Suppository for treating postpartum infection and metritis and preparation method thereof

Abstract

The invention relates to a suppository for treating postpartum infection and metritis and a preparation method thereof. The suppository for treating postpartum infection and metritis comprises the following raw materials: active pharmaceutical ingredients and auxiliary materials, the mass ratio of the components is 1: (1-2.5). The active pharmaceutical ingredients comprise scutellaria baicalensis, safflower carthamus, angelica sinensis, radix angelicae, poria cocos, liquorice, codonopsis pilosula, radix bupleuri, radix sophorae flavescentis, rhizoma atractylodis and agastache rugosus; the auxiliary materials comprise a matrix and an additive. The suppository has the advantages of being capable of avoiding the first-pass effect of the liver, high in bioavailability, fast in effect taking, convenient to use and the like.

Description

Technical Field

[0001] The present invention relates to the field of veterinary medicine, and in particular to a suppository for treating postpartum infection and uterine inflammation and a preparation method thereof. Background Art

[0002] In recent years, with the improvement of people's living standards, dairy products have become an indispensable part of people's lives, leading to rapid growth in the dairy cattle industry. However, the continuous calving and milk production characteristics of dairy cows have led to the occurrence of various postpartum diseases in dairy cows. Postpartum infections and uterine inflammation caused by dystocia, birth canal damage, and retained placenta are common postpartum diseases in dairy cows. These diseases lead to reduced reproductive performance, prolonged calving intervals, and decreased milk production, seriously undermining the economic benefits of the dairy industry. Studies have shown that 39.9% of dairy cows suffer from uterine diseases after giving birth.

[0003] Currently, treatments for postpartum infections and uterine inflammation in cattle, both domestically and internationally, rely primarily on chemical drugs, microbial agents, immunomodulatory agents, and hormone therapy. However, the long-term overuse of antibiotics has led to excessive drug residues and the accelerated evolution of drug-resistant strains, while immunotherapy and hormone-based medications are prohibitively expensive and difficult to popularize. Therefore, the development of new veterinary drugs for postpartum infections and uterine inflammation in cattle is urgent. Summary of the Invention

[0004] Based on the above-mentioned existing problems, Chinese medicine has become a preferred solution for the prevention and treatment of postpartum infection in cattle through the synergistic effect of multiple components and the innovation of safe dosage forms. The dosage forms of current Chinese medicine in clinical practical applications are powders, oral liquid preparations, uterine perfusions, suppositories, etc., among which suppositories have broad application prospects in postpartum infectious diseases due to their precise treatment, low residue, economy, convenience and other characteristics. The Chinese medicine suppository of the present invention has the characteristics of high stability, strong safety, zero drug-free period, etc., and can be rapidly softened under the action of the body after administration, and can be mixed with body fluids, thereby exerting the therapeutic effect of the medicine. In terms of process preparation, the present invention adopts suppository dosage form, has a large drug loading capacity, can slowly release the drug, increases the action time of the drug, can continuously treat the disease, thereby strengthening treatment, reducing the number of administrations, and is convenient for clinical application.

[0005] The first invention of the present invention is: a suppository for treating postpartum infection and uterine inflammation, the raw materials of which include active pharmaceutical ingredients and auxiliary materials; the mass ratio of the raw materials is 1:(1-2.5).

[0006] Furthermore, the active ingredients of the medicine include scutellaria baicalensis, safflower, angelica sinensis, angelica dahurica, poria cocos, licorice, codonopsis pilosula, bupleurum, sophora flavescens, atractylodes, and patches of patchouli.

[0007] Further, the drug active ingredients are proportioned by weight: 10-20 parts of Scutellaria baicalensis, 10-20 parts of Carthamus tinctorius, 20-30 parts of Angelica sinensis, 5-15 parts of Angelica dahurica, 5-15 parts of Poria cocos, 5-15 parts of Glycyrrhiza uralensis, 20-60 parts of Codonopsis pilosula, 15-45 parts of Bupleurum chinense, 15-60 parts of Sophora flavescens, 15-60 parts of Atractylodes lancea, 15-45 parts of Pogostemon cablin.

[0008] Further, the excipients include a matrix and additives, and the dosage of the additives is 0.1% - 5% of the total weight of the excipients (the rest is the matrix).

[0009] Further, the matrix includes one or more of mixed fatty acid glycerides, cocoa butter, hydrogenated vegetable oil, and glycerogelatin.

[0010] Further, the additives include one or more of poloxamer, Tween, lecithin, polysorbate, and polyethylene glycol stearate, and their dosage is 0.1% - 5% of the total weight of the excipients.

[0011] Further, the drug active ingredient is dry extract powder; preferably, the suppository is torpedo-shaped.

