Eye health-care liquid based on cortex berberidis and saffron crocus extract and preparation method of eye health-care liquid

Abstract

The invention discloses eye health care liquid based on cortex berberidis and saffron crocus extracts and a preparation method of the eye health care liquid, and relates to the technical field of traditional Chinese medicine preparations and eye health care, in particular to the eye health care liquid based on the cortex berberidis and saffron crocus extracts and the preparation method of the eye health care liquid. According to the eye health-care liquid, a cortex berberidis extract and a saffron crocus extract are used as main active ingredients, a fructus lycii extract, a radix stemonae extract, a mint extract, a honeysuckle flower extract and other functional ingredients are used as auxiliary ingredients, and sodium hyaluronate, taurine and vitamin B6 are added to enhance the moisturizing, anti-oxidation and metabolic regulation effects. The preparation method comprises the steps of raw material extraction, extract concentration, auxiliary material mixing and pH adjustment, filtration and sterilization and the like. The product is suitable for eye atomization application, has the effects of relieving eye inflammation, improving microcirculation, relieving dryness, redness and swelling and the like, meanwhile strictly controls heavy metal and microbiological indexes, and guarantees use safety.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparations and eye health care technology, specifically to an eye care solution based on extracts of berberis bark and saffron and its preparation method. Background Technology

[0002] With the fast pace of modern life and the widespread use of electronic display devices, people's work and entertainment habits have changed significantly, leading to unprecedented pressure on the visual system. Prolonged exposure to computer screens, mobile phones, and other electronic devices not only easily triggers eye strain syndrome but also frequently causes discomfort such as dry eye, eye strain, photophobia, and tearing. According to relevant clinical observations, reduced tear secretion, meibomian gland dysfunction, and ocular surface microenvironment imbalance caused by excessive eye use have become one of the major public health problems affecting public eye health.

[0003] Currently, eye drops for eye discomfort on the market are mainly divided into two categories: chemically synthesized eye drops and traditional Chinese medicine eye drops. While chemically synthesized eye drops are fast-acting, they often contain preservatives (such as benzalkonium chloride) or vasoconstrictors. Long-term use can easily lead to drug dependence, rebound congestion, and even damage to the corneal epithelium, disrupting the normal physiological structure of the ocular surface. Traditional Chinese medicine eye drops, although offering improved safety, often suffer from low dissolution rates of active ingredients, limited target sites, and unpleasant taste or feel in actual use.

[0004] Specifically, current technologies for treating eye inflammation often focus on a single anti-inflammatory approach, neglecting the improvement of microcirculation. For relieving dry eyes, most products only provide physical hydration, lacking fundamental nourishment and conditioning to address liver and kidney deficiency. Furthermore, the eyes are an extremely sensitive organ, placing extremely high demands on the osmotic pressure, pH stability, and preservative system of products. Many existing formulas fail to adequately consider the synergistic effects of multiple active ingredients, resulting in a difficulty in simultaneously achieving antibacterial effects, cooling comfort, and long-lasting moisturizing.

[0005] Therefore, developing a multifunctional eye care solution that can quickly relieve acute symptoms such as redness, swelling, and itching of the eyes, fundamentally improve the microcirculation and nutrient supply of the eyes by nourishing the liver and kidneys, and is also mild and non-irritating, is a technical challenge that urgently needs to be solved in the field of eye health product development. Summary of the Invention

[0006] The purpose of this invention is to provide an eye care solution based on barley bark and saffron extracts and its preparation method. By optimizing the extraction and preparation process, the invention solves the problems of existing products having limited functions and strong irritation, and achieves the goal of safely and effectively relieving discomfort symptoms such as eye inflammation, dryness, redness and swelling.

[0007] To achieve the above objectives, the present invention provides the following technical solution: an eye care solution based on barley bark and saffron extracts and its preparation method. The eye care solution is a topical preparation, and its main active ingredients are derived from extracts from natural plants. The eye care solution contains barley bark extract and saffron extract as the main active ingredients, and the mass ratio of the two in the compound system is strictly controlled at 5:3. This formulation system aims to achieve the dual effects of relieving ocular inflammation and improving ocular microcirculation disorders through the synergistic effect of the two core ingredients.

