CN115192597A - Pharmaceutical composition for preventing and treating pulmonary hypertension, preparation method and application thereof - Google Patents
Pharmaceutical composition for preventing and treating pulmonary hypertension, preparation method and application thereof Download PDFInfo
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- CN115192597A CN115192597A CN202210945935.1A CN202210945935A CN115192597A CN 115192597 A CN115192597 A CN 115192597A CN 202210945935 A CN202210945935 A CN 202210945935A CN 115192597 A CN115192597 A CN 115192597A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7032—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a polyol, i.e. compounds having two or more free or esterified hydroxy groups, including the hydroxy group involved in the glycosidic linkage, e.g. monoglucosyldiacylglycerides, lactobionic acid, gangliosides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Abstract
The invention relates to a pharmaceutical composition, in particular to a pharmaceutical composition for preventing and treating pulmonary hypertension, a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. A pharmaceutical composition for preventing and treating pulmonary hypertension is prepared from active components and pharmaceutically acceptable auxiliary materials, wherein the active components account for 0.1-99% of the total weight of the pharmaceutical composition, and are prepared by mixing gallic acid, vanillic acid, p-coumaric acid, caffeic acid, ferulic acid, salidroside, eriodictyol, kaempferol, quercetin, isoquercitrin, epicatechin and luteolin, wherein the mass ratio of the gallic acid, vanillic acid, p-coumaric acid, caffeic acid, ferulic acid, salidroside, eriodictyol, kaempferol, quercetin, isoquercitrin, epicatechin and luteolin is 27:26:4:2:1:48:4:22:7:6:15:7.
Description
Technical Field
The invention relates to a pharmaceutical composition, in particular to a pharmaceutical composition for preventing and treating pulmonary hypertension, a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions.
Background
Pulmonary Arterial Hypertension (PAH) is a group of diseases or clinical syndromes characterized by elevated pulmonary arterial pressure and pulmonary vascular resistance due to different etiologies, the pathogenesis of which includes vasoconstriction, vascular remodeling and thrombosis. The classification system proposed by the international primary pulmonary hypertension workshop classifies pulmonary hypertension into 5 types: 1) pulmonary hypertension associated with respiratory diseases and/or hypoxemia; 2) Pulmonary venous hypertension; 3) Chronic thrombotic and/or embolic disease; 4) Pulmonary arteriolar hypertension; 5) Directly affects pulmonary hypertension caused by pulmonary vascular tissue diseases. If PAH is left untreated, it can eventually lead to right heart failure, increased volume loading and death. At present, drugs for treating pulmonary hypertension are mainly vasodilators, such as alpha receptor blockers, calcium antagonists angiotensin converting enzyme inhibitors, phosphodiesterase inhibitors, prostanoid (PG) drugs, nitro vasodilators, and the like. These drugs have the effects of improving dyspnea, 6 minute walk distance (6 MWD), pulmonary hemodynamics, etc. of patients, but have different drawbacks in terms of therapeutic effects, preparation and administration costs, and convenience of treatment.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition for preventing and treating pulmonary hypertension, which is prepared from a group of traditional Chinese medicine active ingredients in a fixed weight ratio and can be used for remarkably reducing the pulmonary hypertension caused by hypoxia.
The technical scheme adopted by the invention for solving the technical problems is as follows:
a pharmaceutical composition for preventing and treating pulmonary hypertension is prepared from active components and pharmaceutically acceptable auxiliary materials, wherein the active components account for 0.1-99% of the total weight of the pharmaceutical composition, and are prepared by mixing gallic acid, vanillic acid, p-coumaric acid, caffeic acid, ferulic acid, salidroside, eriodictyol, kaempferol, quercetin, isoquercitrin, epicatechin, and luteolin, wherein the mass ratio of gallic acid, vanillic acid, p-coumaric acid, caffeic acid, ferulic acid, salidroside, eriodictyol, kaempferol, quercetin, isoquercitrin, epicatechin, and luteolin is 27:26:4:2:1:48:4:22:7:6:15:7.
the composition containing the chemical components with different structural types is designed based on the multi-component-multi-target characteristic of the traditional Chinese medicine, and experiments prove that the pulmonary hypertension caused by low oxygen can be remarkably reduced, the preparation method of the pharmaceutical preparation is simple and convenient, the medication cost is low, and the treatment convenience of the pulmonary hypertension is improved.
The dose of the pharmaceutical composition to be administered depends on many factors such as the nature and severity of the disease to be prevented or treated, the sex, age, body weight, character and individual response of the patient or animal, the administration route, the number of administrations, the therapeutic purpose, and thus the therapeutic dose may vary widely from 0.1mg/kg to 300mg/kg.
