A kind of medical grade vaseline and preparation method thereof

Abstract

The present invention relates to the technical field of vaseline preparation, and specifically discloses a pharmaceutical-grade vaseline and a preparation method thereof. A preparation method of pharmaceutical-grade vaseline, comprising hydrogenation refining, degassing and deodorization, product adjustment and three-stage filtration, wherein the product adjustment is by adding an appropriate amount of a product regulator composed of gelatin, microcrystalline cellulose, sucrose stearate and lanolin alcohol, and the mass ratio of gelatin, microcrystalline cellulose, sucrose stearate and lanolin alcohol is 1: (0.8~1.2): (0.5~0.8): (0.1~0.5). The present application realizes precise control of the dropping point and cone penetration of pharmaceutical-grade vaseline through a specific product regulator, thereby obtaining pharmaceutical-grade vaseline with excellent stability and use effect.

Description

Technical Field

[0001] The invention relates to the technical field of vaseline preparation, in particular to pharmaceutical grade vaseline and a preparation method thereof. Background Art

[0002] With the rapid development of the pharmaceutical industry, the demand for pharmaceutical-grade vaseline continues to increase. As an important basic material in the pharmaceutical industry, vaseline is widely used in medical devices, such as medical vaseline gauze or gauze strips, mainly used for general wound dressings and skin care. The quality stability and use effect of pharmaceutical-grade vaseline are crucial to ensure the safety and effectiveness of drugs and medical devices. Among them, the consistency of vaseline directly affects its use effect. At present, the consistency of pharmaceutical-grade vaseline is mainly evaluated by two parameters: dropping point and cone penetration. The dropping point reflects its stability at high temperatures, while the cone penetration affects the convenience of application and the coverage effect.

[0003] At present, adjusting the consistency of pharmaceutical-grade vaseline mainly depends on the selection of raw materials and the control of parameters such as temperature and pressure during processing. However, this method has problems such as limited adjustment range and poor stability, and it is difficult to adjust the consistency of pharmaceutical-grade vaseline to an ideal range, resulting in the quality of the produced pharmaceutical-grade vaseline being not stable enough and may not meet the needs of the pharmaceutical industry. Therefore, it is very important to develop a method that can further adjust the consistency in the later stage of pharmaceutical-grade vaseline preparation to ensure the stability of the quality of pharmaceutical-grade vaseline. Summary of the invention

[0004] In order to better adjust the consistency of pharmaceutical-grade vaseline and obtain pharmaceutical-grade vaseline with better use effect, the present application provides a pharmaceutical-grade vaseline and a preparation method thereof. The present application provides a novel preparation method of pharmaceutical-grade vaseline, which achieves precise control of the consistency of pharmaceutical-grade vaseline within a certain range through a specific product regulator, thereby obtaining pharmaceutical-grade vaseline with excellent stability and use effect, and meeting the demand of the pharmaceutical industry for high-quality vaseline.

[0005] In the first aspect, the present application provides a method for preparing pharmaceutical grade vaseline using the following technical solution:

[0006] Step 1, hydrogenation refining: mixing the basic raw materials for preparing vaseline, and refining them by using a series hydrogenation refining process;

[0007] Step 2: Degassing and deodorizing: Separate the gas and liquid of the vaseline obtained in step 1, and deodorize it in vacuum;

[0008] Step 3, product adjustment: cool the vaseline obtained in step 2 to 70-80° C., add an appropriate amount of a product adjuster consisting of gelatin, microcrystalline cellulose, sucrose stearate and lanolin alcohol, wherein the mass ratio of the gelatin, microcrystalline cellulose, sucrose stearate and lanolin alcohol is 1:(0.8-1.2):(0.5-0.8):(0.1-0.5);

[0009] Step 4: The vaseline obtained in step 3 is filtered through three stages to obtain medical grade vaseline.

[0010] In the above technical scheme, this application adopts a series hydrogenation refining process to remove sulfides, nitrides, oxides, polycyclic aromatic hydrocarbons and other components in vaseline to improve the purity and stability of vaseline; vaseline is further purified by degassing and deodorization to enhance its stability. By adding a certain amount of product regulators such as gelatin, microcrystalline cellulose, sucrose stearate and lanolin alcohol, a three-dimensional spatial structure is formed inside the vaseline to construct a stable structural dispersion, further improving the consistency and performance of vaseline; in addition, the combination of these ingredients can also adjust the use experience of vaseline, reduce its stickiness and stuffy feeling, and make vaseline smoother and more refreshing when used; by finely filtering vaseline, tiny impurities and particles are removed to ensure the purity and safety of medical grade vaseline and the excellent quality of the final product.