[0012] The second inventive point of the present invention is a preparation method of the above-mentioned suppository for treating postpartum infection and uterine inflammation, and the specific steps are as follows:

[0013] Step 1): Weigh Scutellaria baicalensis, Carthamus tinctorius, Angelica sinensis, Angelica dahurica, Poria cocos, Glycyrrhiza uralensis, Codonopsis pilosula, Bupleurum chinense, Sophora flavescens, Atractylodes lancea, and Pogostemon cablin according to the weight ratio of the drug active ingredients, and set aside;

[0014] Step 2): Take all the drug active ingredients in Step 1), soak them in water, decoct, extract, combine the extracts, and then concentrate to obtain a concentrated solution;

[0015] Step 3): Dry the concentrated solution obtained in Step 2) into a dry extract, crush the dry extract through a sieve, and set aside;

[0016] Step 4): Weigh the excipients according to the mass ratio of the dry extract powder of the drug active ingredient and the excipients. First, heat and melt the matrix, and then add the additives and stir evenly, and set aside;

[0017] Step 5): Add the dry extract powder in Step 3) to the melted excipients in Step 4) and stir evenly;

[0018] Step 6): Pour the mixture evenly in Step 5) into the suppository mold while it is hot;

[0019] Step 7): Place the suppository mold in Step 6) at room temperature to cool;

[0020] Step 8): Take out, demold and package.

[0021] Further, the amount of water added in step 2) is 8 - 12 times the weight of the drug active ingredient, the soaking time is 1 - 2 hours, the decocting time each time is 1 - 2 hours, and it is extracted 2 - 3 times. After combining the extraction solutions, the extraction solution is concentrated under reduced pressure to a concentrated solution with a relative density of 1.05 - 1.25, and the concentration temperature is 50 - 60°C.

[0022] Further, the mesh sieve in step 3) is 100 - 120 meshes.

[0023] The third inventive point of the present invention is a drug for treating postpartum infection and uterine inflammation, which comprises the suppository described in any one of claims 1 - 6 or the suppository prepared according to claims 7 - 9.

[0024] Compared with the prior art, the advantages of the present invention are:

[0025] The suppository of the present invention has the advantages of avoiding the first - pass effect of the liver, high bioavailability, rapid onset, and convenient use. The suppository is a solid at normal temperature. After being inserted into the body cavity, it can quickly soften, melt or dissolve in the secretion fluid at body temperature, gradually release the drug and produce local or systemic effects. Because of its advantages such as simple operation, definite curative effect, and easy acceptance by patients, it has been widely used in clinical practice.

[0026] Through the synergistic effect, the drug active ingredient of the present invention significantly improves the inhibitory effect on pathogenic bacteria and the cure rate. By using pure traditional Chinese medicine ingredients, it avoids the problems of antibiotic resistance and drug residues, realizes a "zero withdrawal period", and ensures the safety of dairy products; the matrix used has been certified by the FDA to be non - irritating to the mucosa and has excellent biocompatibility.

[0027] The traditional Chinese medicine in the present invention adopts the suppository dosage form, which has a large drug - loading capacity, can slowly release the drug, increases the action time of the drug, can continuously treat diseases, thereby strengthening the treatment, reducing the number of drug administrations, and being convenient for clinical application.

[0028] Specific embodiments

[0029] To make the purpose, technical solution and advantages of this application clearer, the following further details this application. However, it should be understood that the description here is only used to explain this application and does not limit the scope of this application.

[0030] Unless otherwise defined, all technical terms and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which this application belongs. The terms used in the description of this application in this specification are only for the purpose of describing specific embodiments and are not intended to limit this application. The reagents and instruments used herein are all commercially available, and the characterization means involved can refer to the relevant descriptions in the prior art and will not be elaborated herein.

[0031] To further understand the present application, the following provides a more detailed description of the present application in combination with the best embodiments.

[0032] Example 1

[0033] The present invention provides a suppository for treating postpartum infection and uterine inflammation, the raw materials of which include a pharmaceutically active ingredient and an adjuvant; the mass ratio thereof is 1:(1 - 2.5).

[0034] According to traditional Chinese medicine theory, postpartum infection and uterine inflammation in cows belong to the category of leukorrhea, which are mostly caused by exogenous damp-heat and damp-toxicity invading the uterine cavity, endogenous damp-heat pouring downward, and spleen deficiency with dampness obstruction. Its main characteristics are damp-heat pouring downward, damp-toxic stasis obstruction, and spleen deficiency with failure of transportation, forming a vicious cycle of "excessive dampness - spleen deficiency - more excessive dampness". Based on the functions and indications of traditional Chinese medicines, combined with the data of modern pharmacological and clinical research on traditional Chinese medicines and traditional medication experience, under the guidance of traditional veterinary medicine theory, the treatment principle of "clearing heat and detoxifying, promoting blood circulation to remove stasis, contracting the uterus and expelling pus, and resolving dampness and strengthening the spleen" is adopted, and Scutellaria baicalensis, safflower, angelica, dahurian angelica root, poria, licorice, codonopsis pilosula, bupleurum, sophora flavescens, atractylodes lancea, and pogostemon cablin are selected to form a prescription.

