiated in each group for 5 days. Daily observations were made of rat activity, appetite, and skin color. Blood samples were collected periodically to test biochemical indicators.

[0134] The experimental results are shown in the table below:

[0135] Group The decrease in serum TBIL on day 5 (μmol / L) TBA change (%) Group A (Model) 35.2 ± 8.7 +12.3 Group B (Silkworm Excrement) 68.5 ± 9.2** -28.7** Group C (Haijinsha) 72.1 ± 10.1** -31.5** Group D (combination) 89.6 ± 11.3**▲ -45.2**▲

[0136] (** indicates p<0.01 vs Group A; ▲ indicates p<0.05 vs Group B / C)

[0137] Experimental conclusions: Both silkworm excrement and Lygodium japonicum, used alone, significantly reduced serum bilirubin levels and total bile acid concentrations in newborn rats, indicating their choleretic and jaundice-reducing effects. The combined use of the two products showed even better results, demonstrating a synergistic effect and supporting the rationale for their combined use in this invention.

[0138] Based on the above cell and animal experiments, the following conclusions can be drawn: silkworm excrement and lygodium japonicum promote the excretion of bile acids and conjugated bilirubin from hepatocytes by activating the FXR-BSEP / MRP2 pathway, thus explaining the scientific basis for "promoting bile secretion" at the molecular level.

[0139] In a newborn rat model, both drugs effectively reduced bilirubin levels, and the combined use of both drugs had a stronger effect, providing empirical support for the "multi-drug synergy" principle of this invention.

[0140] Cell and animal experiments: Verifying the advantages of "rod-like medicinal materials" in jaundice treatment

[0141] I. Background and Scientific Questions

[0142] Traditional Chinese medicine often uses the flower buds of wild chrysanthemum and honeysuckle for medicinal purposes, while this invention innovatively uses their stems (stalks). This change is based on the following assumptions: the stems are rich in specific active ingredients (such as flavonoids and polysaccharides), which have stronger effects in clearing the liver and removing dampness, and promoting diuresis and detoxification; the stems do not contain pollen, which can reduce the risk of allergies and is more suitable for external use in newborns; the structure of the stems is more conducive to the dissolution of active ingredients during decoction and is suitable for repeated packaging in medicine bags.

[0143] To verify the above hypothesis, the following experiment was designed.

[0144] Experiment 1: Comparison of chemical components and in vitro antioxidant activity of wild chrysanthemum stalks vs. wild chrysanthemum and honeysuckle stalks vs. honeysuckle

[0145] Experimental objective: To compare the content of active ingredients and antioxidant capacity of medicinal materials from the stem and flower parts, and to evaluate their medicinal value.

[0146] Experimental methods

[0147] Sample preparation: Wild chrysanthemum stems, wild chrysanthemum flowers, honeysuckle stems, and honeysuckle flowers from the same source plants were collected, dried, and then pulverized.

[0148] Detection indicators: Total flavonoid content (ultraviolet spectrophotometry), total polysaccharide content (phenol-sulfuric acid method), antioxidant activity (DPPH free radical scavenging rate).

[0149] The experimental results are shown in the table below:

[0150] sample Total flavonoids (mg / g) Total polysaccharides (mg / g) DPPH removal rate (%) wild chrysanthemum stem 48.7 ± 2.3 65.4 ± 3.1 78.5 ± 2.6 wild chrysanthemum 52.1 ± 2.5 38.9 ± 2.8 82.3 ± 2.1 Honeysuckle stem 45.3 ± 2.1 70.2 ± 3.4 75.8 ± 2.4 honeysuckle 49.8 ± 2.4 41.5 ± 2.6 80.1 ± 2.3

[0151] As shown in the table above: the total flavonoid content in the flower buds was slightly higher than that in the stems, but the difference was not significant (p>0.05); the total polysaccharide content in the stems was significantly higher than that in the flowers (p<0.01), and the polysaccharides have immunomodulatory and hepatoprotective effects; the antioxidant activities were similar, indicating that the stems still have strong biological activity. Although the stems have slightly lower flavonoid content, their polysaccharide content is higher, and their overall medicinal value is no less than that of the flowers, and they are more unique.

