Traditional Chinese medicine compound preparation for purging heat and removing stagnation as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a heat-purging stagnation-removing traditional Chinese medicine compound preparation and a preparation method and application thereof. The traditional Chinese medicine compound preparation for purging heat and removing stagnation is prepared from the following raw materials in parts by weight: 10-60 parts of radix bupleuri, 10-30 parts of radix scutellariae, 10-30 parts of radix paeoniae rubra, 10-30 parts of rhizoma pinelliae preparata, 10-40 parts of fresh ginger, 10-40 parts of fructus aurantii, 10-40 parts of cortex mori radicis, 10-30 parts of peach kernels, 10-30 parts of liquorice, 1-15 parts of cassia twig, 10-30 parts of fructus forsythiae, 1-15 parts of rhizoma cimicifugae and 8-30 parts of honeysuckle. The traditional Chinese medicine compound preparation for purging heat and removing stagnation is a self-formulated formula, takes bowel purging, heat purging, blood circulation promoting and blood stasis removing as main treatment methods, improves clinical symptoms of patients suffering from systemic inflammatory reaction, reduces the incidence rate of multi-organ dysfunction, and improves the living quality and prognosis of the patients.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a compound preparation of traditional Chinese medicine for purging heat and relieving stagnation, its preparation method, and its application. Background Technology

[0002] Systemic inflammatory response syndrome (SIRS) often leads to multiple organ dysfunction, making clinical treatment challenging. Currently, Western medicine primarily employs comprehensive treatment methods including anti-infection, immunomodulation, and organ support, but these methods have limitations, such as antibiotic resistance and the side effects of immunomodulatory drugs.

[0003] In Traditional Chinese Medicine (TCM) theory, the etiology and pathogenesis of systemic inflammatory response are complex and can be categorized under terms such as "excessive heat and toxins" and "stagnation of Qi." Its pathogenesis is largely related to internal accumulation of heat and toxins, impaired Qi flow, and blood stasis. In recent years, TCM has demonstrated certain advantages in treating systemic inflammatory response, but systematic and effective formulas and clinical application research are lacking. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine compound preparation for purging heat and relieving stagnation, its preparation method and application, for the treatment of systemic inflammatory response, in order to achieve the effects of clearing heat and detoxifying, promoting qi circulation and removing blood stasis, and to provide new ideas and methods for the treatment of systemic inflammatory response.

[0005] According to a first aspect of the present invention, a traditional Chinese medicine compound preparation for purging heat and relieving stagnation is provided, which is prepared from the following raw materials in parts by weight: Bupleurum chinense 10-60 parts, Scutellaria baicalensis 10-30 parts, Paeonia lactiflora 10-30 parts, Pinellia ternata 10-30 parts, Zingiber officinale 10-40 parts, Citrus aurantium 10-40 parts, Morus alba root bark 10-40 parts, Prunus persica kernel 10-30 parts, Glycyrrhiza uralensis 10-30 parts, Cinnamomum cassia twig 1-15 parts, Forsythia suspensa 10-30 parts, Cimicifuga foetida 1-15 parts, and Lonicera japonica 8-30 parts.

[0006] The traditional Chinese medicine compound preparation for purging heat and unblocking stagnation provided by this invention is a self-formulated prescription. Its main treatment methods are purging heat and unblocking the bowels, promoting blood circulation and removing blood stasis. It improves the clinical symptoms of patients with systemic inflammatory response (such as reducing fever, improving heart rate, improving bowel movements, and anti-inflammation), reduces the incidence of multiple organ dysfunction, and improves patients' quality of life and prognosis. The prescription includes: Bupleurum soothes the liver and relieves stagnation, expelling pathogens; Scutellaria baicalensis clears heat, dries dampness, purges fire, and detoxifies; Morus alba root bark clears lung heat, purges lung heat, and relieves asthma. These three herbs, when used together, soothe liver stagnation and purge heat to relieve asthma, serving as the principal herbs. Peach kernel invigorates blood circulation, removes blood stasis, moistens the intestines, and promotes bowel movement; Forsythia suspensa clears heat, detoxifies, reduces swelling, and dissipates nodules; Cimicifuga foetida raises yang, lifts prolapse, clears heat, and detoxifies, serving as the assistant herbs. Honeysuckle clears heat, detoxifies, and disperses wind-heat; Paeonia lactiflora clears heat, cools blood, invigorates blood circulation, and removes blood stasis; Pinellia ternata clears dampness, resolves phlegm, and relieves nausea and vomiting; Citrus aurantium regulates qi, relieves chest tightness, and eliminates fullness; Zingiber officinale warms the middle jiao, dispels cold, and relieves nausea and vomiting; Glycyrrhiza uralensis harmonizes the other herbs; Cinnamomum cassia warms the meridians, unblocks the vessels, and assists yang and qi, serving as the adjuvant herbs. The entire formula is meticulously formulated, working together to clear heat, detoxify, promote qi circulation, and invigorate blood circulation to remove blood stasis, thereby achieving the goal of treating systemic inflammatory response.