[0035] As a further preferred embodiment, the pharmaceutically active ingredient includes Scutellaria baicalensis, safflower, angelica, dahurian angelica root, poria, licorice, codonopsis pilosula, bupleurum, sophora flavescens, atractylodes lancea, and pogostemon cablin.

[0036] Preferably, the pharmaceutically active ingredient is proportioned by weight: 10 - 20 parts of Scutellaria baicalensis, 10 - 20 parts of safflower, 20 - 30 parts of angelica, 5 - 15 parts of dahurian angelica root, 5 - 15 parts of poria, 5 - 15 parts of licorice, 20 - 60 parts of codonopsis pilosula, 15 - 45 parts of bupleurum, 15 - 60 parts of sophora flavescens, 15 - 60 parts of atractylodes lancea, and 15 - 45 parts of pogostemon cablin.

[0037] Scutellaria baicalensis: Bitter in taste and cold in nature. It belongs to the lung, gallbladder, spleen, large intestine, and small intestine meridians. It has the effects of drying dampness, purging fire and detoxifying, stopping bleeding, and preventing miscarriage. It is mainly used to treat lung heat cough, gastrointestinal damp-heat, diarrhea, jaundice, high fever with excessive thirst, hematochezia, epistaxis, red and swollen eyes, carbuncles and sores, and threatened abortion.

[0038] Preferably, the proportion of Scutellaria baicalensis by weight can be, for example, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value between any two values.

[0039] Safflower: Pungent in taste and warm in nature. It belongs to the heart and liver meridians. It has the effects of promoting blood circulation, dispelling stasis, and relieving pain. It is mainly used to treat traumatic injury, stasis pain, retention of fetal membranes, and lochiorrhea.

[0040] Preferably, the proportion of safflower by weight can be, for example, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value between any two values.

[0041] Angelica sinensis: Sweet, pungent, warm in nature. It acts on the liver, heart, and spleen meridians. It has the effects of enriching blood, promoting blood circulation to relieve pain, and moistening the intestines for defecation. It is mainly used to treat blood deficiency and fatigue, blood stasis pain, traumatic injury, carbuncles and sores, intestinal dryness and constipation, and various diseases during pregnancy and childbirth.

[0042] Preferably, the weight portion ratio of Angelica sinensis can be, for example, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 parts or any value between any two values.

[0043] Angelica dahurica: Pungent, warm in nature. It acts on the stomach, large intestine, and lung meridians. It has the effects of dispersing wind and removing dampness, reducing swelling and discharging pus, and dredging the orifices to relieve pain. It is mainly used to treat exogenous wind-cold, wind-damp arthralgia, sores and boils, and nasal congestion.

[0044] Preferably, the weight portion ratio of Angelica dahurica can be, for example, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 parts or any value between any two values.

[0045] Poria cocos: Sweet and bland, neutral in nature. It acts on the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and percolating dampness, strengthening the spleen, and calming the heart. It is mainly used to treat edema with oliguria, spleen deficiency with reduced food intake, loose stools and diarrhea, and restlessness of the mind.

[0046] Preferably, the weight portion ratio of Poria cocos can be, for example, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 parts or any value between any two values.

[0047] Glycyrrhiza uralensis: Sweet, neutral in nature. It acts on the heart, lung, spleen, and stomach meridians. It has the effects of invigorating the spleen and replenishing qi, resolving phlegm and relieving cough, regulating the middle energizer and alleviating spasm, detoxifying, coordinating the properties of various drugs, and alleviating the toxicity and potency of drugs. It is mainly used to treat spleen and stomach weakness, lassitude and weakness, cough and asthma, sore throat, poisoning, and sores.

[0048] Preferably, the weight portion ratio of Glycyrrhiza uralensis can be, for example, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 parts or any value between any two values.

[0049] Codonopsis pilosula: Sweet, neutral in nature. It acts on the spleen and lung meridians. It has the effects of tonifying the middle-jiao and replenishing qi, strengthening the spleen and nourishing the lung. It is mainly used to treat spleen and stomach weakness, reduced food intake and diarrhea, lung deficiency cough and asthma, physical fatigue and weakness, and qi deficiency with prolapse.

[0050] Preferably, the weight portion ratio of Codonopsis pilosula can be, for example, 20, 25, 30, 35, 40, 45, 50, 55, 60 parts or any value between any two values.

[0051] Bupleurum chinense: Pungent and bitter, slightly cold in nature. It acts on the liver, gallbladder, and lung meridians. It has the effects of inducing sweating and regulating the interior, ascending yang qi, and soothing the liver and relieving depression. It is mainly used to treat common cold with fever, alternating chills and fever, chronic diarrhea due to spleen deficiency, uterine prolapse, and rectal prolapse.

[0052] Preferably, the Bupleurum chinense DC. can be taken in parts by weight such as 15, 18, 20, 22, 25, 18, 30, 33, 35, 38, 40, 42, 45 parts or any value between any two values.

[0053] Sophora flavescens Aiton: Bitter in taste and cold in nature. It belongs to the Heart, Liver, Stomach, Large Intestine, and Bladder meridians. It has the effects of clearing heat and drying dampness, killing insects, and inducing diuresis. It is mainly used to treat damp-heat diarrhea, jaundice, dysuria, scabies, fish enteritis, and erect scales.