[0152] Experiment 2: Protective effect of rod-shaped medicinal materials on a hepatocyte inflammation model (cell experiment)

[0153] Experimental objective: To verify whether extracts from wild chrysanthemum stems and honeysuckle stems can reduce hepatocellular inflammation and damage and improve liver function.

[0154] Experimental materials: Cells: HepG2 hepatocytes; Injury model: LPS (lipopolysaccharide) induced inflammation;

[0155] Treatment groups: blank control, LPS model, LPS + wild chrysanthemum stem extract, LPS + wild chrysanthemum extract, LPS + honeysuckle stem extract, LPS + honeysuckle extract

[0156] Detection indicators: IL-6, TNF-α (inflammatory factor), ALT, AST (liver enzyme)

[0157] The experimental results are shown in the table below:

[0158] Group IL-6 (pg / mL) TNF-α (pg / mL) ALT (U / L) blank 12.3 ± 1.5 8.7 ± 1.2 25.4 ± 3.1 LPS model 89.6 ± 8.7** 76.5 ± 7.3** 189.2 ± 15.6** wild chrysanthemum stem 45.2 ± 4.3▲ 38.1 ± 3.8▲ 67.8 ± 5.9▲ wild chrysanthemum 52.7 ± 5.1▲ 42.3 ± 4.1▲ 75.3 ± 6.2▲ Honeysuckle stem 48.5 ± 4.6▲ 40.2 ± 3.9▲ 70.1 ± 5.8▲ honeysuckle 55.8 ± 5.3▲ 45.6 ± 4.3▲ 80.4 ± 6.7▲

[0159] (** indicates p < 0.01 vs. blank; ▲ indicates p < 0.05 vs. model group)

[0160] Experimental conclusions: Extracts from both wild chrysanthemum stems and honeysuckle stems significantly inhibited LPS-induced hepatocellular inflammatory responses and reduced inflammatory factors and liver enzyme levels. The stem extracts showed slightly better or equivalent effects than the flower extracts, indicating their good hepatoprotective and anti-inflammatory effects, supporting their use in the treatment of jaundice.

[0161] Experiment 3: Comparison of skin irritation and transdermal absorption of external washing with rod-shaped medicinal materials in newborn rats (animal experiment)

[0162] Experimental objective: To evaluate the safety and transdermal properties of rod-shaped medicinal materials used for external washing.

[0163] Experimental methods

[0164] Animals: 7-day-old SD rat pups with hair loss on their backs.

[0165] Groups: Group A (wiping with decoction of wild chrysanthemum stalks), Group B (wiping with decoction of wild chrysanthemum), Group C (honeysuckle stalks), Group D (honeysuckle), Group E (physiological saline control).

[0166] Observation: For 5 consecutive days, observe the skin for redness, swelling, itching, rash and other irritation reactions daily.

[0167] Transdermal absorption: Fluorescently labeled flavonoids were used to determine the amount of drug retained in the skin.

[0168] The experimental results are shown in the table below:

[0169] Group Skin irritation score (0–4) Fluorescence intensity (relative units) A (wild chrysanthemum stem) 0.3 ± 0.2 125.6 ± 10.3 B (Wild Chrysanthemum) 1.8 ± 0.4** 118.4 ± 9.7 C (Honeysuckle stem) 0.4 ± 0.3 130.2 ± 11.1 D (Honeysuckle) 2.1 ± 0.5** 122.8 ± 10.5 E (Control) 0.1 ± 0.1 —

[0170] (** indicates p<0.01 vs. the rod set)

[0171] Experimental conclusions: Higher safety: Flower extracts, due to their pollen protein content, are more likely to cause skin allergic reactions, with irritation scores significantly higher than those of stem extracts; Good transdermal absorption: The active ingredients of stem extracts can still effectively penetrate the skin of newborn rats to reach therapeutic concentrations; Supporting the rationale for "stem instead of flower": While ensuring efficacy, it significantly improves the safety of topical application, making it particularly suitable for newborns.

[0172] In summary, based on the above three sets of experiments, the following conclusions can be drawn: Chemical basis: Although the flavonoid content of stem-type medicinal materials is slightly lower, their polysaccharide content is higher, giving them unique medicinal value. Pharmacological activity: The stem extract is no less effective than, and may even be superior to, the flower extract in terms of anti-inflammatory and hepatoprotective effects. Safety advantages: Removing pollen significantly reduces the risk of skin irritation and allergies, which is an important innovation of this invention. Transdermal feasibility: The active ingredients can be absorbed through the skin, supporting the external wash administration method.

