Instant single-component analgesic drug, preparation method and application thereof

Abstract

The application relates to the technical field of medicines, and particularly discloses a fast-acting single-component analgesic medicine, a preparation method and application thereof. The fast-acting single-component analgesic medicine can be quickly released after entering the stomach, has a relatively fast effect, and has an effect time reaching the level of an injection. For patients needing fast analgesia, the fast-acting single-component analgesic medicine can fully overcome various inconveniences of using an injection, and has a much faster effect speed after taking medicine than a commercially available dexketoprofen oral preparation, and has great value in clinical treatment.

Description

Technical Field

[0001] This application relates to the field of pharmaceutical technology, and more specifically, to a fast-acting single-ingredient analgesic drug, its preparation method, and its application. Background Technology

[0002] In modern healthcare, the development of analgesics remains a core topic at the intersection of medicinal chemistry and clinical medicine. Statistics show that approximately 1.5 billion people worldwide require drug intervention annually due to postoperative pain, traumatic pain, or chronic pain. Traditional nonsteroidal anti-inflammatory drugs (NSAIDs) work by inhibiting cyclooxygenase (COX), but pose gastrointestinal damage and cardiovascular risks; morphine-like opioids, while possessing potent analgesics, are accompanied by serious side effects such as addiction and respiratory depression. With the advancement of precision medicine, the clinical demand for novel analgesics that combine rapid onset of action, high safety, and targeted therapy is increasingly urgent. Especially in scenarios such as perioperative surgical management, emergency trauma care, and cancer pain control, the bioavailability of drug formulations, onset time, and suitability for administration directly affect treatment efficacy and patient safety.

[0003] The chemical name of dextrokeprofen is (+)-S-α-methyl-3-benzoyl-phenylacetic acid, which is the dextrorotatory enantiomer of ketoprofen. Ketoprofen is widely used clinically to treat various types of rheumatoid arthritis, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, gouty arthritis, as well as dysmenorrhea, toothache, postoperative pain, cancer pain, and acute renal colic. Currently, the most commonly used ketoprofen preparations in clinical practice include injections and oral formulations. Injections, due to their rapid peak concentration within 30 minutes, have become the standard medication in emergency departments and operating rooms. However, the practical application of injections is limited by contraindications to intravenous puncture (such as coagulation disorders and peripheral vascular disease) and the need for long-term medication. Therefore, the market demand for oral formulations is also continuously growing. Existing oral formulations, due to limitations in their manufacturing processes, exhibit a significant lag in drug release from the gastrointestinal tract.

[0004] Regarding the aforementioned technologies, the inventors believe that while dexketoprofen injections have a relatively fast effect, their use is subject to stringent conditions, requiring a comprehensive assessment based on the patient's current condition and past medical history. In contrast, while oral formulations have fewer restrictions, currently available commercially available oral dexketoprofen formulations have a slower onset of action, making it difficult to meet patients' needs for rapid pain relief. Summary of the Invention

[0005] In related technologies, currently available commercially available oral dexketoprofen formulations have a slow onset of action, making it difficult to meet patients' needs for rapid pain relief. To overcome this deficiency, this application provides a fast-acting single-agent analgesic drug, its preparation method, and its application.

[0006] In the first aspect, this application provides a fast-acting single-agent analgesic drug, which adopts the following technical solution: A fast-acting single-ingredient analgesic drug, comprising an analgesic active ingredient and pharmaceutical excipients, wherein the analgesic active ingredient is dexketoprofen or a pharmaceutically acceptable salt thereof, and the pharmaceutical excipients include a pH adjuster, wherein the pH adjuster is a pharmaceutically acceptable alkaline component; wherein the active ingredient content per tablet of the fast-acting single-ingredient analgesic drug is 50 mg based on the weight of dexketoprofen.

[0007] By adopting the above technical solution, this application limits the content of the analgesic active ingredient in the fast-acting single-agent analgesic drug and limits the pH adjuster in the pharmaceutical excipients to a pharmaceutically acceptable alkaline component. Under the dosage conditions specified in this application, the tablet can maintain a high content of the analgesic active ingredient for a long time during the drug release process, thereby maintaining a high concentration difference of the analgesic active ingredient between the tablet and the surrounding environment. Therefore, the release efficiency of the analgesic active ingredient is less affected by the drug release progress. The alkaline component added in this application can create an alkaline microenvironment in the local area around the tablet, reducing the obstacle caused by the environmental pH value to the dissolution process of the active ingredient. Under the synergistic effect of the alkaline component and the content of the active ingredient, the fast-acting single-agent analgesic drug of this application can rapidly release the analgesic active ingredient after administration. For patients who need rapid pain relief, taking the fast-acting single-agent analgesic drug of this application can fully overcome the various inconveniences of using injections, and the speed of action after administration is much faster than that of commercially available dexketoprofen oral preparations, achieving an analgesic effect similar to that of injections with lower risk. Furthermore, tablets prepared according to the method described in this application exhibit better stability, produce fewer impurities under high-temperature conditions, and have better storage stability, effectively reducing the loss of efficacy during storage and transportation.