[0008] Furthermore, the berberine extract is rich in alkaloid active ingredients, among which the content of berberine needs to be quantitatively controlled to ensure that it is within the physiological activity threshold range that can effectively exert anti-inflammatory and antibacterial effects; at the same time, the content setting also needs to meet the safety requirements of ocular topical preparations to ensure that there is no irritation or toxic side effects at the prescribed dosage.

[0009] Furthermore, the eye care solution also contains wolfberry extract and stemona extract as auxiliary functional ingredients; wolfberry extract nourishes the yin of the liver and kidneys, provides necessary antioxidant support for the eyes and enhances nutrient supply, while stemona extract uses its natural properties to inhibit the growth and reproduction of bacteria and fungi, thereby reducing the risk of secondary eye infections in the formula system.

[0010] Furthermore, the eye care solution also contains peppermint extract and honeysuckle extract; peppermint extract is used to give the product a cooling sensation and provide an immediate anti-itch and soothing experience, while honeysuckle extract is used to assist in exerting the effects of clearing heat and detoxifying, as well as anti-inflammatory and swelling-reducing, to relieve eye discomfort symptoms.

[0011] Furthermore, the eye care solution also contains pharmaceutically acceptable excipients, specifically sodium hyaluronate, taurine, and vitamin B6; wherein, sodium hyaluronate plays a physical role in moisturizing and lubricating the conjunctiva and corneal surface of the eye in the matrix, taurine participates in maintaining the osmotic pressure balance of eye cells and works with other active ingredients to maintain the normal physiological function of the eye, and vitamin B6 participates in regulating the energy metabolism process of eye tissues.

[0012] Furthermore, the preparation method includes a water extraction process for barley bark and saffron, with specific process parameters as follows: the extraction temperature is controlled at 90°C, the extraction time is 2 hours, and the solvent used is purified water at 10 times the weight of the medicinal materials.

[0013] Furthermore, after the water extraction process is completed, the obtained extract needs to be concentrated to concentrate the relative density of the extract to 1.10-1.15 (measured under standard conditions); then, the concentrated extract is mixed with the pre-dissolved excipient solution, and the pH of the entire system is adjusted to the range of 6.5-7.0 by an acid-base adjuster to adapt to the physiological environment of the eye.

[0014] Furthermore, before the liquid medicine is filled and sealed, a fine filtration and terminal sterilization process must be performed; the sterilization process adopts a 100°C flowing steam sterilization method, and the action time lasts for 15 minutes to ensure that the microbial limits of the product meet the regulations.

[0015] Furthermore, the eye care solution is administered via external atomization, acting directly on the ocular mucosa; the recommended frequency of use is 2 to 3 times daily, to prevent and relieve symptoms of dry eyes, redness, and blurred vision caused by eye strain or environmental factors.

[0016] Furthermore, the finished eye care solution must meet specific safety and quality standards, including heavy metal limits: lead (Pb) content ≤ 0.089 mg / kg, arsenic (As) content < 0.01 mg / kg; and microbiological requirements: total bacterial count < 10 CFU / g.

[0017] This invention provides an eye care solution based on barley bark and saffron extracts and its preparation method, which has the following beneficial effects: 1. This eye care solution uses a scientifically formulated blend of berberine extract (rich in berberine) and saffron extract in a 5:3 ratio to achieve dual effects of anti-inflammation and improved microcirculation. Berberine, a natural alkaloid, has significant anti-inflammatory and antibacterial properties, effectively combating eye inflammation. Saffron extract, on the other hand, excels at promoting blood circulation and removing blood stasis, effectively increasing the dilation of capillaries and blood flow in the eyes, thereby improving blood supply to the retina and ciliary body. This combination of "anti-inflammatory + blood-activating" not only targets surface symptoms such as redness and swelling, but also addresses the root cause of eye fatigue caused by ischemia and hypoxia, providing both symptomatic relief and a cure for soreness and pain caused by prolonged eye strain.