[0011] Preferably, the preparation method of the product regulator is as follows: heat gelatin to 65-80° C., add microcrystalline cellulose, sucrose stearate and lanolin alcohol, and stir until mixed evenly to obtain the product regulator.

[0012] In the above technical solution, the present application mixes gelatin with microcrystalline cellulose, sucrose stearate and lanolin alcohol at a specific temperature to ensure that the components are fully and evenly mixed to form a stable product regulator. Such a preparation method can ensure the uniformity of the distribution of the components in the product regulator, and then when added to vaseline, it can more evenly play its role in adjusting the consistency, thereby improving the quality stability and use effect of medical grade vaseline.

[0013] Preferably, the tandem hydrogenation refining process of step 1 refers to mixing the basic raw material of vaseline with hydrogen, passing it through a first-stage catalyst bed filled with a refining catalyst to complete desulfurization, denitrogenation and deoxygenation reactions, and then passing the vaseline that has completed the first-stage reaction through a second-stage catalyst bed filled with a refining catalyst to complete the vaseline refining process for removing polycyclic aromatic hydrocarbons.

[0014] In the above technical scheme, the present application realizes the effective removal of impurities in the vaseline basic raw material through a specific refining catalyst and a hydrogenation refining process, thereby improving the purity and stability of vaseline.

[0015] Preferably, the active metal components of the refined catalyst are composed of W, Co, Mo, and Ni, and the carrier of the refined catalyst is Al2O3.

[0016] In the above technical scheme, the present application achieves effective purification of vaseline by fully and completely reacting the active metal components of the refined catalyst and the carrier selection, as well as two different operating conditions with the impurities in vaseline.

[0017] Preferably, the first stage operating conditions are: reaction temperature 320-360°C, reaction pressure 12-16 MPa, volume space velocity 0.1-0.5 h -1 , hydrogen-oil volume ratio 1: (400-800); the second stage operating conditions are: reaction temperature 200-280°C, reaction pressure 12-16MPa, volume space velocity 0.1-0.5h -1 , hydrogen-oil volume ratio 1:(400~800).

[0018] In the above technical scheme, the present application accurately controls the operating conditions of the two-stage hydrofining process to ensure that the refined catalyst can fully play its role under the appropriate temperature, pressure and hydrogen-to-oil ratio, and effectively remove the impurities such as sulfides, nitrides, oxides and polycyclic aromatic hydrocarbons in the vaseline base raw material. The first stage operating conditions are mainly aimed at the removal of impurities. Through higher temperature and pressure, and appropriate hydrogen-to-oil ratio, the refined catalyst and impurities are fully reacted to improve the purity of vaseline; the second stage operating conditions focus on the removal of polycyclic aromatic hydrocarbons. Through lower temperature and appropriate hydrogen-to-oil ratio, it is ensured that polycyclic aromatic hydrocarbons can be effectively removed, further improving the stability and use effect of vaseline.

[0019] Preferably, the basic raw materials for preparing vaseline in step 1 include petroleum lubricating oil and petroleum wax paste, and the mass ratio of the petroleum lubricating oil to the petroleum wax paste is (60-80): (20-30).

[0020] In the above technical scheme, the present application selects petroleum lubricating oil and petroleum wax paste as the basic raw materials for preparing vaseline, and controls their mass ratio to ensure the basic quality of vaseline. Petroleum lubricating oil and petroleum wax paste are mixed at a specific mass ratio, which not only provides a good raw material basis for the preparation of vaseline, but also can form an ideal consistency and performance in the subsequent processing. At the same time, by accurately proportioning the basic raw materials, the stability and use effect of vaseline can be further improved, meeting the demand of the pharmaceutical industry for high-quality vaseline.

[0021] Preferably, the amount of the product regulator added in step 3 is 0.5% to 5% of the mass percentage of vaseline.