[0008] Preferably, the pharmaceutically acceptable alkaline component is one of alkaline inorganic salts, inorganic bases, or organic bases.

[0009] Preferably, the organic base includes basic amino acids.

[0010] Preferably, the pharmaceutically acceptable alkaline component is one of tromethamine, sodium carbonate, disodium hydrogen phosphate, sodium citrate, arginine, sodium hydroxide, and calcium hydrogen phosphate.

[0011] By adopting the above technical solution, this application has selected pharmaceutically acceptable alkaline components. These alkaline components can create an alkaline microenvironment around the tablet, which can synergistically work with the analgesic active ingredient content specified in this application and, to a certain extent, help the rapid release of the analgesic active ingredient.

[0012] Preferably, the pharmaceutically acceptable alkaline component is sodium bicarbonate.

[0013] By adopting the above technical solution, among the aforementioned alkaline components, sodium bicarbonate can more effectively promote the rapid release of analgesic active ingredients compared to the other alkaline components.

[0014] Preferably, sodium bicarbonate accounts for 5-20 wt% of the raw material components of the fast-acting single-agent analgesic.

[0015] By adopting the above technical solution, this application has optimized the proportion of sodium bicarbonate, which helps to promote the rapid release of analgesic active ingredients.

[0016] Preferably, the pharmaceutical excipients also include fillers, binders, disintegrants, flow aids, fillers, and lubricants.

[0017] By employing the above-mentioned technical solutions, the filler can improve the compressibility of the drug, enabling the tablet to form a uniform and dense structure during compression. The binder can bind the components in the tablet together, thereby increasing the tablet's hardness and mechanical strength. The disintegrant can synergistically promote the release of the active ingredient within the tablet with the pH adjuster, facilitating drug absorption. The gliding agent can improve the flowability of the powder, allowing the material to be uniformly filled into the mold during tableting. The lubricant can reduce the friction between the tablet and the die wall, preventing the tablet from adhering to the die during compression and ensuring tablet integrity and appearance quality. Through the combination of the above-mentioned pharmaceutical excipients, analgesic active ingredients, and pH adjusters, the rapid-acting single-ingredient analgesic of this application not only possesses good molding properties and physical stability but also achieves rapid drug release in vivo, enabling emergency analgesia without injection.

[0018] Secondly, this application provides a method for preparing a fast-acting single-agent analgesic drug, using the following technical solution.

[0019] A method for preparing a fast-acting single-agent analgesic includes the following steps: (1) Divide the pharmaceutical excipients into two parts: internal excipients and external excipients, then crush and sieve them for later use; (2) Granulate the internal excipients, then mix the obtained granules with the analgesic active ingredient and external excipients, and put the resulting mixture into a tablet press to compress tablets to obtain a fast-acting single-ingredient analgesic drug.

[0020] By adopting the above technical solution, this application sequentially adds internal and external excipients to the analgesic active ingredient and pH adjuster, and obtains a fast-acting single-ingredient analgesic drug by dry pressing.

[0021] Thirdly, this application provides an application of a fast-acting single-agent analgesic drug, using the following technical solution.

[0022] The application of a fast-acting single-agent analgesic includes applying any of the above-described fast-acting single-agent analgesics in clinical situations requiring rapid pain relief, including postoperative analgesia.

[0023] By adopting the above technical solution, the fast-acting single-agent analgesic of this application can achieve rapid pain relief with an efficiency close to that of dextromethorphan injection, and the time to take effect is significantly shorter than that of commercially available oral dextromethorphan preparations. Moreover, it avoids the adverse reactions that may be caused by direct injection, and patients have a higher adaptability to this method of administration. It can effectively relieve patients' pain in clinical situations such as postoperative analgesia where patients need rapid pain relief.