[0018] The formula incorporates extracts of Stemona japonica and Lonicera japonica, forming a powerful plant-based antibacterial matrix with Berberis vulgaris. Stemona japonica extract is renowned for its exceptional antibacterial and antifungal properties, effectively reducing the risk of conjunctivitis and keratitis caused by bacterial infections. Lonicera japonica extract possesses both anti-inflammatory and detoxifying properties, neutralizing the harmful effects of external heat toxins on the eyes. Furthermore, by strictly controlling the berberine content within safe and effective thresholds, and adhering to stringent limits for heavy metals (lead, arsenic) and microbial indicators, the product ensures that it exerts a powerful antibacterial effect without causing irritation or damage to the cornea or conjunctiva, achieving a perfect balance between high efficacy and safety.

[0019] To address the shortcomings of traditional eye drops that only focus on treating the symptoms, this product innovatively incorporates goji berry extract, taurine, and vitamin B6. Goji berry extract, rich in polysaccharides and carotene, nourishes the liver and kidneys, replenishes essential trace elements for the eyes, and fundamentally improves eye fatigue. Taurine, an important amino acid in the retina, works synergistically to maintain the normal function of photoreceptor cells. Vitamin B6 focuses on regulating eye metabolism and accelerating the removal of waste products from the eyes. This combination not only provides immediate nutritional support but also enhances the eyes' self-repair capabilities and resistance by regulating physiological functions, making it suitable for daily care for people who spend long hours in front of electronic screens.

[0020] Recognizing the importance of "comfort" in eye care products, this manufacturing process incorporates peppermint extract and sodium hyaluronate. The cooling sensation of peppermint extract quickly reaches nerve endings, effectively relieving itching and the feeling of something in the eye, providing an immediate refreshing experience. Sodium hyaluronate, as a highly effective natural moisturizing factor, forms a breathable, water-retaining film on the eye surface, locking in moisture and combating dryness. This "cooling + hydrating" physical experience greatly enhances the user's enjoyment during use, making consistent use easier and ensuring the product's long-term effects in preventing vision loss and relieving eye strain.

[0021] This product uses a 90℃, 2-hour water extraction process, combined with 10 times the volume of purified water. This ensures maximum dissolution of the heat-sensitive active ingredients in berberine and saffron while avoiding damage to plant proteins caused by prolonged high temperatures. Subsequent concentration to a specific relative density (1.10-1.15) and pH adjustment to a slightly acidic level (6.5-7.0) further refines it, closely resembling the physiological environment of human tears and reducing irritation. Finally, it undergoes 100℃ flowing steam sterilization and precision filtration, thoroughly eliminating potential pathogens and removing impurities, ensuring that every drop of eye drops is pure and sterile. This standardized production process maximizes the preservation of the raw materials' bioactivity, ensuring stable and controllable product quality and giving consumers peace of mind. Detailed Implementation

[0022] The technical solutions in the embodiments of the present invention will be clearly and completely described below. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0023] How to use: I. Product Preparation and Inspection Before using this eye care solution, please check that the product packaging is intact and that the product has not expired. If the product has been opened, please note its expiration date.

[0024] II. Applicable Symptoms and Population This eye care solution is suitable for relieving discomfort symptoms such as dryness, redness, and blurred vision caused by excessive eye use or environmental irritants, as well as for maintaining daily eye health.

[0025] III. Usage Method 1. Clean hands: Wash hands thoroughly with running water and soap before use to avoid contaminating the eyes or the product with bacteria from your hands.

[0026] Choose an environment: Select a well-lit, quiet, and comfortable environment for operation, and avoid direct wind blowing into your eyes.

[0027] Preparation position: You can sit or lie on your back with your head tilted back slightly. Use one hand to gently pull open the lower eyelid to form the conjunctival sac.

[0028] Nebulized application: Position the bottle opening of this eye care solution at the conjunctival sac (the gap between the lower eyelid and the eyeball) at the inner edge of the lower eyelid, maintaining an appropriate distance (specific distance may vary depending on the product instructions or the actual droplet size, usually a few centimeters).

[0029] Frequency and duration control: Use 2-3 times daily as per product instructions. Each time, spray the atomized health care solution evenly into the conjunctival sac, generally 1-2 sprays per eye. The specific amount can be adjusted according to individual feelings and product characteristics, but it is recommended to follow the recommended dosage.

[0030] Rest with eyes closed: After spraying, gently close your eyes and gently press the inner corner of your eye (lacrimal sac area) with your fingers for 1-2 minutes to reduce medication loss through the nasolacrimal duct and help the medication be evenly distributed and absorbed on the ocular surface. Afterward, let your eyes rest naturally for a while and avoid opening or rubbing them immediately.