[0007] The raw materials of this invention's heat-clearing and stagnation-relieving traditional Chinese medicine compound preparation are all processed in accordance with the "Chinese Pharmacopoeia" and the "National Processing Standards," specifically sourced from: Bupleurum: Bupleurum chinense, a plant in the Apiaceae family. Bupleurum chinense or narrow-leaved Bupleurum Bupleurum scorzonerifolium The dried root.

[0008] Scutellaria baicalensis: a plant of the Lamiaceae family. Scutellaria baicalensis Georgi The dried root.

[0009] Red peony: Paeonia lactiflora, a plant in the Ranunculaceae family. Paeonia lactiflora Pall. Or Sichuan red peony Paeonia veitchii Lynch The dried root.

[0010] Prepared Pinellia: Pinellia ternata is a processed form of Pinellia ternata, a plant belonging to the Araceae family. Pinellia ternata(Thunb.) Breit. The dried tubers.

[0011] Ginger: ginger (Zingiber officinale), a plant in the ginger family. Zingiber officinale Rosc. Fresh rhizomes.

[0012] Citrus aurantium: Citrus aurantium, a plant in the Rutaceae family. Citrus aurantium L. The dried, immature fruit of its cultivated varieties.

[0013] Mulberry bark: Mulberry (Morus alba) is a plant belonging to the Moraceae family. Morus alba L. The dried root bark.

[0014] Peach kernel: a plant of the Rosaceae family called peach. Prunus persica(L.)Batsch or Prunus davidiana (Carr.)Franch. The dried, mature seeds.

[0015] Licorice: Licorice, a plant in the legume family. Glycyrrhiza uralensis Fisch. licorice root Glycyrrhiza inflata Bat. Or licorice root Glycyrrhiza glabra L. The dried roots and rhizomes.

[0016] Cinnamon twig: Cinnamon (Lauraceae family) Cinnamomum cassia Presl The dried young branches.

[0017] Forsythia: Forsythia suspensa, a plant in the Oleaceae family Forsythia suspensa(Thunb.)Vahl Dried fruit.

[0018] Cimicifuga: A plant of the Ranunculaceae family, Cimicifuga macrocarpa Cimicifuga heracleifolia Kom. Xingan Cimicifuga Cimicifuga dahurica(Turcz.)Maxim. or Cimicifuga Cimicifuga foetida L. The dried rhizome.

[0019] Honeysuckle: The dried flower buds or newly opened flowers of Lonicera japonica Thunb., a plant in the Caprifoliaceae family.

[0020] In some embodiments, the traditional Chinese medicine compound preparation for purging heat and relieving stagnation is prepared from the following raw materials in parts by weight: Bupleurum chinense 20-40 parts, Scutellaria baicalensis 10-20 parts, Paeonia lactiflora 10-20 parts, Pinellia ternata 10-20 parts, Zingiber officinale 20-30 parts, Citrus aurantium 20-30 parts, Morus alba root bark 20-30 parts, Prunus persica kernel 10-20 parts, Glycyrrhiza uralensis 10-20 parts, Cinnamomum cassia twig 5-10 parts, Forsythia suspensa 10-20 parts, Cimicifuga foetida 5-10 parts, and Lonicera japonica 10-20 parts.

[0021] In some embodiments, the traditional Chinese medicine compound preparation for purging heat and relieving stagnation is prepared from the following raw materials in parts by weight: Bupleurum chinense 24 parts, Scutellaria baicalensis 12 parts, Paeonia lactiflora 18 parts, Pinellia ternata 12 parts, Zingiber officinale 24 parts, Citrus aurantium 24 parts, Morus alba root bark 24 parts, Prunus persica 15 parts, Glycyrrhiza uralensis 12 parts, Cinnamomum cassia 6 parts, Forsythia suspensa 15 parts, Cimicifuga foetida 6 parts, and Lonicera japonica 12 parts.

[0022] In some embodiments, the herbal compound preparation for purging heat and relieving stagnation, by weight, also includes at least one of 10-20 parts of dandelion and 10-20 parts of wild chrysanthemum. Thus, the addition of heat-clearing and detoxifying herbs is intended to address the patient's condition of severe heat toxicity.

[0023] In some embodiments, the herbal compound preparation for purging heat and relieving stagnation, by weight, also includes at least one of Cyperus rotundus (10-20 parts) and Curcuma longa (10-20 parts). Thus, the addition of qi-regulating and stagnation-relieving herbs addresses the patient's significant qi stagnation.