[0054] Preferably, the Sophora flavescens Aiton can be taken in parts by weight such as 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 parts or any value between any two values.

[0055] Atractylodes lancea (Thunb.) DC.: Pungent and bitter in taste, warm in nature. It belongs to the Spleen, Stomach, and Liver meridians and has the effects of drying dampness and strengthening the spleen, dispelling wind and cold, and improving eyesight. It is mainly used to treat diarrhea, edema, wind-cold-damp arthralgia, wind-cold cold, and night blindness.

[0056] Preferably, the Atractylodes lancea (Thunb.) DC. can be taken in parts by weight such as 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 parts or any value between any two values.

[0057] Agastache rugosa (Fisch. ex O. Ktze.) O. Ktze.: Pungent in taste, slightly warm in nature. It belongs to the Lung, Spleen, and Stomach meridians. It has the effects of inducing sweating and relieving summer heat, aromatic dampness elimination, and stopping nausea. It is mainly used to treat summer injury by dampness and heat, summer dampness diarrhea, nausea and vomiting, and abdominal distension.

[0058] Preferably, the Agastache rugosa (Fisch. ex O. Ktze.) O. Ktze. can be taken in parts by weight such as 15, 18, 20, 22, 25, 18, 30, 33, 35, 38, 40, 42, 45 parts or any value between any two values.

[0059] Among them, Scutellaria baicalensis Georgi, Sophora flavescens Aiton, and Poria cocos (Schw.) Wolf clear heat and promote diuresis, mainly attacking the pathogenesis and directly hitting the disease source. Scutellaria baicalensis Georgi clears and purges damp-heat in the middle and lower jiao, detoxifies and dries dampness. "Compendium of Materia Medica" records that it treats "leukorrhea with red and white discharge"; Sophora flavescens Aiton clears heat and dries dampness, kills insects and relieves itching, aiming at the foul and itching of damp-heat leukorrhea; Poria cocos (Schw.) Wolf strengthens the spleen and promotes diuresis, percolates dampness and stops leukorrhea, and regulates the metabolism of body fluids.

[0060] Atractylodes lancea (Thunb.) DC., Agastache rugosa (Fisch. ex O. Ktze.) O. Ktze., and Bupleurum chinense DC. assist the monarch drug to relieve the middle jiao, strengthen the spleen and remove turbidity. Atractylodes lancea (Thunb.) DC. dries dampness and strengthens the spleen, aromatically eliminates turbidity, enhances the power of removing dampness, and when combined with Poria cocos (Schw.) Wolf, it can strengthen the spleen and promote diuresis; Agastache rugosa (Fisch. ex O. Ktze.) O. Ktze. aromatically eliminates dampness, awakens the spleen and promotes appetite, resolves damp-turbidity blocking the middle jiao, and Bupleurum chinense DC. soothes the liver and relieves depression, raises yang qi, regulates the rise and fall of qi movement, and prevents the stagnation of damp-heat.

[0061] Codonopsis pilosula (Franch.) Nannf., Angelica sinensis (Oliv.) Diels, and Carthamus tinctorius L. harmonize and treat comprehensively, activate blood circulation and remove stasis, contract the uterus and expel pus. Codonopsis pilosula (Franch.) Nannf. replenishes middle qi, strengthens the healthy qi and consolidates the root, enhances the spleen transportation function to remove dampness; Angelica sinensis (Oliv.) Diels nourishes blood and promotes blood circulation, regulates menstruation and relieves pain, and improves the unsmooth leukorrhea caused by qi and blood stasis; Carthamus tinctorius L. promotes blood circulation and dredges the meridians, removes stasis and generates new blood, and promotes uterine contraction to expel pathological products.

[0062] Angelica dahurica and Glycyrrhiza uralensis are used to harmonize the herbs and guide them to the affected channels. Angelica dahurica dries dampness and stops leukorrhea, has a fragrant aroma and opens the orifices, guiding the herbs into the Yangming meridian, targeting fishy and foul leukorrhea; Glycyrrhiza uralensis harmonizes all the herbs, invigorates the spleen and benefits qi, and alleviates the cold nature of Scutellaria baicalensis and Sophora flavescens.

[0063] In this invention, by selecting the medicinal herb Pogostemon cablin, through the "moisture-eliminating - antibacterial - regulating" trinity effect of Pogostemon cablin, an innovative combination of traditional Chinese medicine theory and modern pathogenic microorganism research is achieved. First, the active substances in Pogostemon cablin play a role in biofilm disruption and antibacterial synergism. The aqueous extract of Pogostemon cablin can dissolve the bacterial biofilm, interact with bacterial membrane proteins to change the cell membrane permeability, making antibacterial components such as Scutellaria baicalensis and Sophora flavescens more easily penetrate the pathogen, and it can also inhibit the proliferation of bacteria such as Escherichia coli, Staphylococcus aureus, and Salmonella, among which the scavenging effect on Staphylococcus aureus is the best. Second, Pogostemon cablin can dynamically regulate the gastrointestinal - reproductive axis, breaking the "damp-heat - spleen deficiency - leukorrhea" cycle through a chain reaction of "aromatic awakening the spleen - promoting nutrient absorption - improving lactation quality - enhancing disease resistance".