[0031] IV. Precautions for use 1. Avoid contact with the bottle opening: Do not allow the bottle opening to come into direct contact with your eyes, eyelashes or other parts of your body to prevent contamination.

[0032] Special populations: If you are using other eye drops, it is recommended to consult a professional before use and pay attention to the interval between applications. Pregnant women, breastfeeding women, children, and people with allergies should use under the guidance of a doctor.

[0033] Adverse reactions: If you experience stinging, itching, increased redness and swelling in your eyes or other discomfort during use, you should stop using the product immediately and seek medical attention promptly.

[0034] Storage method: Please store the product in a cool, dry place, away from direct sunlight and high temperatures. Use within the specified time after opening, and ensure it is sealed tightly.

[0035] Product characteristics: Do not use the product if you find any abnormalities such as odor, discoloration, or turbidity.

[0036] V. Daily Eye Care Recommendations To better protect eye health, it is recommended to combine the following measures: Pay attention to eye hygiene, avoid prolonged close-range use of your eyes, and take breaks to look into the distance to relax your eyes every now and then.

[0037] Maintain appropriate indoor humidity and avoid direct airflow from air conditioners or heaters into your eyes.

[0038] Ensure sufficient sleep, maintain a balanced diet, and consume plenty of foods rich in vitamins and minerals.

[0039] Wear sunglasses when going out to reduce the damage of ultraviolet rays to your eyes.

[0040] Example: Example 1: Preparation of Basic Formula Eye Care Solution This embodiment demonstrates a basic formula and preparation process for an eye care solution based on barley bark and saffron extracts. The formula strictly adheres to the proportioning principles of the main active ingredients, aiming to fully leverage the synergistic effects of the core medicinal materials.

[0041] First, high-quality berberine bark and saffron are selected as starting materials. They are weighed according to a specific mass ratio to ensure that the content of both in the final product meets the design requirements. Then, a water extraction process is used. The weighed berberine bark and saffron are placed together in an extraction tank, and purified water of a specified ratio is added as a solvent. The extraction temperature and time are set, and reflux extraction is performed. The purpose of this step is to fully extract the effective components from the medicinal materials, especially berberine from berberine bark and the blood-activating components from saffron. After extraction, the residue is removed by filtration to obtain a crude extract.

[0042] Next comes the concentration stage. The crude extract is concentrated under reduced pressure to form a paste with a specific density. This step not only removes excess water and increases the concentration of the active ingredients, but also improves the stability of subsequent formulations. After the concentrated paste is cooled to room temperature, appropriate excipients are added for dissolution and dilution to prepare the base solution for the eye care solution. During this process, the pH of the solution needs to be precisely adjusted to maintain it within a suitable range to ensure the product's gentleness and minimal irritation to the eyes.

[0043] Finally, the prepared solution is filtered and clarified to remove any possible minute impurities. It is then filled and subjected to rigorous sterilization to ensure that the product's microbiological indicators meet requirements. After sterilization, it is packaged to obtain the basic formula eye care solution of this invention. The product obtained in this embodiment is mainly used to relieve eye inflammation and improve microcirculation.

[0044] Example 2: Preparation of Compound Nourishing Eye Care Solution This embodiment, based on the basic formula, further adds excipients with liver and kidney nourishing and antioxidant functions to prepare a compound nourishing eye care solution. This formula not only retains the original anti-inflammatory and circulation-improving effects but also enhances the nutritional supply to the eyes.

[0045] The preparation process begins with the acquisition of the base extracts, namely, the preparation of barley bark and saffron extracts according to the method in Example 1. Based on this, wolfberry extract and stemona root extract are introduced as new functional components. Wolfberry extract is rich in various amino acids and trace elements, which can provide essential nutrients for eye cells; while stemona root extract has good biological activity and can inhibit the growth of bacteria and fungi. These two extracts are added to the base extract in predetermined proportions.

[0046] Next, add appropriate amounts of solvent and excipients to the mixture and stir to dissolve. During this step, pH adjustment is also necessary to ensure the stability of the entire system. To further enhance the overall performance of the product, some auxiliary ingredients, such as peppermint extract with a cooling sensation, can be selectively added to provide an immediate soothing experience. After all ingredients are thoroughly mixed, filter to remove insoluble particles and ensure the clarity of the solution.