[0024] In summary, this application has the following beneficial effects: 1. For patients who need rapid pain relief, taking the fast-acting single-agent analgesic drug of this application can fully overcome the various inconveniences of using injections, and the speed of action after taking the drug is much faster than that of commercially available dexketoprofen oral preparations, and can achieve analgesic effects similar to injections with lower risks.

[0025] 2. The tablets prepared according to the method of this application have good stability, produce fewer impurities under high temperature conditions, have good storage stability, and can effectively reduce the loss of efficacy during storage and transportation.

[0026] 3. This application preferentially uses pharmaceutically acceptable alkaline components, all of which can create an alkaline microenvironment. Simultaneously, crospovidone and low-substituted hydroxypropyl cellulose, both disintegrants, exhibit good water absorption and swelling properties, and their swelling has minimal negative impact on tablet hardness. Through the synergistic effect of the alkaline components and disintegrants, under the specifications defined in this application, the fast-acting single-agent analgesic readily releases its active ingredient, facilitating rapid analgesia. Detailed Implementation

[0027] The present application will be further described in detail below with reference to the embodiments, preparation examples and comparative examples. The raw materials involved in the present application can all be obtained commercially. Example

[0028] In the following examples (and comparative examples which are referenced in connection with the examples), when calculating the dosage, the weight of a single tablet of the fast-acting single-ingredient analgesic was ultimately made up to 400 mg by the filler (microcrystalline cellulose M101) in the internal excipients.

[0029] Example 1 This embodiment provides a fast-acting single-ingredient analgesic drug with a single tablet weighing 400mg. The prescription amount of raw material components and the amount of raw materials used to produce 2000 tablets are shown in Table 1.

[0030] Table 1. Raw material usage in Example 1 This embodiment provides a method for preparing a fast-acting single-agent analgesic, comprising the following steps: (1) Divide the pharmaceutical excipients into two parts: internal excipients and external excipients, then crush and sieve them for later use; (2) Granulate the internal excipients, then mix the obtained granules with dextromethorphan tromethamine and the pH adjuster, disintegrant, glidant and filler in the external excipients for 20 min, then add lubricant and mix for 7 min, and put the resulting mixture into a tablet press for tableting to obtain a fast-acting single-agent analgesic.

[0031] This embodiment also provides an application of a fast-acting single-agent analgesic, including applying the above-mentioned fast-acting single-agent analgesic to postoperative analgesia.

[0032] Example 2 The difference between this embodiment and Embodiment 1 is that the prescribed dosage of sodium bicarbonate is reduced from 30 mg to 20 mg.

[0033] Example 3 The difference between this embodiment and Embodiment 1 is that the dosage of sodium bicarbonate is increased from 30 mg to 40 mg.

[0034] Example 4 The difference between this embodiment and Embodiment 1 is that the dosage of sodium bicarbonate is increased from 30 mg to 60 mg.

[0035] Example 5 The difference between this embodiment and Embodiment 1 is that the prescribed dosage of sodium bicarbonate is increased from 30 mg to 80 mg.

[0036] Example 6 The difference between this embodiment and Embodiment 1 is that tromethamine is used as the pH adjuster.

[0037] Example 7 The difference between this embodiment and Embodiment 1 is that sodium carbonate is used as the pH adjuster.

[0038] Example 8 The difference between this embodiment and Embodiment 1 is that disodium hydrogen phosphate is used as the pH adjuster.

[0039] Example 9 The difference between this embodiment and Embodiment 1 is that sodium citrate is used as the pH adjuster.

[0040] Example 10 The difference between this embodiment and Embodiment 1 is that arginine is used as the pH adjuster.

[0041] Example 11 The difference between this embodiment and Embodiment 1 is that sodium hydroxide is used as the pH adjuster.

[0042] Example 12 The difference between this embodiment and Embodiment 1 is that the pH adjuster used is dicalcium phosphate.

[0043] Comparative Example Comparative Example 1 This comparative example provides a commercially available dextromethorphan tromethamine injection as a control, marketed as Enantyum, with a specification of 2ml:50mg (calculated as C16H14O3), manufactured by LABORATORIOS MENARINI SA.

[0044] Comparative Example 2 This comparative example provides a commercially available dextromethorphan tromethamine tablet as a control, marketed as Enantyum, with a strength of 25 mg (calculated as C16H14O3), manufactured by LABORATORIOS MENARINI SA.