[0024] In some embodiments, the herbal compound preparation for purging heat and clearing stagnation, by weight, also includes at least one of the following: 10-20 parts of Salvia miltiorrhiza and 10-20 parts of Carthamus tinctorius. Thus, the addition of blood-activating and stasis-removing herbs addresses the patient's severe blood stasis.

[0025] In some embodiments, the herbal compound preparation for purging heat and relieving stagnation, by weight, also includes at least one of the following: 10-20 parts of Codonopsis pilosula, 10-20 parts of Atractylodes macrocephala, and 10-20 parts of Poria cocos. Thus, the addition of spleen-strengthening and qi-tonifying herbs is intended to address the patient's condition of spleen and stomach weakness.

[0026] In some implementations, the dosage forms of the traditional Chinese medicine compound preparation for purging heat and relieving stagnation are existing common dosage forms such as decoction, granules, ointment, pills, and powder. The dosage of different dosage forms can be appropriately adjusted according to clinical needs and preparation processes, but the proportion of each raw material remains unchanged. Granules are manufactured in accordance with the "Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Formula Granules" issued by the National Medical Products Administration.

[0027] In some embodiments, the traditional Chinese medicine compound preparation for purging heat and relieving stagnation may also include pharmaceutically acceptable excipients, which may include at least one of sustained-release agents, excipients, fillers, binders, wetting agents, disintegrants, absorption promoters, surfactants, and lubricants.

[0028] According to a second aspect of the present invention, a method for preparing a traditional Chinese medicine compound preparation for purging heat and relieving stagnation is provided, wherein when the preparation is a decoction, the method includes the following steps: (1) Weigh each raw material according to the weight, add water and soak for 20-50 minutes. The amount of water added is 8-12 times the total mass of the raw materials.

[0029] (2) First bring to a boil over high heat, then simmer over low heat for 25-40 minutes, and filter to obtain the first decoction and dregs; (3) Add water to the dregs, the amount of water being 6-10 times the total mass of the raw materials. Bring to a boil over high heat, then simmer over low heat for 15-30 minutes. Filter to obtain the second decoction. Combine the first and second decoctions to obtain the final product.

[0030] When the formulation is in granule form, the following steps are included: (1) First, obtain the decoction by following the steps for preparing the decoction, and then concentrate the decoction to a clear paste with a relative density of 1.10 (60℃); (2) Concentrate the clear paste under reduced pressure to a thick paste with a relative density of 1.20 (60℃); (3) Add excipients (such as dextrin, sucrose, etc.) to the thick paste, mix evenly, and then spray dry to obtain dry paste powder; (4) Sift the dry paste powder, add lubricant (such as magnesium stearate), mix evenly, and then press into granules.

[0031] According to a third aspect of the present invention, the application of a traditional Chinese medicine compound preparation for purging heat and relieving stagnation in the preparation of a drug for treating or improving systemic inflammatory response syndrome is provided. The systemic inflammatory response syndrome of this application belongs to the category of Yang syndrome and is a state of high inflammation. Its core symptoms include floating, slippery and rapid pulse, red eyelids, dry stools, irritability, fever, etc.

[0032] Based on the fact that the root cause of systemic inflammatory response lies in the internal accumulation of heat toxins and stagnation of Qi, while its manifestation lies in blood stasis and obstruction of bowel Qi, the traditional Chinese medicine compound preparation for purging heat and unblocking stagnation disclosed in this invention treats systemic inflammatory response by mainly clearing heat from the bowels and promoting blood circulation and removing blood stasis. It can not only improve the patient's inflammatory indicators and alleviate clinical symptoms, but also prevent and treat systemic inflammatory response syndrome by regulating the body's immune function and improving microcirculation. The treatment effect is significant and the safety is acceptable. Detailed Implementation

[0033] The present invention will be further described in detail below with reference to specific embodiments. It is worth noting that the following embodiments are only for better explaining the content of the present invention and do not limit the scope of protection of the present invention. Process steps not disclosed in the embodiments are prior art. Unless otherwise specified, all raw materials are commercially available.

[0034] Example 1 This traditional Chinese medicine compound preparation for purging heat and relieving stagnation is prepared from the following raw materials in parts by weight: Bupleurum chinense 24g, Scutellaria baicalensis 12g, Paeonia lactiflora 18g, Pinellia ternata 12g, Zingiber officinale 24g, Citrus aurantium 24g, Morus alba root bark 24g, Prunus persica kernel 15g, Glycyrrhiza uralensis 12g, Cinnamomum cassia 6g, Forsythia suspensa 15g, Cimicifuga foetida 6g, Lonicera japonica 12g.