[0047] The filtered medication is then conveyed to the filling process, where it is dispensed under sterile conditions. After filling, the product undergoes a specific sterilization process to kill any potentially harmful microorganisms and ensure safe use. The eye care solution prepared in this embodiment, due to the addition of ingredients such as goji berries and stemona root, is particularly suitable for people who need to use their eyes for extended periods, experience severe eye strain, or wish to improve their eye nutrition. It can relieve inflammation while providing deep nourishment and protection.

[0048] Example 3: Preparation of Cooling and Soothing Eye Drops This embodiment focuses on improving the user experience of eye care solution by adding ingredients with cooling, antipruritic, and anti-inflammatory effects to create a cooling and soothing product that provides immediate comfort.

[0049] The preparation process begins with the preparation of the core extracts, namely concentrated extracts of barley bark and saffron. Based on this, peppermint extract and honeysuckle extract are added. Peppermint extract provides a significant cooling sensation, effectively relieving eye itching and burning; honeysuckle extract has heat-clearing, detoxifying, and anti-inflammatory properties, enhancing the overall efficacy of the product. These two extracts are then mixed with the base extract in a specific ratio.

[0050] During the mixing process, appropriate solvents and additives need to be added to ensure complete dissolution of all components. At this point, the physicochemical properties of the solution (such as viscosity and pH value) need to be carefully controlled to ensure both good spreadability and no eye irritation. To increase the product's moisturizing effect, the addition of appropriate amounts of high-molecular-weight moisturizers such as sodium hyaluronate can also be considered.

[0051] After the solution is prepared, it must undergo precise filtration to ensure product purity. Then, it enters the filling stage, where the solution is quantitatively filled into specialized containers. To prevent microbial contamination, the product must be sterilized immediately after filling. The sterilization conditions are designed to maximize the preservation of the activity of heat-sensitive active ingredients while ensuring that sterility levels are met. The final product is a cooling and soothing eye drop with a clear appearance and refreshing scent, suitable for the rapid relief of discomfort such as redness, dryness, and itching in the eyes.

[0052] Example 4: Preparation of a Multifunctional Nutritionally Fortified Eye Care Solution This embodiment aims to develop a multifunctional, nutritionally enhanced eye care solution that integrates moisturizing, nutritional metabolism regulation, and other functions by compounding various functional excipients. While meeting basic anti-inflammatory needs, this product places greater emphasis on maintaining the ocular microenvironment and regulating physiological functions.

[0053] In terms of preparation method, the core extracts of berberine bark and saffron are first obtained. Then, key excipients such as sodium hyaluronate, taurine, and vitamin B6 are compounded on this basis. Sodium hyaluronate, as a highly effective moisturizing factor, can form a breathable moisturizing film on the surface of the eyes to lock in moisture; taurine is an important amino acid in the retina, which helps maintain the normal function of eye cells; and vitamin B6 plays an important role in regulating eye metabolism. These excipients are added sequentially to the solution containing the core extracts and thoroughly stirred to emulsify or dissolve.

[0054] To ensure uniform distribution and long-term stability of various components in the solution, small amounts of thickeners or stabilizers may need to be added, and homogenization treatment may be used to improve the system's stability. During this process, the pH and osmotic pressure of the solution are also critical control parameters, and must be adjusted to a range close to that of human tears to ensure user comfort. After passing testing, the solution undergoes multi-stage filtration to remove any potential particulate impurities.

[0055] Finally, the product is filled and sealed in a GMP-compliant cleanroom. After filling, terminal sterilization is required to ensure that its hygienic indicators meet the regulations. The eye care solution prepared in this embodiment is particularly suitable for use in dry environments or after prolonged use of electronic devices, effectively replenishing the nutrients and moisture lost from the eyes and maintaining their health.

[0056] Example 5: Preparation of eye care solution under specific processes and quality control This embodiment details the entire process of preparing a high-quality eye care solution under strict control of process parameters and quality standards. The process covers every key step from raw material extraction to finished product inspection, ensuring the safety and effectiveness of the product.