[0045] Comparative Example 3 The difference between this comparative example and Example 1 is that the pH adjuster in the fast-acting single-ingredient analgesic is replaced with the same weight of microcrystalline cellulose M101.

[0046] Performance testing methods I. Related substances The determination was performed according to high performance liquid chromatography (Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter 0512).

[0047] Test solution: Accurately measure an appropriate amount of this product, dilute it with mobile phase A-mobile phase B (65:35) to prepare a solution containing approximately 1 mg of dextroprofen per 1 mL, shake well, and use it as the test solution.

[0048] Control solution: Accurately measure an appropriate amount of the test solution and quantitatively dilute it with mobile phase A-mobile phase B (65:35) to prepare a solution containing approximately 2 μg of dextroprofen per 1 mL, which is used as the control solution.

[0049] SL-0333+0335 reference solution: Take appropriate amounts of impurity SL-0333 and impurity SL-0335 reference standards, accurately weigh them, and dilute them with mobile phase A-mobile phase B (65:35) to prepare a solution containing approximately 2 μg of each of impurity SL-0333 and impurity SL-0335 reference standards per 1 mL, which is used as impurity SL-0333+0335 reference solution.

[0050] System suitability solution: Take appropriate amounts of dextromethorphan tromethamine reference standard, impurity SL-0333 reference standard, impurity SL-0334 reference standard, and impurity SL-0340 reference standard, dissolve and dilute them in mobile phase A-mobile phase B (65:35) to prepare a solution containing approximately 1 mg of dextromethorphan and approximately 5 μg of each of the impurities SL-0333, SL-0334, and SL-0340 per mL. This solution is used as the system suitability solution.

[0051] Sensitivity solution: Take an appropriate amount of dexketoprofen tromethamine reference standard, dilute it with mobile phase A-mobile phase B (65:35) to prepare a solution containing approximately 0.3 μg of dexketoprofen per 1 mL, which is used as the sensitivity solution.

[0052] Chromatographic conditions: Octylsilane-bonded silica gel was used as the packing material (Waters RP8 column, 250 mm × 4.6 mm × 5 μm, or a column with equivalent performance is recommended); mobile phase A was pH 3.5 phosphate buffer (1.56 g sodium dihydrogen phosphate dihydrate dissolved in water and diluted to 1000 mL, pH adjusted to 3.5 with phosphoric acid), and mobile phase B was acetonitrile. Gradient elution was performed according to the program in the table below; the flow rate was 1.0 mL per minute; the column temperature was 30 °C; the detection wavelength was 233 nm; and the injection volume was 20 μL.

[0053] The relationship between the proportion of mobile phase and time in this test is shown in Table 4.

[0054] Table 4 Relationship between mobile phase ratio and time Time / min Mobile phase A / % Mobile phase B / % 0 75 25 10 70 30 12 60 40 30 60 40 50 35 65 55 35 65 56 75 25 65 75 25 System suitability requirements: In the system suitability solution chromatogram, the resolution of the dextromethorphan peak, impurity SL-0333 peak, impurity SL-0334 peak, and impurity SL-0340 peak should all meet the requirements, and the theoretical plate number based on the dextromethorphan peak should not be less than 3000. In the sensitivity solution chromatogram, the signal-to-noise ratio of the highest peak of the main component should not be less than 20.

[0055] Determination method: Accurately measure the test solution, control solution and reference solution, inject them into the liquid chromatograph, record the chromatograms, and the final detection results are shown in Table 5.

[0056] II. Dissolution curve Dissolution and release were determined according to the method described in Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter 0931, Method I, with the basket method used for dissolution, a medium volume of 900 mL, a medium temperature of 37.0 ± 0.5 °C, and a rotation speed of 100 rpm.

[0057] Dissolution medium: Refer to the "Guidelines for the Determination and Comparison of Dissolution Curves of Common Oral Solid Dosage Forms", and the observation time points are 5 min, 10 min, 15 min, and 30 min.

[0058] pH 1.2 hydrochloric acid: Add 7 mL of hydrochloric acid to 1 L of water.

[0059] pH 6.8 phosphate (Chinese Pharmacopoeia): 0.94g sodium hydroxide + 6.8g potassium dihydrogen phosphate, add water to 1L.

[0060] Reference solution: Accurately weigh an appropriate amount of dexketoprofen tromethamine reference standard, dissolve and dilute it in the mobile phase to prepare a solution containing approximately 0.56 mg of dexketoprofen per mL, which will be used as the reference stock solution. Accurately transfer an appropriate amount of the reference stock solution and dilute it with dissolution medium to prepare a solution containing approximately 56 g of dexketoprofen per mL, which will be used as the reference solution.