[0064] Pogostemon cablin and Atractylodes lancea form a "dual core for eliminating dampness": Pogostemon cablin focuses on dispersing damp turbidity in the middle jiao, and Atractylodes lancea strengthens drying dampness and invigorating the spleen. Compared with simply using diuretic herbs such as Alisma orientale, this compatibility better suits the physiological characteristics of postpartum dairy cows with "spleen deficiency as the root".

[0065] Pogostemon cablin plays a role in connecting the pivot of qi ascending and descending: While Bupleurum chinense raises the clear yang, Pogostemon cablin forms a dynamic balance of "raising the clear and lowering the turbid" by aromatic awakening the spleen and assisting the spleen in ascending the clear, can neutralize coldness, avoid damaging the spleen and stomach by bitter and cold herbs (Scutellaria baicalensis and Sophora flavescens), and protects the weak spleen and stomach functions of postpartum dairy cows, reflecting the compatibility wisdom of "eliminating pathogens without harming the healthy qi".

[0066] In summary, the formula of this invention is unique. The traditional Chinese medicine suppository has the effects of clearing heat and detoxifying, promoting blood circulation and removing stasis, contracting the uterus and discharging pus, and eliminating dampness and strengthening the spleen. Each component acts synergistically, has a good relieving and therapeutic effect on treating postpartum infections and uterine inflammation in cows, and is suitable for the clinical treatment and popularization of postpartum infections and uterine inflammation diseases in cows.

[0067] As a further preferred embodiment, the excipients include a matrix and additives, and the dosage of the additives is 0.1% - 5% of the total weight of the excipients (the rest is the matrix).

[0068] As a further preferred embodiment, the matrix includes one or more of mixed fatty acid glycerides, cocoa butter, hydrogenated vegetable oil, and glycerogelatin.

[0069] Among them, mixed fatty acid glycerides as a vaginal suppository matrix have passed the FDA review. Clinical studies have shown that its regular use is non-toxic and non-irritating to the mucosa, and its safety, adaptability, and sustained-release characteristics make it an ideal choice.

[0070] The matrix melts at bovine body temperature (about 38.5 °C) to form a lipophilic carrier, slowly releasing the drug components, prolonging the local action time (6 - 8 hours), and avoiding frequent drug administration.

[0071] As a further preferred embodiment, the additive includes one or more of poloxamer, Tween, lecithin, polysorbate, polyethylene glycol stearate, and its dosage is 0.1% - 5% of the total weight of the matrix.

[0072] In the present invention, the additive is a surfactant, which improves the solubility of hydrophobic components (such as baicalin and matrine) by forming micelles, enhances the dispersion of the drug in the secretion, reduces the surface tension of the mucus layer, promotes the drug to penetrate the biofilm barrier, and improves the bioavailability (30% - 40% higher than traditional dosage forms).

[0073] As a further preferred embodiment, the drug active ingredient is dry extract powder; preferably, the suppository is torpedo-shaped.

[0074] In the present invention, the shape of the suppository is set to be torpedo-shaped. The surface area of the torpedo-shaped suppository is moderate, and it can release the drug evenly when melting at body temperature, avoiding too high or too low local concentration. The tip design helps the matrix to diffuse directionally in the cavity, making the drug cover the mucosal surface more evenly, enhancing the local treatment effect, and having a smooth surface, reducing the risk of mechanical irritation.

[0075] In the present invention, the drug active ingredient clears pathogens and repairs tissues through multi-target synergy, and the excipients optimize drug release and absorption through dosage form design. The combination of the two achieves the comprehensive treatment effect of "rapid onset - long-term maintenance - safe and low irritation", meeting the complex pathological needs of bovine postpartum uterine inflammation.

[0076] Example 2

[0077] Based on Example 1, this example provides a preparation method of a suppository for treating postpartum infection and uterine inflammation, and the specific steps are as follows:

[0078] Step 1): Weigh Scutellaria baicalensis, Carthamus tinctorius, Angelica sinensis, Angelica dahurica, Poria cocos, Glycyrrhiza uralensis, Codonopsis pilosula, Bupleurum chinense, Sophora flavescens, Atractylodes lancea, and Pogostemon cablin according to the weight ratio of the drug active ingredient, and set aside;

[0079] Step 2): Take all the drug active ingredients in Step 1), soak them in water, decoct, extract, combine the extracts, and then concentrate to obtain a concentrated solution;

[0080] Step 3): Dry the concentrated solution obtained in Step 2) into a dry extract, crush the dry extract through a sieve, and set aside;

[0081] Step 4): Weigh the excipients according to the mass ratio of the drug active ingredient dry extract powder and the excipients. First, heat and melt the matrix, then add the additive, and stir evenly for later use;

[0082] Step 5): Add the dry extract powder in Step 3 to the melted auxiliary materials in Step 4 and stir evenly.