The pharmaceutical composition can be taken alone or in combination with other therapeutic or symptomatic drugs and adjusted in dosage. For administration purposes, to enhance the therapeutic effect, administration can be carried out by any known method of administration.
Preferably, the route of administration of the pharmaceutical composition is gastrointestinal or pulmonary, nasal, subcutaneous, sublingual, dermal, muscular, rectal. Preferably, the pharmaceutical composition is administered orally.
Preferably, the pharmaceutical composition is administered in a solid, semi-solid or liquid form. Further, the solid dosage form is powder, pellet, dripping pill, granule, capsule, tablet, suppository, pellicle, patch, gas or powder spray, or spray; semisolid dosage forms are ointments, gels or pastes; the liquid dosage form is a solution, emulsion, suspension, injection, eye drop, nasal drop, lotion or liniment. The capsule includes hard capsule, soft capsule, and enteric capsule; the tablet comprises common tablet, enteric coated tablet, buccal tablet, dispersible tablet, chewable tablet, effervescent tablet, and orally disintegrating tablet.
Preferably, the pharmaceutical composition can be prepared into common preparations, sustained release preparations, controlled release preparations, targeting preparations and various microparticle delivery systems.
A preparation method of the pharmaceutical composition comprises the steps of mixing the active ingredients with pharmaceutically acceptable auxiliary materials, and preparing into powder, pills, granules, capsules, tablets or liquid preparations.
The therapeutic dose may be between 0.1mg/kg and 300mg/kg.
The invention has the beneficial effects that: the pharmaceutical composition for preventing and treating pulmonary hypertension consists of a group of traditional Chinese medicine effective components in a fixed weight ratio, can obviously reduce pulmonary hypertension and pulmonary vessel remodeling caused by hypoxia, has the same effect as that of a clinical drug sildenafil, is simple and convenient in preparation method and low in medication cost, and improves the treatment convenience of pulmonary hypertension.
Drawings
FIG. 1 is a graph of the effect of a pharmaceutical composition on the mean pulmonary arterial pressure (mPAP) and right ventricular remodeling in HAPH rats, where A is the effect of the pharmaceutical composition on the mean pulmonary arterial pressure (mPAP) in HAPH rats and B is the effect of the pharmaceutical composition on the right ventricular remodeling in HAPH rats;
FIG. 2 is the results of the effect of hypoxia on pulmonary arteriole vascular remodeling, where A is the HE staining of pulmonary vessels in rats in each group, B is the effect of the pharmaceutical composition on the percent of pulmonary vessel wall area (WA%) in HAPH rats, and C is the effect of the pharmaceutical composition on the percent of pulmonary vessel wall thickness (WT%) in HAPH rats.
Detailed Description
The technical solution of the present invention will be further specifically described below by way of specific examples. It is to be understood that the practice of the invention is not limited to the following examples, and that any variations and/or modifications may be made thereto without departing from the scope of the invention.
In the present invention, all parts and percentages are by weight, unless otherwise specified, and the equipment and materials used are commercially available or commonly used in the art. The methods in the following examples are conventional in the art unless otherwise specified.
Example 1
A pharmaceutical composition for preventing and treating pulmonary hypertension is prepared from an active component and pharmaceutically acceptable auxiliary materials, wherein the active component accounts for 1% of the total weight of the pharmaceutical composition, and the preparation method of the pharmaceutical composition comprises the following steps:
(1) Preparation of active ingredients:
according to the mass ratio of 27:26:4:2:1:48:4:22:7:6:15: weighing gallic acid, vanillic acid, p-coumaric acid, caffeic acid, ferulic acid, salidroside, eriodictyol, kaempferol, quercetin, isoquercitrin, epicatechin, and luteolin, and mixing for use.
(2) Precisely weighing 1g of the composition powder, adding 100mL of 0.5% sodium carboxymethylcellulose solution, and performing ultrasonic treatment for 15min to obtain a suspension with a drug content of 1% (g/mL).
Pharmacological activity test of application example
Experimental animals: healthy male Sprague-Dawley (SD) rats, purchased from the animal experiment center of the university of Xian traffic (the experimental animals use license number SCXK (shan) 2017-003), 6-8 weeks old and 250-300g in weight.