[0061] Chromatographic conditions: Octadecylsilane-bonded silica gel was used as the packing material (Waters RP18 column, 150 mm × 4.6 mm × 3.5 μm, or a column with equivalent performance is recommended); the mobile phase was phosphate buffer (1.56 g of sodium dihydrogen phosphate dihydrate dissolved in water and diluted to 1000 mL, pH adjusted to 2.5 with phosphoric acid) - acetonitrile (57:43), with a flow rate of 1.0 mL per minute; the detection wavelength was 256 nm; and the injection volume was 20 μL.

[0062] System suitability requirements and testing methods: The dissolution amount per tablet was calculated by peak area using the external standard method. The results obtained under pH 1.2 conditions are shown in Table 6, and the results obtained under pH 6.8 conditions are shown in Table 7.

[0063] III. Clinical Data The test subjects were the dexketoprofen tromethamine tablets (50mg, product code T1), dexketoprofen tromethamine oral solution (10mL:50mg, product code T2), and dexketoprofen tromethamine injection (2ml:50mg, product code: Fenni) from Example 1. (R), pharmacokinetics were tested in healthy subjects to evaluate the bioequivalence of the three formulations in fasting and postprandial states. The results of blood drug concentration tests in the fasting state are shown in Table 8, and the summary results of pharmacokinetic parameters are shown in Table 9; the results of blood drug concentration tests in the postprandial state are shown in Table 10, and the summary results of pharmacokinetic parameters are shown in Table 11.

[0064] Table 5 Stability Data Table Table 6 Dissolution data (pH 1.2) Table 7 Dissolution data (pH 6.8) Table 8. Blood drug concentration-time relationship (fasting) Table 9 Pharmacokinetic parameters (fasting) parameter T1 T2 R Lambda_z(1 / h) 0.245 0.353 0.277 HL_Lambda_z(h) 2.83 1.96 2.5 <![CDATA[T max (h)]]> 0.33 0.33 0.5 <![CDATA[C max (ng / mL)]]> 1500 13700 14100 <![CDATA[AUC last (mg / mL)]]> 16674.25 17149.9 16672.2 <![CDATA[AUC INF_obs (mg / mL)]]> 16845.53 17263.96 16814.09 <![CDATA[AUC_% Extrap_obs (%)]]> 1.02 0.66 0.84 Vz_F_obs(mL) 12104.6 8197.14 10736.4 Cl_F_obs(mL / h) 2968.15 2896.21 2973.7 <![CDATA[MRT INF_obs (h)]]> 1.83 1.75 1.87 Table 10 Blood drug concentration-time relationship (postprandial) Table 11 Pharmacokinetic Parameters (Postprandial) parameter T1 T2 R Lambda_z(1 / h) 0.256 0.382 0.250 HL_Lambda_z(h) 2.71 1.82 2.77 <![CDATA[T max (h)]]> 0.33 3.50 0.50 <![CDATA[C max (ng / mL)]]> 8410 2440 8760 <![CDATA[AUC last (mg / mL)]]> 10738.36 10005.34 10676.89 <![CDATA[AUC INF_obs (mg / mL)]]> 10816.60 10155.18 10754.04 <![CDATA[AUC_% Extrap_obs (%)]]> 0.72 1.48 0.72 <![CDATA[MRT INF_obs (h)]]> 1.63 4.27 1.28 As can be seen from Examples 1-12 and Comparative Examples 1-2, and Table 5, the fast-acting single-agent analgesics of Examples 1-12 produced significantly fewer impurities after being stored at 60°C for 15 days. This indicates that the coated tablets prepared according to the method of this application have better stability, produce fewer impurities under high temperature conditions, have better storage stability, and can effectively reduce the loss of efficacy during storage and transportation.

[0065] Combining Examples 1-12 and Comparative Examples 1-2 with Tables 6-7, it can be seen that the dissolution rate measured in Examples 1-12 reaches over 90% within 15 minutes and is almost completely released within 20 minutes. The efficiency of releasing the active ingredient, dexketoprofen tromethamine, is far higher than that of commercially available dexketoprofen tromethamine coated tablets. Commercially available dexketoprofen tromethamine injections typically reach peak concentration within 20 minutes. Therefore, the rapid-acting single-agent analgesic of this application is sufficient to replace dexketoprofen tromethamine injection in clinical situations requiring emergency analgesia, and is particularly suitable for patients who cannot receive injections, demonstrating significant value in clinical treatment.