[0035] When the compound preparation of traditional Chinese medicine for purging heat and relieving stagnation is in the form of a decoction, it is prepared through the following steps: (1) Weigh each raw material according to the weight parts; (2) Soak the above raw materials in water for 30 minutes, with the amount of water being 10 times the total mass of the raw materials; (3) First bring to a boil over high heat, then simmer over low heat for 30 minutes, and filter to obtain the first decoction and dregs; (4) Add water to the dregs, the amount of water being 8 times the total mass of the raw materials. Bring to a boil over high heat, then simmer over low heat for 20 minutes. Filter to obtain the second decoction. (5) Combine the first and second decoctions and concentrate them to about 100ml.

[0036] Example 2 This traditional Chinese medicine compound preparation for purging heat and relieving stagnation is prepared from the following raw materials in parts by weight: Bupleurum chinense 24g, Scutellaria baicalensis 12g, Paeonia lactiflora 18g, Pinellia ternata 12g, Zingiber officinale 24g, Citrus aurantium 24g, Morus alba root bark 24g, Prunus persica kernel 15g, Glycyrrhiza uralensis 12g, Cinnamomum cassia 6g, Forsythia suspensa 15g, Cimicifuga foetida 6g, Lonicera japonica 12g.

[0037] When the compound preparation of traditional Chinese medicine for purging heat and relieving stagnation is in granule form, it is prepared through the following steps: (1) First, the decoction was prepared according to the steps of Example 1. The decoction was then concentrated to a clear paste with a relative density of 1.10 (60°C). (2) Concentrate the clear paste under reduced pressure to a thick paste with a relative density of 1.20 (60℃); (3) Add excipients (such as dextrin, sucrose, etc.) to the thick paste, mix evenly, and then spray dry to obtain dry paste powder; (4) Sift the dry paste powder, add lubricant (such as magnesium stearate), mix evenly, and then press into granules.

[0038] Example 3 This traditional Chinese medicine compound preparation for purging heat and relieving stagnation is prepared from the following raw materials in parts by weight: Bupleurum chinense 45g, Scutellaria baicalensis 28g, Paeonia lactiflora 25g, Pinellia ternata 22g, Zingiber officinale 30g, Citrus aurantium 30g, Morus alba root bark 32g, Prunus persica kernel 25g, Glycyrrhiza uralensis 25g, Cinnamomum cassia twig 15g, Forsythia suspensa 20g, Cimicifuga foetida 10g, and Lonicera japonica 25g.

[0039] The traditional Chinese medicine compound preparation for purging heat and relieving stagnation can be prepared into a decoction by referring to the method in Example 1.

[0040] Example 4 This traditional Chinese medicine compound preparation for purging heat and relieving stagnation is prepared from the following raw materials in parts by weight: Bupleurum chinense 20g, Scutellaria baicalensis 10g, Paeonia lactiflora 10g, Pinellia ternata 12g, Zingiber officinale 12g, Citrus aurantium 15g, Morus alba root bark 15g, Prunus persica kernel 10g, Glycyrrhiza uralensis 12g, Cinnamomum cassia twig 2g, Forsythia suspensa 10g, Cimicifuga foetida 3g, and Lonicera japonica 8g.

[0041] The traditional Chinese medicine compound preparation for purging heat and relieving stagnation can be prepared into a decoction by referring to the method in Example 1.

[0042] Example 5 If the patient has severe heat toxicity, a traditional Chinese medicine compound preparation for purging heat and clearing stagnation can be prepared from the following raw materials in parts by weight: Bupleurum 24g, Scutellaria baicalensis 20g, Paeonia lactiflora 18g, Pinellia ternata 12g, Zingiber officinale 24g, Citrus aurantium 24g, Morus alba root bark 24g, Prunus persica 15g, Glycyrrhiza uralensis 12g, Cinnamomum cassia 6g, Forsythia suspensa 15g, Cimicifuga foetida 6g, Lonicera japonica 20g, Taraxacum mongolicum 10g, and Chrysanthemum indicum 10g.

[0043] The traditional Chinese medicine compound preparation for purging heat and relieving stagnation can be prepared into a decoction by referring to the method in Example 1.

[0044] Example 6 If the patient has significant qi stagnation, a traditional Chinese medicine compound preparation for purging heat and unblocking stagnation can be prepared from the following raw materials in parts by weight: Bupleurum chinense 42g, Scutellaria baicalensis 10g, Paeonia lactiflora 15g, Pinellia ternata 10g, Zingiber officinale 20g, Citrus aurantium 30g, Morus alba root bark 24g, Prunus persica kernel 10g, Glycyrrhiza uralensis 10g, Cinnamomum cassia 6g, Forsythia suspensa 15g, Cimicifuga foetida 6g, Lonicera japonica 15g, Cyperus rotundus 10g.