[0022] In the above technical scheme, the application controls the amount of product regulator added, and the amount of product regulator added is set to 0.5% to 5% of the mass percentage of vaseline. The amount added within this range can achieve effective regulation of the consistency of vaseline, while ensuring the quality stability and safety of vaseline. The product regulator added in an appropriate amount can form evenly distributed tiny particles in vaseline, and effectively regulate the consistency of vaseline by changing the molecular structure and interaction force inside vaseline. At the same time, the addition of product regulators can also improve the lubricity and ductility of vaseline, and improve its performance and comfort. By accurately controlling the amount of product regulator added, the application can prepare pharmaceutical-grade vaseline with excellent stability and use effect, meeting the demand of the pharmaceutical industry for high-quality vaseline.

[0023] In the second aspect, the present application provides a pharmaceutical grade vaseline using the following technical solution:

[0024] A pharmaceutical grade vaseline is prepared by the preparation method of the pharmaceutical grade vaseline as described in the first aspect.

[0025] In the above technical scheme, the present application effectively removes impurities and harmful substances in vaseline through steps such as serial hydrogenation refining process and fine filtration, thereby improving the purity and safety of the product. At the same time, by adding a product regulator of a specific ratio, accurate regulation of the consistency of vaseline is achieved, and pharmaceutical grade vaseline with excellent stability and use effect is prepared. The pharmaceutical grade vaseline of the present application not only has adjustable consistency, but also has stability at high temperature and good application performance, which meets the demand of the pharmaceutical industry for high-quality vaseline.

[0026] In summary, the present application includes at least one of the following beneficial technical effects:

[0027] 1. This application realizes precise control of the consistency of pharmaceutical-grade vaseline by connecting the hydrogenation refining process and consistency regulation in series, and by using a new type of refining catalyst and product regulator, thereby improving the purity and quality stability of vaseline and making it have excellent stability and use effect.

[0028] 2. Through the product regulator developed in this application, the consistency of pharmaceutical grade vaseline can be adjusted within a certain range, thereby preparing pharmaceutical grade vaseline with different dropping points and cone penetrations to meet the needs of different pharmaceutical products. This production flexibility makes this application have broad application prospects in the pharmaceutical industry. DETAILED DESCRIPTION

[0029] In order to better illustrate the purpose, technical solutions and advantages of the present invention, the present invention will be further described below in conjunction with specific embodiments.

[0030] Preparation Example 1

[0031] A product adjuster, which is different from Preparation Example 1 in that it includes 1 kg of gelatin, 1 kg of microcrystalline cellulose, 0.75 kg of sucrose stearate and 0.25 kg of lanolin alcohol.

[0032] The preparation method of the product regulator is as follows:

[0033] Heat gelatin to 75°C, add microcrystalline cellulose, lanolin alcohol and sucrose stearate, and stir until mixed evenly to obtain a product adjuster.

[0034] Among them, gelatin is medical grade gelatin purchased from Shandong Zhenhao Biotechnology Co., Ltd.

[0035] Among them, microcrystalline cellulose is medical grade microcrystalline cellulose purchased from Shanxi Jinyang Pharmaceutical Excipients Co., Ltd.

[0036] Among them, lanolin alcohol is medical grade lanolin alcohol purchased from Hubei Rishengchang New Material Technology Co., Ltd.

[0037] Among them, sucrose stearate is pharmaceutical grade sucrose stearate purchased from Shaanxi Yangyuanshen Biotechnology Co., Ltd.

[0038] Preparation Example 2

[0039] A product adjuster, which is different from Preparation Example 1 in that it includes 1 kg of gelatin, 1.2 kg of microcrystalline cellulose, 0.8 kg of sucrose stearate and 0.1 kg of lanolin alcohol.

[0040] The preparation method of the product regulator is as follows:

[0041] Heat gelatin to 80°C, add microcrystalline cellulose, lanolin alcohol and sucrose stearate, and stir until mixed evenly to obtain a product adjuster.

[0042] Preparation Example 3

[0043] A product adjuster comprises 1 kg of gelatin, 1.2 kg of microcrystalline cellulose, 0.5 kg of sucrose stearate and 0.5 kg of lanolin alcohol.

[0044] The preparation method of the product regulator is as follows:

[0045] Heat gelatin to 65°C, add microcrystalline cellulose, lanolin alcohol and sucrose stearate, and stir until mixed evenly to obtain a product adjuster.

[0046] Comparative Preparation Example 1

[0047] A product adjuster, which is different from Preparation Example 1 in that an equal amount of gelatin is replaced by agar.