[0083] Step 6): Pour the evenly stirred mixture in Step 5 into the suppository mold while it is still hot.

[0084] Step 7): Place the suppository mold in Step 6 at room temperature for cooling.

[0085] Step 8): Take out, demold and package.

[0086] As a further preferred method, the amount of water added in Step 2 is 8 - 12 times the weight of the drug active ingredient, the soaking time is 1 - 2 hours, the decocting time each time is 1 - 2 hours, and it is extracted 2 - 3 times. After combining the extraction solutions, the extraction solution is concentrated under reduced pressure to a concentrated solution with a relative density of 1.05 - 1.25, and the concentration temperature is 50 - 60°C.

[0087] As a further preferred method, the mesh sieve in Step 3 is 100 - 120 meshes.

[0088] A drug for treating postpartum infection and uterine inflammation, which includes the suppository described above or the suppository prepared as above.

[0089] Example 3

[0090] Test Example 1

[0091] A suppository for treating postpartum infection and uterine inflammation, the mass ratio of the dry extract powder of the drug active ingredient to the auxiliary materials is 1:1.5; among them, the drug active ingredient is proportioned by weight: 20 g of Scutellaria baicalensis, 20 g of Carthamus tinctorius, 30 g of Angelica sinensis, 15 g of Angelica dahurica, 15 g of Poria cocos, 15 g of Glycyrrhiza uralensis, 20 g of Codonopsis pilosula, 15 g of Bupleurum chinense, 15 g of Sophora flavescens, 15 g of Atractylodes lancea, 15 g of Pogostemon cablin, and in the auxiliary materials, the suppository matrix is 91 g of mixed fatty acid glycerides, and the additive is 0.5 g of poloxamer.

[0092] Its preparation method is as follows:

[0093] Step 1): Weigh 20 g of Scutellaria baicalensis, 20 g of Carthamus tinctorius, 30 g of Angelica sinensis, 15 g of Angelica dahurica, 15 g of Poria cocos, 15 g of Glycyrrhiza uralensis, 20 g of Codonopsis pilosula, 15 g of Bupleurum chinense, 15 g of Sophora flavescens, 15 g of Atractylodes lancea, 15 g of Pogostemon cablin according to the weight proportion, and 89.5 g of mixed fatty acid glycerides as the suppository matrix and 0.5 g of poloxamer as the additive in the auxiliary materials, and set aside.

[0094] Step 2): Take all the drug active ingredients in Step 1, add 12 times water and soak for 1 hour, decoct for 2 times, 1 hour each time, filter, and combine the extraction solutions; when setting the temperature at 60°C, the obtained extraction solution is concentrated under reduced pressure to a concentrated solution with a relative density of 1.05 - 1.15, and set aside;

[0095] Step 3): Dry the concentrated solution obtained in Step 2) into a dry extract, crush the dry extract through a 100-mesh sieve, weigh 60 g of the dry extract powder, and reserve it for use;

[0096] Step 4): Weigh the excipients according to the mass ratio of 1:1.5 of the dry extract powder of the active pharmaceutical ingredient and the excipients; among them, take 89.5 g of the mixed fatty acid glyceride matrix and heat it to melt, add 0.5 g of the additive poloxamer, and stir evenly;

[0097] Step 5): Add the dry extract powder in Step 3) to the melted excipients in Step 4), mix and stir evenly;

[0098] Step 6): Pour the well-stirred mixture in Step 5) into a torpedo-shaped suppository mold while it is still hot;

[0099] Step 7): Place the suppository mold in Step 6) at room temperature to cool;

[0100] Step 8): Take out, demold and package to prepare 14 torpedo-shaped suppositories.

[0101] Test Example 2

[0102] A suppository for treating postpartum infection and uterine inflammation, with the mass ratio of the dry extract powder of the active pharmaceutical ingredient and the excipients being 1:2; among them, the active pharmaceutical ingredient is formulated by weight: 10 g of Scutellaria baicalensis, 10 g of Carthamus tinctorius, 30 g of Angelica sinensis, 15 g of Angelica dahurica, 15 g of Poria cocos, 15 g of Glycyrrhiza uralensis, 20 g of Codonopsis pilosula, 15 g of Bupleurum chinense, 15 g of Sophora flavescens, 20 g of Atractylodes lancea, 15 g of Pogostemon cablin, and in the excipients, the suppository matrix is 10X g of mixed fatty acid glyceride, and the additive is 1 g of poloxamer.

[0103] The steps of its preparation method are basically the same as those in Test Example 1.