[0173] This series of experiments demonstrates that the use of wild chrysanthemum stalks and honeysuckle stalks to replace traditional flower buds in this invention is not a simple substitution, but a scientific decision based on differences in components, comparable efficacy, and improved safety. This innovation not only aligns with the modern concept of "reducing toxicity and increasing efficacy" in traditional Chinese medicine, but also reflects precise care for the special constitution of newborns, providing strong scientific support for its "creativity" in the patent application.

[0174] The embodiments of the present invention are given for illustrative and descriptive purposes only, and are not intended to be exhaustive or to limit the invention to the forms disclosed. Many modifications and variations will be apparent to those skilled in the art. The embodiments were chosen and described in order to better illustrate the principles and practical application of the invention, and to enable those skilled in the art to understand the invention and to design various embodiments with various modifications suitable for a particular purpose.

Claims

1. A medicine pack for treating jaundice, characterized in that, The herbal ingredients comprise the following parts by weight: 1–5 parts Solanum nigrum, 1–5 parts Chrysanthemum indicum stem, 1–4 parts Gynostemma pentaphyllum, 1–5 parts Lonicera japonica stem, 1–4 parts Corn silk, 1–4 parts Silkworm excrement, 1–5 parts Artemisia argyi, 1–5 parts Spirodela polyrhiza, 2–6 parts Lygodium japonicum, 1–4 parts Artemisia capillaris, 1–4 parts Lysimachia christinae, and 1–4 parts Plantago asiatica; the outer packaging material of the herbal packet is permeable non-woven fabric or cotton cloth.

2. The medicine pack for treating jaundice according to claim 1, characterized in that, The weight parts of the medicinal materials are as follows: 3 parts of Solanum nigrum, 3 parts of Chrysanthemum indicum stem, 2 parts of Gynostemma pentaphyllum, 3 parts of Lonicera japonica stem, 2 parts of corn silk, 2 parts of silkworm excrement, 3 parts of Artemisia argyi, 3 parts of Prickly ash, 4 parts of Lygodium japonicum, 2 parts of Artemisia capillaris, 2 parts of Lysimachia christinae, and 2 parts of Plantago asiatica.

3. A medicine pack for treating jaundice according to claim 1, characterized in that, The wild chrysanthemum stems, honeysuckle stems, and prickly ash stems are the stems of the plants; the lygodium japonicum is the vine leaves harvested during the spore maturation period in August-September, and its spores are retained.

4. A method for preparing a medicine pack for jaundice treatment as described in any one of claims 1-3, characterized in that, Includes the following steps: (1) Weigh each Chinese medicinal material according to the stated weight proportions, wherein wild chrysanthemum stems, honeysuckle stems, thorny rhizome, and sea lychnophora are harvested according to specific requirements and chopped into 1–3 cm sections; (2) After washing and drying all the Chinese medicinal materials, mix them evenly to obtain the core material; (3) The drug core is placed into a dialysis-compatible non-woven fabric or cotton bag and sealed to obtain the drug pack.

5. The method for preparing the medicine pack for jaundice treatment according to claim 4, characterized in that, In step (1), the sea chrysanthemum is air-dried, while the stems of wild chrysanthemum, honeysuckle, and thorn are sun-dried.

6. A method for treating jaundice using a medicine pack as described in any one of claims 1-3, characterized in that, Includes the following steps: a) Soak the medicine packet in water for 2–3 hours; b) Boil the soaked herb packet together with the water until boiling, then simmer over low heat for 0.5 hours to obtain the medicinal liquid; c) Pour the medicinal liquid into warm water, adjust the water temperature to 38–40℃, and give the person who needs treatment a full-body constant temperature bath for 10 minutes each time.

7. The method for treating jaundice using a medicated pack according to claim 6, characterized in that, The patient requiring treatment is a newborn, and the jaundice is neonatal physiological jaundice, breast milk jaundice, or refractory jaundice that does not respond well to blue light therapy.