[0045] The traditional Chinese medicine compound preparation for purging heat and relieving stagnation can be prepared into a decoction by referring to the method in Example 1.

[0046] Example 7 If the patient has severe blood stasis, a traditional Chinese medicine compound preparation for clearing heat and unblocking stagnation can be prepared from the following raw materials in parts by weight: Bupleurum chinense 24g, Scutellaria baicalensis 12g, Paeonia lactiflora 22g, Pinellia ternata 12g, Zingiber officinale 24g, Citrus aurantium 24g, Morus alba root bark 24g, Prunus persica kernel 25g, Glycyrrhiza uralensis 12g, Cinnamomum cassia 6g, Forsythia suspensa 15g, Cimicifuga foetida 6g, Lonicera japonica 12g, and Carthamus tinctorius 12g.

[0047] The traditional Chinese medicine compound preparation for purging heat and relieving stagnation can be prepared into a decoction by referring to the method in Example 1.

[0048] Example 8 If the patient also has spleen and stomach weakness, a traditional Chinese medicine compound preparation for purging heat and relieving stagnation can be prepared from the following raw materials in parts by weight: Bupleurum chinense 24g, Scutellaria baicalensis 12g, Paeonia lactiflora 18g, Pinellia ternata 12g, Zingiber officinale 24g, Citrus aurantium 24g, Morus alba root bark 24g, Prunus persica 15g, Glycyrrhiza uralensis 12g, Cinnamomum cassia 6g, Forsythia suspensa 15g, Cimicifuga foetida 6g, Lonicera japonica 12g, Codonopsis pilosula 15g, Atractylodes macrocephala 12g, Poria cocos 12g.

[0049] The traditional Chinese medicine compound preparation for purging heat and relieving stagnation can be prepared into a decoction by referring to the method in Example 1.

[0050] The efficacy and safety of the traditional Chinese medicine compound preparation for purging heat and relieving stagnation prepared in Example 1 were studied.

[0051] 1. Test subjects (1) Diagnostic criteria SIRS is diagnosed if two or more of the following diagnostic criteria are met; 1) Body temperature >38℃ or <36℃; 2) Heart rate > 90 min / min; 3) Respiratory rate > 20 breaths / min or PaCO2 < 32 mmHg (< 43 kPa); 4) Peripheral blood leukocyte count >12×10 9 / L or <4×10 9 / L or the proportion of immature granulocytes ≥10%.

[0052] (2) Inclusion criteria 1) Inclusion criteria: Patients who meet the Western medicine diagnostic criteria for systemic inflammatory response syndrome. 2) Age 18-70, gender not limited.

[0053] 3) The patient has not used antibiotics, lipid-lowering drugs, antioxidants, anticoagulants, steroids, or immunosuppressants within one month prior to admission.

[0054] 4) Referring to "Clinical Terminology of Traditional Chinese Medicine, Part 2: Syndromes", the diagnostic criteria for Yang syndromes were proposed as follows: 1) Fever; 2) Mania; 3) Abdominal distension; 4) Constipation; 5) Red eyelids; 6) Floating, slippery, and rapid pulse. All cases were confirmed by three associate chief physicians or above. Cases with disputed diagnoses were not included in this study.

[0055] (3) Exclusion criteria 1) Patients with a history of malignant arrhythmias, cardiogenic shock, or cardiopulmonary resuscitation; 2) Patients with contraindications to anticoagulation or antiplatelet aggregation; 3) Patients with severe liver or kidney dysfunction; 4) The patient has an autoimmune disease, a hemorrhagic disease, a severe trauma, a tumor, a severe systemic infectious disease, or a vital organ. 5) Pregnant or breastfeeding women, etc.

[0056] (4) Exclusion criteria: Patients with missing key data.

[0057] 2. Test methods Basic treatment: Both the control and treatment groups received routine Western medicine treatment, including controlling the primary disease, organ support, infection prevention and control, immune modulation, and early enteral nutrition support when conditions permit. Organ support treatment included fluid resuscitation, vasoactive drugs to maintain hemodynamic stability, mechanical ventilation, and bedside continuous renal replacement therapy (CRRT).

[0058] In addition to the treatment given to the control group, the treatment group received the heat-clearing and stagnation-relieving traditional Chinese medicine compound preparation prepared in Example 1, one dose per day, orally. For those who could not take the medicine orally, it was administered via nasogastric tube or nasoenteric tube for 5 days.

[0059] 3. Results of efficacy evaluation (1) Comparison of body temperature The body temperatures of the treatment group (n=30) and the control group (n=30) were compared and analyzed. Before the intervention, the body temperature of the treatment group was (38.07±0.71)℃, and the body temperature of the control group was (38.08±0.95)℃. There was no statistically significant difference in body temperature between the two groups (t=0.046, P=0.963), indicating that the body temperatures of the two groups were at similar levels at the beginning of the intervention and were comparable.