[0104] Step 2): Take all the active pharmaceutical ingredients in Step 1), soak them in 8 times the amount of water for 1 hour, decoct them twice, each time for 2 hours, filter, and combine the extracts; when the temperature is set at 60 °C, the obtained extract is concentrated under reduced pressure to a concentrated solution with a relative density of 1.05 - 1.25, and reserve it for use;

[0105] Step 3): Dry the concentrated solution obtained in Step 2) into a dry extract, crush the dry extract through a 100-mesh sieve, weigh 54 g of the dry extract powder, and reserve it for use;

[0106] Step 4): Weigh the excipients according to the mass ratio of 1:2 of the dry extract powder of the active pharmaceutical ingredient and the excipients; among them, take 107 g of the mixed fatty acid glyceride matrix and heat it to melt, add 1 g of the additive poloxamer, and stir evenly;

[0107] Step 8): Take out, demold and package to prepare 15 torpedo-shaped suppositories;

[0108] All other steps are the same as those in Test Example 1. Note: In the translation of the content of "10X g" in item , since the original text seems to be incorrect or incomplete, it is directly translated as "10X g" for the time being. You can check and correct it according to the actual situation.

[0109] Experimental Example 3

[0110] A suppository for treating postpartum infection and uterine inflammation, the mass ratio of the dry extract powder of the drug active ingredient to the auxiliary material is 1:1; among them, the drug active ingredient is proportioned by weight: 20 g of Scutellaria baicalensis, 15 g of safflower, 25 g of Angelica sinensis, 10 g of Angelica dahurica, 15 g of Poria cocos, 5 g of licorice, 20 g of Codonopsis pilosula, 15 g of Bupleurum chinense, 20 g of Sophora flavescens, 15 g of Atractylodes lancea, 15 g of Pogostemon cablin. In the auxiliary material, the suppository matrix is 52 g of mixed fatty acid glycerides, and the additive is ulfonic acid 2 g of poloxamer.

[0111] The steps of its preparation method are basically the same as those in Experimental Example 1.

[0112] Step 2): Take all the drug active ingredients in Step 1, soak them in 10 times the amount of water for 1 hour, decoct them 3 times, each time for 1 hour, filter, and combine the extracts; when the temperature is set at 50 °C, the obtained extract is concentrated under reduced pressure to a concentrated solution with a relative density of 1.05 - 1.25, and set aside; all other steps are the same as those in Experimental Example 1.

[0113] Step 3): Dry the concentrated solution obtained in Step 2 into a dry extract, crush the dry extract through a 100-mesh sieve, weigh 54 g of dry extract powder, and set aside;

[0114] Step 4): Weigh the auxiliary materials according to the mass ratio of 1:1 of the dry extract powder of the drug active ingredient to the auxiliary material; among them, take 52 g of the mixed fatty acid glyceride matrix, heat and melt it, add 2 g of the additive poloxamer, and stir evenly;

[0115] Step 8): Take out, demold and package to prepare 10 torpedo-shaped suppositories; all other steps are the same as those in Experimental Example 1.

[0116] Clinical Efficacy of Experimental Example 1

[0117] 1. Diagnosis of postpartum infection and uterine inflammation diseases in cows

[0118] In large-scale farms, all postpartum dairy cows on the site were screened through general clinical examinations combined with rectal examinations, vaginal examinations, and B-ultrasound examinations. A total of 40 dairy cows suffering from postpartum infection and uterine inflammation were included in the trial. The body weight range of the dairy cows was 450 - 650 kg. The trial grouping and drug administration information are shown in Table 1. The traditional Chinese medicine suppository group was the suppository prepared according to Experimental Example 1, each pill was 10.5 g, and the positive drug was chlorhexidine acetate suppository.

[0119] Table 1 Trial Grouping and Drug Administration Information

[0120] Group Quantity (heads) Drug administration regimen Traditional Chinese medicine suppository group 20 Two pills each time, once every other day, for 3 - 5 consecutive times Drug control group 20 Two pills each time, once a day, for 3 - 5 consecutive times

[0121] 2. Efficacy Judgment Criteria

[0122] The treatment effect is evaluated according to the following criteria:

[0123] ① Cured: Clinical symptoms disappear. After treatment, the cow secretes clear mucus or no mucus, without abnormal smell; the vulva and vagina are normal; during rectal examination, the uterus is elastic, normal in size, and no abnormal secretion is discharged when massaging the uterus; there is no echo in the uterine cavity during B-ultrasound examination; no recurrence during the observation period is judged as cured. Calculate the cure rate.

[0124] ② Effective: Clinical symptoms are partially improved. After treatment, the secretion volume of the cow decreases, and the secretion is significantly improved; the vulva and vagina are swollen and slightly congested; during rectal examination, the elasticity of the uterus is significantly restored; during B-ultrasound examination, the inflammatory secretion in the uterus is significantly reduced; the symptoms do not worsen during the observation period, which is judged as effective. Calculate the effective rate.

[0125] ③ Ineffective: Clinical symptoms are not significantly improved or even worsened. After treatment, the secretion volume of the cow increases, the secretion is abnormal, with abnormal smell; the vulva and vagina are swollen and highly congested; during rectal examination, the uterus is swollen, the uterine horn is enlarged, and the elasticity of the uterus is weakened; a large amount of inflammatory secretion exists in the uterus during B-ultrasound examination, which is judged as ineffective. Calculate the ineffectiveness rate.