[0048] Comparative Preparation Example 2

[0049] A product regulator, which is different from Preparation Example 1 in that an equal amount of microcrystalline cellulose is replaced by hydroxypropyl methylcellulose.

[0050] Comparative Preparation Example 3

[0051] A product regulator, which is different from Preparation Example 1 in that sucrose stearate is replaced by glyceryl monostearate in an equal amount.

[0052] Comparative Preparation Example 4

[0053] A product adjuster, which is different from Preparation Example 1 in that lanolin alcohol is replaced by lanolin in an equal amount.

[0054] Example 1

[0055] A pharmaceutical grade vaseline, the preparation method comprising the following steps:

[0056] Step 1, hydrofining: petroleum lubricating oil and petroleum wax paste are mixed evenly at a mass ratio of 70:30, then mixed with hydrogen, and passed through the first stage catalyst bed filled with a refined catalyst to complete the desulfurization, denitrification and deoxygenation reactions. The operating conditions are: reaction temperature 360°C, reaction pressure 16MPa, volume space velocity 0.5h -1 , hydrogen-oil volume ratio 1:400; then the vaseline that has completed the first stage of reaction is passed through the second stage catalyst bed filled with refined catalyst to complete the vaseline refining process for removing polycyclic aromatic hydrocarbons. The operating conditions are: reaction temperature 240℃, reaction pressure 12MPa, volume space velocity 0.1h -1 , hydrogen to oil volume ratio 1:800.

[0057] Step 2: Degassing and deodorizing: Separate the gas and liquid of the vaseline obtained in step 1 and deodorize it in vacuum.

[0058] Step 3, product adjustment: cool the vaseline obtained in step 2 to 75°C, add an appropriate amount of product adjuster, and stir until uniform;

[0059] Step 4: The vaseline obtained in step 3 is filtered through three stages to obtain medical grade vaseline.

[0060] The refined catalyst was purchased from Liaoning Haitai Technology Development Co., Ltd., the active metal components are composed of W, Co, Mo, and Ni, and the carrier is Al2O3.

[0061] Among them, the third-level filtration filters out impurities in vaseline with a particle size larger than 0.05μm.

[0062] Wherein, the product regulator comes from Preparation Example 1.

[0063] Among them, under different addition amounts of the product regulator of Preparation Example 1 (measured in terms of mass percentage of pharmaceutical grade vaseline), the test results of the dropping point and cone penetration (25°C) of the pharmaceutical grade vaseline of Example 1 are shown in Table 1:

[0064] Table 1:

[0065]

[0066] Among them, when the addition amount of the product adjuster in Preparation Example 1 (measured as a percentage by mass of pharmaceutical grade vaseline) is fixed at 2%, the various test indicators of the pharmaceutical grade vaseline in Example 1 are shown in Table 2, and the test execution standard is the 2020 edition, Part IV of the "Chinese Pharmacopoeia".

[0067] Table 2:

[0068]

[0069] Example 2

[0070] A pharmaceutical grade vaseline, which differs from Example 1 in that a product regulator comes from Preparation Example 2, and the added amount of the product regulator (based on the mass percentage of the pharmaceutical grade vaseline) is 2%.

[0071] Example 3

[0072] A pharmaceutical grade vaseline, which is different from Example 1 in that a product regulator comes from Preparation Example 3, and the added amount of the product regulator (based on the mass percentage of the pharmaceutical grade vaseline) is 2%.

[0073] Example 4

[0074] A pharmaceutical grade vaseline, which differs from Example 1 in that a product regulator comes from Comparative Preparation Example 1, and the added amount of the product regulator (based on the mass percentage of the pharmaceutical grade vaseline) is 2%.

[0075] Example 5

[0076] A pharmaceutical grade vaseline, which differs from Example 1 in that a product regulator comes from Comparative Preparation Example 2, and the added amount of the product regulator (based on the mass percentage of the pharmaceutical grade vaseline) is 2%.

[0077] Example 6

[0078] A pharmaceutical grade vaseline, which differs from Example 1 in that a product regulator comes from Comparative Preparation Example 3, and the added amount of the product regulator (based on the mass percentage of the pharmaceutical grade vaseline) is 2%.

[0079] Example 7

[0080] A pharmaceutical grade vaseline, which differs from Example 1 in that a product regulator comes from Comparative Preparation Example 4, and the added amount of the product regulator (based on the mass percentage of the pharmaceutical grade vaseline) is 2%.