An experimental instrument: an electron balance: SHANGPING (YP 601N), biopac polygraph, roller slicer (come card-2016, germany); TSJ-II type fully automatic closed tissue dehydrator (Wien electronics Co., ltd., changzhou city); BMJ-III type embedding machine (Wei electronics, inc. in the suburbs of Changzhou); PHY-III type bleaching and baking instrument for pathological tissues (Wei electronic instruments, inc. in Changzhou city); a Digital trinocular imaging microscope (BA 400 Digital, mcondi industry group ltd), etc.; image analysis software Motic Images Advanced.
The pulmonary hypertension model replicates SD rats and is randomly grouped into 6 groups, which are respectively: (1) normal control group (Ctr): rats were anesthetized with 20% urethane abdominal cavity (0.5 mL/0.1 kg) on the same day and pulmonary artery pressure was measured, the thoracic cavity was opened after supine fixation, the heart and lung were quickly removed, and the sample was taken and left; (2) hypoxic control group (Hyp): the rat is placed in a low-pressure oxygen chamber for feeding (with the altitude of 5000 meters) for 30 days, and a rat HPH model is copied; (3) hypoxic administration pharmaceutical combination suspension (Hyp + mixed): after hypoxic exposure in rats, the rats were administered daily by gavage (suspension of the pharmaceutical composition obtained in example 1) at a dose of 25mg/kg (Hyp + mixed-L) and 50mg/kg (Hyp + mixed-H) of the composition, respectively, for 28 consecutive days; (4) positive drug control group (Hyp + Sildenafil): sildenafil was administered daily by gavage at a dose of 30mg/kg for 28 consecutive days after hypoxic exposure in rats.
Right ventricular systolic pressure was measured by catheterization: after 28 days, the rats were anesthetized with urethane (1 g/kg), fixed on an operating table, the right external jugular vein was isolated, the distal end was ligated, the proximal end was blocked with an arterial clamp, and the right jugular vein was cannulated using a polyethylene catheter (filled with 0.5% heparin solution) to connect a pressure transducer and a physiological recorder. After the catheter enters the blood vessel, the catheter is slowly pushed, the display of the recorder is observed at the same time, after the right ventricular artery pressure curve is displayed, the catheter is fixed, and the 30s pressure curve is recorded. Right-ventricular systole pressure (RVSP) was calculated by the recorder analysis software.
Measurement of right ventricular hypertrophy index: after the measurement of mean pulmonary artery pressure (mPAP) mPAP, the rat thorax was cut open immediately, and the catheter position was determined in the right ventricle, the heart was removed, the left and right atrial tissues were cut off, and the right ventricular tissue was cut off along the ventricular septal border and weighed separately. And (4) calculating the ratio of the right ventricle to the left ventricle plus the ventricular interval (RV/LV + S) so as to determine whether the right ventricle is hypertrophied or not.
Tissue sampling and fixing: lung small blood vessel remodeling observation and image processing, fixing the left lung tissue of a rat by neutral buffered formalin, embedding a section by paraffin, HE staining, and observing the pulmonary small blood vessel remodeling condition under a light microscope. The pulmonary artery with a diameter of about 100 μm is taken, morphometric analysis is carried out by an image analysis system, and the pulmonary artery reconstruction of the rat is evaluated by calculating the percentage of the vessel wall area (the percentage of wall area, WA%) and the percentage of the vessel wall thickness (WT%) of the arterioles in the lung according to the ratio (WT%) of the vessel wall cross-sectional area to the vessel cross-sectional area.
Statistical analysis: the results of the experiment are expressed as mean ± standard deviation (mean ± SEM), and the data are analyzed using SPSS 27.0 software. Differences between groups were analyzed using One-way ANOVA with statistical differences of P < 0.05.
The experimental results are as follows:
effect on HAPH rat mean pulmonary artery pressure (mPAP) and right ventricular remodeling: compared with a normal control group (Ctr), mPAP of the hypoxia control group (Hyp) rats is obviously increased (P is less than 0.05), which indicates that the hypoxia pulmonary hypertension rats are successfully modeled. As shown in FIG. 1A, mPAP of rats in the drug group (Hyp + mixed,25mg/kg, 50 mg/kg) was significantly reduced (P < 0.05) and superior to that in the sildenafil group, compared to the model control group. Meanwhile, compared with the normal control group (Ctr), the right ventricular hypertrophy index (RV/LV + S) of the rat with the hypoxic control group (Hyp) is obviously increased (P is less than 0.05), which indicates that the right ventricle of the rat with the hypoxic pulmonary hypertension is obviously reconstructed. As shown in FIG. 1B, the right ventricular hypertrophy index (RV/LV + S) of rats in the drug group (Hyp + mixed,25mg/kg, 50 mg/kg) was significantly reduced (P < 0.05) compared to the model control group, and was not statistically different from that in the sildenafil group. The low and high doses (25 mg/kg and 50 mg/kg) of the pharmaceutical composition can obviously reduce the right ventricular remodeling caused by hypoxia.