[0060] One day after the intervention, the body temperature in the treatment group dropped to (37.67 ± 0.64) °C, while the body temperature in the control group was (38.29 ± 0.96) °C. The body temperature in the treatment group was significantly lower than that in the control group, and the difference was statistically significant (t = 2.925, P = 0.005). This suggests that the treatment measures began to lower body temperature one day after the intervention, and the effect was better than that in the control group.

[0061] Three days after the intervention, the body temperature in the treatment group further decreased to (37.32 ± 0.53)℃, while the body temperature in the control group was (37.84 ± 0.66)℃. The difference in body temperature between the treatment group and the control group was more significant (t = 3.364, P = 0.001), indicating that the cooling effect of the treatment measures increased over time. Moreover, three days after the intervention, the body temperature in the treatment group was significantly lower than that in the control group, demonstrating a significant cooling effect.

[0062] Five days after the intervention, the body temperature in the treatment group was (37.11±0.51)℃, and the body temperature in the control group was (37.37+0.53)℃. There was no statistically significant difference between the two groups (t=0.691, P=0.493). This indicates that the treatment was still more effective in reducing fever than the control group five days after the intervention, but the difference was not statistically significant. This suggests that the fever-reducing effect of the treatment tended to stabilize five days after the intervention, but it still had a certain advantage over the control group. See Table 1 for details.

[0063] Table 1 Comparison of body temperature (unit: °C)

[0064] Note: * indicates P < 0.05.

[0065] (2) Comparison of heart rate The heart rates of the treatment group (n=30) and the control group (n=30) were compared and analyzed. Before the intervention, the heart rate of the treatment group was (99.10±13.82) beats / min, and the heart rate of the control group was (104.83±16.11) beats / min. There was no statistically significant difference in heart rate between the two groups (t=1.479, P=0.144), indicating that the heart rates of the two groups were at similar levels at the beginning of the intervention and were comparable.

[0066] One day after the intervention, the heart rate in the treatment group decreased to (95.87±14.59) beats / min, while the heart rate in the control group was (105.40±14.14) beats / min. The heart rate in the treatment group was significantly lower than that in the control group, and the difference was statistically significant (t=2.571, P=0.013). This suggests that the treatment measures began to reduce heart rate one day after the intervention, and the effect was better than that in the control group.

[0067] Three days after the intervention, the heart rate in the treatment group was (96.63 ± 15.35) beats / min, and the heart rate in the control group was (99.77 ± 16.16) beats / min. There was no statistically significant difference in heart rate between the two groups (t = 0.770, P = 0.444), indicating that the heart rates of the two groups were similar at this time, and the treatment measures did not show a significant advantage in reducing heart rate 3 days after the intervention.

[0068] After 5 days of intervention, the heart rate in the treatment group further decreased to (95.57 ± 15.43) beats / min, while the heart rate in the control group was (103.73 ± 14.24) beats / min. The heart rate in the treatment group was significantly lower than that in the control group, and the difference was statistically significant (t = 2.131, P = 0.037). This indicates that the treatment measures were still effective in reducing heart rate 5 days after intervention, and compared with the control group, the heart rate in the treatment group remained at a lower level. The effect of reducing heart rate was re-emerged and statistically significant after 5 days of intervention. See Table 2 for details.

[0069] Table 2 Comparison of Heart Rate (Unit: beats / min)

[0070] Note: * indicates P < 0.05.

[0071] (3) Comparison of bowel movements A comparative analysis of defecation status between the treatment group (n=30) and the control group (n=30) showed that before the intervention, 2 subjects (6.7%) in the treatment group and 1 subject (3.3%) in the control group had defecation. There was no statistically significant difference in defecation status between the two groups (X=0.351, P=0.554), indicating that the defecation status of the two groups was similar at the beginning of the intervention and they were comparable.

[0072] One day after the intervention, 14 subjects (46.7%) in the treatment group had a bowel movement, while only 4 subjects (13.3%) in the control group had a bowel movement. The difference in bowel movement between the two groups was significant (x2-7.937P=0.005), suggesting that the treatment measures began to promote bowel movement one day after the intervention, and the effect was significantly better than that of the control group.

[0073] Three days after the intervention, 18 subjects (60.0%) in the treatment group had a bowel movement, while only 4 subjects (13.3%) in the control group had a bowel movement. The difference in bowel movement between the two groups was more significant (x2=14.067, P=0.000), indicating that the bowel-promoting effect of the treatment measures further increased over time, and that the bowel improvement in the treatment group was significantly better than that in the control group at three days after the intervention.