[0081] Detection 1

[0082] The dropping point and cone penetration (25° C.) of the pharmaceutical grade vaseline of Examples 1-7 were tested respectively. The test results are shown in Table 3.

[0083] Table 3:

[0084]

[0085] Sensory Testing 2

[0086] A review group consisting of quality inspectors with more than 2 years of experience in vaseline quality control was selected to discuss and evaluate the use experience of the pharmaceutical-grade vaselines of Examples 1-7 above. The evaluation results are shown in Table 4.

[0087] Table 4:

[0088]

[0089]

[0090] Combining the analysis of Examples 1-7 and Tables 3 and 4, it is not difficult to see that Examples 1-3 have good dropping points, cone penetration and skin feel, that is, Examples 1-3 have good consistency and skin feel adjustment effects, that is, the product regulator compounded by gelatin, microcrystalline cellulose, sucrose stearate and lanolin alcohol in this application has particularity. Such a product regulator can construct a more stable internal structure of vaseline, can further improve the consistency of vaseline, and improve the stickiness and stuffiness of vaseline, thereby significantly improving the use performance of vaseline, making the vaseline prepared in this application more suitable for the pharmaceutical industry.

[0091] Combining the analysis of Example 1 and Table 1, it is not difficult to see that the product regulator of the present application can adjust the consistency of vaseline within a certain range when the addition amount is within the range of 0.5% to 5%. It can be seen that the product regulator of the present application can achieve effective and significant regulation of the consistency of vaseline, thereby improving the performance of vaseline.

[0092] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make modifications to the present embodiment without any creative contribution as needed, but such modifications are protected by the patent law as long as they are within the scope of the claims of the present application.

Claims

1. A method for preparing pharmaceutical grade vaseline, characterized in that: The following steps are involved: Step 1, hydrogenation refining: mixing the basic raw materials for preparing vaseline, and refining them by using a series hydrogenation refining process; Step 2: Degassing and deodorizing: Separate the gas and liquid of the vaseline obtained in step 1, and deodorize it in vacuum; Step 3, product adjustment: cool the vaseline obtained in step 2 to 70-80°C, add an appropriate amount of a product adjuster consisting of gelatin, microcrystalline cellulose, sucrose stearate and lanolin alcohol, wherein the mass ratio of the gelatin, microcrystalline cellulose, sucrose stearate and lanolin alcohol is 1: (0.8-1.2): (0.5-0.8): (0.1-0.5); The preparation method of the product regulator is as follows: heating gelatin to 65-80° C., adding microcrystalline cellulose, lanolin alcohol and sucrose stearate, and stirring until the mixture is uniform to obtain the product regulator.

2. The method for preparing pharmaceutical grade vaseline according to claim 1, wherein: The tandem hydrogenation refining process of step 1 refers to mixing the basic raw material of vaseline with hydrogen, passing it through a first-stage catalyst bed filled with a refining catalyst to complete desulfurization, denitrogenation and deoxygenation reactions, and then passing the vaseline that has completed the first-stage reaction through a second-stage catalyst bed filled with a refining catalyst to complete the vaseline refining process for removing polycyclic aromatic hydrocarbons.

3. A method for preparing pharmaceutical grade vaseline according to claim 2, characterized in that, The first stage operating conditions are: reaction temperature 320~360℃, reaction pressure 12~16MPa, volume space velocity 0.1~0.5h -1 , hydrogen-oil volume ratio 1: (400~800); the second stage operating conditions are: reaction temperature 200~280℃, reaction pressure 12~16MPa, volume space velocity 0.1~0.5h -1 , hydrogen to oil volume ratio 1: (400~800).

4. The method for preparing pharmaceutical grade vaseline according to claim 1, wherein: The basic raw materials for preparing vaseline in step 1 include petroleum lubricating oil and petroleum wax paste, and the mass ratio of the petroleum lubricating oil to the petroleum wax paste is (60-80): (20-30).

5. The method for preparing pharmaceutical grade vaseline according to claim 1, wherein: The amount of the product regulator added in step 3 is 0.5% to 5% of the mass percentage of vaseline.

6. A pharmaceutical grade vaseline, characterized in that: The pharmaceutical grade vaseline is prepared by the preparation method of any one of claims 1 to 5.

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