The effect on pulmonary arteriole vascular remodeling due to hypoxia is shown in figure 2. As shown in fig. 2A, the pulmonary artery vessel wall of the rats in the hypoxic control group (Hyp) WAs significantly thickened, and the vessel wall area percentage WA% and the vessel wall thickness percentage WT% of the arterioles in the lung were significantly increased (P < 0.05) compared to the normal control group (Ctr), which indicates that the pulse vessels of the rats with hypoxic pulmonary hypertension were significantly reconstructed. As shown in FIGS. 2B and C, the WA% and WT% of pulmonary arterioles in the drug group (Hyp + mixed,25mg/kg, 50 mg/kg) were significantly reduced compared to the model control group (P < 0.05). The pharmaceutical composition suspension provided by the invention can obviously inhibit pulmonary arteriolar vascular remodeling.
Therefore, the composition has the effect of remarkably reducing the pulmonary artery pressure and can remarkably inhibit the reconstruction of pulmonary vessels. Under the administration dosage of 25mg/kg and 50mg/kg, the intervention effect on pulmonary artery pressure and pulmonary vascular remodeling has no significant difference compared with the clinical drug sildenafil (30 mg/kg), which indicates that the composition has equivalent drug effect with the current clinical drug. Can be used for preventing and treating pulmonary hypertension.
The embodiments are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same or similar parts among the embodiments are referred to each other. For the embodiment, because the method corresponds to the method disclosed in the embodiment, the description is simple, and the relevant points can be referred to the method part for description.
The pharmaceutical composition for preventing and treating pulmonary hypertension, the preparation method and the application thereof provided by the invention are described in detail above. The principles and embodiments of the present invention are explained herein using specific examples, which are presented only to assist in understanding the method and its core concepts. It should be noted that, for those skilled in the art, it is possible to make various improvements and modifications to the present invention without departing from the principle of the present invention, and those improvements and modifications also fall within the scope of the claims of the present invention.
Claims (6)
1. A pharmaceutical composition for preventing and treating pulmonary hypertension is prepared from an active component and pharmaceutically acceptable auxiliary materials, and is characterized in that: the active component accounts for 0.1-99% of the total weight of the pharmaceutical composition, and is formed by mixing gallic acid, vanillic acid, p-coumaric acid, caffeic acid, ferulic acid, salidroside, eriodictyol, kaempferol, quercetin, isoquercitrin, epicatechin and luteolin, wherein the mass ratio of the gallic acid, vanillic acid, p-coumaric acid, caffeic acid, ferulic acid, salidroside, eriodictyol, kaempferol, quercetin, isoquercitrin, epicatechin and luteolin is 27:26:4:2:1:48:4:22:7:6:15:7.
2. the pharmaceutical composition for the prevention and treatment of pulmonary hypertension according to claim 1, wherein: the administration route of the pharmaceutical composition is gastrointestinal tract or pulmonary, nasal cavity, subcutaneous, sublingual, skin, muscle, rectum.
3. The pharmaceutical composition for the prevention and treatment of pulmonary hypertension according to claim 1, characterized in that: the pharmaceutical composition is administered orally.
4. The pharmaceutical composition for the prevention and treatment of pulmonary hypertension according to claim 1, characterized in that: the administration form of the pharmaceutical composition is a solid form, a semi-solid form or a liquid form.
5. The pharmaceutical composition for the prevention and treatment of pulmonary hypertension according to claim 1, characterized in that: the solid dosage form is powder, pellet, dripping pill, granule, capsule, tablet, suppository, pellicle, patch, gas or powder spray, or spray; semisolid dosage forms are ointments, gels or pastes; the liquid dosage form is a solution, emulsion, suspension, injection, eye drop, nasal drop, lotion or liniment.
6. A process for preparing a pharmaceutical composition according to claim 1, characterized in that: mixing the active components with pharmaceutically acceptable adjuvants, and making into powder, pill, granule, capsule, tablet or liquid preparation.
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Cited By (1)
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|---|---|---|---|---|
| CN115998789A (en) * | 2023-01-16 | 2023-04-25 | 青海民族大学 | Application of Tibetan medicine caragana with arrow in preparation of pulmonary arterial hypertension medicine |
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