[0074] Five days after the intervention, 19 subjects (63.3%) in the treatment group and 14 subjects (46.7%) in the control group experienced defecation. There was no statistically significant difference in defecation between the two groups (X2=1.684, P=0.194), indicating that the difference in defecation between the treatment group and the control group did not reach a statistically significant level after 5 days of intervention. However, the improvement in defecation in the treatment group was still better than that in the control group, suggesting that the defecation-promoting effect of the treatment tended to stabilize after 5 days of intervention, but still had certain advantages.

[0075] Table 3 Comparison of bowel movement patterns

[0076] Note: * indicates P < 0.05.

[0077] (4) Comparison of inflammation status Regarding white blood cell count (WBC), before intervention, the WBC level in the treatment group was (17.04±5.68)x10⁻¹. 9 / L, the control group was (16.19±5.28)x10 9 The baseline WBC count was not statistically different between the two groups (t=-0.601, P=0.550), indicating that the baseline levels were similar. One day after intervention, the WBC level in the treatment group was (16.98±5.99) x 10⁹ / L. 9 / L, the control group was (18.76±7.20)x10 9 / L, there was no statistically significant difference between the two groups (t=1.036, P=0.305). Three days after intervention, the WBC level in the treatment group significantly decreased to (14.10±7.47)x10. 9 L, while the control group was (17.85±6.62)x10 9 The WBC count in the treatment group was significantly lower than that in the control group (t=2.440, P=0.018), indicating that the treatment began to significantly affect WBC levels 3 days after intervention, effectively reducing the inflammatory response. Five days after intervention, the WBC level in the treatment group was (14.20±6.01) x10⁻⁶ / L. 9 / L, the control group was (16.49±7.47)x10 9 The WBC level in the treatment group was lower than that in the control group, indicating that the anti-inflammatory effect of the treatment measures persisted to some extent.

[0078] Regarding the percentage of neutrophils (NEUT), before intervention, the NEUT level in the treatment group was (85.27±7.91)%, and in the control group it was (83.01±8.89)%, with no statistically significant difference between the two groups (t=-1.041, P=0.302), indicating that the baseline levels of the two groups were consistent. One day after intervention, the NEUT level in the treatment group was (85.13±6.42)%, while that in the control group was (88.58±4.40)%, with the treatment group significantly lower than the control group (t=2.401, P=0.020), indicating that the treatment measures began to reduce NEUT levels and alleviate the inflammatory response one day after intervention. Three days after intervention, the NEUT level in the treatment group further decreased to (82.88±5.31)%, while that in the control group was (87.74±4.37)%, with a highly significant difference between the two groups (t=3.808, P=0.000). This indicates that the treatment measures achieved peak regulatory effect on NEUT levels three days after intervention, significantly inhibiting the inflammatory response. Five days after intervention, the NEUT level in the treatment group was (81.24±5.31)%, while that in the control group was (84.14±6.97)%, with no statistically significant difference between the two groups (t=1.667, P=0.101). However, the NEUT level in the treatment group was still lower than that in the control group, suggesting that the anti-inflammatory effect of the treatment measures remained effective even five days after intervention.

[0079] Regarding the percentage of lymphocytes (NEUT), before intervention, the LYM level in the treatment group was (6.24±6.32)%, and in the control group it was (11.88±16.55)%, with no statistically significant difference between the two groups (t=-1.765, P=0.083), indicating that the baseline levels of the two groups were similar. One day after intervention, the LYM level in the treatment group was (5.95±3.98)%, and in the control group it was (4.47±2.18)%, with no statistically significant difference between the two groups (t=-1.765, P=0.083). Three days after intervention, the LYM level in the treatment group significantly increased to (7.36±3.80)%, while that in the control group was (5.21±2.56)%, with the treatment group significantly higher than the control group (t=-2.519, P=0.015), suggesting that the treatment measures began to have a significant effect on LYM levels 3 days after intervention, which may be related to the improvement of the inflammatory response. Five days after the intervention, the LYM level in the treatment group further increased to (9.00±5.22)%, while that in the control group was (7.79±5.34)%. There was no statistically significant difference between the two groups (t=-0.887, P=0.379). However, the LYM level in the treatment group was still higher than that in the control group, indicating that the treatment measures had a sustained effect on improving LYM levels to a certain extent.

[0080] Table 4 Comparison of Inflammation Status

[0081] Note: * indicates P < 0.05.

[0082] 4. Safety evaluation results No significant abnormalities were found in the safety indicators of the two groups of laboratory tests. Overall, there were no adverse reactions. The traditional Chinese medicine formula for purging heat and relieving stagnation of qi in this invention has significant clinical efficacy and good safety.