[0057] First, weigh the bark of berberis and the saffron according to the specified mass ratio. Extraction is performed using water extraction, with strict control over the extraction temperature, time, and amount of water added to ensure the full dissolution of the active ingredients. After filtration, the extract is concentrated under reduced pressure to adjust the relative density of the extract to the specified range. This step is crucial for improving the content of active ingredients and the stability of the formulation. The concentrated extract is then mixed with various pre-prepared excipients (such as wolfberry, stemona root, peppermint, honeysuckle, sodium hyaluronate, taurine, vitamin B6, etc., selected according to the specific formula).

[0058] During the mixing process, high-purity solvents must be used, and the pH of the solution must be precisely adjusted to the ideal range of slightly acidic to neutral to minimize irritation to the ocular surface. After thorough mixing, the solution must be filtered through a 0.22-micron microporous membrane for sterilization to remove bacteria and pyrogens. The filtered solution is then immediately filled under aseptic conditions to prevent secondary contamination.

[0059] Once filled, the products immediately enter a sterilization process, where they are treated under specific sterilization conditions to thoroughly kill any microorganisms. After sterilization, the products undergo visual inspection to remove any leaking or damaged items. Finally, the finished products undergo comprehensive quality testing, including but not limited to pH value, relative density, active ingredient content, heavy metal limits (such as lead and arsenic), and microbial limits (such as total bacterial count). Only products that meet all preset standards can be accepted into the warehouse or shipped as qualified products. This embodiment demonstrates the advantages of this invention in terms of process rigor and quality control.

[0060] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. An eye care solution based on barley bark and saffron extracts and its preparation method, characterized in that: It contains berberine bark extract and saffron extract as the main active ingredients, with a mass ratio of 5:3, and is used to relieve eye inflammation and improve microcirculation.

2. The eye care solution based on barley bark and saffron extract and its preparation method according to claim 1, characterized in that: The berberine extract contains berberine, and its content must reach an effective concentration for anti-inflammatory and antibacterial effects to ensure product safety.

3. The eye care solution based on barley bark and saffron extract according to claim 1, and its preparation method, characterized in that: It also contains wolfberry extract and stemona extract, which nourish the liver and kidneys and provide antioxidant support, enhancing the nutritional supply to the eyes. The stemona extract is used to inhibit the growth of bacteria and fungi and reduce the risk of eye infections.

4. The eye care solution based on barley bark and saffron extract and its preparation method according to claim 1, characterized in that: It also contains peppermint extract and honeysuckle extract to provide a cooling and anti-itch sensation and instantly soothe eye discomfort. The honeysuckle extract also helps to exert anti-inflammatory and heat-clearing effects.

5. The eye care solution based on barley bark and saffron extract according to claim 1, and its preparation method, characterized in that: It also contains sodium hyaluronate, taurine, and vitamin B6. Sodium hyaluronate plays a role in moisturizing and lubricating eye tissues in eye care solutions. Taurine can work synergistically with other ingredients to maintain normal physiological functions of the eyes. Vitamin B6 helps regulate eye metabolism.

6. An eye care solution based on barley bark and saffron extracts and its preparation method according to claims 1-5, characterized in that: The process includes water extraction of barley bark and saffron, with an extraction temperature of 90℃, an extraction time of 2 hours, and a solvent of 10 times the volume of purified water.

7. An eye care solution based on barley bark and saffron extracts according to claim 6, characterized in that: After extraction, the extract needs to be concentrated to a relative density of 1.10-1.15 and mixed with excipients to adjust the pH to 6.5-7.

0.

8. An eye care solution based on barley bark and saffron extract according to claim 6, and its preparation method thereof, characterized in that: Before filling, the product needs to be filtered and sterilized. The sterilization conditions are 100°C and flowing steam for 15 minutes.

9. An eye care solution based on barley bark and saffron extracts according to claim 1, and its preparation method thereof, characterized in that: Apply externally to the eyes in the form of a nebulizer, 2-3 times daily, to prevent and relieve dryness, redness, and blurred vision.

10. An eye care solution based on barley bark and saffron extract according to claim 1, and its preparation method, characterized in that: It meets the requirements of heavy metal content of lead ≤0.089mg / kg, arsenic <0.01mg / kg, and total bacterial count <10CFU / g.