[0126] Finally, the total effective rate is counted. The total effective rate is the sum of the cure rate and the effective rate.

[0127] Taking the cure rate and the total effective rate as the main indicators, evaluate the treatment effect of the traditional Chinese medicine suppository on postpartum infection and uterine inflammation in cows.

[0128] 3. The test results are shown in Table 2.

[0129] Table 2 Treatment effect of the suppository on postpartum infection and uterine inflammation diseases in cows

[0130]

[0131] It can be seen from the results that the suppository of the present invention can effectively treat postpartum infection and uterine inflammation diseases in cows. Its cure rate reaches 65.0%, and the total effective rate reaches 85.0%, with excellent effects.

[0132] The preparation methods and clinical curative effects of Test Examples 2 and 3 are similar to those of Test Example 1, and the difference lies only in the adjustment of the drug active ingredient ratio.

[0133] The above are only the preferred embodiments of the present application, and are not used to limit the present application. Any modification, equivalent replacement or improvement made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A suppository for treating postpartum infection and uterine inflammation, characterized in that, The raw materials include a pharmaceutically active ingredient and excipients; the mass ratio thereof is 1:(1 - 2.5).

2. The suppository according to claim 1, characterized in that, The pharmaceutically active ingredient includes Scutellaria baicalensis, Carthamus tinctorius, Angelica sinensis, Angelica dahurica, Poria cocos, Glycyrrhiza uralensis, Codonopsis pilosula, Bupleurum chinense, Sophora flavescens, Atractylodes lancea, Pogostemon cablin; preferably, the pharmaceutically active ingredient is proportioned by weight: 10 - 20 parts of Scutellaria baicalensis, 10 - 20 parts of Carthamus tinctorius, 20 - 30 parts of Angelica sinensis, 5 - 15 parts of Angelica dahurica, 5 - 15 parts of Poria cocos, 5 - 15 parts of Glycyrrhiza uralensis, 20 - 60 parts of Codonopsis pilosula, 15 - 45 parts of Bupleurum chinense, 15 - 60 parts of Sophora flavescens, 15 - 60 parts of Atractylodes lancea, 15 - 45 parts of Pogostemon cablin.

3. The suppository according to claim 1, characterized in that, The excipients include a matrix and additives, and the dosage of the additives is 0.1% - 5% of the total weight of the excipients (the rest is the matrix).

4. The suppository according to claim 2, wherein The matrix includes one or more of mixed fatty acid glycerides, cocoa butter, hydrogenated vegetable oil, and glycerogelatin.

5. The suppository according to claim 2, characterized in that, The additives include one or more of poloxamer, Tween, lecithin, polysorbate, and polyethylene glycol stearate.

6. The suppository according to claim 1, characterized in that, The pharmaceutically active ingredient is dry extract powder; preferably, the suppository is torpedo-shaped.

7. A method for preparing the suppository for treating postpartum infection and uterine inflammation according to any one of claims 1-6, characterized in that, The specific steps are as follows: Step 1): Weigh Scutellaria baicalensis, Carthamus tinctorius, Angelica sinensis, Angelica dahurica, Poria cocos, Glycyrrhiza uralensis, Codonopsis pilosula, Bupleurum chinense, Sophora flavescens, Atractylodes lancea, Pogostemon cablin according to the weight ratio of the pharmaceutically active ingredient, and set aside. Step 2): Take all the pharmaceutically active ingredients in Step 1), soak them in water, decoct, extract, combine the extracts, and then concentrate to obtain a concentrated solution. Step 3): Dry the concentrated solution obtained in Step 2) into a dry extract, crush the dry extract through a sieve, and set aside. Step 4): Weigh the excipients according to the mass ratio of the dry extract powder of the pharmaceutically active ingredient and the excipients. First, heat and melt the matrix, and then add the additives and stir evenly, and set aside. Step 5): Add the dry extract powder in Step 3) to the melted excipients in Step 4) and stir evenly. Step 6): Pour the mixture in Step 5) into the suppository mold while it is hot and stir evenly. Step 7): Place the suppository mold in Step 6) at room temperature to cool. Step 8): Take out, demold and package.

8. The preparation method according to claim 7, wherein In Step 2), the water addition amount is 8 - 12 times the weight of the pharmaceutically active ingredient, the soaking time is 1 - 2 hours, the decocting time each time is 1 - 2 hours, extract 2 - 3 times, after combining the extracts, concentrate the extract under reduced pressure to a concentrated solution with a relative density of 1.05 - 1.25, and the concentration temperature is 50 - 60°C.

9. The preparation method according to claim 7, characterized in that, In Step 3), the sieve is 100 - 120 mesh.

10. A drug for treating postpartum infection and uterine inflammation, characterized in that, It includes the suppository according to any one of claims 1 - 6 or the suppository prepared according to claims 7 - 9.

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