[0083] The above descriptions are merely some specific embodiments of the present invention. For those skilled in the art, various modifications and improvements can be made without departing from the inventive concept of the present invention, and all such modifications and improvements fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine compound preparation for purging heat and relieving stagnation, characterized in that, It is prepared from the following raw materials in parts by weight: Bupleurum chinense 10-60 parts, Scutellaria baicalensis 10-30 parts, Paeonia lactiflora 10-30 parts, Pinellia ternata 10-30 parts, Zingiber officinale 10-40 parts, Citrus aurantium 10-40 parts, Morus alba root bark 10-40 parts, Prunus persica kernel 10-30 parts, Glycyrrhiza uralensis 10-30 parts, Cinnamomum cassia twig 1-15 parts, Forsythia suspensa 10-30 parts, Cimicifuga foetida 1-15 parts, and Lonicera japonica 8-30 parts.

2. The traditional Chinese medicine compound preparation for purging heat and relieving stagnation according to claim 1, characterized in that, It is prepared from the following raw materials in parts by weight: Bupleurum chinense 20-40 parts, Scutellaria baicalensis 10-20 parts, Paeonia lactiflora 10-20 parts, Pinellia ternata 10-20 parts, Zingiber officinale 20-30 parts, Citrus aurantium 20-30 parts, Morus alba root bark 20-30 parts, Prunus persica kernel 10-20 parts, Glycyrrhiza uralensis 10-20 parts, Cinnamomum cassia twig 5-10 parts, Forsythia suspensa 10-20 parts, Cimicifuga foetida 5-10 parts, Lonicera japonica 10-20 parts.

3. The traditional Chinese medicine compound preparation for purging heat and relieving stagnation according to claim 1, characterized in that, It is prepared from the following raw materials in parts by weight: Bupleurum chinense 24 parts, Scutellaria baicalensis 12 parts, Paeonia lactiflora 18 parts, Pinellia ternata 12 parts, Zingiber officinale 24 parts, Citrus aurantium 24 parts, Morus alba root bark 24 parts, Prunus persica 15 parts, Glycyrrhiza uralensis 12 parts, Cinnamomum cassia 6 parts, Forsythia suspensa 15 parts, Cimicifuga foetida 6 parts, Lonicera japonica 12 parts.

4. The traditional Chinese medicine compound preparation for purging heat and relieving stagnation according to any one of claims 1-3, characterized in that, By weight, it also includes at least one of 10-20 parts of dandelion and 10-20 parts of wild chrysanthemum.

5. The traditional Chinese medicine compound preparation for purging heat and relieving stagnation according to any one of claims 1-3, characterized in that, By weight, it also includes at least one of Cyperus rotundus and Curcuma longa, 10-20 parts each.

6. The traditional Chinese medicine compound preparation for purging heat and relieving stagnation according to any one of claims 1-3, characterized in that, It also includes at least one of the following in parts by weight: 10-20 parts of Salvia miltiorrhiza and 10-20 parts of Carthamus tinctorius.

7. The traditional Chinese medicine compound preparation for purging heat and relieving stagnation according to any one of claims 1-3, characterized in that, By weight, it also includes at least one of the following: 10-20 parts of Codonopsis pilosula, 10-20 parts of Atractylodes macrocephala, and 10-20 parts of Poria cocos.

8. The traditional Chinese medicine compound preparation for purging heat and relieving stagnation according to any one of claims 1-3, characterized in that, The drug also includes pharmaceutically acceptable excipients.

9. The method for preparing the traditional Chinese medicine compound preparation for purging heat and relieving stagnation according to any one of claims 1-3, characterized in that, When the compound preparation is a decoction, it includes the following steps: (1) Weigh each raw material according to the weight proportions, add water and soak for 20-50 minutes. The amount of water added should be 8-12 times the total mass of the raw materials. (2) First bring to a boil over high heat, then simmer over low heat for 25-40 minutes, and filter to obtain the first decoction and dregs; (3) Add water to the dregs, the amount of water being 6-10 times the total mass of the raw materials. Bring to a boil over high heat, then simmer over low heat for 15-30 minutes. Filter to obtain the second decoction. Combine the first and second decoctions. When the compound preparation is in granule form, the following steps are included: (1) Concentrate the decoction to a clear extract with a relative density of 1.10 (60℃); (2) Concentrate the clear paste under reduced pressure to a thick paste with a relative density of 1.20 (60℃); (3) Add excipients to the thick paste, mix evenly, and then spray dry to obtain dry paste powder; (4) Sift the dry powder, add lubricant, mix evenly, and then press into granules.

10. The use of the traditional Chinese medicine compound preparation for purging heat and relieving stagnation according to any one of claims 1-8 in the preparation of a drug for improving or treating systemic inflammatory response syndrome.

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