[0066] Based on Examples 1-12 and Comparative Example 3, and in conjunction with Tables 6-7, it can be seen that in the absence of a pH adjuster, the active ingredient of the fast-acting single-acid analgesic is difficult to be fully released within 30 minutes in either a strongly acidic environment (pH 1.2) or a slightly acidic environment (pH 6.8), resulting in an inability to achieve the same effective time as the injection solution.

[0067] As can be seen from Examples 2-5 and Tables 6-7, when the proportion of sodium bicarbonate in the raw material components of fast-acting single-ingredient analgesics is 5-20 wt%, both dexketoprofen and tromethamine can achieve rapid release.

[0068] As can be seen from Examples 6-12 and Tables 6-7, when the pH adjuster is any one of tromethamine, sodium carbonate, disodium hydrogen phosphate, sodium citrate, arginine, sodium hydroxide, or calcium hydrogen phosphate, although the release effect varies when different pH adjusters are added, all of them can achieve rapid release of dexketoprofen tromethamine.

[0069] As can be seen from the data in Table 8-11, the dexketoprofen tromethamine tablets prepared in this application have similar pharmacokinetic parameters to the commercially available dexketoprofen tromethamine injection. The trends and ranges of blood drug concentration changes are similar to those of dexketoprofen tromethamine injection, and the results measured under fasting and postprandial conditions are not significantly different. In contrast, the results for dexketoprofen tromethamine oral solution show a greater difference, and the peak blood drug concentration is lower. The time to reach the peak concentration also differs significantly from that of dexketoprofen tromethamine tablets and dexketoprofen tromethamine injection. This indicates that the dexketoprofen tromethamine tablets of this application can effectively replace dexketoprofen tromethamine injection in clinical treatment.

[0070] The above embodiments are merely explanations of this application and are not intended to limit it. After reading this specification, those skilled in the art can make modifications to the embodiments of this application without contributing any inventive step, but such modifications are protected by patent law as long as they are within the scope of the claims of this application.

Claims

1. A fast-acting single-ingredient analgesic, characterized in that, The components of the fast-acting single-ingredient analgesic include an analgesic active ingredient and pharmaceutical excipients. The analgesic active ingredient is dexketoprofen or a pharmaceutically acceptable salt thereof. The pharmaceutical excipients include a pH adjuster, which is a pharmaceutically acceptable alkaline component. In the fast-acting single-ingredient analgesic, the active ingredient content per tablet is 50 mg based on the weight of dexketoprofen.

2. The fast-acting single-agent analgesic drug according to claim 1, characterized in that, The pharmaceutically acceptable alkaline component is one of the following: alkaline inorganic salt, inorganic base, or organic base.

3. The fast-acting single-agent analgesic drug according to claim 2, characterized in that, The organic base includes basic amino acids.

4. The fast-acting single-agent analgesic drug according to claim 3, characterized in that, The pharmaceutically acceptable alkaline component is one of the following: tromethamine, sodium carbonate, disodium hydrogen phosphate, sodium citrate, arginine, sodium hydroxide, and calcium hydrogen phosphate.

5. The fast-acting single-agent analgesic drug according to claim 4, characterized in that, The pharmaceutically acceptable alkaline component is sodium bicarbonate.

6. The fast-acting single-agent analgesic drug according to claim 5, characterized in that, The proportion of sodium bicarbonate in the raw material components of the aforementioned fast-acting single-agent analgesic drug is 5-20 wt%.

7. The fast-acting single-agent analgesic drug according to claim 1, characterized in that, The pharmaceutical excipients also include fillers, binders, disintegrants, flow aids, fillers, and lubricants.

8. The method for preparing a fast-acting single-agent analgesic according to any one of claims 1-7, characterized in that, Includes the following steps: (1) Divide the pharmaceutical excipients into two parts: internal excipients and external excipients, then crush and sieve them for later use; (2) Granulate the internal excipients, then mix the obtained granules with the analgesic active ingredient and external excipients, and put the resulting mixture into a tablet press to compress tablets to obtain a fast-acting single-ingredient analgesic drug.

9. The application of a fast-acting single-ingredient analgesic, characterized in that, This includes applying the fast-acting single-agent analgesic drug according to any one of claims 1-7 in clinical situations where patients require rapid pain relief, including postoperative analgesia.

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